Statins may improve PCa outcomes

Transcription

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Since 2001
*Source: Kantar Media
®
UrologyTimes.com
The Leading News Source for Urologists
APRIL 15, 2015
VOL. 43, NO. 5
Time toHelp
disease progression
make
longer than in non-statin group
it easier
for patients
to get the
Urologic Care
they need
Wayne Kuznar
TTP in men on ADT:
Statin users vs. nonusers
UT CORRESPONDENT
hormone-sensitive prostate cancer, and one possible
mechanism responsible may have been discovered.
Two retrospective studies presented at the Genitourinary Cancers Symposium in Orlando, FL showed
an increase in the time to disease progression (TTP)
in users of statins who initiated androgen deprivation therapy (ADT), and one of the two studies also
showed improved overall and prostate cancer-specific
survival in statin users treated with ADT following
primary or salvage radiation therapy. A third study
found that lethal prostate cancers have potentially
lower cholesterol uptake.
Among 1,364 men with PSA levels >3.0 ng/mL
Please see STATINS, page 46
Inside
APRIL 15, 2015
■
VOL. 43, NO. 5
MEN TAKING STATINS
MEN NOT TAKING STATINS
0
5
10
15
17.4
MONTHS
20
25
30
Median time to progression on ADT
(months)
Source: Lauren Harshman, MD
12 t h A nn ua l Stat e of Urolo g y
Our experts’ top picks for AUA 2015
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Sexual Dysfunction
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are you heard about (and
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03.24.2015
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labeling update for approved testosterone
The AUA meeting is massive in scope, as shown with everyproducts. Look for further discussion on TRT
thing from the exhibitors’ elaborate booths to the phone-bookat this year’s meeting; the topic is the subject
sized collection of abstracts produced every year. With so much
of this year’s “AUA Town Hall,” moderated by
research being presented, the task of choosing which presentaGregory A. Broderick, MD, Ajay K. Nangia, MD,
tions to catch can be daunting. To help you maximize your AUA
and Ridwan Shabsigh, MD, and will also be
experience, Urology Times’ editorial board and other thought
discussed in multiple research presentations.
leaders have pored over hundreds of abstracts to identify the
CONTENT MANAGING EDITOR
19 Are
Image: Getty images/ Science Photo Library
27.5
MONTHS
Orlando, FL —Statins may improve outcomes in
key trends and can’t-miss research from this year’s meeting.
Please see STATE OF UROLOGY, page 48
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UrologyTimes.com
APRIL 15, 2015
VOL. 43, NO. 5
*
With
special
financing
options
Time to disease progression
fromgroup
CareCredit
longer than in non-statin
TTP in men on ADT:
Wayne Kuznar
High out-of-pocket costs, including insurance deductibles and co-pays, can make it
UT CORRESPONDENT
difficult for patients to move forward with Urologic treatment. Accept the CareCredit
27.5
Orlando, FL —Statins may improve
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Two retrospective studies presented
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an increase in the time to disease progression
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Inside
APRIL 15, 2015
■
VOL. 43, NO. 5
Clinical Updates
8 Robotic,
open RP:
Outcomes from
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Sexual Dysfunction
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gathering attests.
therapy and cardiovascular risk, which culAs always, this year’s meeting promises a rich assortment of
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cyan
yellow B u s i n e s s o f U r o l o g y
black
24 IPAs: Joining forces to
The AUA meeting is massive in scope, as shown with everyproducts. Look for further discussion on TRT
retain independence
thing from the exhibitors’ elaborate booths to the phone-bookat this year’s meeting; the topic is the subject
sized collection of abstracts produced every year. With so much
research being presented, the task of choosing which presentaN ew P r o d u c t s & S e r v i c e s
Gregory A. Broderick, MD, Ajay K. Nangia, MD,
tions to catch can be daunting. To help you maximize your AUA
44 Take a look at what
these AUA 2015
with
Readers*
Since 2001
®
UrologyTimes.com
APRIL 15, 2015
VOL. 43, NO. 5
Time to disease progression
longer than in non-statin group
Wayne Kuznar
TTP in men on ADT:
UT CORRESPONDENT
Two retrospective studies presented at the Genitourinary Cancers Symposium in Orlando, FL showed
an increase in the time to disease progression (TTP)
in users of statins who initiated androgen deprivation therapy (ADT), and one of the two studies also
primary or salvage radiation therapy. A third study
Inside
APRIL 15, 2015
Q
VOL. 43, NO. 5
MEN TAKING STATINS
MEN NOT TAKING STATINS
0
5
10
15
17.4
MONTHS
20
25
30
(months)
Clinical Updates
8 Robotic,
open RP:
Outcomes from
650,000 patients
Speak Out
19 Are
you satisifed
Business of Urology
24 IPAs:
Joining forces to
retain independence
N ew P r o d u c t s & S e r v i c e s
44 Take a
look at what
these AUA 2015
27.5
MONTHS
Orlando, FL —Statins may improve outcomes in
Benjamin P. Saylor
practice setting or area of subspecialization, the AUA annual meeting
gathering attests.
As always, this year’s meeting promises a rich assortment of
clinical research as well as practical forums and courses to help
The AUA meeting is massive in scope, as shown with everything from the exhibitors’ elaborate booths to the phone-booksized collection of abstracts produced every year. With so much
research being presented, the task of choosing which presentations to catch can be daunting. To help you maximize your AUA
Sexual Dysfunction
perhaps participated in)
MD, MBA
therapy and cardiovascular risk, which culminated recently with the FDA ordering a
products. Look for further discussion on TRT
at this year’s meeting; the topic is the subject
Gregory A. Broderick, MD, Ajay K. Nangia, MD,
I
smooth sailing
FOR YOUR URETHRAL PROCEDURES
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FEATURING
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Packaging and Labeling
SM
All trademarks herein are the property of Sagent Pharmaceuticals, Inc.
PreventIV Measures is a service mark of Sagent Pharmaceuticals, Inc.
©2014 Sagent Pharmaceuticals, Inc. Printed in USA 1932
GLYDO (lidocaine HCl jelly USP, 2%)
Brief Summary of Prescribing Information
INDICATIONS AND USAGE
GLYDO (lidocaine HCl jelly USP, 2%) is indicated for prevention and control of pain in procedures involving the
male and female urethra, for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal
intubation (oral and nasal).
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction
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CONTRAINDICATIONS
Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide
type or to other components of GLYDO.
Labor and Delivery
Lidocaine is not contraindicated in labor and delivery. Should GLYDO be used concomitantly with other products
containing lidocaine, the total dose contributed by all formulations must be kept in mind.
WARNINGS
EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, CAN RESULT IN HIGH PLASMA LEVELS AND
SERIOUS ADVERSE EFFECTS. PATIENTS SHOULD BE INSTRUCTED TO STRICTLY ADHERE TO THE RECOMMENDED
DOSAGE AND ADMINISTRATION GUIDELINES AS SET FORTH IN THIS PACKAGE INSERT.
THE MANAGEMENT OF SERIOUS ADVERSE REACTIONS MAY REQUIRE THE USE OF RESUSCITATIVE EQUIPMENT,
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GLYDO should be used with extreme caution in the presence of sepsis or severely traumatized mucosa in the area of
application, since under such conditions there is the potential for rapid systemic absorption.
When used for endotracheal tube lubrication care should be taken to avoid introducing the product into the lumen
of the tube. Do not use the jelly to lubricate the endotracheal stylettes. If allowed into the inner lumen, the jelly
may dry on the inner surface leaving a residue which tends to clump with flexion, narrowing the lumen. There have
been rare reports in which this residue has caused the lumen to occlude. (See also ADVERSE REACTIONS and
DOSAGE AND ADMINISTRATION.)
Nursing Mothers
Lidocaine is secreted in human milk. The clinical significance of this observation is unknown. Caution should be
exercised when lidocaine is administered to a nursing woman.
PRECAUTIONS
General
The safety and effectiveness of lidocaine depend on proper dosage, correct technique, adequate precautions, and
readiness for emergencies. (See WARNINGS and ADVERSE REACTIONS.) The lowest dosage that results in
effective anesthesia should be used to avoid high plasma levels and serious adverse effects. Repeated doses of
lidocaine may cause significant increases in blood levels with each repeated dose because of slow accumulation
of the drug or its metabolites. Tolerance to elevated blood levels varies with the status of the patient. Debilitated,
elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their age and
physical status. Lidocaine should also be used with caution in patients with severe shock or heart block.
GLYDO should be used with caution in patients with known drug sensitivities. Patients allergic to paraaminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine.
Many drugs used during the conduct of anesthesia are considered potential triggering agents for familial malignant
hyperthermia. Since it is not known whether amide-type local anesthetics may trigger this reaction and since the
need for supplemental general anesthesia cannot be predicted in advance, it is suggested that a standard protocol
for management should be available. Early unexplained signs of tachycardia, tachypnea, labile blood pressure,
and metabolic acidosis may precede temperature elevation. Successful outcome is dependent on early diagnosis,
prompt discontinuance of the suspect triggering agent(s) and institution of treatment, including oxygen therapy,
indicated supportive measures and dantrolene (consult dantrolene sodium intravenous package insert before
using).
Information for Patients
When topical anesthetics are used in the mouth, the patient should be aware that the production of topical
anesthesia may impair swallowing and thus enhance the danger of aspiration. For this reason, food should not
be ingested for 60 minutes following use of local anesthetic preparations in the mouth or throat area. This is
particularly important in children because of their frequency of eating.
Numbness of the tongue or buccal mucosa may enhance the danger of unintentional biting trauma. Food and
chewing gum should not be taken while the mouth or throat area is anesthetized.
Carcinogenesis—Long-term studies in animals have not been performed to evaluate the carcinogenic potential of
lidocaine.
Mutagenesis—The mutagenic potential of lidocaine has been tested in the Ames Salmonella reverse mutation
assay, an in vitro chromosome aberrations assay in human lymphocytes and in an in vivo mouse micronucleus
assay. There was no indication of any mutagenic effect in these studies.
Impairment of Fertility: The effect of lidocaine on fertility was examined in the rat model.
Administration of 30 mg/kg, s.c. (180 mg/m2) to the mating pair did not produce alterations in fertility or general
reproductive performance of rats. There are no studies that examine the effect of lidocaine on sperm parameters.
There was no evidence of altered fertility.
Use in Pregnancy
Teratogenic Effects: Pregnancy Category B
Reproduction studies for lidocaine have been performed in both rats and rabbits. There was no evidence of harm
to the fetus at subcutaneous doses of up to 50 mg/kg lidocaine (300 mg/m2 on a body surface area basis) in the rat
model. In the rabbit model, there was no evidence of harm to the fetus at a dose of 5 mg/kg, s.c. (60 mg/m2 on a
body surface area basis). Treatment of rabbits with 25 mg/kg (300 mg/m2) produced evidence of maternal toxicity
and evidence of delayed fetal development, including a non-significant decrease in fetal weight (7%) and an
increase in minor skeletal anomalies (skull and sternebral defect, reduced ossification of the phalanges). The effect
of lidocaine on post-natal development was examined in rats by treating pregnant female rats daily subcutaneously
at doses of 2, 10, and 50 mg/kg (12, 60, and 300 mg/m2) from day 15 of pregnancy and up to 20 days post partum.
No signs of adverse effects were seen either in dams or in the pups up to and including the dose of 10 mg/kg (60
mg/m2); however, the number of surviving pups was reduced at 50 mg/kg (300 mg/m2), both at birth and the
duration of lactation period, the effect most likely being secondary to maternal toxicity. No other effects on litter
size, litter weight, abnormalities in the pups and physical developments of the pups were seen in this study.
A second study examined the effects of lidocaine on post-natal development in the rat that included assessment of
the pups from weaning to sexual maturity.
Rats were treated for 8 months with 10 or 30 mg/kg, s.c. lidocaine (60 mg/m2 and 180 mg/m2 on a body surface
area basis, respectively). This time period encompassed 3 mating periods. There was no evidence of altered postnatal development in any offspring; however, both doses of lidocaine significantly reduced the average number of
pups per litter surviving until weaning of offspring from the first 2 mating periods.
Pediatric Use
Although, the safety and effectiveness of GLYDO in pediatric patients have not been established, a study of 19
premature neonates (gestational age <33 weeks) found no correlation between the plasma concentration of
lidocaine or monoethylglycinexylidide and infant body weight when moderate amounts of lidocaine (i.e. 0.3 mL/
kg of lidocaine gel 20 mg/mL) were used for lubricating both intranasal and endotracheal tubes. No neonate had
plasma levels of lidocaine above 750 mcg/L. Dosages in children should be reduced, commensurate with age, body
weight, and physical condition. (See DOSAGE AND ADMINISTRATION.)
ADVERSE REACTIONS
Adverse experiences following the administration of lidocaine are similar in nature to those observed with other
amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high
plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy, or
diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The
following types are those most commonly reported:
There have been rare reports of endotracheal tube occlusion associated with the presence of dried jelly residue in
the inner lumen of the tube. (See also WARNINGS and DOSAGE AND ADMINISTRATION.)
Central Nervous System
CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness,
apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of
heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression, and arrest. The
excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity
may be drowsiness merging into unconsciousness and respiratory arrest.
Drowsiness following the administration of lidocaine is usually an early sign of a high blood level of the drug and
may occur as a consequence of rapid absorption.
Cardiovascular System
Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and
cardiovascular collapse, which may lead to cardiac arrest.
Allergic
Allergic reactions are characterized by cutaneous lesions, urticaria, edema, or anaphylactoid reactions. Allergic
reactions may occur as a result of sensitivity either to the local anesthetic agent or to other components in the
formulation. Allergic reactions as a result of sensitivity to lidocaine are extremely rare and, if they occur, should be
managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.
OVERDOSAGE
Acute emergencies from local anesthetics are generally related to high plasma levels encountered during
therapeutic use of local anesthetics. (See ADVERSE REACTIONS, WARNINGS, and PRECAUTIONS.)
Management of Local Anesthetic Emergencies
The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and
respiratory vital signs and the patient’s state of consciousness after each local anesthetic administration. At the
first sign of change, oxygen should be administered.
The first step in the management of convulsions consists of immediate attention to the maintenance of a patent
airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate
positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of
the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the
circulation when administered intravenously. Should convulsions persist despite adequate respiratory support, and
if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental
or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously. The clinician should be
familiar, prior to use of local anesthetics, with these anticonvulsant drugs. Supportive treatment of circulatory
depression may require administration of intravenous fluids and, when appropriate, a vasopressor as directed by
the clinical situation (e.g., ephedrine).
If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis,
bradycardia, arrhythmias, and cardiac arrest. If cardiac arrest should occur, standard cardiopulmonary resuscitative
measures should be instituted.
Dialysis is of negligible value in the treatment of acute overdosage with lidocaine.
The oral LD50 of lidocaine HCl in non-fasted female rats is 459 (346 to 773) mg/kg (as the salt) and 214 (159 to 324)
mg/kg (as the salt) in fasted female rats.
Mfd. for SAGENT Pharmaceuticals
Schaumburg, IL 60195 (USA)
Mfd. by Klosterfrau Berlin GmbH
Made in Germany
©2014 Sagent Pharmaceuticals, Inc.
March 2014
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full prescribing information for GLYDO (lidocaine HCl jelly USP, 2%).
FEATURING
PreventIV Measures
Packaging and Labeling
SM
All trademarks herein are the property of Sagent Pharmaceuticals, Inc.
PreventIV Measures is a service mark of Sagent Pharmaceuticals, Inc.
©2014 Sagent Pharmaceuticals, Inc. Printed in USA 1932
www.SagentPharma.com | www.glydo.com
4
❳InBrief❲
Genetic PCa risk factors identified in study
❯❯
Findings from a large international study have identified 22 genetic variations that are associated with an increased risk of developing prostate cancer.
The study, which was published in Cancer Discovery (2015; 5:35879), was conducted by the PRACTICAL (Prostate Cancer Association
Group to Investigate Cancer-Associated Alterations in the Genome)
consortium, whose goal is to identify genetic risk factors associated
with prostate cancer.
The authors compared the genetic information from 22,301 prostate
cancer cases and 22,320 normal control cases from 23 different clinical studies. The research team focused their analysis on microRNAs.
The authors discovered 22 microRNA binding site variations that
influence the risk of developing prostate cancer. Among these 22 variations, 10 of them were not investigated thoroughly as being potential
risk factors. Seven of the variants could differentiate between aggressive and nonaggressive disease.
In addition, the authors discovered that one of the variants plays an
important role in mediating expression of PSA, and another variant
controls expression of a gene involved in metabolism.
“The hope is that this research may eventually lead to a simple
genotyping-based blood test that could be used in conjunction with the
PSA and DRE tests to aid the medical team and patient in accurately
predicting disease risk,” said co-author Jong Park, PhD, in a news
release from Moffitt Cancer Center, Tampa, FL, which participated in
the study.
PCa Tx shows significant PFS increase
❯❯
The androgen receptor inhibitor enzalutamide (XTANDI) demonstrated a statistically significant increase in progression-free survival (PFS) in men with non-metastatic or metastatic castration-resistant
prostate cancer compared with bicalutamide (Casodex), according to
recent phase II trial results.
The phase II STRIVE trial enrolled 396 castration-resistant prostate cancer patients in the U.S. The trial randomized 257 patients
with metastatic prostate cancer and 139 patients with non-metastatic
prostate cancer whose disease progressed despite treatment with a
luteinizing hormone-releasing hormone (LHRH) analogue therapy or
following surgical castration. The primary endpoint of the trial was
PFS, defined as time from randomization to radiographic (bone or
soft tissue) progression, PSA progression (defined by Prostate Cancer Working Group 2 criteria), or death due to any cause, whichever
occurs first.
The trial was designed to evaluate enzalutamide, 160 mg once daily,
versus bicalutamide, 50 mg once daily, the approved dose in combination
with a LHRH analogue.
Median PFS was 19.4 months in the enzalutamide group compared
with 5.7 months in the bicalutamide group (Hazard Ratio=0.24; 95%
Confidence Interval, 0.18-0.32; p<.0001), according to a news release
from Medivation, Inc. and Astellas Pharma Inc.
The median time on treatment in the STRIVE trial was 14.7
months in the enzalutamide group versus 8.4 months in the bicalutamide group. Serious adverse events were reported in 29.4% of
enzalutamide-treated patients and 28.3% of bicalutamide-treated
patients.
“These results demonstrate the potential for enzalutamide to provide a longer duration of disease control compared with bicalutamide
in the studied patient population,” said STRIVE co-principal investigator David F. Penson, MD, MPH, of Vanderbilt University Medical
Center, Nashville, TN.
APRIL 15, 2015 VOL. 43, NO. 5
UrologyTimes.com
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Urology Times takes the lead in providing news analysis of key advances in surgical and nonsurgical techniques, treatments and practice management. As the #1 read publication reaching
the full universe of specialists treating urologic disorders, Urology Times keeps urologists up to
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❳Editorial Consultants❲
Leading urologic surgeons, with broad experience,
who help ensure the quality of our editorial
J. Brantley Thrasher, MD Professor and Chair of Urology | University of Kansas Medical Center, Kansas City
Philip M. Hanno, MD, MPH Professor of Urology | University of Pennsylvania, Philadelphia
Stephen Y. Nakada, MD Professor and Chairman | Department of Urology | University of Wisconsin, Madison
❳Editorial Council❲
Experts in 12 key subspecialties of urology who direct
in-depth coverage of their field
BPH Steven A. Kaplan, MD Professor of Urology | Weill Cornell Medical College, New York
CLINICAL EPIDEMIOLOGY Peter C. Albertsen, MD Chief of Urology | University of Connecticut Health Center, Farmington
ERECTILE DYSFUNCTION John Mulcahy, MD, PhD | Private Practice, Madison, AL
FEMALE UROLOGY Shlomo Raz, MD Professor of Surgery/Urology | University of California School of Medicine, Los Angeles
INFECTIONS Anthony Schaeffer, MD Professor and Chairman of Urology | Northwestern University Medical School, Chicago
MALE REPRODUCTIVE MEDICINE Craig S. Niederberger, MD Professor and Head of Urology | University of Illinois, Chicago
PEDIATRICS Howard Snyder, III, MD Professor of Surgery in Urology | University of Pennsylvania School of Medicine, Philadelphia
SOCIOECONOMICS William F. Gee, MD | Private Practice, Lexington, KY
STONES/ENDOUROLOGY Dean G. Assimos, MD Professor and Chair of Urology | University of Alabama, Birmingham
TRAUMA/RECONSTRUCTION Allen F. Morey, MD Professor of Urology | UT Southwestern Medical Center, Dallas
UROLOGIC CANCER Leonard G. Gomella, MD Professor and Chairman of Urology | Thomas Jefferson University, Philadelphia
UROLOGIC LAPAROSCOPY J. Stuart Wolf, Jr, MD Professor of Urology | University of Michigan, Ann Arbor
❳Clinical Practice Board❲
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physicians “in the trenches”
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Sheila K. Gemar, MD Willmar, MN
Daniel M. Kaplon, MD Sarasota, FL
Sivaprasad D. Madduri, MD Poplar Bluff, MO
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Barry R. Rossman, MD Princeton, NJ
Neal D. Shore, MD Myrtle Beach, SC
Steven M. Wahle, MD Cedar Rapids, IA
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❳Inter
ctive❲
Your guide to what’s happening online at UrologyTimes.com
APRIL 15, 2015
∣
Urology Times
BLOG
Urology group expands reach
to include small practices
Although independent urology practices have significant
impact on their communities, their existence is imperiled by
regulatory and market forces. To this end, LUGPA (formerly
the Large Urology Group Practice Association) is expanding to
encompass smaller practices, as Urology Times blogger Neal D.
Shore, MD, discusses in his latest blog post.
DR. SHORE
‘Y’TUBE
Video section offers guidance on men’s health
‘Y’tube, a new UrologyTimes.com section, is a video resource for urologists and other
New Orleans urologist Neil Baum,
MD, shares with UT his top spots to
eat, visit, and enjoy in “NOLA” while
attending the AUA annual meeting.
Check out our exclusive audovisual
content at www.urologytimes.com/
new-orleans -preview.
physicians who focus on men’s health. Videos cover surgical aspects of a variety of
men’s health issues, including robot-assisted prostatectomy, urethroplasty, vasectomy
reversal, and more.
urologytimes.com/ytube
TECHNOLOGY
Urology Times Resource Center
Mining EHR data for quality improvement
METASTATIC CASTRATION-RESISTANT
PROSTATE CANCER
For many, EHR systems represent a drain of precious time and finances. However,
Videos, news, and more to help you manage your
patients with advanced disease
with the rise of value-based reimbursement, EHRs’ data-mining capabilities could
http://urologytimes.com/CRPCA
help clinicians see how well they’re doing or to update their care delivery processes.
modernmedicine.com/EHR-data
UT FOLLOWER OF THE MONTH
@RoboticsUrology
Mutahar Ahmed, MD, a urologist in Hackensack, NJ, is the Urology Times Twitter follower of
TWITTER.COM/UROLOGYTIMES
the month! To be featured in this section, engage with us.
Our followers tweet about specimen labeling and more
Henry Woo
@DrHWoo
A labeling of prostate biopsy specimens in a coded
form that only the one urologist doing the biopsies
knows, is not good patient care.
Ashley Winter MD
@AshleyGWinter
Today is #DoctorsDay. Gotta give a bit of love to
my relentless & deeply #humanistic friends and coworkers. #residentLife #hospitalLife
Dr Brian Stork
@StorkBrian
Afraid of the Easter Bunny?
There’s a Code for That...
ICD-10 F40.218
#hitsm
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@chrbayne
Kid cries for nearly an hour, then falls immediately
asleep when I start reading from Campbell’s exstrophy
chapter. Found the secret weapon
Urology Times App
*HWDFFHVVWRDOOWKHEHQHÀWV
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READ DR. SHORE’S BLOG POST AT: urologytimes.com/LUGPA-expands
8
❳ Clinical Updates ❲
APRIL 15, 2015
∣
Urology Times
Robotic, open RP: Outcomes from 650,000 patients
Fewer transfusions but higher costs associated with robotic procedure
UT CORRESPONDENT
Orlando, FL—A review of more than 650,000
non-metastatic prostate cancer patients “represents the best available evidence for the morbidity and cost profile” of robot-assisted radical
prostatectomy (RARP) versus the open procedure (ORP), according to study author Jeffrey
J. Leow, MBBS, MPH.
❳ Prostate Cancer ❲
RARP is associated with less morbidity but
at a higher cost than ORP. The cost efficiency of
RARP can be improved by limiting operating
room time, most likely achieved by high-volume surgeons, said Dr. Leow, a research fellow
at the Center for Surgery and Public Health at
Brigham and Women’s Hospital, Boston, who
presented the findings at the Genitourinary
Cancers Symposium in Orlando, FL.
These findings come from a population-based
retrospective cohort study of 654,030 patients
with non-metastatic prostate cancer who underwent radical prostatectomy between 2003 and
2013 at 449 hospitals in the United States.
“Our contemporary analysis found that
RARP confers a perioperative morbidity advantage over ORP, but at higher costs, which are
heavily contributed by supplies and OR costs,”
said Dr. Leow, who worked on the study with
Steven L. Chang, MD, MS, and colleagues.
Urology Times Editorial Consultant J. Brantley Thrasher, MD, said the advantages conferred
Clinical Updates
Kidney Cancer
page 10
Hypogonadism
page 14
Infection
page 16
Infertility
page 18
For up-to-date news, visit
urologytimes.com/InBrief
by the robotic procedure in this and other studies
must be weighed against its higher costs.
RARP has been adopted rapidly in the United States over the past decade despite the lack
of level 1 evidence, aided initially by results
from single-institution studies showing benefits
over ORP. Subsequent patient-driven marketing
and inter-hospital competition contributed to
its emergence, Dr. Leow said. Over the study
period, the use of RARP grew from 2% to about
85% of radical prostatectomies.
Using regression analysis, Dr. Leow and colleagues compared 90-day postoperative complications, blood transfusions, operating room
time, and direct hospital costs between the two
groups, using an all-payer discharge database
(Premier Hospital Database).
❳
❲
15,000
JEFFREY J. LEOW, MBBS, MPH
A unique feature of the study was the use of
charge master descriptions to classify RARP by
identifying supplies unique to robotic procedures.
90-day hospital costs assessed
The median 90-day direct hospital costs exceeded $14,000 in patients undergoing RARP, with
supplies contributing $4,267 of this cost and OR
time contributing $7,013. The median 90-day
direct hospital costs were a little more than
$9,000 in the patients undergoing ORP, with supplies contributing $1,089 and OR time contributing $4,529 of this cost. The excess cost of RARP,
therefore, was $5,339 compared with ORP.
The adjusted odds ratio (OR) of any complication with RARP compared with ORP was
0.72 (94% CI, 0.6-0.87). Patients undergoing
RARP had a lower risk of blood transfusion
(OR: 0.3; 95% CI, 0.14-0.64).
A sub-analysis of the highest volume robotic surgeons found no difference in the rate of
complications but a reduced risk of transfusions
compared with the entire cohort. The OR of
transfusion was 0.11 for the highest volume surgeons performing RARP compared with ORP
(95% CI, 0.03 to 0.42).
The median OR time for the entire cohort
$14,000
$9,000
0
“Our contemporary analysis found
that RARP confers a perioperative
morbidity advantage over ORP, but
at higher costs, which are heavily
contributed by supplies and OR costs.”
Median costs
UT Figure for RARP vs. ORP
Median 90-day direct hospital costs ($)
Wayne Kuznar
RARP group
ORP group
Source: Jeffrey J. Leow, MBBS, MPH
was 155 minutes. Highest volume surgeons
spent less time in the OR, and in this group,
the difference in cost between RARP and ORP
was $1,188, but it was no longer significant.
“This suggests that there may be a role for
centralization of robotic procedures to highvolume providers in the U.S.,” said Dr. Leow.
“Surgeons need to hit a threshold OR time of
about 145 minutes for robotic surgery to be more
cost efficient than open surgery,” assuming a
10% complication rate (the average), he added.
The widespread adoption of RARP for
the management of localized prostate cancer
implies that a large randomized trial will not
likely be conducted, so the current large retrospective study “represents the best available
evidence for the morbidity and cost profile of
RARP vs. ORP,” according to Dr. Leow.
In an email to Urology Times, Dr. Thrasher
said he found it interesting that the authors
found fewer transfusions in patients treated
robotically and no significant difference in
other 90-day complications but that the robotic
procedure’s costs were much higher.
“Ultimately, what needs to be considered
here is if fewer transfusions, earlier discharge
in some studies, and less pain for the robotic
group is enough to justify the higher cost. Other studies have shown that in the hands of expert
surgeons, cancer outcomes, incontinence, and
erectile function are very similar with both
approaches, so the other variables I mention
have to be weighed against the extra cost,” said
Dr. Thrasher, professor and chair of urology at
the University of Kansas, Kansas City, who was
not involved with the study. UT
9
Delayed RP does not raise
adverse pathology risk
Surveillance does not miss window
for cure in appropriately selected men
OVER 2000
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Wayne Kuznar
UT CORRESPONDENT
Orlando, FL—Men with prostate cancer who meet the criteria for active
surveillance and undergo delayed radical prostatectomy after a period
of active surveillance do not have a higher risk of adverse pathology
compared with men with similar pre-treatment biopsy features who
undergo immediate prostatectomy.
The finding from a recent study indicates that a window for cure was
likely not missed by active surveillance in appropriately selected men
with prostate cancer, said Christopher J. Welty, MD, at the Genitourinary
As part of his group’s study, Dr. Welty and colleagues reviewed clinical data for men on active surveillance for at least 6 months following
diagnostic biopsy who subsequently underwent prostatectomy. Active
surveillance consisted of quarterly PSA testing, re-imaging with transrectal ultrasound, and serial prostate biopsy.
They examined pathologic outcomes associated with delayed prostatectomy following active surveillance compared with immediate
treatment of prostate cancer with similar grades in two cohorts of men.
“We chose adverse pathology because it’s an earlier endpoint to look
at and it’s correlated with longer term outcomes,” said Dr. Welty, clinical
fellow at the University of California, San Francisco, who worked on
the study with Peter Carroll, MD, MPH, and colleagues.
Adverse pathologic features were defined as upstaging to pT3/N1
disease, positive surgical margins, or an upgrade to Gleason 4+3 disease.
The first cohort consisted of a subset of men who initially met strict
criteria for active surveillance, defined as Gleason score ≤6, PSA ≤10.0
ng/mL, clinical stage <T3, ≤ 33% biopsy cores positive, and ≤50%
of any single core positive. In this group, pathologic outcomes were
compared between the 157 men who were managed by active surveillance and then underwent prostatectomy and the 521 men who had
immediate surgery.
The median time to prostatectomy was 3 months in the group undergoing immediate surgery and 20 months in the delayed group.
“We showed that there is a higher rate of adverse pathologic features
in the men who underwent delayed RP, which is not surprising because
these were men who were observed looking for higher risk disease, and
then were recommended and selected for surgery,” said Dr. Welty. “This
is a very selective group of patients with higher risk disease.”
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Higher major upgrade rate in delayed group
The rate of any adverse pathology was 44% in the delayed group versus
23% in the immediate group (p<.01). Twelve percent in the delayed
group and 5% in the immediate group (p<.01) had a major upgrade
(increase in Gleason score at surgery and the presence of primary pattern 4 or 5). Extracapsular extension (25% vs. 11%; p<.01), seminal
vesicle invasion (4% vs. 2%; p=.03), and positive margins (21% vs. 11%;
p<.01) were all more common in the delayed group. The adjusted odds
of any adverse pathology in the immediate versus delayed group was
0.34 (p<.01).
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10
APRIL 15, 2015
∣
Urology Times
No efficacy benefit seen with two agents
Adjuvant therapy fails in locally advanced kidney Ca
UT CORRESPONDENT
Orlando, FL—Two angiogenesis inhibitors that
are widely used in metastatic renal cell carcinoma (RCC) did not improve survival compared
with placebo when used as adjuvant treatment,
a new study found. The federally funded randomized trial studied the agents’ use in patients
with locally advanced kidney cancer.
❳ Kidney Cancer ❲
“Patients with locally advanced kidney cancer should not be treated with either adjuvant
sorafenib or sunitinib,” stated lead author Naomi B. Haas, MD, associate professor of medicine at the Abramson Cancer Center, University
of Pennsylvania, Philadelphia, speaking at a
pre-meeting press event for the Genitourinary
No benefit was seen for adjuvant therapy
with either sunitinib (Sutent) or sorafenib
(Nexavar) compared to placebo. Treatment
with either drug resulted in median diseasefree survival (DFS) of 5.6 years; DFS was 5.7
years with placebo. The 40% rate of recurrence
was also similar among the two treatment arms
and placebo group.
These findings are of importance because
both drugs have been used in the adjuvant setting off-label in about 45% of patients with
locally advanced kidney cancer.
The phase III ASSURE (Adjuvant Sorafenib
or Sunitinib in Unfavorable REnal cell carcinoma) trial was designed to test whether these
agents would prove as effective in the adjuvant
setting as they have for patients with advanced/
metastatic RCC.
The randomized, double-blind, multicenter
trial enrolled 1,943 patients with resected,
intermediate, and very high-risk clear cell and
non-clear cell RCC who had no prior systemic
DE L AY E D RP
continued from page 9
The second cohort consisted of a subset of
54 of the men who met active surveillance
criteria who were then upgraded to Gleason
3+4 disease on follow-up biopsy. They were
matched to 162 men who had similar PSA,
age, and biopsy characteristics (Gleason 3+4)
and who had immediate surgery. These two
treatment. Patients were
randomized to receive
sorafenib, sunitinib, or
placebo.
The trial was designed
to detect a 25% reduction in the hazard ratio,
which would equate to
an improvement in estiDr. Haas
mated median DFS of
5.8 years with placebo
to 7.7 years with the experimental agents. DFS
was the primary endpoint; secondary endpoints
were overall survival and tolerability.
Rates of adverse events and patient intolerance compelled lowering the original dosage
of sorafenib, 400 mg twice daily to once daily,
and of sunitinib, 50 mg once daily to 35 mg once
daily. Discontinuation rates decreased from
about 26% of patients on the original schedule to
about 14% of patients who started on the lower
dosages. The authors also found that discontinuation rates were reduced by dose titration.
❳
❲ vs. placebo
Median DFS:
UT Figure Adjuvant therapy
10
Median DFS (years)
Alice Goodman
0
5.6
5.7
Treatment with
sunitinib or
sorafenib
Placebo
Source: Naomi B. Haas, MD
Both drugs were associated with an increased
incidence of hypertension (16% for active
agents vs. 4% placebo). Compared to placebo,
the sorafenib arm had higher rates of hand-foot
syndrome and rash (15% vs. <1%) and diarrhea
(9% vs. 0%). Patients in the sunitinib arm had
higher rates of fatigue (18% vs. 3% placebo),
hand-foot syndrome (33%), and diarrhea (10%).
With 62% of the study information available at an interim analysis, no evidence of any
trend toward efficacy benefit, and significant
high-grade toxicity seen with both sorafenib
and sunitinib, the Data Safety Monitoring Committee recommended release of results even
though no efficacy or futility boundaries had
been reached.
The results of this study raise the question of
whether anti-angiogenic agents have any role as
treatment and prevention of recurrence in the
adjuvant setting. If they do, how long should
they be administered? Hopefully, the answers to
these and other questions will emerge from further studies. Currently, ATLAS (NCT0599754)
is looking at another anti-angiogenesis agent,
axitinib (Inlyta), in very high-risk clear cell
RCC patients; and SORCE (NCT00492258) is
investigating sorafenib versus placebo for 1 or
3 years in resected patients with clear cell and
non-clear cell RCC.
Dr. Haas has stock and other ownership interests in TetraLogic Pharmaceuticals, serves as
a consultant/adviser for Bristol-Myers Squibb,
GlaxoSmithKline, and Merck; and has provided expert testimony for Lilly. One of Dr.
Haas’ co-authors is a consultant/adviser for
Bayer and Pfizer and has received travel,
accommodations, and expenses remuneration
from Pfizer, and others have served as consultants/advisers to and/or have received honoraria from pharmaceutical companies. UT
groups had similar rates of all adverse pathologic features, including any adverse pathology (44% in the immediate group vs. 46% in
the delayed group), major upgrade (15% vs.
13%), extracapsular extension (24% vs. 20%),
seminal vesicle invasion (4% vs. 7%), and positive margins (21% vs. 20%).
Of the 162 immediate surgery and 30 delayed
surgery patients with at least 3 years of followup, PSA recurrence-free survival after surgery
was 88% versus 100%.
“Essentially, we’re saying that likely many
of these men in the delayed group just had
under-recognized Gleason 3+4 disease to start
with,” with no worse outcomes during the time
it took to recognize the 3+4 disease, said Dr.
Welty.
“The point we make is that by using this
early endpoint of adverse pathology, you don’t
miss a window for cure in these men who have
Gleason 3+4 disease appreciated on follow-up
biopsy during active surveillance,” he said. UT
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12
APRIL 15, 2015
∣
Urology Times
Penile transplant could happen here, U.S. surgeons say
Possible indications for surgery include penile cancer, severe trauma
Richard R. Kerr
GROUP CONTENT DIRECTOR
Cape Town, South Africa—Penile transplant
surgery, performed successfully for the first
time in South Africa, is technically feasible and
has potential clinical applications in the United
States, according to two leading U.S. urologists.
❳ Trauma ❲
The groundbreaking, 9-hour surgery was
performed in December 2014 at Tygerberg
Hospital in Bellville, Cape Town and led by
urologist André van der Merwe, MB, ChB, of
Stellenbosch University. The 21-year-old recipient’s penis had to be amputated to save his life
when he developed severe complications after
a traditional circumcision.
While such “ritual” circumcisions are rare in
the U.S., two of the country’s leaders in sexual
medicine told Urology Times the transplant surgery could play a role in
certain patients.
“To show that this is
something that’s technically feasible, I think
that’s great,” said Arthur
L. Burnett, II, MD,
MBA, professor of urology at Johns Hopkins
Dr. Burnett
Medicine, Baltimore.
“I think there are situations where men can sustain serious genital
trauma in somewhat less sensational but more
noble situations here, from war injuries to postpenile cancer penectomies. So I think there are
some real indications.”
“We are fortunate in this country that this
particular injury—loss of the phallus after a traditional, non-medical circumcision—is vanishingly rare, but there are situations in which this
might be applicable such
as after various types of
trauma or cancer,” added
William O. Brant, MD,
assistant professor of
surgery (urology) at the
Center for Reconstructive Urology and Men’s
Dr. Brant
Health, University of
Utah Health Care in Salt
Lake City. “Currently, the approach is a ‘freeflap phalloplasty’ to create a new phallus, but
this is also done uncommonly and by a few
experienced practitioners.
Expert, thorough care of patient key
“In my view, the most important aspect of this
surgery is that this 21-year-old man was cared
for expertly and thoroughly,” Dr. Brant wrote
in an email to Urology Times. “In both the lay
press and even in the views of insurance payers,
penile and sexual health is often treated as a
purely cosmetic issue. Worse, it is often treated
as something that is not important for patient
health or quality of life.
“However, we know that phallic loss or significant erectile dysfunction (which might be
better termed as ‘end-stage penile disease’) is
a truly significant issue with ramifications that
include loss of self-esteem, loss of relationship
intimacy and communication, a decline in the
man’s feelings of general health and masculinity, etc.”
The South African group is not the first to perform a penile transplant. Surgeons in China completed the procedure in a 44-year-old man in 2006,
and reported their findings in European Urology
(2006; 50:851-3). However, the transplanted penis
was removed after 2 weeks “because of a severe
psychological problem of the recipient and his
wife,” the Chinese authors wrote.
In the surgery by Dr. van der Merwe and
colleagues in multiple specialties, the patient
has “made a full recovery and has regained all
function in the newly transplanted organ,” Stellenbosch University reported in a March 2015
news release.
“Our goal was that he would be fully functional at 2 years and we are very surprised by
his rapid recovery,” said Dr. van der Merwe.
The result was the restoration of all the patient’s
urinary and reproductive functions, he said.
The planning and preparation for the study
started in 2010. After extensive research, Dr.
van der Merwe and his surgical team decided to
employ some parts of the model and techniques
developed for the first facial transplant.
“We used the same type of microscopic surgery to connect small blood vessels and nerves,
and the psychological evaluation of patients was
also similar. The procedure has to be sustainable and has to work in our environment at
Tygerberg,” he said.
Use for ED ‘would be a stretch’
Like Dr. Burnett and Dr. Brant, Dr. van der
Merwe said the procedure could eventually also
be extended to men who have lost their penises
from penile cancer. But he went a step further
in adding that it also could be a “a last-resort
treatment for severe erectile dysfunction.”
“That would be a stretch,” Dr. Burnett said.
“If somebody at least has the structure of the
penis intact, we can conceivably do other
things.”
“I do not know whether the costs associated
with immunosuppression and other care will
prohibit penile transplant in general [in the U.S.],
nor what the long-term effects will be as compared to flap phalloplasty,” Dr. Brant said. “But
I am encouraged that dedicated practitioners are
willing to improve care and caring, advance the
field, and take these issues seriously.”
As part of the South African group’s study,
nine more patients are scheduled to receive
penile transplants. UT
Kidney injuries from sports often occur in isolation
Fewer signs of hemodynamic instability compared with nonsports trauma
Don Schrader
UT CONTRIBUTING EDITOR
Salt Lake City—Sports-related high-grade renal
injuries occurred more often in isolation from
other abdominal organ injury and without associated hemodynamic instability as compared
with nonsports renal trauma, a statewide review
of traumatic renal injuries showed.
Overall, sporting incidents accounted for
30% of high-grade renal injuries seen over a
6-year period at level 1 trauma centers in Utah.
A majority of the sport-related renal trauma
resulted from snow sports.
Renal trauma due to sporting incidents had
a severity level similar to that of nonsportsrelated high-grade renal injuries but required
intervention less often, first author Jeffrey Redshaw, MD, reported at the 2014 AUA annual
meeting in Orlando, FL.
Please see KIDNEY INJURIES, page 13
UrologyTimes.com
∣
APRIL 15, 2015
K IDNE Y IN JURIE S
“The findings supported our hypothesis
that sports-related renal injuries would not be
associated with polytrauma,” Dr. Redshaw told
Urology Times.
“Patients with sports-related renal injuries
tended not to have tachycardia and they weren’t
hypotensive, which are signs that are often associated with renal trauma,” added Dr. Redshaw,
a urology resident at the University of Utah,
Salt Lake City, who worked on the study with
Jeremy B. Myers, MD, and colleagues.
The American Association for the Surgery
of Trauma (AAST) defines high-grade renal
injuries as grade III-IV. Motor vehicle accidents account for a majority of high-grade
renal trauma, usually occurring in the setting
of polytrauma involving numerous concomitant injuries.
In contrast to motor vehicle-associated renal
trauma, sports-related injuries usually involve a
solitary blow to the flank or abdomen.
Because of the different circumstances
between sports-related and nonsporting renal
trauma, Dr. Redshaw and colleagues hypothesized that sports-related high-grade renal
injuries would be less likely to involve polytrauma. To test the hypothesis, they retrospectively reviewed medical records of patients with
high-grade renal injuries treated at Utah trauma
centers from 2005 to 2011.
The analysis included 138 patients identified
as having AAST III-IV renal injuries. Sporting
activities accounted for 42 (30%) of the injuries. Skiing and snowboarding accounted for
26 sports-related renal trauma incidents (62%).
Most of the remaining sports-related injuries
involved individual contact during a sporting
activity, such as football or cycling. The investigators excluded renal injuries associated with
snowmobile and all-terrain vehicle accidents,
considering them more closely related to motor
vehicle injuries.
(such as hypotension or tachycardia) were
observed in 47.6% of patients with sportsrelated renal trauma compared with 67% of
patients with nonsports-related renal trauma
(p=.037).
Almost twice as many patients with nonsports injuries required secondary interventions
as compared with patients who had sports-related renal trauma (20% vs. 11.9%), although the
difference did not reach statistical significance
(p=.332).
13
“Statewide, sports-related renal injuries
accounted for 30% of all high-grade renal
trauma, which surprised us, because we did not
think the percentage would be that high. We
were also surprised to see that males made up
more than 90% of all sports-related renal injuries. Overall, males account for a majority of
high-grade renal injuries, but the proportion
was much higher for sports-related injuries
than for nonsports-related injuries,” said Dr.
Redshaw. UT
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Males dominate sports-related injuries
The AAST mean renal grade was 3.5 for
sports-related renal injuries and 3.7 for nonsports-related injuries (p=.08). Male patients
predominate in renal trauma, and the predominance increased in the sports-related renal
injuries (90.5% vs. 61% of nonsports injuries,
p<.001).
Sports-related renal injuries were associated with a mean injury severity score (ISS)
of 12.6, whereas patients with nonsports renal
trauma had a mean ISS of 27.3 (p<.001).
Sports-related renal trauma was more than
twice as likely to occur in isolation from injury to other abdominal organs (78% vs. 36%,
p<.001). Signs of hemodynamic instability
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14
APRIL 15, 2015
∣
Urology Times
Depression, CVD among topics of research
Studies examine risk factors, risks for low, high T
Benjamin P. Saylor
CONTENT EDITOR
San Diego—A handful of studies reveal new
information about risk factors for both low and
high testosterone as well as the potential risks
associated with each.
❳
Hypogonadism
❲
The research was presented at ENDO 2015,
the Endocrine Society’s annual meeting, in San
Diego.
In the first study, men with borderline testosterone levels were found to have higher rates of
depression and depressive symptoms than the
general population. Principal author Michael
S. Irwig, MD, associate professor of medicine
and director of the Center for Andrology in the
division of endocrinology at George Washington University in Washington, and colleagues
studied 200 adult men between 20 and 77 years
of age whose testosterone levels were borderline (between 200 ng/dL and 350 ng/dL). The
authors collected the men’s demographic information, medical histories, medication use, and
signs and symptoms of hypogonadism.
They remeasured the men’s total testosterone
and assessed depression from their medical history and depressive symptoms with the validated Patient Health Questionnaire 9 (PHQ-9).
Using a score of 10 or higher on the PHQ9, 56% of the study participants had significant depressive symptoms, known diagnosis
of depression, and/or use of an antidepressant.
Their rates of depressive symptoms were markedly higher than the 15% to 22% in an ethnically
diverse sample of primary care patients and the
5.6% among overweight and obese U.S. adults.
The men also had a high prevalence of overweight (39%), obesity (40%), and physical inactivity; other than walking, 51% of the men did not
engage in regular exercise. The most common
symptoms reported were erectile dysfunction
(78%), low libido (69%), and low energy (52%).
“This study found that men seeking management for borderline testosterone have a very
high rate of depression, depressive symptoms,
obesity, and physical inactivity. Clinicians need
to be aware of the clinical characteristics of this
sample population and manage their comorbidities such as depression and obesity,” Dr. Irwig
said in an Endocrine Society press release.
Relationship between T, sexual function
Another study explored the relationship
between declining reproductive hormones and
decreasing sexual function in older men.
For the study, lead author Benjumin Hsu,
MPH, a PhD candidate in the School of Public
Health and the ANZAC Research Institute of
the University of Sydney in New South Wales,
Australia, and colleagues assessed men 70
years of age and above in Sydney, Australia,
who took part in the Concord Health and Ageing in Men Project. The authors tested the men
at baseline (n=1,705) and again 2 years later
(n=1,367).
At both visits, the authors asked the participants questions about their sexual functions
and measured the men’s serum testosterone,
dihydrotestosterone (DHT), estradiol (E2), and
estrone (E1) by liquid chromatography-tandem
mass spectrometry; and they measured the
men’s sex hormone-binding globulin, luteinizing hormone, and follicle-stimulating hormone
by immunoassay.
Over 2 years, baseline serum testosterone,
DHT, E2, and E1 did not predict decline in
“This study found that men seeking
management for borderline
testosterone have a very high rate
of depression, depressive symptoms,
obesity, and physical inactivity.”
MICHAEL S. IRWIG, MD
sexual activity, sexual desire, and erectile function. By contrast, the decline in testosterone
(but not in DHT, E2, or E1) over time, though
less than 10%, was strongly related to decreased
sexual activity and desire, but not to erectile
dysfunction.
“We found that over 2 years, men with declining serum concentrations of testosterone were
more likely to develop a significant decrease in
their sexual activity and sexual desire. In older
men, decreased sexual activity and desire may
be a cause—not an effect—of low circulating
testosterone level,” Hsu said in a press release
from the Endocrine Society.
Insights into cardiovascular disease
In the third study, researchers reported findings
that could shed light on how hormone levels
impact heart disease in men.
The study, conducted in 400 healthy men
ages 20 to 50 years, found that higher levels
of testosterone led to lower levels of HDL cho-
UTSTAT
Decline in testosterone over time,
though less than 10%, was strongly
related to decreased sexual
activity and desire, but not to erectile
dysfunction.
lesterol, but that estrogen appeared to have
no effect on HDL cholesterol. In contrast, the
authors found that low levels of estrogen led to
higher fasting blood glucose levels, worsening
insulin resistance, and more fat in muscle.
“These observations may help explain why
men have a higher risk of cardiovascular disease,” lead investigator Elaine Yu, MD, MSc,
assistant professor at Harvard Medical School,
Boston, said in a press release from the Endocrine Society.
Dr. Yu and her co-authors were able to determine whether estrogen or testosterone regulated
various cardiovascular risk factors by comparing two groups of men whose hormone levels
were temporarily changed with combinations
of medications.
At the start of the study, all men received
goserelin (Zoladex) to suppress production of
testosterone and estrogen. Then the 198 men
in the first group received daily treatment for 4
months with either a placebo gel or one of four
doses of testosterone gel (AndroGel), ranging
from low to high (1.25 to 10 grams). This treatment set the men’s testosterone levels from very
low (as in before puberty) to high-normal, Dr.
Yu said.
The other group, made up of 202 men, received
the same treatment as in group 1 but also received
anastrozole (Arimidex) to block conversion of
testosterone to estrogen. Men naturally convert
some testosterone to estrogen. Blocking this process resulted in very low levels of estrogen in the
second group, according to Dr. Yu.
Study participants had their weight measured and had fasting blood tests for markers
of heart disease and diabetes. At the start and
end of the study, they had a thigh scan with
quantitative computed tomography to measure
muscle fat.
The authors found that neither testosterone
nor estrogen regulated changes in LDL cholesterol, blood pressure, and body weight.
Grants from the National Institutes of Health
and AbbVie supported the study. The drug makers provided the medications used in this study
at no cost. UT
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16
APRIL 15, 2015
∣
Urology Times
Change in surgeon behavior needed, authors say
Extended antimicrobial prophylaxis raises C. diff risk
Cheryl Guttman Krader
UT CONTRIBUTING EDITOR
Seattle—Whereas best practice policy states
that antimicrobial prophylaxis for urologic
procedures should be discontinued within 24
hours, extended regimens are common among
patients undergoing surgery for urologic cancer
and putting them at risk for hospital-acquired
Clostridium difficile colitis, say researchers
from the University of Washington, Seattle.
❳ Infection ❲
“A recent review indicates that the rate of C.
difficile colitis has been increasing worldwide
and points to increased antimicrobial use as
a major contributing factor,” said first author
Joshua Calvert, MPH, a medical student at the
University of Washington.
“Our study demonstrates that inappropriate antimicrobial prophylaxis is exposing
patients undergoing
genitourinary cancer
surgery to a preventDr. Gore
able complication and
one that is also a source
of increased health care costs. These findings
indicate a need for efforts that will improve
provider compliance with evidence-based
approaches to postoperative care.”
The authors suggested that surgeon-led quality collaboratives might be a viable approach
for successfully changing surgeon behavior in
terms of antimicrobial prescribing for patients
undergoing urologic cancer surgery.
“Processes of care that reflect ingrained
provider practices respond well to feedback
reporting that is a common strategy for quality
improvement within existing surgical collaboratives,” noted senior author John Gore, MD,
MS, assistant professor of urology at the University of Washington.
In the research, which was presented at the
2014 AUA annual meeting in Orlando, FL, and
subsequently published in the Journal of Urology (2014; 192:425-9), practice patterns for antimicrobial prophylaxis during the years 2007
to 2012 and the impact of using an extended
regimen on hospital-acquired C. difficile colitis were analyzed using data from the Premier
Perspectives Database. Based on searching by
ICD-9 codes, the study included 59,184 patients
who underwent radical prostatectomy, 27,921
patients who underwent partial or radical
Please see PROPHYLAXIS, page 18
Risks higher with salvage AUS, but success is possible
5-year device survival rates similar between primary, salvage procedures
Benjamin P. Saylor
CONTENT EDITOR
Rochester, MN—Although salvage artificial
urinary sphincter (AUS) implantations are
associated with an increased risk of recurrent
erosion/infection requiring explantation, excellent long-term success rates can be attained in
carefully selected patients, according to a recent
study.
❳ Incontinence ❲
“We have a high volume of patients that come in
either for primary AUS or after previous implantations, looking for additional management.
Either they had continued leakage or they had an
infection or erosion, requiring it to be removed.
So they come in, asking, ‘What are the chances
of success with a repeated implantation?’ ” first
author Brian J. Linder, MD, told Urology Times.
To answer this question, Dr. Linder and colleagues identified 704 consecutive AUS implantations performed at Mayo Clinic, Rochester,
MN, between 1998 and 2012. Of these, 497
were primary implantations, 138 were revision
surgeries for device malfunction, and 69 were
salvage implantations. A salvage procedure was
defined as placement after a previous device
explantation for erosion or infection. Median
follow-up for the primary cohort
was 24 months for the primary
Primary vs. salvage
Table
AUS cohort and 34 months for
AUS placement
the salvage patients.
After comparing outcomes
Primary AUS Salvage AUS
between primary and salvage
6.4%
18.8%
Erosion rate
implantations, the authors found
11.1%
6%
Rate of revision surgery
a significantly increased risk of
76%
68%
5-year device survival
infection or erosion in patients
with salvage AUS compared
Source: Brian J. Linder, MD
with patients undergoing primary implantation. Specifically,
32 patients in the primary AUS arm
“Repeat infection/erosion after a salvage
(6.4%) experienced an erosion event compared implantation is about one in five patients, but
with 13 (18.8%) in the salvage arm. In addi- that means 80% of patients don’t have an event,
tion, 55 of the primary AUS patients (11.1%) and for those patients, excellent 5-year device
underwent revision surgery compared with four outcomes can be achieved. It’s a feasible and
patients (6%) in the salvage group. The findings promising operation for quality of life improvewere presented at the 2014 AUA annual meeting ment in some patients after AUS erosion,” said
in Orlando, FL and subsequently published in Dr. Linder, a urology resident at Mayo Clinic,
the Journal of Urology (2014; 191:734-8).
who worked on the study with Daniel S. Elliott,
“Comorbid conditions that would place the MD, and Mitra R. De Cogain, MD.
patient at increased risk for infection or erosion
Dr. Linder and Dr. Elliott said they will
were highly prevalent—things like radiation, continue following these patients to evaluate
smoking, obesity,” Dr. Linder said.
long-term device outcomes. In addition, Dr.
Elliott explained that their group is planning
5-year device survival rates ‘surprising’
to build a database of male artificial sphincter
Interestingly, when looking at device survival, data that will go back to span more than 30
the authors found similar 5-year rates of 76% years.
for primary AUS and 68% for salvage AUS, a
“We’re going back to 1983,” Dr. Elliott comfinding Dr. Linder called “surprising.”
mented. UT
❳ UT
❲
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18
APRIL 15, 2015
∣
Urology Times
Hypertension also linked to fertility problems
Workplace exertion among factors related to infertility
Lisette Hilton
UT CORRESPONDENT
Palo Alto, CA—It’s the perfect storm for male
fertility problems: working in a physically
demanding job, taking multiple medications,
and having high blood pressure. That’s according to a recent study examining relationships
among workplace exertion, certain health factors, and semen quality.
❳ Infertility ❲
An expert in men’s health gave the research
high marks for its population-based design, but
urged caution in interpreting its results.
For the study, which was published online
in Fertility and Sterility (March 9, 2015),
researchers from the National Institutes of
Health, Bethesda, MD, and Stanford University, Palo Alto, CA followed 501 couples who
stopped using contraception and were trying
to conceive for a year. Of those, 473 men provided one semen sample; 80% provided a second sample. The final study group included 456
men, with an average age of 31.8 years. More
than three-quarters of participants were Cauca-
PROPH Y L A X IS
nephrectomy, and 5,425 patients who had radical cystectomy.
Mean duration of antimicrobial prophylaxis
was 10.3 days for the cystectomy patients, 4.0
days in the nephrectomy group, and 1.9 days for
men undergoing prostatectomy. Extended antimicrobial prophylaxis, defined as receipt of the initially prescribed antimicrobial or antimicrobial
within the same class beyond 24 hours postoperatively, was identified in 56.3% of the cystectomy
cohort, 28.8% of nephrectomy patients, and 17.7%
of patients undergoing radical prostatectomy.
3.8-fold risk increase in nephrectomy cohort
Rates of postoperative C. difficile colitis in
the cystectomy, nephrectomy, and prostatectomy groups were 1.7%, 0.23%, and 0.02%,
respectively. In multivariate logistic regression
analysis adjusting for age, gender, race, marital
status, comorbidity, insurance status, and hospital type, extended antimicrobial prophylaxis
increased the risk of C. difficile colitis by 3.8fold among patients who underwent nephrectomy and by 1.6 times in the cystectomy cohort.
sian, more than 90% were college educated, and
more than half had never fathered a pregnancy.
Thirteen percent of men who reported heavy
work-related activity had lower sperm counts,
compared to 6% of the men who reported no
workplace exertion. Other work-related exposures, such as shift work, night work, vibration,
heat, noise, or prolonged sitting, did not appear
to have an effect.
Among men who said they had received a
diagnosis of high blood pressure, diabetes, or
high cholesterol, only those with hypertension
had a lower percentage of normally shaped
sperm, compared to men who reported no high
blood pressure.
“As men are having children later in life, the
importance of diseases we once thought as separate from fertility must be re-explored. Future
investigations need to examine whether it’s the
high blood pressure itself or the treatment that
is driving these trends,” principal investigator
Michael L. Eisenberg, MD, director of Male
Reproductive Medicine and Surgery at Stanford
University, said in a press release from the NIH.
Dr. Eisenberg and his co-authors also
observed that while 7% of the men who did
not take medications had sperm counts below
39 million, 15% of those who reported taking
two or more medications had low counts.
James M. Hotaling, MD, MS, assistant professor of surgery (urology) at the Center for
Reconstructive Urology and Men’s Health,
University of Utah Health Care, Salt Lake City,
wrote in an email to Urology Times that this
study has notable strengths and weaknesses.
“The main strengths of this study are its
population-based design and rigorous semen
analysis metrics as well as in-depth examination of exposures. Perhaps the most novel component of the study is that it examined a cohort
of patients from the population, not men from
an infertility clinic,” said Dr. Hotaling, who was
not involved with the study.
“However, its conclusions that increased occupational exertion, hypertension, and increased
medication use were associated with poorer
semen quality need to be interpreted with caution. Although these results are statistically significant, they are unlikely to be clinically significant. Further, lack of information on motility, and inability to ascertain the total motile
count, is a major limitation of the study. Nonetheless, this is an important and relevant examination of the determinants of sperm parameters in
a population-based cohort, that, sadly, is very
hard to find in the male infertility literature.” UT
Study patients
were operated
Antimicrobial prophylaxis,
Table
on at more than
C. difficile infection
4 0 0 d i f ferent
Radical
Radical
Radical
hospitals, and
cystectomy nephrectomy prostatectomy
the analyses also
determined that
Mean duration, antimi10.3
4.0
1.9
crobial prophylaxis (days)
hospital identity
was a major facPatients receiving
56.3%
28.8%
17.7%
extended antimicrobial
tor in extended
prophylaxis
a ntim icrobial
Rate of postoperative
use. Variation at
1.7%
0.23%
0.02%
C. difficile colitis
the hospital level was greatest
Source: Joshua Calvert, MPH, and John Gore, MD, MS
within the prostatectomy patient
group and least
possibility that C. difficile colitis rates are
prominent for radical cystectomy.
underreported, as the database does not capture
Calvert acknowledged that since the Premier infections that occurred after patient discharge.
Perspective Database represents a subset of In addition, while the definition for extended
American hospitals, the study results might not antimicrobial prophylaxis was designed to help
be fully generalizable to the entire nation. Nev- exclude patients who might have been receiving
ertheless, they are expected to be fairly represen- prolonged treatment because of a suspected or
tative of nationwide trends because the database existing infection, there is not granularity in the
encompasses a large, heterogeneous group of data to identify variables that could otherwise
hospitals and includes all patients regardless of explain ongoing antimicrobial treatment or that
payer.
might have increased patient risk for the hospiOther limitations of the study include the tal-acquired infection. UT
❳ UT
❲
UrologyTimes.com
∣
19
APRIL 15, 2015
Speak Out
Are you satisfied
the VA in Palo Alto, Santa Clara Valley
Medical Center, and Kaiser Santa Clara.
They’re all different in what they do for
infection, but as soon as anyone has a
contagious infection, they get put in
isolation with contact precautions.
In urology, the infections we deal
with most often postoperatively are
either skin infections or urinary tract
infections, like C. diff, which can occur
in outpatients who have had antibiot-
ics when they’re scheduled for surgery. Even a single dose of antibiotics can lead to a C. diff infection. At
Stanford, if a postoperative patient
has loose stools, a sample is almost
automatically sent off for testing.
From urology’s perspective, I
feel very comfortable with all the
hospitals.”
Dr. Zlatev
Dimitar Zlatev, MD
Stanford, CA
“F
or general infection control, I think the
hospital is operating the same way it did
5 to 10 years ago.
Hospitals are the worst place for people who
are not healthy; they harbor all the bad bacteria
of the world under one roof. That’s really been
part of the impetus to get surgical patients out
of the hospital quickly.
We see patients every day in clinic all day
with no precautions. We talk to patients, shake
hands, and the next day we see them at the
hospital to do a procedure and put on gloves,
gowns, and facemasks. It’s like, ‘Wait a minute,
if I have to do all this now, why didn’t I have to
do it 12 hours ago in the clinic?’ That’s the great
irony. Sure, it’s a problem with the multidrugresistant bacteria out there, but what’s being
done is probably appropriate for the problem.”
Join us at AUA booth # 309
Daniel Zapzalka, MD
St. Louis Park, MN
“I
’m not satisfied. We could all do better.
The actual source of the problem with
multidrug-resistant organisms is the community or ER physician. Community and ER physicians should determine if patients are symptomatic before prescribing antibiotics.
The other issue is the question of infections like Ebola. In the United States, everyone
travels. Subways and
airplanes are all enclosed
spaces, so if Ebola ever
became an epidemic
here in the United States,
it would be very problematic to contain it.
I don’t have an issue
putting my patients
Dr. Sonn
in the hospital. I don’t
hospitalize them unnecessarily, but there’s no
Ebola outbreak, so it’s not an issue right now.
A lot of multidrug-resistant organisms circulate in the hospital, although they’ve done
a great job the past few years with infection
control.”
Donald Sonn, MD
Helping physicians thoughtfully treat
their patients for over 25 years.
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20
❳Business of Urology❲
How to manage conflict
with patients
Effective communication is vital to managing disagreements
and preventng negative outcomes
S
aying no to a patient request can
be a challenge. Physicians strive to
maintain good relationships with
patients, while not wanting to agree
to anything not medically indicated. While
this is certainly not a new problem, it is likely
expanding due to inaccurate information on
the Internet, and direct-to-consumer advertising can increase patient requests for specific
things.
Patient encounters that often lead to hard
feelings can include denying a request for narcotics or antibiotics that are not warranted,
refusing a request for a prolonged excuse from
work, or declining to order costly tests that are
not needed.
Many experts say that good communication
is the key to managing these encounters in a
way that does not escalate into bad feelings,
anger, and poor patient outcomes.
Diffusing the situation
David A. Fleming, MD, president of the American College of Physicians, says he believes
conflict occurs because when the patient and
physician disagree, the patient feels vulnerable
and distressed.
Business
of Urology
❯❯PRACTICE MANAGEMENT
24 IPAs: Joining forces to retain
independence
❯❯LEGAL CONSULT
26 You’ve been sued for malpractice: Now
“We need to recognize the power differential
that is present,” Dr. Fleming said. “Patients are
often fearful and uncomfortable, and we need
to help them work through that.”
Dr. Fleming says he often knows when an
encounter is going to lead to conflict, and he
follows a few guidelines to diffuse it.
First, always remain professional. “Address
the patient respectfully. Don’t get reactive or
respond in an emotional way,” he said.
Next, be empathetic and compassionate but
do not be swayed from solid decision-making,
Dr. Fleming advises. Explain clearly the evidence-based practice guidelines you are following.
Third, support and inform the patient.
“Information can be powerful. Often conflict
arises because there is lack of communication
about the information that has been provided,
either from the patient giving information
to the physician or the physician convening
information back to the patient,” said Dr.
Fleming, who is also professor of medicine at
the University of Missouri School of Medicine, Columbia and chairs the department of
medicine and is director of the MU Center for
Health Ethics.
Always maintain a steady voice, use terminology patients can understand, and ensure they
understand what you have told them before they
leave, Dr. Fleming adds.
Catherine Hambley, PhD, an organizational
psychologist with LeapFrog Consulting, recommends evoking the teamwork nature of the
relationship at times like these.
“Say, ‘I am your partner in your care,’ ” she
advised. “Do not say ‘I am the doctor’ because
ultimately it is the patient who decides what
they are going to do about their health, not
you.”
what?
❯❯TECHNOLOGY
32 These EHR strategies can optimize your
workflow
❯❯PRACTICE FINANCES
34 Patient financing: How it helps your
patients and practice
❯❯MONEY MATTERS
38 Calculate risk/return with this time-tested
strategy
Calling them out
Robert A. Lee, MD, a family physician in
Johnston, IA, and a member of the board of
directors of the American Academy of Family Physicians, says that sometimes a physician
needs to call out a patient who is getting angry.
“Some people are just nasty and they don’t
get along with anyone, and you may just need to
call a spade a spade,” he said. “I may tell them
I know they have difficulties with relationships
and if they want this relationship to work, here’s
what I need from them and here’s what they
APRIL 15, 2015
∣
Urology Times
Practice Management
Beth Thomas Hertz
Beth Thomas Hertz is a contributing author for
Medical Economics, where this article first appeared.
can expect out of me. Open it up and have that
frank discussion.”
He uses pointed questions, such as asking
about their relationships with their co-workers
and their family. Do they have friends? Their
answers can be very revealing, to him as well
as to the patient. “When they start running
through this, they make the connection,” he
said.
Dr. Lee will sometimes say “you seem angry
with me today.” This puts the focus on him, not
them, which can lower their levels of offensiveness. “They may agree that they are being
demanding,” he said.
Diffusing the situation at the time helps avoid
patients developing the expectation that they
can demand whatever they want from him in
the future.
“Some of my most rewarding patient relationships started with us being at loggerheads,
but once we worked through it, they are very
loyal patients,” Dr. Lee said. “It feels great for
me to earn their trust and for them to know I
have their back.”
Wanted: An explanation
Arvind R. Cavale, MD, a specialist in diabetes
and endocrinology in Feasterville, PA, believes
that patients who express anger or frustration at
a denied request usually just want a thorough
explanation.
Patients often ask him for a medication they
saw advertised, such as testosterone. They complain that they are tired and the drug seems
like a solution. Sometimes their primary care
physician has even suggested testosterone and
referred the patient to him. He tests them for
low testosterone levels but often finds no justification for the medication. When this happens,
he often has to “go back to the basics.”
“I tell them everyone is tired. No one sleeps
well,” he said. “I ask them when was the last
time they felt well. It is important that I understand their issues because what they really want
is to feel better, not necessarily use a certain
medication.”
This can be time consuming, but asking
open-ended questions is the only way to get to
the heart of their actual problems. “Once we do
that, we can provide alternative options, in most
cases,” he said. “We need to give them a reason
to be optimistic when they leave.”
Please see CONFLICT, page 22
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CYSC20153154
22
C O N F L IC T
Preemptive policies
Jonathan Weiss, MD, an internist and pulmonary medicine specialist in Monticello, NY,
doesn’t see a great deal of conflict in his office.
He attributes at least part of that to his policy
of not prescribing narcotics for new patients
unless they have cancer.
“My office staff tells them this when they
call, so we set the expectations upfront that narcotics are not on the agenda,” he said. “I used to
engage in debates and negotiations about this
with patients, but having a general rule shortcircuits the whole conversation.”
Patients are told that Dr. Weiss is happy to
work with them to manage pain, of course, but
that he utilizes other approaches, such as physical therapy or referrals to an appropriate specialist, such as pain management, orthopedics,
or psychiatry.
“I would employ this policy in other areas of
my practice if I felt it was needed, but narcotics
is the area in which it most frequently arises,”
he said.
Insurance
Several physicians noted that insurance can also
be a factor when facing inappropriate patient
requests. While they are willing to fight to get
an approval for a legitimate patient need, they
do not want to expend the time and energy for
ones they do not think are necessary. They let
an insurance rejection speak for itself.
Matthew P. Finneran, MD, a family physician in Wadsworth, OH, finds that changes in
insurance can actually be helpful when denying
a request for tests that he feels are excessive.
“The economies of health care today make
it easier to insist on following evidence-based
guidelines,” he said. “Plus, with many patients
facing high deductibles, they are less adamant
about doing something they will have to pay
for.”
In fact, he sometimes finds this dynamic can
make conflict run in the opposite direction, as
some patients have to be convinced that a test is
worth the out-of-pocket expense they will face.
“This is always easier with a long-time
patient who knows and trusts me already,” he
said.
Train your staff
Some unhappy patients will attempt to talk a
staff member into giving them what they want.
Dr. Weiss says he tries to counsel his staff
to be as patient as possible when dealing with
such requests. He offers occasional pep talks
when staff morale seems to be flagging under
the pressure. He also offers to take a call off
the staff member’s hands if he is nearby and
APRIL 15, 2015
∣
Urology Times
Removing a patient from your practice?
Do it the right way
✓ Provide written notice
The physician should issue a written termination letter to the patient prior to the effective date of termination.
The letter should clearly state a termination date (we suggest 30 days in advance) and the reason for termination.
✓ Include a list of suitable alternative providers
The letter also should include a list of alternative health care providers in the area, and if appropriate, referral
to the patient’s insurance network.
✓ Time the termination properly
Avoid withdrawing from treating the patient when the patient is in medical crisis, unless the patient requires the
services of a different specialist and arrangements are made for transferring the patient’s care to such specialist.
✓ Examine managed care contracts and communicate with health plans
If you are a participating provider in a managed care network in which the patient is covered, contact the
payer, explain the situation, and ensure everything is done properly per the contract to prevent problems later.
✓ Provide record access
Offer to send a copy of the discharged patient’s medical records to the patient’s new doctor. Numerous states
have laws that require that records not be withheld solely because of a patient’s inability or refusal to pay.
✓ Communicate
Be sure to apprise all physicians and office staff members of the termination to avoid inadvertent
reestablishment of the physician-patient relationship.
Source: Eve Green Koopersmith, JD
feels the staff member is being particularly
challenged. “Sometimes, if I offer to talk, it
helps deflate the situation,” he said.
He understands that staff members need to
vent to each other sometimes, but encourages
them to do it in private so they can maintain a
happier face to the public. “We are not always
successful, but we do our best,” Dr. Weiss said.
Dr. Cavale says he works to instill his practice principles into his staff, and tries to empower them to interact with patients to the best of
their abilities.
“They can’t make everyone happy, but we
should try to help them as best we can,” he said.
“I remind the staff that the patient may have
other issues going on at home or work, and we
should try to give them as much leeway as we
can.”
Leaving the practice
Some patients will choose to leave a practice
if their requests are not granted. Most of the
physicians interviewed say they will help them
make arrangements to do so, if they want.
“Maybe they will find that someone with a
fresh eye will give them a different message,
but often they still will have the same issues,”
Dr. Lee said.
On occasion, Dr. Weiss has told patients that
they are welcome to find another physician if
they did not feel he was meeting their needs.
“This is usually a final play. Most do not take
me up on it,” he said.
Call a time out
Dr. Hambley says that, rarely, some patients
can get so upset with the physician that they
may be unable to continue the conversation in
a civil manner.
In those instances, she suggests the physician offer to go to see the next patient, giving
the distraught patient a few moments to gather
his or her thoughts before resuming the visit.
“Acknowledge their anger and stress that you
want to get on the same page,” she said. “If you
can really convey that message, it is much more
likely that you will develop a trusting relationship in the future.”
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APRIL 15, 2015
IPAs: Joining forces
to retain independence
Independent physician associations can help you meet
business challenges, but do your homework first
T
he steady drumbeat of reports about
health systems, hospitals, insurance
payers, and other corporate entities
buying up independent practices
may give you pause. A growing number of
physicians are responding to the changing
reimbursement and regulatory landscape by
opting for alternatives to traditional independent practice arrangements; indeed, the “2014
Survey of America’s Physicians” by the Physicians Foundation, an advocacy group, found
that 53% of physicians were hospital or medical
group employees compared with 44% in 2012
and 38% in 2008.
The steady drumbeat of reports about health
systems, hospitals, insurance payers, and other
corporate entities buying up independent practices may give you pause. A growing number of
physicians are responding to the changing reimbursement and regulatory landscape by opting
for alternatives to traditional independent practice arrangements; indeed, the “2014 Survey of
America’s Physicians” by the Physicians Foundation, an advocacy group, found that 53% of physicians were hospital or medical group employees
compared with 44% in 2012 and 38% in 2008.
Between the challenges of keeping up with
government incentive programs, payers’ threats
to eject you from their networks, and declining
reimbursement, is it even possible to operate
independently any longer?
If you’re an independent physician, employment may appear to be the only sensible route
out of this turbulence. If employment is right
for you, then by all means, explore it. However,
if you want to retain your independence but
also be sheltered from the storm, joining an
independent physician association (IPA) may
be your best option.
IPA benefits
An IPA is an association of independent physicians. It offers members a way to improve cooperation with insurance companies and reduce
the administrative burdens of negotiating payer
contracts, while continuing to maintain independent practices, and, importantly, make their
own decisions about reimbursement.
“Another major benefit from being a part of an
IPA is that it can assist in keeping physicians and
offices from being isolated because a good IPA
can also provide access to networking, resources,
education, and training that would otherwise
be difficult to obtain,” said Ann Bellah, MBA,
executive director of Pueblo Health Care, an IPA
with 265 physicians in southern Colorado.
An IPA may be an association, but there is
nothing casual about its structure as a legal
entity. An IPA may be structured as a nonprofit
entity, a limited liability company, a corporation,
or other type of shareholder-owned entity. The
structure of most IPAs also allows participating
members to continue caring for patients outside
of the contracts the IPA maintains with payers.
An August 2013 study published in Health
Affairs reveals that 24% of small-to-mediumsized practices participate in an IPA or a physician hospital organization (PHO), a similar
model that includes a hospital. Typically tied to
a specific geographic location, an IPA enables
independent physicians to exert greater influence over contract terms in a marketplace typically dominated by a handful of payers, but not
∣
Urology Times
Practice Management
Elizabeth Woodcock, MBA, FACMPE,
CPC, and Casey Crotty
Elizabeth Woodcock, MBA,
FACMPE, CPC
(pictured) is a consultant,
speaker, trainer, and author
with Woodcock & Associates in
Atlanta. Casey Crotty is chief
executive officer of Suan Juan
IPA in New Mexico.
infrequently by just one payer.
While IPAs come in all shapes and sizes, they
nearly always bring an important value proposition to their members: negotiating power for
contracting. Particularly in the western United
States, IPAs negotiate risk-bearing, capitated
medical services agreements on behalf of their
members, working as an entity somewhat akin to
a health maintenance organization. Many IPAs,
especially those that are clinically integrated,
have already converted to an accountable care
organization (ACO) or provide the infrastructure for their members to organize as one.
Because many of these organizations have
Questions to ask before
joining an IPA
Physicians should consider many factors before joining an IPA. They include: how long the association has existed,
its track record, member benefits, resources, and even less-quantifiable factors such as the opportunities IPA
membership may offer for networking with other physicians.
“The reputation, competence, and trustworthiness of the IPA staff are important, of course, but is that staff
accessible to the members—available for questions and assistance, and responsive to requests?” said Ann Bellah,
the executive director of Pueblo Health Care in Colorado.
Q. What is the legal structure of the IPA? If forprofit, how are shares distributed?
Q. How is the IPA’s Board of Governance structured? How many board members and of
what specialties? What is the makeup of the
executive leadership?
Q. Does the IPA negotiate payer contracts on
behalf of its members? If so, how is negotiation for reimbursement handled among the
member, the payer, and the IPA?
Q. Is the IPA considered an “exclusive” or “non-
IPA? Are there different membership levels
or classifications?
exclusive” organization? Do the members
have the opportunity to participate in all,
some, or none of the payer contracts? Are
members able to affiliate with other networks as well?
Q. Does the IPA require a complete integration
Q. What are the services offered by the IPA? Are
Q. What are the dues and obligations to join the
of the medical practices or participants? If so,
how does the IPA define “integration”? What
other contractual obligations are there?
these services included with membership or
do they require additional fees?
UrologyTimes.com
∣
25
APRIL 15, 2015
already operated as risk-bearing provider
networks, IPAs are well positioned to take
leading roles in developing ACOs or acting
as sustaining member organizations. Even if
the physician organization has operated in a
fee-for-service environment, an IPA can bring
expertise regarding contracting, analytics, and
management.
In addition to payer relations, an IPA may
offer management services organization (MSO)
amenities such as payroll, bookkeeping, benefits management, group purchasing, and compliance. The IPA can serve as the information
technology platform for all automation, often
offering the capability of connecting disparate
EHR technology, or perhaps just linking practices with a data warehouse. These administrative services can be shared across the IPA
membership, thereby reducing costs for individual members.
For those who think employment or affiliation with a hospital or health system requires
surrendering too much control, an IPA may
offer a viable alternative. An IPA structured as
a risk-bearing entity can be especially useful to
physicians who may want to participate in risk
contracts but don’t have the time or administrative support to hammer out the many details
required for such arrangements.
Using an IPA, physicians can work directly
with payers on reimbursement issues pertinent
to their practices—even opt out of a risk contract
arrangement—while maintaining access to the
IPA’s menu of other administrative services.
While IPAs may bring substantial advantages from a contracting and administrative perspective, the most powerful opportunity may
be their unique position in the changing health
care landscape. The director of care coordination for the Connecticut State Medical SocietyIPA, Inc., a statewide IPA with 7,000 physician
members, Kelly Ann Pappa, RN, agrees.
“No truer an expression than ‘there is
strength in numbers,’ ” Pappa said. “IPA members expect to provide a high level of service
on behalf of their patients; however, many
providers feel overwhelmed by the myriad of
administrative regulations and reporting criteria that they must meet in order to receive
just compensation for the quality of care that
they deliver.”
IPAs may offer the opportunity to participate
in quality programs that reward improved outcomes that are often not otherwise available to
the independent or solo practitioner.
Critical to the achievement of success in
these programs and practice transformation is
the improved communication, coordination,
and resource sharing brought by the IPA. With
an engaged membership, an IPA can serve as
the platform for independent practices to participate in coordinated care. An IPA can provide
the infrastructure for physicians in small-to-
medium-size practices to make unified efforts
to coordinate care by gathering, analyzing, and
reporting quality data across the continuum of
patients’ care; and effectively deploying population health management strategies.
In supporting initiatives to coordinate care,
IPAs can also:
develop protocols for point-of-care clinical
decision support
send reminders to patients for recommended preventive or follow-up care
r
r
r
r
use registries to monitor patients with
chronic illnesses
employ or contract with nurses to serve as
patient care managers.
Connecticut State Medical Society (CSMS)IPA, Inc., for example, provides opportunities
for its member physicians to use value-added
services that improve the quality and costeffectiveness of their care and receive additional compensation from payers for their efforts.
Please see IPAS, page 26
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26
You’ve been sued for
malpractice: Now what?
If you are faced with a lawsuit, here are five concrete steps to take
B
eing sued for malpractice, especially for the first time, can be an
unsettling and frustrating experience. The consequences of a lost
case can range from an increase in future insurance premiums to a health department investigation, which could affect your license. So
it is imperative that you immediately report a
malpractice claim to your professional liability
insurance carrier and retain an attorney specializing in the defense of medical malpractice
cases in order to protect your interests.
With so much at stake, it is very important
that you work closely with your attorney to
defend the claim. A collaboration with your
attorney will afford you the best opportunity
to obtain favorable results. To that end, here
are a few suggestions that we believe will be
IPA S
Recent relationships established with commercial payers bring CSMS-IPA, Inc. members
additional compensation for attesting to predetermined metrics.
Regardless of the specific services an IPA
provides, its presence enables independent
physicians to leverage their data to build busi-
particularly helpful in forging that relationship
effectively.
Meet with your attorney early
Experience shows that meeting with a lawyer
within 2 weeks of the commencement of the
lawsuit is important. If you have never been
sued before, this early meeting is an opportunity for the lawyer to explain the litigation
process to you.
This meeting also provides you with the
opportunity to explain to the lawyer the medical care that was provided to the patient. The
patient’s record can be reviewed and you can
relay information that may not be contained in
the record. All information about the patient
and his or her family, the care rendered by you
and other defendants, if any, is important.
ness intelligence about their patients’ care.
The Health Affairs study offers quantifiable
proof of this value: physicians participating in
IPAs or PHOs provided approximately three
times as many care management processes for
their patients with chronic conditions as did
nonparticipating practices: 10.45% compared
with 3.85%, according to the survey of 1,164
practices with 20 or fewer physicians.
That said, IPAs are not for everyone. Not all
IPAs are created equal; some may have grown
Considerations before
joining an IPA
Anti-trust considerations
Many IPAs can face antitrust issues because they
include competing health care providers, says Peter
Pavarini, JD, partner at Squire Patton Boggs LLP in
Columbus, OH.
“There are no fixed limits on IPA size; however,
Federal Trade Commission and Department of
Justice guidelines and policy statements define
safety zones in terms of percentages of competing
physicians [by specialty] who are included in an
IPA, ACO (accountable care organization), or other
kind of provider network. Non-exclusive networks
can generally be larger than exclusive networks,”
Pavarini said.
ACO conversion
A growing number of IPAs are converting to ACOs,
a structure requiring more formal legal, management, and leadership structure, along with shared
savings arrangements between providers and payers.
Find out if the IPA you are considering is making this
change before joining.
Do your homework
Check with legal counsel before signing on to an IPA
to make sure it abides by antitrust and price fixing
laws, and also to ensure its management fees are
reasonable, says Alan S. Gassman, JD, of Gassman
Law Associates P.A. in Clearwater, FL.
APRIL 15, 2015
∣
Urology Times
Legal Consult
Richard C. Baker, JD
Richard C. Baker, JD, is a partner at Meiselman,
Packman, Nealon, Scialabba & Baker, P.C., in White
Plains, NY.
Meeting early also means that your recollection of the events may be sharper than if the
meeting is delayed for months.
Prepare for your deposition
A deposition is a question and answer session
conducted under oath. The lawyer for the plaintiff asks you questions. It is one of the most critical parts of the litigation process. You cannot
win your case at your deposition, but you can
damage your chances for a favorable outcome.
Your preparation has two major components.
The first is that you review in detail all your
records, including any hospital records where
you participated in the patient’s treatment.
The second is to meet with your lawyer for an
Please see MALPRACTICE, page 27
too quickly and do not have a sufficiently
experienced management team in place. The
number of processes and tasks tied in with
information technology—not to mention the
swift pace of change in the field—means that
the technology solutions an IPA offers may
outpace, or lag behind, its members’ needs, or
willingness to pay. Some physicians may feel
out of step with their IPA’s approach to customer service quality, marketing, or internal
communications.
In addition, an IPA does not free its physician
members from all of the time commitments and
responsibilities of maintaining the business of
a medical practice.
Not all markets have IPAs, and the ones that
do vary in scope and services. If there is an IPA
in your market, evaluate the benefits of joining.
Contact colleagues who have joined the IPA,
probing them for both the qualitative and quantitative benefits they receive. Recognize the
contracting opportunities, but compare them
to what you already receive.
In other words, do your homework before
proceeding with an IPA affiliation. Get the IPA
agreement for membership in writing. Before
you join, consult a health care attorney to
review the contract and all relevant documents.
The IPA model is gaining new attention as
more physicians look for ways to stay in independent private practice yet not feel forced to
sail today’s blustery seas completely alone. An
IPA may just be your perfect shelter from the
storm.
UrologyTimes.com
∣
27
APRIL 15, 2015
M A L PR AC T ICE
ration was more focused and comprehensive
than the plaintiff attorney’s questions.
Attend depositions
extensive discussion of the medicolegal issues.
Except in the rarest of cases, it is not sufficient
to meet briefly with your attorney immediately
prior to your deposition.
It is often best to meet 3 or 4 days in advance.
An early meeting provides time to brush up on any
loose ends, and a meeting relatively close to the
deposition will keep the matter fresh in your mind.
At that time, you and your lawyer will extensively examine the issues that will be the focus
of the deposition. He or she can help you phrase
your answers to be concise and accurate.
Thorough preparation will be evident to the
attorney for the plaintiff and you will be sending a message that you are serious about defending yourself. You should be so well prepared
that at the end of your deposition, you will be in
a position to tell your attorney that your prepa-
You have a right to be present at all depositions
in your case. Physicians often do not attend other-party depositions for many reasons, starting
with the fact that it is, of course, time away from
the practice.
On occasion, however, your presence might
be helpful. There is no more forceful motivation for the witness to tell the
truth than having you present in the room and being in
a position to immediately
notify your attorney when
you believe the plaintiff’s
responses are inaccurate
or untrue. Whether present
or not, ask for copies of all
transcripts of the depositions.
Common reasons for malpractice lawsuits
➤ Lack of informed consent
It’s essential to verbally communicate the risks before a procedure, not after—and
to include this information in a written consent form that the patient signs. The
patient must receive a proper explanation of the form’s purpose that clearly spells
out the risks inherent in the procedure.
➤ Faulty communication
Honest and open communication is the best approach; that’s why it’s often referred
to as “disclosure.” When patients feel that health care providers genuinely care and
have their best interests in mind, they tend to be more forgiving of errors.
➤ Failure to stay up-to-date on standards and training
Physicians also need to be aware of new and revised developments in their areas
of practice and specialties. This includes changes in disease management for acute
and chronic conditions, technological innovations, recently published research, and
practice standards.
➤ Inadequate follow-up of diagnostic tests and specialist
referrals
Problems resulting in litigation involve physician orders for tests and the corresponding lab or x-ray results, such as when test results aren’t received by the
physician, patients don’t follow through with tests as directed, or the results are
filed away and the patient isn’t briefed.
➤ Variations in policies and procedures
Policies and procedures should be specific and readily available to all staff members.
They can be kept in a notebook or manual or in an electronic format that is easy for
the office staff to access. Physicians should review policies and procedures on an
annual basis to ensure that they reflect preferences and requirements.
➤ Avoidance behavior
Compassionate gestures count. If a hospitalized patient has a bad outcome, some
physicians may avoid making rounds in the presence of relatives. Don’t be afraid to face
them. It’s important to let them know you understand how they feel. Make eye contact
with whomever you’re addressing and put a comforting hand on the individual’s arm.
Select witnesses
Your lawyer should know what he or she is looking for in selecting an expert witness, but your
insight on the case should be considered as well.
Keep in contact with your lawyer
Ask for status reports on what is happening.
While it may be convenient to put the lawsuit
out of your mind, you should not ignore it.
Unfortunately, malpractice lawsuits rarely just
go away.
Second-line therapy for your adult
overactive bladder (OAB) patients
After the prescription you write
Turn to one you perform.
injection
To learn more about BOTOX® visit
www.botoxforoab.com/hcp
If you would like to be contacted by a BOTOX® representative,
please call 1-800-44-BOTOX, Option 1
Indication
Overactive Bladder
BOTOX® for injection is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and
frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
Warning: Distant Spread of Toxin Effect
Postmarketing reports indicate that the effects of BOTOX® and all botulinum toxin products may spread from the area of injection to
produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia,
ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported
hours to weeks after injection. Swallowing and breathing difficulties can be life threatening, and there have been reports of death.
The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for
spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to
these symptoms. In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have
been reported at doses comparable to those used to treat cervical dystonia and at lower doses.
Please see the adjacent page for additional Important Safety Information.
IMPORTANT SAFETY INFORMATION (cont.)
CONTRAINDICATIONS
BOTOX® (onabotulinumtoxinA) is contraindicated in the presence
of infection at the proposed injection site(s) and in individuals with
known hypersensitivity to any botulinum toxin preparation or to any
of the components in the formulation.
Intradetrusor injection of BOTOX® is contraindicated in patients
with overactive bladder who have a urinary tract infection (UTI),
in patients with urinary retention, and in patients with postvoid residual (PVR) urine volume >200 mL who are not routinely
performing clean intermittent self-catheterization (CIC).
WARNINGS AND PRECAUTIONS
Lack of Interchangeability Between Botulinum Toxin Products
The potency Units of BOTOX® are specific to the preparation and
assay method utilized. They are not interchangeable with other
preparations of botulinum toxin products and, therefore, units of
biological activity of BOTOX® cannot be compared to nor converted
into units of any other botulinum toxin products assessed with any
other specific assay method.
Spread of Toxin Effect
See Boxed Warning.
Injections in or Near Vulnerable Anatomic Structures
Care should be taken when injecting in or near vulnerable anatomic
structures. Serious adverse events including fatal outcomes have
been reported in patients who had received BOTOX® injected directly
into salivary glands, the oro-lingual-pharyngeal region, esophagus
and stomach. Some patients had pre-existing dysphagia or significant
debility. (Safety and effectiveness have not been established for
indications pertaining to these injection sites.) Pneumothorax
associated with injection procedure has been reported following
the administration of BOTOX® near the thorax. Caution is warranted
when injecting in proximity to the lung, particularly the apices.
Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been
reported. These reactions include anaphylaxis, serum sickness,
urticaria, soft-tissue edema, and dyspnea. If such a reaction
occurs, further injection of BOTOX® should be discontinued and
appropriate medical therapy immediately instituted. One fatal case
of anaphylaxis has been reported in which lidocaine was used as
the diluent, and consequently the causal agent cannot be reliably
determined.
Pre-existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic
lateral sclerosis, or neuromuscular junctional disorders (eg,
myasthenia gravis or Lambert-Eaton syndrome) should be
monitored particularly closely when given botulinum toxin. Patients
with neuromuscular disorders may be at increased risk of clinically
significant effects including severe dysphagia and respiratory
compromise from therapeutic doses of BOTOX®.
Urinary Tract Infections in Patients With Overactive Bladder
BOTOX® increases the incidence of urinary tract infection. Clinical
trials for overactive bladder excluded patients with more than
2 UTIs in the past 6 months and those taking antibiotics chronically
due to recurrent UTIs. Use of BOTOX® for the treatment of overactive
bladder in such patients and in patients with multiple recurrent UTIs
during treatment should only be considered when the benefit is
likely to outweigh the potential risk.
Urinary Retention in Patients Treated for Overactive Bladder
Due to the risk of urinary retention, treat only patients who are willing
and able to initiate catheterization post-treatment, if required, for
urinary retention.
In patients who are not catheterizing, post-void residual (PVR) urine
volume should be assessed within 2 weeks post-treatment and
periodically as medically appropriate up to 12 weeks, particularly
in patients with multiple sclerosis or diabetes mellitus. Depending
on patient symptoms, institute catheterization if PVR urine volume
exceeds 200 mL and continue until PVR falls below 200 mL. Instruct
patients to contact their physician if they experience difficulty in
voiding as catheterization may be required.
In clinical trials, 6.5% of patients (36/552) initiated clean intermittent
catheterization for urinary retention following treatment with
BOTOX® (onabotulinumtoxinA) 100 Units as compared to 0.4%
of patients (2/542) treated with placebo.The median duration of
catheterization for these patients treated with BOTOX® 100 Units
was 63 days (minimum 1 day to maximum 214 days) as compared
to a median duration 11 days (minimum 3 days to maximum
18 days) for patients receiving placebo.
Patients with diabetes mellitus treated with BOTOX® were more
likely to develop urinary retention than non-diabetics. In clinical
trials, 12.3% of patients with diabetes (10/81) developed urinary
retention following treatment with BOTOX® 100 Units as compared
to 0% of patients (0/69) treated with placebo. In patients without
diabetes, 6.3% of patients (33/526) developed urinary retention
following treatment with BOTOX® 100 Units as compared to
0.6% of patients (3/516) treated with placebo.
Human Albumin and Transmission of Viral Diseases
This product contains albumin, a derivative of human blood.
Based on effective donor screening and product manufacturing
processes, it carries an extremely remote risk for transmission of
viral diseases. A theoretical risk for transmission of CreutzfeldtJakob disease (CJD) is also considered extremely remote. No cases
of transmission of viral diseases or CJD have ever been reported
for albumin.
ADVERSE REACTIONS
The following adverse reactions to BOTOX® for injection are
discussed in greater detail in the following sections: Spread of
Toxin Effect (see Boxed Warning), Hypersensitivity Reactions (see
Contraindications and Warnings and Precautions), and Urinary
Retention in Patients treated for Overactive Bladder (see Warnings
and Precautions).
The most frequently reported adverse reactions for overactive
bladder occurring within 12 weeks of injection include urinary tract
infection (BOTOX® 18%, placebo 6%), dysuria (BOTOX® 9%, placebo
7%), urinary retention (BOTOX® 6%, placebo 0%), bacteriuria
(BOTOX® 4%, placebo 2%), and residual urine volume (BOTOX® 3%,
placebo 0%).
A higher incidence of urinary tract infection was observed in
patients with diabetes mellitus treated with BOTOX® 100 Units and
placebo than non-diabetics.
The incidence of UTI increased in patients who experienced a
maximum post-void residual (PVR) urine volume ≥200 mL following
BOTOX® injection compared to those with a maximum PVR <200 mL
following BOTOX® injection, 44% versus 23%, respectively.
Post Marketing Experience
There have been spontaneous reports of death, sometimes
associated with dysphagia, pneumonia, and/or other significant
debility or anaphylaxis, after treatment with botulinum toxin. There
have also been reports of adverse events involving the cardiovascular
system, including arrhythmia and myocardial infarction, some with
fatal outcomes. Some of these patients had risk factors including
cardiovascular disease. The exact relationship of these events to
the botulinum toxin injection has not been established.
DRUG INTERACTIONS
Co-administration of BOTOX® and aminoglycosides or other agents
interfering with neuromuscular transmission (eg, curare-like
compounds) should only be performed with caution as the effect
of the toxin may be potentiated. Use of anticholinergic drugs after
administration of BOTOX® may potentiate systemic anticholinergic
effects. The effect of administering different botulinum neurotoxin
products at the same time or within several months of each
other is unknown. Excessive neuromuscular weakness may
be exacerbated by administration of another botulinum toxin
prior to the resolution of the effects of a previously administered
botulinum toxin. Excessive weakness may also be exaggerated by
administration of a muscle relaxant before or after administration
of BOTOX®.
For more information on BOTOX®, please see brief summary of
Prescribing Information on the following pages.
©2013 Allergan, Inc., Irvine, CA 92612 ® marks owned by Allergan, Inc.
www.botoxforoab.com/hcp 1-800-44-BOTOX APC00UU13
BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION
BOTOX® (onabotulinumtoxinA) for injection for intradetrusor use
WARNING: DISTANT SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that the effects of BOTOX and all botulinum toxin
products may spread from the area of injection to produce symptoms consistent with
botulinum toxin effects. These may include asthenia, generalized muscle weakness,
diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing
difficulties. These symptoms have been reported hours to weeks after injection.
Swallowing and breathing difficulties can be life threatening and there have been
reports of death. The risk of symptoms is probably greatest in children treated for
spasticity but symptoms can also occur in adults treated for spasticity and other
conditions, particularly in those patients who have an underlying condition that would
predispose them to these symptoms. In unapproved uses, including spasticity in
children, and in approved indications, cases of spread of effect have been reported at
doses comparable to those used to treat cervical dystonia and at lower doses. [See
Warnings and Precautions]
Overactive Bladder
BOTOX (onabotulinumtoxinA) for injection is indicated for the treatment of overactive
bladder with symptoms of urge urinary incontinence, urgency, and frequency, in adults
who have an inadequate response to or are intolerant of an anticholinergic medication.
CONTRAINDICATIONS
Known Hypersensitivity to Botulinum Toxin
BOTOX is contraindicated in patients who are hypersensitive to any botulinum toxin
preparation or to any of the components in the formulation [see Warnings and Precautions].
Infection at the Injection Site(s)
BOTOX is contraindicated in the presence of infection at the proposed injection site(s).
Urinary Tract Infection or Urinary Retention
Intradetrusor injection of BOTOX is contraindicated in patients with overactive bladder
who have a urinary tract infection. Intradetrusor injection of BOTOX is also contraindicated
in patients with urinary retention and in patients with post-void residual (PVR) urine
volume >200 mL, who are not routinely performing clean intermittent self-catheterization
(CIC).
Lack of Interchangeability between Botulinum Toxin Products
The potency Units of BOTOX are specific to the preparation and assay method utilized.
They are not interchangeable with other preparations of botulinum toxin products and,
therefore, units of biological activity of BOTOX cannot be compared to nor converted into
units of any other botulinum toxin products assessed with any other specific assay method.
Spread of Toxin Effect
Postmarketing safety data from BOTOX and other approved botulinum toxins suggest
that botulinum toxin effects may, in some cases, be observed beyond the site of local
injection. The symptoms are consistent with the mechanism of action of botulinum toxin
and may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia,
dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms
have been reported hours to weeks after injection. Swallowing and breathing difficulties
can be life threatening and there have been reports of death related to spread of toxin
effects. The risk of symptoms is probably greatest in children treated for spasticity but
symptoms can also occur in adults treated for spasticity and other conditions, and
particularly in those patients who have an underlying condition that would predispose
them to these symptoms. In unapproved uses, including spasticity in children, and in
approved indications, symptoms consistent with spread of toxin effect have been
reported at doses comparable to or lower than doses used to treat cervical dystonia.
Patients or caregivers should be advised to seek immediate medical care if swallowing,
speech or respiratory disorders occur.
Injections In or Near Vulnerable Anatomic Structures
Care should be taken when injecting in or near vulnerable anatomic structures. Serious
adverse events including fatal outcomes have been reported in patients who had received
BOTOX injected directly into salivary glands, the oro-lingual-pharyngeal region, esophagus
and stomach. Safety and effectiveness have not been established for indications pertaining
to these injection sites. Some patients had pre-existing dysphagia or significant debility.
Pneumothorax associated with injection procedure has been reported following the
administration of BOTOX near the thorax. Caution is warranted when injecting in proximity
to the lung, particularly the apices.
Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported. These reactions
include anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea. If such a
reaction occurs, further injection of BOTOX should be discontinued and appropriate medical
therapy immediately instituted. One fatal case of anaphylaxis has been reported in which
lidocaine was used as the diluent, and consequently the causal agent cannot be reliably
determined.
Pre-Existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or
neuromuscular junction disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome)
should be monitored particularly closely when given botulinum toxin. Patients with
neuromuscular disorders may be at increased risk of clinically significant effects
including severe dysphagia and respiratory compromise from therapeutic doses of
BOTOX [see Adverse Reactions].
Urinary Tract Infections in Patients with Overactive Bladder
BOTOX increases the incidence of urinary tract infection [see Adverse Reactions]. Clinical
trials for overactive bladder excluded patients with more than 2 UTIs in the past 6 months
and those taking antibiotics chronically due to recurrent UTIs. Use of BOTOX for the
treatment of overactive bladder in such patients and in patients with multiple recurrent
UTIs during treatment should only be considered when the benefit is likely to outweigh
the potential risk.
Urinary Retention in Patients Treated for Bladder Dysfunction
Due to the risk of urinary retention, treat only patients who are willing and able to initiate
catheterization post-treatment, if required, for urinary retention.
In patients who are not catheterizing, post-void residual (PVR) urine volume should be
assessed within 2 weeks post-treatment and periodically as medically appropriate up to
12 weeks, particularly in patients with multiple sclerosis or diabetes mellitus. Depending
on patient symptoms, institute catheterization if PVR urine volume exceeds 200 mL and
continue until PVR falls below 200 mL. Instruct patients to contact their physician if they
experience difficulty in voiding as catheterization may be required.
The incidence and duration of urinary retention is described below for patients with
overactive bladder who received BOTOX or placebo injections.
Overactive Bladder
In double-blind, placebo-controlled trials in patients with OAB, the proportion of subjects
who initiated clean intermittent catheterization (CIC) for urinary retention following
treatment with BOTOX or placebo is shown in Table 1. The duration of post-injection
catheterization for those who developed urinary retention is also shown.
Table 1: Proportion of Patients Catheterizing for Urinary Retention and Duration of
Catheterization following an injection in double-blind, placebo-controlled clinical trials
in OAB
BOTOX 100 Units
Placebo
Timepoint
(N=552)
(N=542)
Proportion of Patients Catheterizing for Urinary Retention
At any time during complete treatment cycle
6.5% (n=36)
0.4% (n=2)
Duration of Catheterization for Urinary Retention (Days)
Median
63
11
Min, Max
1, 214
3, 18
Patients with diabetes mellitus treated with BOTOX were more likely to develop urinary
retention than those without diabetes, as shown in Table 2.
Table 2. Proportion of Patients Experiencing Urinary Retention following an injection
in double-blind, placebo-controlled clinical trials in OAB according to history of
Diabetes Mellitus
Patients with Diabetes
Patients without Diabetes
BOTOX 100 Units
Placebo
BOTOX 100 Units
Placebo
(N=81)
(N=69)
(N=526)
(N=516)
Urinary retention
12.3% (n=10)
0
6.3% (n=33)
0.6% (n=3)
Human Albumin and Transmission of Viral Diseases
This product contains albumin, a derivative of human blood. Based on effective donor
screening and product manufacturing processes, it carries an extremely remote risk for
transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob
disease (CJD) is also considered extremely remote. No cases of transmission of viral
diseases or CJD have ever been reported for albumin.
ADVERSE REACTIONS
The following adverse reactions to BOTOX (onabotulinumtoxinA) for injection are
discussed in greater detail in other sections of the labeling:
H &=?2.1<3'<E6;3320A@[see Warnings and Precautions]
H F=2?@2;@6A6C6AF[see Contraindications and Warnings and Precautions]
H (?6;.?F%2A2;A6<;6;$.A62;A@'?2.A213<?9.112?F@3B;0A6<;[see Warnings and
Precautions]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the adverse reaction
rates observed in the clinical trials of a drug cannot be directly compared to rates in the
clinical trials of another drug and may not reflect the rates observed in clinical practice.
BOTOX and BOTOX Cosmetic contain the same active ingredient in the same formulation,
but with different labeled Indications and Usage. Therefore, adverse reactions observed
with the use of BOTOX Cosmetic also have the potential to be observed with the use of
BOTOX.
In general, adverse reactions occur within the first week following injection of BOTOX and
while generally transient, may have a duration of several months or longer. Localized
pain, infection, inflammation, tenderness, swelling, erythema, and/or bleeding/bruising
may be associated with the injection. Needle-related pain and/or anxiety may result in
vasovagal responses (including e.g., syncope, hypotension), which may require
appropriate medical therapy.
Local weakness of the injected muscle(s) represents the expected pharmacological action
<3/<AB96;B:A<E6;<D2C2?D2.8;2@@<3;2.?/F:B@092@:.F.9@<<00B?1B2A<@=?2.1
of toxin [see Warnings and Precautions].
Overactive Bladder
Table 3 presents the most frequently reported adverse reactions in double-blind, placebocontrolled clinical trials for overactive bladder occurring within 12 weeks of the first
BOTOX treatment.
Table 3: Adverse Reactions Reported by ≥2% of BOTOX treated Patients and More Often
than in Placebo-treated Patients Within the First 12 Weeks after Intradetrusor Injection,
in Double-blind, Placebo-controlled Clinical Trials in Patients with OAB
BOTOX
Placebo
100 Units
(N=542)
Adverse Reactions
(N=552)
Urinary tract infection
99 (18%)
30 (6%)
Dysuria
50 (9%)
36 (7%)
Urinary retention
31 (6%)
2 (0%)
Bacteriuria
24 (4%)
11 (2%)
Residual urine volume*
17 (3%)
1 (0%)
*Elevated PVR not requiring catheterization. Catheterization was required for PVR ≥350 mL
regardless of symptoms, and for PVR ≥200 mL to <350 mL with symptoms (e.g., voiding
difficulty).
A higher incidence of urinary tract infection was observed in patients with diabetes
mellitus treated with BOTOX 100 Units and placebo than in patients without diabetes, as
shown in Table 4.
Table 4: Proportion of Patients Experiencing Urinary Tract Infection following an
Injection in Double-blind, Placebo-controlled Clinical Trials in OAB according to history
of Diabetes Mellitus
Patients with Diabetes
Patients without Diabetes
BOTOX
BOTOX
100 Units
Placebo
100 Units
Placebo
(N=81)
(N=69)
(N=526)
(N=516)
Urinary tract infection
25 (31%)
8 (12%)
135 (26%)
51 (10%)
(UTI)
The incidence of UTI increased in patients who experienced a maximum post-void
residual (PVR) urine volume ≥200 mL following BOTOX injection compared to those with
a maximum PVR <200 mL following BOTOX injection, 44% versus 23%, respectively. No
change was observed in the overall safety profile with repeat dosing during an openlabel, uncontrolled extension trial.
Immunogenicity
As with all therapeutic proteins, there is a potential for immunogenicity. Formation of
neutralizing antibodies to botulinum toxin type A may reduce the effectiveness of BOTOX
treatment by inactivating the biological activity of the toxin.
In a long term, open-label study evaluating 326 cervical dystonia patients treated for an
average of 9 treatment sessions with the current formulation of BOTOX, 4 (1.2%) patients
had positive antibody tests. All 4 of these patients responded to BOTOX therapy at the
time of the positive antibody test. However, 3 of these patients developed clinical
resistance after subsequent treatment, while the fourth patient continued to respond to
BOTOX therapy for the remainder of the study.
One patient among the 445 hyperhidrosis patients (0.2%), two patients among the 380
adult upper limb spasticity patients (0.5%), no patients among 406 migraine patients, no
patients among 615 overactive bladder patients, and no patients among 475 detrusor
overactivity associated with a neurologic condition patients with analyzed specimens
developed the presence of neutralizing antibodies.
The data reflect the patients whose test results were considered positive or negative for
neutralizing activity to BOTOX in a mouse protection assay. The results of these tests are
highly dependent on the sensitivity and specificity of the assay. Additionally, the observed
incidence of antibody (including neutralizing antibody) positivity in an assay may be
influenced by several factors including assay methodology, sample handling, timing of
sample collection, concomitant medications, and underlying disease. For these reasons,
comparison of the incidence of neutralizing activity to BOTOX with the incidence of
antibodies to other products may be misleading.
The critical factors for neutralizing antibody formation have not been well characterized.
The results from some studies suggest that BOTOX injections at more frequent intervals
or at higher doses may lead to greater incidence of antibody formation. The potential for
antibody formation may be minimized by injecting with the lowest effective dose given at
the longest feasible intervals between injections.
Post-Marketing Experience
The following adverse reactions have been identified during post-approval use of BOTOX.
Because these reactions are reported voluntarily from a population of uncertain size, it is
not always possible to reliably estimate their frequency or establish a causal relationship
to drug exposure. These reactions include: abdominal pain; alopecia, including madarosis;
anorexia; aspiration pneumonia; brachial plexopathy; denervation/muscle atrophy; diarrhea;
dry mouth; dysarthria; dyspnea; facial palsy; facial paresis; hyperhidrosis; hypoacusis;
hypoaesthesia; localized numbness; malaise; muscle weakness; myalgia; myasthenia
gravis; nausea; paresthesia; peripheral neuropathy; pruritus; pyrexia; radiculopathy;
respiratory depression and/or respiratory failure; skin rash (including erythema
multiforme, dermatitis psoriasiform, and psoriasiform eruption); strabismus; syncope;
tinnitus; vertigo; vision blurred; visual disturbances; and vomiting.
There have been spontaneous reports of death, sometimes associated with dysphagia,
pneumonia, and/or other significant debility or anaphylaxis, after treatment with
botulinum toxin [see Warnings and Precautions].
There have also been reports of adverse events involving the cardiovascular system,
including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these
patients had risk factors including cardiovascular disease. The exact relationship of these
events to the botulinum toxin injection has not been established.
New onset or recurrent seizures have also been reported, typically in patients who are
predisposed to experiencing these events. The exact relationship of these events to the
botulinum toxin injection has not been established.
DRUG INTERACTIONS
Aminoglycosides and Other Agents Interfering with Neuromuscular Transmission
Co-administration of BOTOX and aminoglycosides or other agents interfering with
neuromuscular transmission (e.g., curare-like compounds) should only be performed with
caution as the effect of the toxin may be potentiated.
Anticholinergic Drugs
Use of anticholinergic drugs after administration of BOTOX may potentiate systemic
anticholinergic effects.
Other Botulinum Neurotoxin Products
The effect of administering different botulinum neurotoxin products at the same time or
within several months of each other is unknown. Excessive neuromuscular weakness may
be exacerbated by administration of another botulinum toxin prior to the resolution of the
effects of a previously administered botulinum toxin.
Muscle Relaxants
Excessive weakness may also be exaggerated by administration of a muscle relaxant
before or after administration of BOTOX.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category C.
There are no adequate and well-controlled studies in pregnant women. BOTOX should be
used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
When BOTOX (4, 8, or 16 Units/kg) was administered intramuscularly to pregnant mice
or rats two times during the period of organogenesis (on gestation days 5 and 13),
reductions in fetal body weight and decreased fetal skeletal ossification were observed at
the two highest doses. The no-effect dose for developmental toxicity in these studies
(4 Units/kg) is approximately 0.7 times the average high human dose for upper limb
spasticity of 360 Units on a body weight basis (Units/kg).
When BOTOX was administered intramuscularly to pregnant rats (0.125, 0.25, 0.5, 1, 4,
or 8 Units/kg) or rabbits (0.063, 0.125, 0.25, or 0.5 Units/kg) daily during the period of
organogenesis (total of 12 doses in rats, 13 doses in rabbits), reduced fetal body weights
and decreased fetal skeletal ossification were observed at the two highest doses in rats and
at the highest dose in rabbits. These doses were also associated with significant maternal
toxicity, including abortions, early deliveries, and maternal death. The developmental
no-effect doses in these studies of 1 Unit/kg in rats and 0.25 Units/kg in rabbits are less
than the average high human dose based on Units/kg.
When pregnant rats received single intramuscular injections (1, 4, or 16 Units/kg) at three
different periods of development (prior to implantation, implantation, or organogenesis),
no adverse effects on fetal development were observed. The developmental no-effect
level for a single maternal dose in rats (16 Units/kg) is approximately 3 times the average
high human dose based on Units/kg.
Nursing Mothers
It is not known whether BOTOX is excreted in human milk. Because many drugs are
excreted in human milk, caution should be exercised when BOTOX is administered to a
nursing woman.
Pediatric Use
Bladder Dysfunction
Safety and effectiveness in patients below the age of 18 years have not been established.
Geriatric Use
Overall, with the exception of Overactive Bladder (see below), clinical studies of BOTOX
did not include sufficient numbers of subjects aged 65 and over to determine whether
they respond differently from younger subjects. Other reported clinical experience has not
identified differences in responses between the elderly and younger patients. There were
too few patients over the age of 75 to enable any comparisons. In general, dose selection
for an elderly patient should be cautious, usually starting at the low end of the dosing
range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function,
and of concomitant disease or other drug therapy.
Overactive Bladder
Of 1242 overactive bladder patients in placebo-controlled clinical studies of BOTOX,
41.4% (n=514) were 65 years of age or older, and 14.7% (n=182) were 75 years of age
or older. Adverse reactions of UTI and urinary retention were more common in patients
65 years of age or older in both placebo and BOTOX groups compared to younger
patients (see Table 5). Otherwise, there were no overall differences in the safety profile
following BOTOX treatment between patients aged 65 years and older compared to
younger patients in these studies.
Table 5. Incidence of Urinary Tract Infection and Urinary Retention according to Age
Group during First Placebo-controlled Treatment, Placebo-controlled Clinical Trials in
Patients with OAB
<65 Years
65 to 74 Years
≥75 Years
BOTOX Placebo BOTOX Placebo BOTOX
Placebo
100 Units (N=348) 100 Units (N=151) 100 Units (N=86)
Adverse Reactions
(N=344)
(N=169)
(N=94)
Urinary tract infection 73 (21%) 23 (7%) 51 (30%) 20 (13%) 36 (38%) 16 (19%)
Urinary retention
21 (6%) 2 (0.6%) 14 (8%)
0 (0%)
8 (9%)
1 (1%)
Observed effectiveness was comparable between these age groups in placebo-controlled
clinical studies.
OVERDOSAGE
Excessive doses of BOTOX (onabotulinumtoxinA) for injection may be expected to
produce neuromuscular weakness with a variety of symptoms.
Symptoms of overdose are likely not to be present immediately following injection.
Should accidental injection or oral ingestion occur or overdose be suspected, the person
should be medically supervised for several weeks for signs and symptoms of systemic
muscular weakness which could be local, or distant from the site of injection [see Boxed
Warning and Warnings and Precautions].
These patients should be considered for further medical evaluation and appropriate
medical therapy immediately instituted, which may include hospitalization.
If the musculature of the oropharynx and esophagus are affected, aspiration may occur
which may lead to development of aspiration pneumonia. If the respiratory muscles
become paralyzed or sufficiently weakened, intubation and assisted respiration may be
necessary until recovery takes place. Supportive care could involve the need for a
tracheostomy and/or prolonged mechanical ventilation, in addition to other general
supportive care.
In the event of overdose, antitoxin raised against botulinum toxin is available from the
Centers for Disease Control and Prevention (CDC) in Atlanta, GA. However, the antitoxin
will not reverse any botulinum toxin-induced effects already apparent by the time of
antitoxin administration. In the event of suspected or actual cases of botulinum toxin
poisoning, please contact your local or state Health Department to process a request for
antitoxin through the CDC. If you do not receive a response within 30 minutes, please
contact the CDC directly at 1-770-488-7100. More information can be obtained at
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5232a8.htm.
Manufactured by: Allergan Pharmaceuticals Ireland a subsidiary of:
Allergan, Inc.
2525 Dupont Dr.
Irvine, CA 92612
© 2013 Allergan, Inc.
® marks owned by Allergan, Inc.
Patented. See: www.allergan.com/products/patent_notices
Based on 72309US13, 72312US13, and 72511US10.
APC40IV13
32
These EHR strategies can
optimize your workflow
Educating staff on processes, looking for opportunities
to standardize will save you time
T
he electronic health record (EHR)
continues to be a tool for both evil
and good. One of my roles in my
health care organization is helping
fellow physicians with workflow and efficiency. Observing other physicians’ struggles and
having challenges of my own with the EHR
compels me to consider ways to incorporate the
computer into the patient-physician encounter
in a manner that supports rather than detracts
from the work that I love to do.
The following strategies and considerations
can help any physician better navigate the use
of EHRs for patient care and efficiency.
Beware the illusion of anonymity
We’ve all made the fatal error of sending a
poorly-worded, emotionally-laced email. It’s
a terrible feeling, but the behavior is so quick
and easy to replicate.
The EHR offers the same illusion of protected communication. But be cautious with
how you word communications to your nursing
staff or what you choose to immortalize forever
in an electronic record.
While many of us are careful with the office
visit notes we write or dictate, we may be less
careful in how we word comments in the
patient’s chart or in electronic communication
with our staff members.
Educate your staff
One of the best things I ever did was take 10
minutes and educate my medical assistant about
the new cervical cancer screening guidelines.
Armed with the information and my preferences, she is now able to determine if a patient
needs a pap smear 90% of the time. This allows
her to educate my patient before I enter the
room and to enter the correct orders electronically for me.
The more you can share with your medical
assistant or nursing staff about your preferences
and processes, the more they can do to help you
with the growing pile of electronic work.
Find opportunities to standardize
Do you tell your patients with bronchitis or
low back pain or toenail fungus the same
thing every time? If you have (as most of us
do) patient information that you use routinely,
standardize that by using the tools available in
your EHR to build custom text.
Look for these opportunities wherever you
can find them. It will improve your documentation because the information will be complete
and well thought out.
It will also save time because you will be able
to short-cut the typing. Any time you can do a
better job in less time is a win.
One-piece flow
Our organization models lean manufacturing
principles. Therefore, one-piece flow figures
high on our list of model behaviors.
Like many physicians, I tend to batch work.
I look at all my results over lunch or finish up
all my charts at the end of the day. This is a
definite no-no in the manufacturing world
and, for the sake of safety, quality, and sanity,
While many of us are careful with the
office visit notes we write or dictate,
we may be less careful in how we
word comments in the patient’s
chart or in electronic communication
with our staff members.
should become a no-no in medicine as well.
Think about how hard it is to remember which
of your six patients with pharyngitis had tonsillar exudate at the end of the day or which of
your patient’s ears was infected.
Attending a recent professional practice
seminar, I vowed to incorporate one-piece flow
into my clinic day. This meant that the note
and orders were completed by the time I left
the exam room.
When I started this process, I had the strangest feeling as I stepped out of the exam room
into the hall at the end of a visit. It was the feeling of a clear and unburdened mind. Instead of
mentally filing away pieces of information for
later about the patient I just saw, I reminded
myself I was done and moved on to the next
patient with improved focus.
Rule of 3s
Despite my admonition to avoid batching work,
inevitably it will happen.
APRIL 15, 2015
∣
Urology Times
Technology
Jennifer Frank, MD
Jennifer Frank, MD, is a family physician practicing in Neenah, WI.
So when work does pile up, think of the
rule of threes. It is daunting to sort through 50
results, but you could sort through three. Do the
work in little chunks throughout your day and
the job becomes more manageable.
Set small goals
Sometimes I run into the note that I really don’t
want to finish. Usually it involves a complex
patient with multiple social and medical issues
that ran over by a good 20 minutes. Sometimes
I haven’t been able to type anything in the exam
room because my attention needed to be fully
on the patient for the entire visit.
Trying to reconstruct a complicated 45-minute office visit in your notes can be painful.
This might be a situation you need to break
into chunks and tackle just one part of the note
throughout the day. Avoid the temptation to
put this off because the task will become more
onerous as the day (or days) pass.
Touch it once
If you’re like me, you probably look at certain
lab results and can instantly and easily address
them with a couple of clicks. Other lab results
require you to review the chart, calculate the
10-year cardiovascular risk score, or consult a
reference.
While our natural inclination is to put aside
the more complicated work, don’t do it. When
you see the result, address it and finish it. Otherwise it will take up electronic space, space
in your brain, and will probably be a result (or
refill request or patient call) that you click on
repeatedly, waiting hours or days to finally
reach a conclusion.
Use your own templates
Previously, I used the standard templates provided by our organization, especially for acute
complaints. This gave the illusion of efficiency,
except that I didn’t necessarily conduct my visit
according to the template, nor did I ask all of
the same questions.
This translated into formulaic notes that
failed to convey the story of the patient and
which required a lot of editing.
So, I moved to my own templates and narrowed it down significantly. For certain conditions (like new-onset headache), I have a
lengthy list of questions I want to remember
Please see EHR STRATEGIES, page 34
34
APRIL 15, 2015
∣
Urology Times
Patient financing: How it helps your
patients and practice
Practice Finances
Programs help patients manage costs, lower your accounts
receivable, improve practice cash flow
I
n today’s insurance environment, many
patients are facing higher out-of-pocket
costs, including insurance deductibles
and co-pays that can make moving forward with urologic treatment a challenge.
A recent analysis by USA Today (published
Dec. 29, 2014) found the minimum deductible
available for a family health insurance plan at
the silver level had increased by as much as
$5,000 over the previous year.
While some patients are seeing lower premiums, co-insurance payments are on the rise
with self-pay portions varying from 10% to
40% under the Affordable Care Act. In addition to these costs, patients with insurance, as
well as those without coverage, still have to
manage the cost of services not covered under
their plans.
Unfortunately, when a practice takes on the
responsibility of billing patients, it also incurs
the cost and risk associated with it as well—
including increased overhead, late payments,
collections, and increasing accounts receivables. Third-party financing programs, as discussed in this article, can provide an effective
solution by offering special financing options
that have been used successfully with practices
and patients.
Third-party patient financing is actually
quite common in many health care special-
E H R S T R AT EG IE S
to ask every time. For other visits, I
have the skeleton of a chronic disease
or problem-focused visit and fill it in as
we go along.
Conclusion
EHRs afford us many advantages compared with the days of a paper chart.
However, as with all technology, unforeseen consequences can result even from
useful technology.
Thinking through your own processes and adopting rigor can tip the
balance of your EHR from aggravating
to helpful.
ties, including ophthalmology, plastic surgery,
dermatology, podiatry, and dentistry. A thirdparty program can be very simple to implement. Patients apply for financing and, if
approved, can immediately access their credit
to pay for treatment with monthly payments
over time. By offering third-party financing,
practices can provide a variety of attractive
payment options that help more patients get
the care they need, and practices can benefit
as well.
Patients often ask physicians for help with
billing and extending time to pay the practice, and physicians are looking for solutions
to address these requests. There appears to be
a trend toward third-party patient financing
options in the current economic environment. It
is estimated that 3% to 5% of urology practices
are offering and utilizing these types of options.
Benefits to your practice and patients
The benefits of making a third-party patient
financing program available include increased
treatment acceptance, reduced accounts
receivable, reduced collection costs, and
improved cash flow. Unlike lending institutions that charge consumers interest for the
opportunity to make payments over time,
when practices bill patients in-house, they
make no interest. In the meantime, overhead
costs including payroll, rent, supplies, and
equipment continue to add up, while fees have
not yet been collected. This can create a cash
flow challenge with monies tied up in accounts
receivable.
When you partner with patient financing
programs and their financial professionals,
you can receive payment as soon as a couple
of days and your practice is able to step out
of the financial relationship, giving you and
your staff more time to focus on practicebuilding activities and providing excellent
patient care.
The greatest benefit that patients enjoy
with special financing options is the ability to
move forward with the care they need immediately, while paying convenient monthly
payments. In addition to providing immediate access to care, many financing programs
feature added benefits to the patients, such
as no annual fees.
Some programs provide patients with an
Amani A. Abou-Zamzam, MBA
Amani A. Abou-Zamzam,
MBA, is CEO-president at
UrologyConsulting.com in Los
Angeles, where she serves as a
urology consultant and urology
launch strategist.
ongoing line of credit, which is used as a
financial resource to pay for additional care
at your practice or at other health care providers that accept the same payment option.
Many liken it to a convenient health care
credit card.
By offering third-party financing,
practices can provide a variety of
attractive payment options that help
more patients get the care they
need, and practices can benefit as
well.
An often-overlooked benefit to third-party
financing is the ability to use it as an effective
marketing tool for your practice. If patients
know that special financing options are available, they may be more likely to seek care at
your practice versus other practices that do not
offer these types of programs.
Most patient financing companies provide
free marketing materials, including patient
brochures that can be strategically placed in
waiting areas and consultation rooms to help
educate your patients. Some companies have
digital tools available, including buttons and
banners, that can be placed on your practice
website to educate patients about financing
options, which can save time for you and
your staff. For your tech-savvy patients, some
providers also offer options to apply online
through their smartphones, tablets, and computers.
Choosing the right program
Because financial needs differ from patient
to patient, it is important to select a patient
Please see PATIENT FINANCING, page 37
®
RENACIDIN
IRRIGATION
(Citric Acid, Glucono Delta-lactone
and Magnesium Carbonate)
Prevents calcification of indwelling catheters
A.
Effects of Renacidin® in preventing
calcification of indwelling catheter.*
*Rendered in color from black and white
photographs.
B.
A. Shows a calcified catheter tube after
being used one month.*
B. Shows a catheter after being used one
month in the same patient but irrigated
with Renacidin.®
*Rendered in color from black and white photographs.
s Keeps long-term, indwelling catheters clean and extends catheter life.
s Eliminates painful withdrawal of encrusted catheter.
s Reduces risks of sudden emergencies due to blocked catheters.
s Low pH of 4 discourages alkaline lovng bacteria.
s Available in prepared solution for immediate use as a bladder irrigant.
Renacidin® (Citric Acid, Glucono Delta-lactone,
and Magnesium Carbonate) Irrigation
Rx Only
DESCRIPTION
Renacidin® (Citric Acid, Glucono delta-lactone, and Magnesium Carbonate) Irrigation is a sterile, non-pyrogenic irrigation
for use within the urinary tract in the prevention and dissolution of calculi.
Each 100 mL of Renacidin Irrigation contains:
Active ingredients:
Citric Acid (anhydrous), USP
6.602 grams
C6H8O7
Glucono delta-lactone, USP
0.198 grams
C6H10O6
Magnesium Carbonate, USP
3.376 grams
(MgCO3)4s-G/(2s(2O
Citric Acid
Glucono delta-lactone
Magnesium Carbonate
(MgCO3)4s-G/(2s(2O
Inert ingredients:
Benzoic Acid, USP
3OLUTIONP(
0.023 grams
CLINICAL PHARMACOLOGY
Renacidin Irrigation’s action on susceptible apatite calculi results from an exchange of magnesium from the irrigating
solution for calcium contained in the stone matrix. The magnesium salts thereby formed are soluble in the gluconocitrate
irrigating solution resulting in the dissolution of the calculus. Struvite calculi are composed mainly of magnesium
ammonium phosphates which are solubilized by Renacidin Irrigation due to its acidic pH.
Renacidin Irrigation is not effective for dissolution of calcium oxalate, uric acid or cysteine stones.
Renacidin Irrigation is indicated for use by local irrigation in the dissolution of renal calculi composed of apatite (a calcium
carbonate phosphate compound) or struvite (magnesium ammonium phosphates) in patients who are not candidates for
surgical removal of the calculi.
It may also be used as adjunctive therapy to dissolve residual apatite or struvite calculi and fragments after surgery or to
achieve partial dissolution of renal calculi to facilitate surgical removal.
Renacidin Irrigation is also indicated for dissolution of bladder calculi of the struvite or apatite variety by local intermittent
irrigation through a urethral catheter or cystostomy catheter as an alternative or adjunct to surgical procedures.
Renacidin Irrigation is also indicated for use as an intermittent irritating solution to prevent or minimize encrustations of
indwelling urinary tract catheters.
Since many complications are experienced by patients receiving infusions of Renacidin Irrigation into the renal pelvis,
considerable caution must be employed. Additionally, hospitalization is prolonged for days to weeks when chemolytic therapy
is used in lieu of, or following surgery. For these reasons, use of this therapy should be reserved for selected patients.
Renacidin Irrigation is not indicated for dissolution of calcium oxalate, uric acid or cysteine calculi.
CONTRAINDICATIONS
The use of Renacidin Irrigation in the treatment of renal calculi is contraindicated in patients with urinary tract infections.
Urea splitting bacteria reside within struvite and apatite stones which therefore serve as a source of infection. Dissolution
therapy with Renacidin Irrigation in the presence of an infected urinary tract may lead to sepsis and death. Urine
specimens should be obtained for culture prior to initiating chemolytic therapy of the renal pelvis. Appropriate antibiotic
therapy should be instituted to treat any infection detected. A sterile urine must be present prior to initiating therapy.
An infected stone can serve as a continual source for infection and, therefore, antibiotic therapy should be continued
throughout the course of dissolution therapy.
Renacidin Irrigation is contraindicated in the presence of demonstrable urinary tract extravasation.
WARNINGS
Renacidin Irrigation use should be stopped immediately if the patient develops fever, urinary tract infection, signs and
symptoms consistent with urinary tract infection, or persistent flank pain. Irrigation should be stopped if hypermagnesemia
or elevated serum creatinine develops.
Severe hypermagnesemia has been reported with Renacidin Irrigation. Caution should be employed when irrigating
the renal pelvis of patients with impaired renal function. Patients should be observed for early signs and symptoms
of hypermagnesemia including nausea, lethargy, confusion and hypotension. Severe hypermagnesemia may result in
hyporeflexia, dyspnea, apnea, coma, cardiac arrest and subsequent death. Serum magnesium levels should be monitored
and deep tendon reflexes should be evaluated. Treatment of hypermagnesemia should include discontinuation of
Renacidin Irrigation followed by medical therapy with intravenous calcium gluconate, fluids and diuresis in severe cases.
PRECAUTIONS
Care must be taken during chemolysis of renal calculi with Renacidin Irrigation to maintain the patency of the irrigating
catheter. Calculus fragments and debris may obstruct the outflow catheter. Continued irrigation under those circumstances
leads to increased intrapelvic pressure with a danger of tissue damage or absorption of the irrigating solution. Catheter
outflow blockage may be prevented by flushing the catheter with saline and repositioning of the catheter. Frequent
monitoring of the system should be performed by a nurse, an aide or any person with sufficient skills to be able to detect
any problems with the patency of the catheter. At the first sign of obstruction, irrigation should be discontinued and the
system disconnected.
)NTRAPELVICPRESSURESMUSTBEMAINTAINEDATORBELOWCMOFWATER4HEPREFERREDMETHODOFPRESSURECONTROLISTHE
insertion of an open Y connection pop-off valve into the infusion line allowing immediate decompression if pressure
EXCEEDSCMOFWATER!NALTERNATIVEMETHODHASBEENPROPOSEDTODIRECTORSTOPTHEmOWOFTHEIRRIGATINGSOLUTIONTO
prevent increased intrapelvic pressure: placement of a pinch clamp on the inflow line which can be used by the patient
or nurse to stop the irrigation at the first sign of flank pain. However, extreme caution must be taken when relying on
cooperation of the patient. Patients may not be sufficiently alert to detect signs and symptoms of out-flow obstruction. This
is especially true in elderly patients or patients who have been sedated or who have severe neurological dysfunction with
varying degrees of sensory loss and/or motor paralysis.
Patients with indwelling urethral or cystostomy catheters frequently have vesicoureteral reflux. Cystogram prior to initiation
of Renacidin Irrigation is essential for such patients. If reflux is demonstrated, all precautions recommended for renal pelvis
irrigation must be taken.
Throughout the course of therapy, patients should be monitored to assure safety. Serum creatinine, phosphate and
magnesium should be obtained every several days. Urine specimens should be collected for culture and antibacterial
sensitivity every three days or less and at the first sign of fever. The irrigation should be stopped if any culture exhibits
growth and appropriate antibacterial therapy should be initiated. The irrigation may be started again after a course of
antibacterial therapy upon demonstration of a sterile urine. Struvite calculi frequently contain bacteria within the stone and
antibacterial therapy should therefore be continued throughout the course of dissolution therapy. Hypermagnesemia or
an elevated serum creatinine level are indications to halt the irrigation until they return to pre-irrigation levels. Evidence of
severe urothelial edema on X-ray is also an indication for temporarily halting the irrigation until the complication resolves.
Concurrent use of magnesium containing medications may contribute to production of hypermagnesemia and is
not recommended.
Carcinogenesis, mutagenesis impairment of fertility: Long-term studies to evaluate carcinogenic potential of
Renacidin Irrigation in animals have not been conducted. Mutagenicity studies have not been conducted.
Pregnancy Category C.: Animal reproduction studies have not been conducted with Renacidin Irrigation. It is also
not known whether Renacidin Irrigation can cause fetal harm when administered to a pregnant woman or can affect
reproduction capacity. Renacidin Irrigation should be given to a pregnant woman only if clearly needed.
Nursing Mothers: Magnesium is known to be excreted into human milk. It is not known whether Renacidin Irrigation is
excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Renacidin
Irrigation is administered to a nursing woman.
ADVERSE REACTIONS
The most common adverse reaction in selected case series is transient flank pain which occurs in most patients. Additional
common reactions include urothelial ulceration and/or edema (13%) or fever (20% but up to 40% in some case series).
Other adverse reactions which occur in 1-10% of cases include: urinary tract infection, back pain, dysuria, transient
hematuria, nausea, hypermagnesemia, hyperphosphatemia, elevated serum creatinine, candidiasis, and bladder irritability.
Adverse reactions which occur in less than 1% of patients include: septicemia, ileus, vomiting and thrombophlebitis. Death
from sepsis has been reported.
OVERDOSAGE: See Warnings
DOSAGE AND ADMINISTRATION
Renacidin Irrigation (sterile, non-pyrogenic) in water for local irrigation within the urinary tract.
The action of Renacidin Irrigation in the prevention and dissolution of calculi results from an ion exchange mechanism or
solvent action. (See CIinical Pharmacology)
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration
whenever solution and container permit.
Renal Calculi: See Precautions. It is essential that patients be free from urinary tract infections prior to initiating
chemolytic therapy. Urine specimens should be collected for culture and appropriate antibiotic therapy should be initiated
for any bacteria identified. A nephrostomy tube is placed at surgery or percutaneously to permit lavage of the calculi. A
single catheter may be sufficient if the calculus is not obstructing the ureter or ureteropelvic junction. In patients with an
obstructed ureter, a retrograde catheter can be placed through the ureter to the renal pelvis via a cystoscope. This second
catheter is used to irrigate the calculus while the percutaneous nephrostomy tube is used for drainage.
Plain radiographs and nephrostomograms are performed to assure proper placement of the catheter(s). Pressure
measurements are made under fluoroscopy to assure that 2-3 mL/min can be infused without causing pain, pyelovenous
or pyelotubular backflow or manometric evidence of elevated pressure within the collecting system.
For postoperative patients irrigation should not be started before the fourth or fifth postoperative day. Irrigation of the
renal pelvis is begun with sterile saline only after a sterile urine has been demonstrated. The saline is infused at a rate of
M,HRINITIALLYANDTHERATEISINCREASEDUNTILPAINORANELEVATEDPRESSURECM(2O) appears, or until a maximum
flow-rate of 120 mL/hr is achieved. The site of insertion should be inspected for leakage. If leakage occurs, the irrigation
is discontinued temporarily to allow for complete healing around the nephrostomy tube.
If no leakage or flank pain occur, irrigation is then started with Renacidin Irrigation with a flow rate equal to the maximum
rate achieved with the saline solution. A clamp should be placed on the inflow tube and patients (see Precautions)
and nursing personnel should be instructed to stop the irrigating solution whenever pain develops. Nursing personnel
who are responsible for performing the irrigation must be instructed concerning the location of the nephrostomy tube(s)
and the direction of flow of the irrigating solution to insure against misconnection of the inflowing and egress tubes.
Nephrostomograms should be performed periodically to assure proper placement of the catheter tip and to assess
efficacy. If stones fail to change size after several days of adequate irrigation the procedure should be discontinued.
Upon demonstration of complete dissolution of the calculus the inflow tube is clamped and left in place for a few days to
ensure that no obstruction exists, after which time the nephrostomy tube is removed.
Bladder Calculi: Chemolysis of bladder calculi is used as an alternative to cystoscopic or surgical removal of the stones
in patients who refuse surgery or cystoscopic removal or in whom these procedures constitute an unwarranted risk.
Following appropriate studies to evaluate possible vesicoureteral reflux, 30 mL of Renacidin Irrigation is instilled through
a urinary catheter into the bladder and the catheter is clamped for 30-60 minutes. The clamp is then released and the
bladder is drained. This is repeated 4-6 times a day. A continuous drip through a 3-way Foley catheter is an alternative
means of dissolving bladder stones. In the presence of bladder spasm and associated high pressure reflux, all precautions
required for irrigation of the renal pelvis must be observed.
Indwelling Urinary Tract Catheter Encrustation: Periodic instillation of Renacidin Irrigation is indicated to minimize
or prevent encrustation of indwelling catheters which frequently results in plugging of the catheter and discomfort to the
patient. This is accomplished by instilling 30 mL of the solution through the catheter and then clamping the catheter for
10 minutes, after which the clamp is removed to allow drainage of the bladder. This process is repeated 3 times a day.
HOW SUPPLIED
2ENACIDIN)RRIGATIONISAVAILABLEASASTERILENONPYROGENICSOLUTIONINM,CONTAINERS
Exposure of Renacidin Irrigation to heat or cold should be minimized. Renacidin Irrigation
SHOULDBESTOREDATCONTROLLEDROOMTEMPERATUREªTOª&ªTOª#!VOID
excessive heat or cold (keep from freezing). Brief exposure to temperatures of up to
ª#ORTEMPERATURESDOWNTOª#DOESNOTADVERSELYAFFECTTHEPRODUCT
.$#
02/$5#4#/$%2.
Revised: November, 2006
Jointly manufactured by
GUARDIAN LABORATORIES
a division of
UNITED-GUARDIAN, INC.
Hauppauge, N.Y. 11788
4EL
&AX
and HOSPIRA, INC.,
,!+%&/2%34),
EN-1389
RENACIDIN
IRRIGATION
®
(Citric Acid, Glucono Delta-lactone
and Magnesium Carbonate)
UrologyTimes.com
∣
37
APRIL 15, 2015
EHR vendors are holding patient data
‘hostage,’ tech expert says Technology
The market should drive down interoperability costs,
Brookings Institution fellow writes
W
hen the Health Information
Technology for Economic and
Clinical Health (HITECH)
Act created the Meaningful
Use Incentive Program, it was a well-meaning
move toward obtaining the complete medical
histories of patients efficiently and cost-effectively. Years after its adoption, it’s also still one
of the few health care reforms that has bipartisan support.
But one major oversight in the creation of the
requirement to use electronic health records
(EHR) systems is that, while it was intended,
the law never specified how systems should be
interoperable to enable data exchange.
Now, lawmakers—who invested $26 billion
in EHR incentives—are trying to fix the problem, but some observers believe market forces
would be the best solution.
Niam Yaraghi, PhD, a fellow at the Brookings Institution Center for Technology Innovation, writes in a new blog post that EHR vendors
have taken patient data “hostage” (See www.
bitly.com/datahostage). That’s because even
though it was the intended second step to EHR
implementation, vendors are claiming that their
systems can’t be interoperable without making
costly fixes to technical problems.
“This prevents physicians from sharing their
patient records with other doctors,” Dr. Yaraghi
said. “This is like T-Mobile claiming that its
users cannot make calls to AT&T customers.
The claimed interoperability limitation does
not end here. The vendors are proposing hefty
charges to allow data sharing between their
own customers.”
Dr. Yaraghi says the government has three
choices in dealing with this problem: pay EHR
vendors to release patient data at a hefty cost,
force vendors to improve interoperability
through new regulations, or allow the market
to dictate a solution.
“This is like T-Mobile claiming that
its users cannot make calls to AT&T
customers.”
NIAM YARAGHI, PHD
The first option is already happening and
laws are already being drawn up to facilitate the
second option, but Dr. Yaraghi says the EHR
industry will resist any such efforts.
“The benefits of regulating the EHR industry, if any, will take a very long time to become
tangible. The EHR vendors will furiously push
PAT IE N T F IN A NC ING
financing program that provides flexibility
and meets the needs of today’s patients. Programs that provide special financing offers
such as 12 months deferred interest—in which
the patient pays no interest charges as long
as the balance is paid off by the end of the
promotional period—are helpful and popular
with patients.
When selecting a plan, consider the initial
costs to patients. Plans that feature no upfront
costs, annual fees, or prepayment penalties will
always be more attractive. Programs that offer
a simple and quick application process, immediate credit decisions, and multiple processing
options can make it easier to integrate third-
A great benefit of offering financing
through a third party is that your
practice is paid for your services
upfront.
party financing into your practice.
Another consideration when selecting a program is when your practice will be paid. A great
benefit of offering financing through a third
party is that your practice is paid for your services upfront. Not all programs are the same.
One program may deliver payment in 2 business days, while others can take longer to pay
your practice. So be sure you clearly understand
the program’s policy.
Rachael Zimlich
Rachael Zimlich is a contributing author for Medical
Economics, where this article was originally published.
back against any kind of regulation and will
insist that technical challenges are a real barrier to interoperability,” he said. “Congress is
poorly situated to adjudicate this claim. Time
is a critical factor in the long-term success of
HITECH plans, which threatens the viability
of this strategy.”
Dr. Yaraghi believes the third option offers
the best fix.
“Because the market for new EHR products
is now saturated, the only revenue sources for
EHR vendors are charges for data exchange.
Currently, they can get away with outlandish charges because they know the incentives
from the federal government allow doctors to
cover their costs,” he explained. “But if the free
money from the government were to stop, then
EHR vendors would have to persuade the physicians to pay for the exchange fees. Just like any
other service, the highest price that the medical
providers would pay is equal to the value of the
service for them.”
Medical providers would be willing to pay a
fair price for a service that will help them lower their costs in the long run, thus allowing the
market to set a price based on value and
demand. EHR vendors who don’t offer reasonable fees will eventually go out of business, Dr.
Yaraghi says.
Also consider how the payment will
be delivered. Some programs offer direct
deposit into an authorized account, while
others simply mail a check to the practice,
increasing the amount of time before payment
is actually credited to your account. Ideally,
the less time you spend on documentation and
paperwork to get compensated, the healthier
it is for your practice overhead.
Conclusion
Adding a third-party patient financing program
is an easy way to help patients manage out-ofpocket costs and get the urologic care they need.
Improved cash flow, reduced accounts receivable, and reduced billing and collection costs
make offering a third-party financing program
a smart decision to help enhance your practice’s
financial health.
38
APRIL 15, 2015
Calculate risk/return with
this time-tested strategy
domestic and global economies, how can
anyone prepare a successful investment
plan?
A
Over time, economic and political climates change, causing investors to question
their current investment philosophy. Physicians,
like all investors, constantly strive to achieve
attractive returns on their portfolios in order to
have their financial assets grow over time. By
accomplishing this feat, investors find that their
portfolios, whether earmarked for retirement,
college education, or other objectives, can be
working for them as opposed to them working
harder to save more, in an oftentimes declining
income environment.
While the perfect investment would have
the attributes of high growth with little or no
risk, the reality of course is quite different.
Not surprisingly, significant time is spent
developing methods or strategies that come
close to that “perfect investment.” None is as
popular or compelling as modern portfolio
theory (MPT).
Developed by Harry Markowitz, PhD, and
published under the title “Portfolio Selection”
in The Journal of Finance (1952; 7:77-91), MPT
explores how risk-adverse investors construct
portfolios in order to optimize market risk
❳t Financial Tips ❲
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against expected returns. The theory quantifies
the benefits of diversification—not having all
of your investment eggs in one basket. In 1990,
38 years after he wrote the paper while teaching
at the University of Chicago, Dr. Markowitz
was awarded, along with fellow academicians
Merton Miller, PhD, MA, and William Sharpe,
PhD, MA, a Nobel Prize for what has become
the most widely used strategy for portfolio
selection.
Even after all these years, and a
number of bull and bear markets and
new investment vehicles, modern
portfolio theory continues to play
a crucial and meaningful role in
investment management strategy.
Although developed in the early 1950s,
recognition for the achievement was delayed
because the task of applying MPT was only
made possible by the use of modern computers
that could handle the vast number of calculations and range of historical data needed by the
model. Portfolio management today combines
theory and technology in order to optimize
portfolio performance.
For most investors, the “risk” they take
in an investment is that the return will be
lower than expected. In other words, it is
the deviation from the average return. The
MPT model calculated for each investment a
“standard deviation” from the mean that the
model calls “risk.” Through diversification,
the “risk” of one investment may offset the
“risk” of another.
The key behind the MPT model is the plotting of an “efficient frontier” of the varying
combinations of investments in a portfolio that
provide the “maximum return and lowest risk.”
For every point along the efficient frontier, the
MPT model displays the combination of investments that produces the optimal level of return
and risk based on past performance of the various investment markets. While the past is not
always a predictor of the future, MPT uses this
data to estimate various risk/return scenarios.
The key today to the utilization of MPT is
Urology Times
Money Matters
Joel M. Blau, CFP,
Ronald J. Paprocki,
JD, CFP, CHBC
Investment diversification key to getting the most
out of modern portfolio theory
Q With all of the issues facing both our
∣
Joel M. Blau, CFP, UPQ
JTQSFTJEFOUBOERonald J. Paprocki, JD, CFP, CHBC, JTDIJFG
FYFDVUJWFPGGJDFSPG.&%*264
"TTFU"EWJTPST*ODJO$IJDBHP
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QBQSPDLJ!NFEJRVTDPN
understanding that a variety of “asset classes”
provides diversification and quantifies the risk
and reward of any given portfolio. Examples of
major asset classes include large U.S. companies, small U.S. companies, international companies, domestic bonds, international bonds,
and real estate. Understanding the various asset
classes and their respective indices leads to the
construction of a portfolio that can still encompass the historical validity of MPT.
Funding the various asset classes can be
easily accomplished through mutual funds or
exchange-traded funds that mirror a specific
index or asset class. Even after all these years,
and a number of bull and bear markets and new
investment vehicles, MPT continues to play a
crucial and meaningful role in investment management strategy.
Q All talk seems to be centered on
interest rate changes. How does this affect
bonds?
A
Bonds carry “market risk.” As interest
rates rise, the value of an existing bond decreases, because it pays a fixed rate of interest that
would be lower than what is being offered in the
market. On the other hand, bond values appreciate when interest rates decline. The longer
the maturity time frame, the more sensitive the
bond is to interest rate changes.
Other risks that impact bond pricing include
“credit risk,” which rating agencies define as
the ability of the issuer to pay back interest as
well as principal. With a higher risk bond, a
greater amount of interest would be promised
as opposed to bonds with a high credit rating,
which pay a lower amount of interest to their
investors. Beyond market and credit risk, there
is also the risk that the issuer will “call” the
bond prior to maturity at a pre-stated value.
This typically happens as interest rates fall, and
the issuer can “refinance” or offer new bonds
at a lower rate.
Before you
can provide a
Urologic Solution,
your patients
may need a
financial one
Help patients get the Urologic Treatment they need
with special financing options* from CareCredit
For almost 30 years, practices have accepted the CareCredit healthcare credit card as a way
to help more patients get care. Today CareCredit is used by over 9 million patients and
accepted by over 185,000 healthcare providers nationwide. With CareCredit:
Q Special financing options* are available to help with out-of-pocket costs
not covered by insurance.
Q Reduce accounts receivable, eliminate billing and improve cash flow.
100% of Urology Practices surveyed who accept CareCredit
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Help more patients get Urologic Care
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www.carecredit.com
UROB0215EA
40
Meeting Calendar
May
2015
... for a full listing of meetings through 2015
and beyond, visit UrologyTimes.com
APRIL 15, 2015
∣
Urology Times
15-19
29-June 2
15
AUA Annual Meeting
AUA Hands-on Urologic Ultrasound
NEW ORLEANS
Tel: 866-746-4282
Email: convention@AUAnet.org
www.auanet.org
American Society of Clinical Oncology
Annual Meeting
NEW ORLEANS
Tel: 800-908-9414
Email: registration@AUAnet.org
www.auanet.org
CHICAGO
Tel: 888-788-1522 or 703-449-6418
Email: ascoregistration@jspargo.com
www.asco.org
16
15-17
AUA Primary Care Update in Urology
Society for Pediatric Urology Annual Meeting
NEW ORLEANS
Tel: 866-746-4282
Email: registration@AUAnet.org
www.auanet.org
NEW ORLEANS
Tel: 978-927-8330
www.spuonline.org
June
2015
11-13
AUA Annual Review Course
NEW ORLEANS
Tel: 800-908-9414
Email: registration@auanet.org
www.auanet.org
Advertisers Index
11-13
Companies featured in this issue
World Congress on Abdominal & Pelvic Pain
To obtain additional information about products advertised in this issue, use the contact
information below. This index is provided as an additional service. The publisher does not
assume any liability for errors or omissions.
NICE, FRANCE
www.pelvicpain-meeting.com
20
Advertiser Name
Brand/Product
Page #
Website
Microspike
45
www.accuratesurgical.com
Botox
28-31
www.botox.com
Astellas
XTANDI
53-CV4
www.xtandihcp.com
Beckman Coulter
phi Test
13
www.beckmancoulter.com
Healthcare Financial
Institution
Covertip, 39
www.carecredit.com
Corporate
5
www.cogentixmedical.com
–
25
www.cookmedical.com
Farr Laboratories
Corporate
9
www.farrlabs.com
Genomic Health
Oncotype DX
11
www.OncotypeDX.com/GPS
Renacidin Irrigation
35-36
www.u-g.com
HealthTronics
Corporate
19
www.healthtronics.con
Imprimis Pharmaceuticals
DefeatIC
7
www.imprimispharma.com
Karl Storz Endoscopy
Flex-Xc
33
www.karlstorz.com
Neotract
UroLift
17
www.urolift.com
Autolith Uro-Touch
27
www.northgatetech.com
OPKO Diagnostics
4Kscore
23
www.opko.com
Photocure
Cysview
21
www.photocure.com
–
44
www.prsnetwork.com
Eragon
41
www.richardwolfusa.com
Uroskop Omnia Max
15
http://usa.healthcare.siemens.com/
urology-systems/family/uroskop-omniamax
Accurate Surgical &
Scientific Instruments
Allergan Medical
CareCredit
Cogentix Medical
Cook Medical
Guardian Laboratories
Northgate Technologies
AUA Hands-on Urologic Ultrasound
C H A R L O T T E S V I L L E , VA
Tel: 800-908-9414
Email: registration@auanet.org
www.auanet.org
20-23
AUA Fundamentals in Urology (formerly known as
the Basic Sciences Course)
C H A R L O T T E S V I L L E , VA
Tel: 516-520-1224
Email: michelelij@aol.com
www.auanet.org
21-23
International Symposium on Focal Therapy
and Imaging in Prostate & Kidney Cancer
AMSTERDAM, THE NETHERL ANDS
Tel: +30 210 7414700
Email: info@focaltherapy.org
http://www.erasmus.gr/microsites/1044
27-30
Canadian Urological Association Annual Meeting
O T TAWA
Tel: +1-514-395-0376
Fax: +1-514-395-1664
Email: cua@cua.org
www.cua.org
28-30
Physician Reimbursement
Systems
Richard Wolf Medical
Instruments
Siemens
Challenges in Endourology & Functional Urology
PA R I S
Tel: +30 210 7414700
Email: info@challenges-endourology.com
www.challenges-endourology.com
Visit us at the AUA
May 16 -19, 2015
Booth 837
Dual uniqueness
meets digital vision
Fits in access sheaths from 9.5 Fr.
LED illumination and distal sensor
Highest torsional stiffness
Slim laser channel with laser shifter
Large working and irrigation channel
270° tip deflection
The new ERAGON modular mini
3.5 mm instruments for minimally
invasive laparoscopic surgery.
Exceptional Flexibility
The ENDOCAM® Logic HD integrates
with 3CCD, 1CCD and C-MOS
digital sensor technologies, addressing
all urological procedures.
www.richardwolfusa.com
© Copyright 2015. Richard Wolf Medical Instruments. All Rights Reserved.
&
The First and Only Dual Channel
Digital Flexible Ureteroscope
1201-02.01-0315USA
42
Product Preview
Liquid biopsy accurately identifies
high-grade prostate cancer
Exosome Diagnostics, Inc. recently
announced positive data from an initial clinical study of the company’s novel prostate
cancer liquid biopsy. The noninvasive, RNAbased test demonstrated the potential to
accurately predict high-grade prostate cancer
by analyzing biomarkers on exosomal RNA via
a urine sample. The prostate cancer liquid
biopsy is being developed to noninvasively
assess the risk for high-grade prostate cancer in men with an elevated gray zone PSA
(2.0–10.0 ng/mL). The data were presented
at the Genitourinary Cancers Symposium in
Orlando, FL.
Maker of HIFU device to pursue
direct de novo 510(k) clearance
Based on a recent meeting with the FDA,
EDAP TMS SA says it plans to seek clearance
of Ablatherm high-intensity focused ultrasound
by way of a direct de novo 510(k) application
as opposed to the pre-market approval application amendment the company had been pursuing. The FDA indicated that while pre-market
approval would be required for specific claims
regarding treatment of prostate cancer, a prostate tissue ablation claim could be cleared via
a direct de novo 510(k) application.
Southern Illinois University awarded
grant to develop ED prosthesis
The division of urology at Southern Illinois
University School of Medicine, Springfield has
received a $65,868 grant from American Medical Systems, Inc. to support the development
of a novel physiologic prosthesis for the treatment of erectile dysfunction. Kevin McVary,
MD, and Alberto Colombo, PhD, of the Southern Illinois division of urology are leading the
development of the device, according to a
news release from the university.
Companies announce agreement
on prostate cancer immunotherapy
Bavarian Nordic and Bristol-Myers Squibb
Co. have entered into an agreement that
provides Bristol-Myers Squibb an exclusive
option to license and commercialize PROSTVAC, Bavarian Nordic’s investigational phase
III PSA-targeting cancer immunotherapy in
development for the treatment of asymptomatic or minimally symptomatic metastatic
castration-resistant prostate cancer. Under
terms of the agreement, Bavarian Nordic will
receive an upfront payment of $60 million,
the companies announced. Bristol-Myers
Squibb can exercise the option in its sole
discretion within a designated time after
DRUGS AND DEVICES
IN THE PIPELINE
data are available from the ongoing phase
III trial.
Company issues updates on agents
for early, advanced prostate Ca
Madison Vaccines Inc. (MVI) announced that
plans are progressing for three projects in
early, advanced, and late-stage prostate cancer. Two additional sites have opened enrollment for the phase II clinical trial for MVI’s
lead product candidate, MVI-816, in nonmetastatic prostate cancer; the company has
selected and will procure a PD-1 inhibitor for
a combination trial with MVI-816 in late-stage
prostate cancer; and the FDA has approved a
phase I investigational new drug application
for MVI-118, MVI’s new vaccine to address
treatment resistance and disease progression in advanced prostate cancer.
SUI system yields statistically
significant decrease in leakage
Data from a multicenter, 63-patient randomized controlled trial of the Vesair Bladder
Control System have met study endpoints
with statistical significance, Solace Therapeutics, Inc. reported. The Vesair is a novel,
office-based, reversible treatment designed
to reduce or eliminate urine leakage in
female patients with stress urinary incontinence. Study results demonstrated statistical
significance of at least a 50% decrease in
urine leakage volume and a 10-point improvement in quality of life score in an intent-totreat population. Data from the study were
presented at the Society of Urodynamics,
Female Pelvic Medicine & Urogenital Reconstruction winter meeting in Scottsdale, AZ.
Toxicology studies initiated
for prostate cancer agent
Aduro Biotech, Inc. has achieved its first
milestone under its collaboration with Janssen Biotech, Inc., by initiating toxicology studies to support an investigational new drug
application for ADU-741, an immuno-oncology
product candidate for the treatment of prostate cancer. The Janssen decision to advance
ADU-741 toward clinical trials was based
on preclinical data generated in the first 8
months of the collaboration. This accomplishment triggered a milestone payment to Aduro,
the company announced.
In May 2014, Aduro entered into an agreement granting Janssen an exclusive, worldwide license to certain product candidates
specifically engineered for the treatment of
prostate cancer based on Aduro’s proprietary
platform of live, attenuated, double-deleted
Listeria monocytogenes strains that have
APRIL 15, 2015
∣
Urology Times
been engineered to initiate a powerful innate
immune response and drive a targeted, durable adaptive immune response.
Bladder cancer test successfully IDs
cancerous cells in urine samples
Micromedic Technologies Ltd.’s CellDetect
noninvasive technology to detect bladder cancer recurrence in patients with a history of
the disease successfully identified cancerous
cells in urine samples, according to recently
reported study results. The test had a sensitivity of 84.4% and specificity of 82.7% for
the study’s primary endpoint. The secondary
endpoint showed that the sensitivity of other
noninvasive comparator tests—urine cytology, BTA stat, and NMP22 BladderCheck—
was 50.0%, 68.8%, and 17.4%, respectively.
The company says it plans to secure a CE
mark approval for a European launch of the
test later this year as well as to submit a preinvestigational device exemption to the FDA.
Two firms enter agreement
to develop agent for CP/CPPS
Insys Therapeutics, Inc. has entered into an
exclusive sub-license agreement with Gold
Coast Therapeutics to develop a unique combination of Cromolyn Sodium and Cetirizine
as a new chemical entity for the treatment
of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).
Data from preclinical studies conducted at
Northwestern University, Chicago implicate
mast cells as mediators of chronic pelvic pain
associated with the prostate, and demonstrate that mast cell markers are elevated in
men with CP/CPPS. Design is underway for
preclinical studies and clinical trials studies
to be conducted at Northwestern University/
Northwestern Medicine.
New drug application resubmitted
for female sexual dysfunction agent
Sprout Pharmaceuticals has resubmitted a
new drug application to the FDA for flibanserin, an investigational, once-daily, nonhormonal pill for hypoactive sexual desire disorder (HSDD) in premenopausal women. The
resubmission comes after Sprout received
a complete response letter from the FDA for
flibanserin in 2013. The company appealed
the FDA’s decision, and at the request of the
agency, completed a phase I pharmacokinetic
study
and
a phase
I driving
Results
To have
information
on your
company’sstudy.
product or
service
from
these
studies
were
included
in
the to:
published in this section, send news releases and photos
resubmission package. If approved, flibanUT@advanstar.com
serin will be the first and only FDA-approved
Publication isfor
subject
to spaceaccording
availability. to a press
treatment
HSDD,
release from Sprout.
2
18
e
us b
i t um
V is o t h n
bo
at
Connection
Receive daily highlights from the AUA
Annual Meeting with the
Urology Times
e-conference briefs
Sign up today for the latest news at
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Whether you are able to attend AUA this year
or not, Urology Times’ e-conference briefs keep
you abreast of any late-breaking, practicerelevant news straight from the 2015 American
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Your Constant
44
New Products & Services
Medical device company cleared
to launch hand-held bladder scanner
Adelaide, Australia—The SignosRT Bladder
Scanner is a portable device designed to use
ultrasound technology to automatically and
noninvasively calculate bladder volume and
has the potential to assist in reducing health
care costs in hospitals and home-care support
services, according to manufacturer Signostics Limited. The product was granted FDA
For more information, visit www.signostics.com.au.
510(k) clearance in January 2015 and is being
sold in Australia and New Zealand with appli-
The urology community will use less than 10% of the ICD-10-CM codes set.
Why wade through a large book and data set to try to find the correct code?
Each 2015 ICD-10-CM Urology SourceBook includes the following:
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Coding, Reimbursement, and Practice Management Solutions
‘Digital card’ enables mobile
payment functionality
Costa Mesa, CA—Synchrony Financial’s CareCredit recently launched an innovative digital
card that enables mobile payment functionality for all CareCredit cardholders and providers. The digital card is device agnostic and
does not require any new hardware or mobile
application download, providing flexibility
and ease of payment through any accepted
mobile wallet or existing point of sale method. The card establishes a secure customer
enrollment and authentication process and
offers a unique mobile device provisioning
through the “add to home screen” feature.
After the initial set-up, the digital card is
accessible by entering a PIN chosen during
the enrollment process.
AUA Booth #2308
For more information, visit www.carecredit.com.
Testosterone nasal gel now
commercially available in U.S.
Dublin, Ireland—Endo International plc
announced that its testosterone nasal gel
(Natesto) is now available commercialy. The
gel is indicated for replacement therapy in
adult males with deficiency or absence of
endogenous testosterone, including primary
hypogonadism (congenital or acquired) or
hypogonadotropic hypogonadism (congenital
or acquired). In 2014, Endo acquired the rights
to the gel in the U.S. and Mexico from Trimel
BioPharma SRL, a wholly-owned subsidiary of
Trimel Pharmaceuticals Corp., for $25 million
plus additional payments upon the achievement of certain regulatory and sales milestones. Endo will collaborate with Trimel on all
regulatory and clinical development activities
regarding the gel, Endo said in a news release.
AUA Booth #117, 937
Fore more information, visit www.endo.com.
Snare removes ureteral stents
without need for cystoscopy
Lansdowne, PA—Uramix’s Stent Removing
Snare allows for the non-visual removal of
UrologyTimes.com
∣
indwelling ureteral stents without the need
for cystoscopy. It’s designed to be passed
over a guide wire if clinically needed. The
Stent Removing Snare has a conical, smooth
appearance with the largest dimension being
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travel through the urethra, and it can hook
the string attached to the stent, according
to Uramix. The procedure has its own CPT
code.
For more information, visit www.uramix.com.
Imaging method enables effective
targeting of bladder biopsies
Center Valley, PA—The FDA granted 510(k)
clearance of narrow band imaging (NBI)
as enabling effective targeting of biopsies
not seen under white light and improved
visualization of tumor boundaries in nonmuscle-invasive bladder cancer (NMIBC)
patients. Based on a weighted average, the
aggregated FDA-reviewed studies show NBI
has visualized NMIBC lesions in 17% additional
patients when compared with white light,
24% additional tumors, and 28% additional
carcinoma in situ. This finding provides new
treatment opportunities for urologists both
in-office and in the OR, Olympus says.
AUA Booth #101
For more information, visit
www.medical.olympusamerica.com.
FDA approves Tx for complicated
intra-abdominal infections
Dublin, Ireland—The FDA recently approved
ceftazidime-avibactam (AVYCAZ), indicated
for the treatment of adult patients with
complicated intra-abdominal infections (in
combination with metronidazole) and complicated urinary tract infections, including pyelonephritis caused by designated susceptible
bacteria, including certain Enterobacteriaceae
and Pseudomonas aeruginosa. Ceftazidimeavibactam received a priority review based
on phase II data from developer Actavis plc’s
clinical development program and supporting
in vitro data, and as such should be reserved
for use in patients who have limited or no
alternative treatment options, the company
says.
AUA Booth #1917
For more information, visit www.AVYCAZ.com.
45
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APRIL 15, 2015
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AUA Booth #1801
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46
❳ Clinical Spotlight❲
S TAT INS
after 1 year of radiotherapy who were randomized to intermittent or continuous ADT, statin
users had a significant reduction in the risk of
death compared with non-users, reported first
author Robert Hamilton, MD, MPH, urologic
oncologist at Princess Margaret Cancer Center, Toronto, and assistant professor of surgical
oncology, University of Toronto.
Few studies have looked at the effect of statin
use in advanced prostate cancer or in combination with ADT, he said.
Of the 1,364 patients enrolled, 585 (43%)
reported statin use during the study. At a median follow-up of 6.9 years, statin use was associated with a 36% reduction in the risk of overall
death (p<.001) and a 36% reduction in the risk
“If a patient on ADT is
about to start a statin
for high cholesterol,
you can tell them that
there may be another
reason to feel good about taking
your statin than just treating your
cholesterol.”
ROBERT HAMILTON, MD, MPH
of prostate cancer-specific mortality (p=.003).
Statin users had 14% longer time to castrateresistant disease, although this difference was
not significant (p=.15). In the arm randomized
to intermittent ADT, statin users had more
off-treatment intervals (p=.04) and more total
time off ADT (hazard ratio [HR]=0.84; p=.05).
Quality of life measures were also significantly
better in statin users versus non-users.
“At the present time we do not have enough
evidence to tell a patient about to start ADT
that they should also start a statin. However, if a
patient on ADT is about to start a statin for high
cholesterol, you can tell them that there may be
another reason to feel good about taking your
statin than just treating your cholesterol,” said
Dr. Hamilton.
Statins increase TTP by 10 months
A second retrospective study showed that men
who were taking a statin at the time of ADT initiation had an increased median TTP by about
10 months compared with those who were not
APRIL 15, 2015
on a statin, said first author Lauren Harshman,
MD, assistant professor of medicine, Harvard
Medical School, Dana-Farber Cancer Institute,
Boston.
Preclinical work by the Kantoff Laboratory
suggested that statins decrease influx of dehydroepiandrosterone (DHEAS) by competing
for its uptake by the organic anionic transporter
SLCO2B1.
“Dr. Wang in the Kantoff Laboratory evaluated how different statins affect DHEAS uptake
by SLCO2B1, and found using two androgensensitive cell lines that statins inhibited DHEAS
uptake,” she said. “Specifically, atorvastatin
was found to decrease DHEAS-induced prostate cancer cell proliferation likely by competing for influx through SLCO2B1.”
The investigators were able to further prove
with knockdown studies that inhibition of
DHEAS uptake was dependent on SLCO2B1
expression.
“If you knock down that transporter, the
administration of atorvastatin doesn’t inhibit
tumor cell proliferation, which supports the
finding that the transporter is important for the
statin’s inhibitory effect on the influx of DHEAS
into the tumor cell,” said Dr. Harshman.
Her group therefore hypothesized that
patients on statins at the time of ADT initiation would have improved prostate cancer outcomes. An interrogation of Dana-Farber’s clinical database of treatment details and outcomes
of patients with prostate cancer identified 1,265
patients with hormone-sensitive disease who
had been treated with ADT. After excluding
patients with inadequate information on PSA
response to ADT or whose statin use was not
known, 926 were left for analysis. Of those,
31% were taking a statin at ADT initiation, and
most of them remained on a statin throughout
ADT use. Statin use generally increased over
time.
Disease progression was defined as two PSA
rises. Date of progression was defined as date of
first PSA rise or radiologic progression. After a
median follow-up of 5.8 years, 70% of patients
had progressed on ADT.
Men on statins had a longer median TTP
on ADT compared with nonusers—27.5 versus
17.4 months. On multivariate analysis, adjusting for biopsy Gleason score, primary therapy
type, metastatic status, and PSA level at ADT
initiation, the association remained statistically
significant (adjusted HR: 0.83; p=.039).
“This work is retrospective and requires
validation, but it fits with the preclinical data
suggesting that one reason that statins may
impact outcomes on ADT is through competitive influx via the transporter, thus decreasing
the tumor’s available androgen stores,” she
said. “The widespread use of statins and their
∣
Urology Times
generally tolerability make them attractive
candidates to combine with our other known
effective therapies.”
Lower LDL expression in lethal PCa
A third study, this one a nested case-control
study within the Health Professionals Followup Study prostate cancer cohort, discovered that
lethal prostate cancers have lower expression of
the LDL receptor, and potentially lower cholesterol uptake. The study included 249 men
“The Kantoff Laboratory evaluated
how statins affect DHEAS uptake
by SLCO2B1, and found using
two androgen sensitive cell lines
that statins inhibited the DHEAS
uptake.”
LAUREN HARSHMAN, MD
who underwent curative-intent prostatectomy,
81 men who died of prostate cancer, and 168
controls who survived for more than 8 years
without evidence of metastasis.
“We went to where the money is and looked
into the expression of genes of cholesterol
metabolism and their association with prostate
cancer outcomes,” said lead investigator Konrad H. Stopsack, MD, MPH, internal medicine
resident at Mayo Clinic, Rochester, MN, who
worked on the study with Jennifer R. Rider,
ScD, MPH, and colleagues at Harvard T.H.
Chan School of Public Health, Boston.
Patients who had very high mRNA expression of the LDL receptor were at decreased risk
of prostate cancer-specific mortality, whereas
those with very high expression of the second
rate-controlling enzyme of cholesterol synthesis, squalene epoxidase (SQLE), had a significantly greater risk of dying from prostate
cancer.
Discrimination among high-grade tumors
improves when adding the LDL receptor and
SQLE genes to a full predictive model of prostate cancer-specific mortality in the long term,
Dr. Stopsack said.
“Patients are much more likely to die from
the cancer when it’s very active in producing
cholesterol,” he said.
Dr. Hamilton has received honoraria from
Bayer and Janssen. Dr. Harshman is a consultant/adviser for Bristol-Myers Squibb, Dendreon, Medivation/Astellas, and Pfizer, and has
received research funding from Medivation/
Astellas and Pfizer. UT
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48
❳
S TAT E OF UROLOGY
“In line with recent attention given to the role
of testosterone replacement therapy, some
abstracts will importantly focus on safety,
indications, and new options for managing
the hypogonadal male,” said Arthur L. Burnett, II, MD, MBA, professor of urology at
Johns Hopkins University, Baltimore.
There will also be TRT research centered
on treatment indications in different hypogonadal populations, as well as novel treatment formulations, Dr. Burnett added.
In the area of penile prosthesis surgery,
look for abstracts on surgical modifications
and innovative techniques to address penile
deformity and length problems, management
of device infections, and sources of patient
dissatisfaction. For those interested in Peyronie’s disease, watch for research examining
expanded indications and outcomes for intralesional collagenase, surgical options, and
national trends in treatment, Dr. Burnett says.
❲
APRIL 15, 2015
∣
Urology Times
serves as vice chairman of the GOP Doctors
Caucus, a group that includes 14 physicians.
Advanced Prostate Cancer
esearchers continue to
explore the possibilities of
new treatments for castrationJ. Brantley Thrasher, MD resistant prostate cancer, so
look for studies on the timing and sequencing of these therapies, says J.
Brantley Thrasher, MD, professor and chair of
urology at the University of Kansas, Kansas City.
R
“Also this year, we are seeing several studies on
imaging and how it might change the approach
to prostate cancer or direct surgery for localized
metastatic lesions—specifically multi-parametric
MRI and PET,” Dr. Thrasher told Urology Times.
Dr. Thrasher says also to look for research
bolstering evidence on the benefits of
statins—“but interestingly, in a patient
with advanced disease on ADT.”
“I was also interested to hear about the new
anti androgen ARN-509,” Dr. Thrasher said.
We hope to see you
in New Orleans
Dear Reader,
As my staff and I eagerly prepare
for this year’s AUA annual
meeting in New Orleans, we look
forward to seeing you at urology’s premier
event. We invite you to meet us at the Urology
Times booth (#1829). Share an idea, register
a complaint, or simply say hello. We’d love to
hear your thoughts about this year’s meeting
and the issues facing your specialty.
We also welcome you to connect with us
through our special multimedia coverage of
the meeting, including:
CONFERENCE BRIEFS
Health Policy
his year’s meeting promises courses and talks on a
variety of health policy/socioeconomics-related topics. One
William F. Gee, MD
forum William F. Gee, MD,
says urologists would do well to attend covers the
AUA’s Quality (AQUA) Registry (Monday, May 18).
Pediatric Urology
T
“The collection of outcomes data is becoming
more and more important to urologists, patients,
and insurers. The AQUA Registry currently
focuses on prostate cancer, but it will gradually
expand to include other urologic conditions.
Many large group practices are already participating in the AQUA Registry,” said Dr. Gee,
who is in private practice in Lexington, KY.
Dr. Gee also pointed out courses on preventing
and defending malpractice lawsuits (Sunday,
May 17), coding and reimbursement (May
18), and telemedicine (May 18) as being of
particular use for practicing urologists.
Finally, Dr. Gee highlighted the AUA/American
Association of Clinical Urologists Health Policy
Forum, slated for May 17. This year’s featured
speakers are Relative Value Scale Update Committee (RUC) Chair Barbara Levy, MD, who
will discuss the RUC and physician reimbursement, and Rep. John Fleming, MD (R-LA), who
nce again, the Society
for Pediatric Urology will
hold its annual meeting
concurrently with the first 3
days of the AUA meeting.
O
Howard M. Snyder,
III, MD
The problem of antibiotic resistance and infection remains a concern for urology and is a
topic urologists can expect to see brought
out in this year’s pediatrics research, says
Howard M. Snyder, III, MD, professor of surgery in urology at the University of Pennsylvania School of Medicine, Philadelphia.
“Pediatric urologists seem to be more aware of
the benign nature of asymptomatic bacteriuria
and the harm that comes from excessive use
of antibiotics,” Dr. Snyder told Urology Times.
The increasing prevalence of pediatric stones
is another trend to watch for, says Dr. Snyder.
“The incidence of stones in kids continues to
grow, and we are realizing that they can be treated by the same techniques as in adults,” he said.
Finally, for this year’s John Duckett Memorial
Lecture (May 17), Chung Kwong Yeung, MD,
PhD, will present, “Minimally invasive surgery
in pediatric urology: Present and future.”
Our daily reports from New Orleans are delivered to
your inbox. Sign up for free at www.urologytimes.
modernmedicine.com/urology-times/enewssignup.
ABSTRACT HIGHLIGHTS
Members of our editorial board and other leaders in
urology outline this year’s can’t-miss research and
health policy sessions. Visit www.modernmedicine.
com/tag/state-urology-2015.
LIVE TWEETS
We’ll be tweeting breaking news from the scientific
sessions. Follow us at www.twitter.com/UrologyTimes, and use the hashtag #AUA15.
FACEBOOK UPDATES
Watch for photos, video clips, news articles, and
more at www.facebook.com/UrologyTimes.
GUIDE TO NEW ORLEANS
Local urologist Neil Baum, MD, offers an insider’s look
at the top dining spots and attractions in the Big Easy.
Our multimedia package can be accessed at www.
urologytimes.com/new-orleans-preview.
BEST OF AUA
Urology Times’ report of the annual meeting’s popular
take-home messages will appear in print and online
after the meeting.
Enjoy AUA 2015 and UT’s coverage!
Richard R. Kerr
Group Content Director
UrologyTimes.com
|
APRIL 15, 2015
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UrologyTimes.com
∣
APRIL 15, 2015
❳
S TAT E OF UROLOGY
Laparoscopy/Robotics
Interstitial Cystitis/Bladder Pain Syndrome
lenary and podium sessions will feature noteworthy research on interstitial cystitis/bladder
pain syndrome, says Philip M. Hanno, MD, MPH,
professor of urology at the
University of Pennsylvania.
P
Philip M. Hanno,
MD, MPH
On May 18, the results of
the 4-year update to the
Interstitial Cystitis/Bladder Pain Syndrome guideline will be presented.
“While the amendment
largely validates the original published guideline based upon review of subsequently
published literature from July 2009 through
July 2013, there are some changes in the
treatment algorithm and classification of
therapies that the treating physician will
want to be aware of,” Dr. Hanno said.
One abstract singled out by Dr. Hanno will
highlight the characteristics of women testing positive for Mycoplasma hominis and
Ureaplasma urealyticum in the urinary tract.
“Symptoms of urgency and pelvic pain will be
discussed along with management of this infection that is one of the ‘confusable diseases’
in the diagnosis of IC/BPS,” Dr. Hanno said.
Dr. Hanno says there are many interesting
presentations at this year’s meeting, including a randomized, multicenter, double-blind,
placebo-controlled trial of intravesical botulinum toxin and a look at an alternative delivery
system for botulinum toxin in the bladder.
Another randomized clinical trial compares the
effect of hydrodistention versus transurethral
fulguration of Hunner’s lesions. In addition,
the latest abstracts from the Multi-Disciplinary
Approach to Chronic Pelvic Pain 10-year
NIDDK research effort will be presented.
“All in all, it looks like a very interesting and
potentially useful trove of new information
that will help clinicians and researchers as
they continue to make advances in diagnosis and treatment,” Dr. Hanno said.
obotic surgery is firmly part
of urologic practice. Now
we are trying to determine
nuances that make a differJ. Stuart Wolf, Jr., MD
ence (such as the role of assistant),” said J. Stuart Wolf, Jr., MD, professor of
urology at the University of Michigan, Ann Arbor.
R
Other themes to expect at the meeting include
application of adjunctive technologies and
patient safety with robotic surgery, Dr. Wolf said.
Abstracts evaluating primary versus salvage laparoscopic pyeloplasty, a tactilefeedback-driven pelvic floor muscle training
smartphone app, and use of a hyaluronic
acid-carboxymethylcellulose adhesion barrier on the neurovascular bundle during robotassisted radical prostatectomy are among
the key research to watch for, Dr. Wolf said.
Infertility
nfertility research being
presented at this year’s
meeting is centered on
practice patterns in the
James M. Hotaling,
MD, MS
care of infertile males, says
James M. Hotaling, MD, MS, assistant professor of surgery (urology) at the Center for
Reconstructive Urology and Men’s Health, University of Utah Health Care, Salt Lake City.
I
“Specifically, authors examined vasovasostomy and epididymovasostomy—new
techniques to make these procedures
easier and characterizing current practice
patterns. Likewise, new techniques for optimizing varicocelectomy and microTESE,
and selecting optimal patients for these
procedures, are also a focus of the work
presented this year,” Dr. Hotaling said.
Another notable trend is re-examination of the
concept that infertile men with poor sperm
parameters and recurrent pregnancy loss have
significantly higher rates of sperm aneuploidy.
“Although this concept was first demonstrated over 20 years ago, many authors
have proposed refining the cut-offs for testing for sperm aneuploidy,” Dr. Hotaling said.
❲
51
He says urologists interested in infertility should
also be on the lookout for the following:
O several studies on new techniques
such as chromosomal and genetic analysis in the evaluation of infertility
O several abstracts exploring novel intra-operative
techniques for testicular sperm extraction and
varicoceletectomy, “which will be of great interest to urologists performing these procedures”
O research on pregnancy rates for fresh
versus frozen testicular sperm for intracystoplasmic sperm injection.
Infection
his year’s infection program
features many relevant topics to the practicing urologist,
says Toby C. Chai, MD, professor of urology at Yale School
of Medicine, New Haven, CT.
T
Toby Chai, MD
One such area is post-urologic procedure infections, where several presentations will suggest
potential methods to prevent these infections.
Other studies will investigate the concept
of the “bladder microbiome”—the theorized population of multiple unculturable
microorganisms in the normal bladder.
“The relationships between the bladder
microbiome and asymptomatic bacteriuria will be presented. The concept of an
existence of a microbiome in the bladder
may change the way we manage several
different bladder conditions and redefine
how we understand host-pathogen interaction in the bladder,” Dr. Chai said.
Additionally, watch for several presentations
on newer diagnostic approaches, as well
as utility of currently used imaging modalities, to assess for urinary tract infections.
“The current urine culture test takes at least 48
hours to get results, and newer technologies
may bridge this time delay,” Dr. Chai told UT.
Finally, abstracts will review the management of radiation hemorrhagic cystitis.
“These patients are usually difficult to manage,
and these abstracts will give the urologist additional insights,” he said. UT
How we do the ‘State of Urology’ Now in its twelfth year, UT’s State of Urology feature highlights the clinical and health policy topics that will make news
at the AUA annual meeting and beyond. We ask our editorial board members and other urology thought leaders to identify the trends and issues shaping the specialty. We also solicit board members’ opinions on the hottest abstracts at the AUA meeting.
52
APRIL 15, 2015
IN THE
PUBLIC
∣
Urology Times
der bites on the local population back in 2000. They found that among
other symptoms, the spider bites could result in priapism.
Study findings were published in Urology (2014; 84:730.e9-17).
WHAT YOUR PATIENTS ARE READING IN PRINT, ONLINE
H E A LT H DAY N E W S
H E A LT H DAY N E W S
Suicide in genitourinary cancer patients
'poses a public health dilemma'
USPSTF PSA recommendation
may be linked to rise in high-grade cancers
SUICIDE is a public health concern for patients with genitourinary cancer,
especially bladder cancer, according to a study published online in Cancer (Feb. 17, 2015).
A SMALL but measurable increase in high-risk prostate cancer cases is
Researchers led by Zachary Klaassen, MD, of Medical College of
potentially due to the U.S. Preventive Services Task Force’s grade “D” recGeorgia-Georgia Regents University in
ommendation for prostate cancer screening, report the authors
Augusta, identified 2,268 suicides among
of a study presented at the Genitourinary Cancers Symposium
1,239,522 individuals with genitourinary
in Orlando, FL.
malignancies. For patients with prostate,
For the study, researchers examined data from roughly
were identified among 1.2 million bladder, and testis cancer, increasing age
87,500 men treated for prostate cancer between January
individuals with GU cancers.
correlated with odds of suicide. In patients
2005 and June 2013.
with prostate, bladder, and kidney cancer,
Between 2011 and 2013, the authors noted a 3% per year
distant disease correlated with suicide.
increase in the percentage of prostate cancer patients who had
“Suicide in patients with genitourinary
a PSA level of 10.0 ng/mL or higher at diagnosis.
malignancies
poses a public health dilem“We believe our data indicate that the USPSTF might reconma, especially among men, the elderly,
sider their recommendation,” said co-author Timothy Schultheand those with aggressive disease,” the
iss, PhD, of City of Hope Medical Center, Duarte, CA.
authors wrote.
2,268 SUICIDES
Spider venom protein could be used
as new ED treatment
A PROTEIN occurring naturally in wandering spider venom could be used to
treat erectile dysfunction, according to a recent study.
The venom protein (PcTx2-6) was tested in mice and rats, and it appears
to increase cavernosal relaxation, according to researchers at the Catholic
University of Korea, Seoul, South Korea.
This discovery came about partially by accident, when research into the
possible use of wandering spider venom arose
after a team in Brazil studied the impact of spi-
A Protein in Wandering Spider
Venom Appears to Increase
Cavernosal Relaxation.
R EU T E RS
Ethicon ordered to pay $5.7 million
in transvaginal mesh lawsuit
A JURY has ordered Johnson & Johnson’s Ethicon, Inc. unit to pay $5.7
million due to injuries from the transvaginal mesh product Abbrevo,
Reuters reported.
This is the fourth win for plaintiffs suing Ethicon, with more than
36,000 lawsuits filed against the company in state and federal courts.
The FDA cleared the Abbrevo in 2010. Ethicon’s lawyers said the product was thoroughly vetted before it hit the market and that physicians
considered the mesh used in the Abbrevo to be the “gold standard” for
incontinence treatment.
The product was used to treat stress urinary incontinence and pelvic
organ prolapse. In this particular trial, the plaintiff claimed the mesh
began to erode in her body.
NEWS ODDITIES
1 IN 5 SURGEONS DON'T WASH HANDS IN BATHROOM
reported that 20% of
attendees at the American College of Surgeons’ 2012 Clinical Congress in Chicago
did not wash their hands after finishing in
the bathroom.
The tally was taken as part of a study published in Ugeskrif for Laeger (2014; 176[50]).
Jacob Rosenberg, MD, DSc, and colleagues
observed 50 attendees visits to the men’s
room and counted 10 who did not wash their
DANISH RESEARCHERS
hands. according to an article from Outpatient
Surgery Magazine.
“This is extremely worrying and it is not
acceptable. You could argue that hand hygiene
isn’t so important so long as the surgeons are
just attending a conference, but if they behave
in the same way in their everyday lives as medical practitioners when they’re dealing with
patients, there’s a risk of infection,” said Dr.
Rosenberg, of the University of Copenhagen,
Copenhagen, Denmark, and Herlev Hospital,
Herlev, Denmark.
Within a month, the authors repeated the
experiment at the American Medical Writers
Association’s annual meeting in Sacramento,
CA. This time, only one of 50 attendees didn’t
wash their hands. The authors said they
believe “the difference in the gender distribution at the two conferences may have distorted the results.”
PHOTOS: GETTY IMAGES/MOMENT (HAND)/STOCKBYTE (SPIDER)
M E DCI T Y N E W S/ M E DIC A L X P R ESS
Table 1. Adverse Reactions in Study 1 (cont.)
Respiratory Disorders
XTANDI® (enzalutamide) capsules for oral use
Initial U.S. Approval: 2012
BRIEF SUMMARY OF PRESCRIBING INFORMATION
The following is a brief summary. Please see the package
insert for full prescribing information.
Grade 3 and higher adverse reactions were reported
among 47% of XTANDI-treated patients and 53% of
placebo-treated patients. Discontinuations due to adverse
events were reported for 16% of XTANDI-treated patients
and 18% of placebo-treated patients. The most common
adverse reaction leading to treatment discontinuation was
seizure, which occurred in 0.9% of the XTANDI-treated
patients compared to none (0%) of the placebo-treated
patients. Table 1 shows adverse reactions reported in Study
1 that occurred at a ≥ 2% higher frequency in the XTANDI
arm compared to the placebo arm.
Table 1. Adverse Reactions in Study 1
Study 2: Chemotherapy-naive Metastatic CastrationResistant Prostate Cancer Study 2 enrolled 1717 patients
with metastatic CRPC who had not received prior cytotoxic
chemotherapy, of whom 1715 received at least one dose
of study drug. The median duration of treatment was 17.5
months with XTANDI and 4.6 months with placebo. Grade
3-4 adverse reactions were reported in 44% of XTANDItreated patients and 37% of placebo-treated patients.
Discontinuations due to adverse events were reported for
6% of XTANDI-treated patients and 6% of placebo-treated
patients. The most common adverse reaction leading to
treatment discontinuation was fatigue/asthenia, which
occurred in 1% of patients on each treatment arm. Table
2 includes adverse reactions reported in Study 2 that
occurred at a ≥ 2% higher frequency in the XTANDI arm
compared to the placebo arm.
XTANDI
N = 800
XTANDI is indicated for the treatment of patients with
metastatic castration-resistant prostate cancer (CRPC).
Grade
1-4a
(%)
CONTRAINDICATIONS
Pregnancy XTANDI can cause fetal harm when
administered to a pregnant woman based on its
mechanism of action and findings in animals. XTANDI is
not indicated for use in women. XTANDI is contraindicated
in women who are or may become pregnant. If this drug
is used during pregnancy, or if the patient becomes
pregnant while taking this drug, apprise the patient of
the potential hazard to the fetus and the potential risk for
pregnancy loss [see Use in Specific Populations (8.1)].
Seizure In Study 1, which enrolled patients who previously
received docetaxel, 7 of 800 (0.9%) patients treated with
XTANDI experienced a seizure and no patients treated with
placebo experienced a seizure. Seizure occurred from 31
to 603 days after initiation of XTANDI. In Study 2, 1 of
871 (0.1%) chemotherapy-naive patients treated with
XTANDI and 1 of 844 (0.1%) patients treated with placebo
experienced a seizure. Patients experiencing seizure were
permanently discontinued from therapy and all seizure
events resolved. There is no clinical trial experience readministering XTANDI to patients who experienced seizure.
Limited safety data are available in patients with
predisposing factors for seizure because these patients
were generally excluded from the trials. These exclusion
criteria included a history of seizure, underlying brain
injury with loss of consciousness, transient ischemic
attack within the past 12 months, cerebral vascular
accident, brain metastases, and brain arteriovenous
malformation. Study 1 excluded the use of concomitant
medications that may lower the seizure threshold,
whereas Study 2 permitted the use of these medications.
Because of the risk of seizure associated with XTANDI
use, patients should be advised of the risk of engaging
in any activity where sudden loss of consciousness could
cause serious harm to themselves or others. Permanently
discontinue XTANDI in patients who develop a seizure
during treatment.
ADVERSE REACTIONS
Clinical Trial Experience Because clinical trials are
conducted under widely varying conditions, adverse
reaction rates observed in the clinical trials of a drug
cannot be directly compared to rates in the clinical trials
of another drug and may not reflect the rates observed
in practice.
Two randomized clinical trials enrolled patients with
metastatic prostate cancer that has progressed on
androgen deprivation therapy (GnRH therapy or bilateral
orchiectomy), a disease setting that is also defined as
metastatic CRPC. In both studies, patients received
XTANDI 160 mg orally once daily in the active treatment
arm or placebo in the control arm. All patients continued
androgen deprivation therapy. Patients were allowed, but
not required, to take glucocorticoids.
The most common adverse reactions (≥ 10%) that
occurred more commonly (≥ 2% over placebo) in the
XTANDI-treated patients from the two randomized
clinical trials were asthenia/fatigue, back pain, decreased
appetite, constipation, arthralgia, diarrhea, hot flush, upper
respiratory tract infection, peripheral edema, dyspnea,
musculoskeletal pain, weight decreased, headache,
hypertension, and dizziness/vertigo.
Study 1: Metastatic Castration-Resistant Prostate
Cancer Following Chemotherapy Study 1 enrolled
1199 patients with metastatic CRPC who had previously
received docetaxel. The median duration of treatment
was 8.3 months with XTANDI and 3.0 months with
placebo. During the trial, 48% of patients on the XTANDI
arm and 46% of patients on the placebo arm received
glucocorticoids.
General Disorders
Asthenic
Conditionsb
Peripheral Edema
Placebo
N = 399
Grade Grade Grade
3-4
1-4
3-4
(%)
(%)
(%)
50.6
9.0
44.4
9.3
15.4
1.0
13.3
0.8
Musculoskeletal And Connective Tissue Disorders
Back Pain
26.4
5.3
24.3
4.0
Arthralgia
20.5
Musculoskeletal
15.0
Pain
Muscular
9.8
Weakness
Musculoskeletal
2.6
Stiffness
Gastrointestinal Disorders
2.5
17.3
1.8
1.3
11.5
0.3
1.5
6.8
1.8
0.3
0.3
0.0
21.8
1.1
17.5
0.3
Hot Flush
20.3
0.0
10.3
0.0
Hypertension
6.4
2.1
2.8
1.3
Diarrhea
Vascular Disorders
Nervous System Disorders
Headache
12.1
0.9
5.5
0.0
Dizzinessc
Spinal Cord
Compression and
Cauda Equina
Syndrome
Paresthesia
Mental
Impairment
Disordersd
Hypoesthesia
9.5
0.5
7.5
0.5
7.4
6.6
4.5
3.8
6.6
0.0
4.5
0.0
4.3
0.3
1.8
0.0
Epistaxis
3.3
0.1
1.3
0.3
a CTCAE v4
b Includes asthenia and fatigue.
c Includes dizziness and vertigo.
d Includes amnesia, memory impairment, cognitive disorder, and
disturbance in attention.
e Includes nasopharyngitis, upper respiratory tract infection, sinusitis,
rhinitis, pharyngitis, and laryngitis.
f Includes pneumonia, lower respiratory tract infection, bronchitis, and
lung infection.
Table 2. Adverse Reactions in Study 2
XTANDI
N = 871
Grade
1-4a
(%)
Grade
3-4
(%)
Placebo
N = 844
Grade
1-4
(%)
Grade
3-4
(%)
General Disorders
Asthenic
46.9
3.4
33.0
2.8
Conditionsb
Peripheral
11.5
0.2
8.2
0.4
Edema
Musculoskeletal And Connective Tissue Disorders
Back Pain
28.6
2.5
22.4
3.0
Arthralgia
21.4
1.6
16.1
1.1
Gastrointestinal Disorders
4.0
Infections And Infestations
Upper
Respiratory Tract 10.9
Infectione
Lower
Respiratory
8.5
Tract And Lung
f
Infection
Psychiatric Disorders
0.3
1.8
0.0
Constipation
23.2
0.7
17.3
0.4
Diarrhea
16.8
0.3
14.3
0.4
Vascular Disorders
Hot Flush
18.0
0.1
7.8
0.0
Hypertension
14.2
7.2
4.1
2.3
Nervous System Disorders
0.0
6.5
0.3
2.4
4.8
1.3
Insomnia
8.8
0.0
6.0
0.5
Anxiety
6.5
0.3
4.0
0.0
Renal And Urinary Disorders
Hematuria
6.9
1.8
4.5
1.0
Pollakiuria
4.8
0.0
2.5
0.0
Injury, Poisoning And Procedural Complications
Fall
4.6
0.3
1.3
Non-pathologic
4.0
1.4
0.8
Fractures
Skin And Subcutaneous Tissue Disorders
0.0
0.3
Pruritus
3.8
0.0
1.3
0.0
Dry Skin
3.5
0.0
1.3
0.0
Dizzinessc
11.3
0.3
7.1
0.0
Headache
11.0
0.2
7.0
0.4
Dysgeusia
7.6
0.1
3.7
0.0
5.7
0.0
1.3
0.1
2.1
0.1
0.4
0.0
0.6
8.5
0.6
0.0
10.5
0.0
1.5
4.7
1.1
0.1
5.7
0.0
Mental
Impairment
Disordersd
Restless Legs
Syndrome
Respiratory Disorders
Dyspneae
11.0
Infections And Infestations
Upper
Respiratory
16.4
Tract
Infectionf
Lower
Respiratory
Tract And
7.9
Lung
Infectiong
Psychiatric Disorders
Insomnia
8.2
Table 2. Adverse Reactions in Study 2 (cont.)
Renal And Urinary Disorders
Hematuria
8.8
1.3
5.8
1.3
Injury, Poisoning And Procedural Complications
Fall
12.7
1.6
NonPathological
8.8
2.1
Fracture
Metabolism and Nutrition Disorders
Decreased
18.9
0.3
Appetite
5.3
0.7
3.0
1.1
16.4
0.7
8.5
0.2
Investigations
Weight
Decreased
12.4
0.8
Reproductive System and Breast Disorders
Gynecomastia
3.4
0.0
1.4
0.0
a
b
c
d
CTCAE v4
Includes asthenia and fatigue.
Includes dizziness and vertigo.
Includes amnesia, memory impairment, cognitive disorder, and
disturbance in attention.
e Includes dyspnea, exertional dyspnea, and dyspnea at rest.
f Includes nasopharyngitis, upper respiratory tract infection, sinusitis,
rhinitis, pharyngitis, and laryngitis.
g Includes pneumonia, lower respiratory tract infection, bronchitis, and
lung infection.
Laboratory Abnormalities In the two randomized
clinical trials, Grade 1-4 neutropenia occurred in 15%
of patients treated with XTANDI (1% Grade 3-4) and in
6% of patients treated with placebo (0.5% Grade 3-4).
The incidence of Grade 1-4 thrombocytopenia was 6% of
patients treated with XTANDI (0.3% Grade 3-4) and 5% of
patients treated with placebo (0.5% Grade 3-4). Grade 1-4
elevations in ALT occurred in 10% of patients treated with
XTANDI (0.2% Grade 3-4) and 16% of patients treated
with placebo (0.2% Grade 3-4). Grade 1-4 elevations in
bilirubin occurred in 3% of patients treated with XTANDI
(0.1% Grade 3-4) and 2% of patients treated with placebo
(no Grade 3-4).
Infections In Study 1, 1% of patients treated with XTANDI
compared to 0.3% of patients treated with placebo died
from infections or sepsis. In Study 2, 1 patient in each
treatment group (0.1%) had an infection resulting in
death.
Falls and Fall-related Injuries In the two randomized
clinical trials, falls including fall-related injuries, occurred
in 9% of patients treated with XTANDI compared to 4% of
patients treated with placebo. Falls were not associated with
loss of consciousness or seizure. Fall-related injuries were
more severe in patients treated with XTANDI and included
non-pathologic fractures, joint injuries, and hematomas.
Hypertension In the two randomized trials, hypertension
was reported in 11% of patients receiving XTANDI and
4% of patients receiving placebo. No patients experienced
hypertensive crisis. Medical history of hypertension
was balanced between arms. Hypertension led to study
discontinuation in < 1% of patients in each arm.
DRUG INTERACTIONS
Drugs that Inhibit or Induce CYP2C8 Co-administration
of a strong CYP2C8 inhibitor (gemfibrozil) increased the
composite area under the plasma concentration-time curve
(AUC) of enzalutamide plus N-desmethyl enzalutamide
by 2.2-fold in healthy volunteers. Co-administration of
XTANDI with strong CYP2C8 inhibitors should be avoided
if possible. If co-administration of XTANDI with a strong
CYP2C8 inhibitor cannot be avoided, reduce the dose of
XTANDI [see Dosage and Administration (2.2) and Clinical
Pharmacology (12.3)].
The effects of CYP2C8 inducers on the pharmacokinetics
of enzalutamide have not been evaluated in vivo.
Co-administration of XTANDI with strong or moderate
CYP2C8 inducers (e.g., rifampin) may alter the plasma
exposure of XTANDI and should be avoided if possible.
Selection of a concomitant medication with no or minimal
CYP2C8 induction potential is recommended [see Clinical
Drugs that Inhibit or Induce CYP3A4 Co-administration
of a strong CYP3A4 inhibitor (itraconazole) increased
the composite AUC of enzalutamide plus N-desmethyl
enzalutamide by 1.3-fold in healthy volunteers [see
Clinical Pharmacology (12.3)].
The effects of CYP3A4 inducers on the pharmacokinetics
of enzalutamide have not been evaluated in vivo.
Co-administration of XTANDI with strong CYP3A4
inducers (e.g., carbamazepine, phenobarbital, phenytoin,
rifabutin, rifampin, rifapentine) may decrease the plasma
exposure of XTANDI and should be avoided if possible.
Selection of a concomitant medication with no or minimal
CYP3A4 induction potential is recommended. Moderate
CYP3A4 inducers (e.g., bosentan, efavirenz, etravirine,
modafinil, nafcillin) and St. John’s Wort may also reduce
the plasma exposure of XTANDI and should be avoided if
possible [see Clinical Pharmacology (12.3)].
Effect of XTANDI on Drug Metabolizing Enzymes
Enzalutamide is a strong CYP3A4 inducer and a moderate
CYP2C9 and CYP2C19 inducer in humans. At steady
state, XTANDI reduced the plasma exposure to midazolam
(CYP3A4 substrate), warfarin (CYP2C9 substrate), and
omeprazole (CYP2C19 substrate). Concomitant use of
XTANDI with narrow therapeutic index drugs that are
metabolized by CYP3A4 (e.g., alfentanil, cyclosporine,
dihydroergotamine, ergotamine, fentanyl, pimozide,
quinidine, sirolimus and tacrolimus), CYP2C9 (e.g.,
phenytoin, warfarin) and CYP2C19 (e.g., S-mephenytoin)
should be avoided, as enzalutamide may decrease their
exposure. If co-administration with warfarin cannot be
avoided, conduct additional INR monitoring [see Clinical
USE IN SPECIFIC POPULATIONS
Pregnancy - Pregnancy Category X [see Contraindications
(4)].
Risk Summary
XTANDI can cause fetal harm when administered to a
pregnant woman based on its mechanism of action and
findings in animals. While there are no human data on the
use of XTANDI in pregnancy and XTANDI is not indicated
for use in women, it is important to know that maternal
use of an androgen receptor inhibitor could affect
development of the fetus. Enzalutamide caused embryofetal toxicity in mice at exposures that were lower than
in patients receiving the recommended dose. XTANDI
is contraindicated in women who are or may become
pregnant while receiving the drug. If this drug is used
during pregnancy, or if the patient becomes pregnant
while taking this drug, apprise the patient of the potential
hazard to the fetus and the potential risk for pregnancy
loss. Advise females of reproductive potential to avoid
becoming pregnant during treatment with XTANDI.
Animal Data
In an embryo-fetal developmental toxicity study in
mice, enzalutamide caused developmental toxicity
when administered at oral doses of 10 or 30 mg/kg/day
throughout the period of organogenesis (gestational days
6-15). Findings included embryo-fetal lethality (increased
post-implantation loss and resorptions) and decreased
anogenital distance at ≥ 10 mg/kg/day, and cleft palate
and absent palatine bone at 30 mg/kg/day. Doses of 30
mg/kg/day caused maternal toxicity. The doses tested
in mice (1, 10 and 30 mg/kg/day) resulted in systemic
exposures (AUC) approximately 0.04, 0.4 and 1.1 times,
respectively, the exposures in patients. Enzalutamide
did not cause developmental toxicity in rabbits when
administered throughout the period of organogenesis
(gestational days 6-18) at dose levels up to 10 mg/kg/day
(approximately 0.4 times the exposures in patients based
on AUC).
Nursing Mothers XTANDI is not indicated for use in
women. It is not known if enzalutamide is excreted
in human milk. Because many drugs are excreted in
human milk, and because of the potential for serious
adverse reactions in nursing infants from XTANDI, a
decision should be made to either discontinue nursing, or
discontinue the drug taking into account the importance
of the drug to the mother.
Pediatric Use Safety and effectiveness of XTANDI in
pediatric patients have not been established.
Geriatric Use Of 1671 patients who received XTANDI
in the two randomized clinical trials, 75% were 65 and
over, while 31% were 75 and over. No overall differences
in safety or effectiveness were observed between these
patients and younger patients. Other reported clinical
experience has not identified differences in responses
between the elderly and younger patients, but greater
sensitivity of some older individuals cannot be ruled out.
Patients with Renal Impairment A dedicated renal
impairment trial for XTANDI has not been conducted.
Based on the population pharmacokinetic analysis
using data from clinical trials in patients with metastatic
CRPC and healthy volunteers, no significant difference
in enzalutamide clearance was observed in patients
with pre-existing mild to moderate renal impairment
(30 mL/min ≤ creatinine clearance [CrCL] ≤ 89 mL/min)
compared to patients and volunteers with baseline
normal renal function (CrCL ≥ 90 mL/min). No initial
dosage adjustment is necessary for patients with mild
to moderate renal impairment. Severe renal impairment
(CrCL < 30 mL/min) and end-stage renal disease have not
been assessed [see Clinical Pharmacology (12.3)].
Patients with Hepatic Impairment A dedicated hepatic
impairment trial compared the composite systemic
exposure of enzalutamide plus N-desmethyl enzalutamide
in volunteers with baseline mild or moderate hepatic
impairment (Child-Pugh Class A and B, respectively)
versus healthy controls with normal hepatic function.
The composite AUC of enzalutamide plus N-desmethyl
enzalutamide was similar in volunteers with mild or
moderate baseline hepatic impairment compared to
volunteers with normal hepatic function. No initial dosage
adjustment is necessary for patients with baseline mild
or moderate hepatic impairment. Baseline severe hepatic
impairment (Child-Pugh Class C) has not been assessed
[see Clinical Pharmacology (12.3)].
OVERDOSAGE
In the event of an overdose, stop treatment with
XTANDI and initiate general supportive measures taking
into consideration the half-life of 5.8 days. In a dose
escalation study, no seizures were reported at < 240
mg daily, whereas 3 seizures were reported, 1 each at
360 mg, 480 mg, and 600 mg daily. Patients may be at
increased risk of seizure following an overdose.
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies have not been conducted to
evaluate the carcinogenic potential of enzalutamide.
Enzalutamide did not induce mutations in the bacterial
reverse mutation (Ames) assay and was not genotoxic in
either the in vitro mouse lymphoma thymidine kinase (Tk)
gene mutation assay or the in vivo mouse micronucleus
assay.
Based on nonclinical findings in repeat-dose toxicology
studies, which were consistent with the pharmacological
activity of enzalutamide, male fertility may be impaired
by treatment with XTANDI. In a 26-week study in rats,
atrophy of the prostate and seminal vesicles was observed
at ≥ 30 mg/kg/day (equal to the human exposure based
on AUC). In 4-, 13-, and 39-week studies in dogs,
hypospermatogenesis and atrophy of the prostate and
epididymides were observed at ≥ 4 mg/kg/day (0.3 times
the human exposure based on AUC).
Manufactured by: Catalent Pharma Solutions, LLC, St.
Petersburg, FL 33716
Manufactured for and Distributed by: Astellas Pharma
US, Inc., Northbrook, IL 60062
Marketed by:
Astellas Pharma US, Inc., Northbrook, IL 60062
Medivation, Inc., San Francisco, CA 94105
Revised: September 2014
14B006-XTA-BRFS
Rx Only
© 2014 Astellas Pharma US, Inc.
XTANDI® is a registered trademark of Astellas Pharma Inc.
076-0472-PM
XTANDI (enzalutamide) capsules is indicated for the treatment of
patients with metastatic castration-resistant prostate cancer (CRPC).
Important Safety Information
Contraindications XTANDI (enzalutamide) capsules can
cause fetal harm when administered to a pregnant woman
based on its mechanism of action and findings in animals.
XTANDI is not indicated for use in women. XTANDI is
contraindicated in women who are or may become pregnant.
Warnings and Precautions In Study 1, conducted in patients
with metastatic castration-resistant prostate cancer (CRPC)
who previously received docetaxel, seizure occurred in
0.9% of patients who were treated with XTANDI and 0%
treated with placebo. In Study 2, conducted in patients with
chemotherapy-naïve metastatic CRPC, seizure occurred in
0.1% of patients who were treated with XTANDI and 0.1%
treated with placebo. Patients experiencing a seizure were
permanently discontinued from therapy and all seizure events
resolved. There is no clinical trial experience re-administering
XTANDI to patients who experienced a seizure, and limited
clinical trial experience in patients with predisposing
factors for seizure. Study 1 excluded the use of concomitant
medications that may lower threshold, whereas Study 2
permitted the use of these medications. Because of the risk
of seizure associated with XTANDI use, patients should be
advised of the risk of engaging in any activity during which
sudden loss of consciousness could cause serious harm to
themselves or others. Permanently discontinue XTANDI in
patients who develop a seizure during treatment.
Adverse Reactions The most common adverse reactions
(≥ 10%) reported from the two combined clinical trials
that occurred more commonly (≥ 2% over placebo) in the
XTANDI-treated patients were asthenia/fatigue, back pain,
decreased appetite, constipation, arthralgia, diarrhea, hot
flush, upper respiratory tract infection, peripheral edema,
dyspnea, musculoskeletal pain, weight decreased, headache,
hypertension, and dizziness/vertigo.
Other Adverse Reactions include:
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group (0.1%) had an infection resulting in death.
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5)):77+*/45,%$6'9/+498;897+'9+*
</9.62')+(5'228<+7+459'885)/'9+*</9.25885,
)548)/5:84+88578+/?:7+'227+2'9+*/40:7/+8<+7+357+
severe in XTANDI patients and included non-pathologic
,7')9:7+805/49/40:7/+8'4*.+3'953'8
A>6+79+48/5449.+9<589:*/+8.>6+79+48/54<'87+6579+*
/4
5,6'9/+4987+)+/;/4-%$'4*5,6'9/+498
receiving placebo. No patients experienced hypertensive
crisis. Medical history of hypertension was balanced
(+9<++4'738>6+79+48/542+*9589:*>*/8)549/4:'9/54/4
< 1% of XTANDI or placebo treated patients.
Drug Interactions
AD+)95, 9.+77:-854%$*3/4/897'9/545,
strong CYP2C8 inhibitors can increase the plasma exposure
to XTANDI. Co-administration of XTANDI with strong
CYP2C8 inhibitors should be avoided if possible.
If co-administration of XTANDI cannot be avoided, reduce
the dose of XTANDI. Co-administration of XTANDI with
89754-5735*+7'9+&!'4*&!/4*:)+783'>
alter the plasma exposure of XTANDI and should be
avoided if possible.
AD+)95,%$54 9.+77:-8%$/8'89754-
&!/4*:)+7'4*'35*+7'9+&!'4*&!
/4*:)+7/4.:3'48;5/*&!&!'4*&!
substrates with a narrow therapeutic index, as XTANDI
may decrease the plasma exposures of these drugs.
If XTANDI is co-administered with warfarin (CYP2C9
substrate), conduct additional INR monitoring.
Please see adjacent pages for Brief Summary of
Full Prescribing Information.
© 2015 Astellas Pharma US, Inc. All rights reserved. Printed in USA. 076-0803-PM 3/15
XTANDI, Astellas, and the flying star logo are trademarks of Astellas Pharma Inc.
94%
of insured patient lives
are covered for XTANDI*2
*As of February 2015. A product’s placement on a plan formulary involves
a variety of factors known only to the plan and is subject to eligibility.
To learn more, please visit XtandiHCP.com
XTANDI (enzalutamide) capsules is indicated for the treatment of
patients with metastatic castration-resistant prostate cancer (CRPC).
*O
ateral o
r after bil
rchiectom
y.1
patient lives
covered for XTANDI
94% ofareinsured
†
†2
As of February 2015. A product’s placement on a plan formulary involves
a variety of factors known only to the plan and is subject to eligibility.
Select Safety Information
To learn more, please visit XtandiHCP.com
XTANDI can cause fetal harm when administered to a pregnant woman based on its mechanism of action
and findings in animals. XTANDI is not indicated for use in women. XTANDI is contraindicated in women
who are or may become pregnant.
Seizure occurred in 0.9% of patients receiving XTANDI who previously received docetaxel and in 0.1% of
patients who were chemotherapy-naive. Patients should be advised of the risk of engaging in any activity
where sudden loss of consciousness could cause serious harm to themselves or others. Permanently
discontinue XTANDI in patients who develop a seizure during treatment.
References: 1. XTANDI [package insert]. Northbrook, IL: Astellas Pharma US, Inc. 2. Data on file, Medivation, Inc.
Please see inside page for additional Important Safety Information.
Please see adjacent pages for Brief Summary of Full Prescribing Information.

Statins may improve PCa outcomes

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