The Two-Piece Prosthesis Has No Role in the Modern Era Point

The Two-Piece Prosthesis Has No Role
in the Modern Era
Point/Counterpoint: CON
SEXUAL MEDICINE SOCIETY
OF NORTH AMERICA
MAY 16, 2015
ASHLEY H. TAPSCOTT, DO
CAROLINA UROLOGY PARTNERS
HUNTERSVILLE, NC
Disclosures
 Consultant/Speaker


American Medical Systems
Coloplast Corporation
Inflatable Penile Prostheses
 Over 40 years
 Penile implants held major position in treatment
algorithm for patients with ED
 Historically data reflects mostly self-
administered vs validated questionnaires
 Studies now producing objective data
 No overt papers 2 piece vs 3 piece for same
patient
Product Comparison
AmericanMedical Systems, Minnetonka, MN, USA
Coloplast Corporation, Minneapolis, MN, USA
Product Comparison
Ambicor
 Introduced 1994, successor to
Dynaflex (1 piece)
 1998 redesign
RTEs: increased durability
 Tubing insertion: stress
protection at flex point

Two-Piece Prosthesis
2007, Levine & Morgentaler
 First
objective and subjective report of performance
of revised IPP, 146 patients
 Up to 6 years follow up
 High device viability
 Low reoperation and infection rates
 No
reported complications
 High patient and partner satisfaction
 No
removals due to dissatisfaction
Lux M, Reyes-Vallejo L, Morgentaler A, Levine LA. Outcomes and satisfaction rates for the redesigned 2-piece penile prosthesis. J Urol.2007;177(1):262–6.
Two-Piece Prosthesis
 91% Ease of use
 95% Little to no trouble learning to use device
 95% Rigidity suitable for intercourse
 Free from reoperation
1
year : 99.2%
 3 years: 99.2%
 ≥ 4 years : 91%
Lux M, Reyes-Vallejo L, Morgentaler A, Levine LA. Outcomes and satisfaction rates for the redesigned 2-piece penile prosthesis. J Urol.2007;177(1):262–6.
Surgical Approach
Surgeon preferences play a role in device choice
 Penoscrotal
 2-piece
 3-Piece
 Infrapubic
 3-Piece
Infection
Decreasing infection rates: active area of design, protocol
development
Mechanical aspect of device (coating)
Reduced infections and colonization
Decreased incidence from 3-5%, to 1-2%
 Surgeon technique/experience
 Patient selection
 Other factors/quality measures

Wilson SK, Salem EA, CostertonW. Anti-infection dip suggestions for the Coloplast Titan inflatable penile prosthesis in the era of the infection retardant coated implant. J Sex Med.
2011;8:2647–54. Carson CC. Efficacy of antibiotic impregnation of inflatable penile prostheses in decreasing infection in original implants. J Urol. 2004;171:1611–4. Richardson B, Caire A,
Hellstrom W. Retrospective long-term analysis of Titan hydrophilic coating: positive reduction of infection compared to non-coated device. J Sex Med. 2010;7:28.
Infection
2-Piece, Wet within packaging, prefilled
o Precludes InhibiZone®
o
2007 study: 0.7% infection rate
Inflation and Deflation
Pump/Inflation
 No
available data on “number of squeezes”
for either device
 Patient dexterity
Inflation and Deflation
2-Piece: Easy deflation, inflation
Fewest pumps inherent in design
Penile Length
Complaint not unique to 2 piece design
 Overall 72% patients subjective decrease in penile
length

Despite lack of significant difference in pre and post
operative measurements
 Maximize cylinder length/perceived length
 “Sellers Sizing”, preoperative VED
 Henry, NLMT, aggressive corporal measurement
 Wilson, Severe fibrosis: narrow expander upsizing
 Carrion, ventral phalloplasty
Deveci S,Martin D, ParkerM,Mulhall JP. Penile length alterations following penile prosthesis surgery. Eur Urol. 2007;51:1128–31.
Sellers T, Dineen M, Salem EA, Wilson SK. Vacuum preparation, optimization of cylinder length and postoperative daily inflation reduces complaints of shortened penile length following implantation of inflatable penile prosthesis. Adv Sex
Med. 2013;03:14–8. Henry G, Houghton L, Culkin D, Otheguy J, Shabsigh R, Ohl DA. Comparison of a new length measurement technique for inflatable penile prosthesis implantation to standard techniques: outcomes and patient
satisfaction. J Sex Med. 2011;8:2640–6. Wilson SK, Delk JR, Mulcahy JJ, Cleves M, Salem EA. Upsizing of inflatable penile implant cylinders in patients with corporal fibrosis. J Sex Med. 2006;3:736–42. Miranda-Sousa A, Keating M,
Moreira S, Baker M, Carrion R. Concomitant ventral phalloplasty during penile implant surgery: a novel procedure that optimizes patient satisfaction and their perception of phallic length after penile implant surgery. J Sex
Med.2007;4:1494–9.
Flaccidity/Concealment
2-piece
 Theoretical
concern for inadequate concealment
 Ease of concealment when deflated
92%
patients
Some men enjoy appearance of partial penile fullness
Lux M, Reyes-Vallejo L, Morgentaler A, Levine LA. Outcomes and satisfaction rates for the redesigned 2-piece penile prosthesis. J Urol. 2007;177(1):262–6.
Rigidity/Erection Quality
Several factors are responsible for cylinder rigidity
 FIXED
Cylinder
length
Cylinder girth
Cylinder pressure
 NOT
FIXED, dependent on patient
Wall
thickness - +/- presence of capsule
Scarring, +/- PD
Tissue elasticity
Mechanical Reliability
2-piece
 146 implants
 Mean 38 month follow up: 0.7% failure
3 piece, Longest-term study, 2,000 implants
10 years: failure 21%
15 years: failure 29%
Lux M, Reyes-Vallejo L, Morgentaler A, Levine LA. Outcomes and satisfaction rates for the redesigned 2-piece penile prosthesis. J Urol.2007;177(1):262–6
Wilson SK, Delk JR, Salem EA, ClevesMA. Long-term survival of inflatable penile prostheses: single surgical group experience with 2,384 first-time implants
spanning two decades. J Sex Med. 2007;4(4 Pt 1):1074–9.
Reservoir Placement
 2-piece
 “Hostile”
abdomen
 Independent of future abdominal surgeries
 Surgeon preference to avoid reservoir placement
 3-piece
 Reports
of placement into surrounding structures +/experience
 Advances in surgical techniques and device modifications
Reservoir Placement
Inguinal ring, gateway to reservoir placement
 Henry et al, Cadaver
Study, external inguinal ring
 2.5–4 cm from the external iliac vein
 5.3–8 cm from the decompressed bladder
 2–4 cm from the filled bladder
 Altered
in location, distance in any
abdominal/pelvic surgery without consideration for
mesh, new organ, scarring, adhesions
Henry G, Jones L, Carrion R, Bella A, Karpman E, Christine B, Kramer A. Pertinent anatomical measurements of the retropubic space: A
guide for inflatable penile prosthesis reservoirs shows that the external iliac vein is much closer than thought. J Sex Med 2012;9(suppl
4):192, A27.
Reservoir Removal
Reported life-threatening bleeding with removal
“Drain and retain” in uninfected cases
Same vs different surgeon implanting/explanting
Levine LA, Hoeh MP. Review of penile prosthetic reservoir: Complications and presentation of a modified reservoir placement
technique. J Sex Med 2012;9:2759–69.
Hinds PR, Wilson SK, Sedeghi-Nejad H. Dilemmas of inflatable penile prosthesis revision surgery: What practices achieve the best
outcome and lowest infection rates. J Sex Med 2012;9:2484–92.
“Ectopic” Reservoir Placement
Alternative sites
 Anterior/Posterior to
abdominal wall
musculature
 Potentially safer location
 ? Worth risk of palpable or
herniated reservoir/affect
patient satisfaction
 ? Create new
complications
Stember DS, Garber BB, and Perito PE. Outcomes of abdominal wall reservoir placement in inflatable penile prosthesis implantation: A safe
and efficacious alternative to the space of Retzius. J Sex Med 2014;11:605–612.
“Ectopic” Reservoir Placement
Survey of high volume prosthetic surgeons
 90% SMSNA members believe placing the
reservoir in an “ectopic” location can be
advantageous for patient safety
“Ectopic” Reservoir Placement
In some patients.......
Safest??.. No reservoir
“Ectopic” Reservoir Placement
“Ectopic” Reservoir Placement
NOT A MAGICAL UNICORN
“Ectopic” Reservoir Placement
Ectopic reservoir placement is not the panacea
for all implant patients
 DESPITE excellent described technique and safety
advantages
 Not all surgeons will be comfortable or proficient
 Not all patients will be candidates
 Not all patients will be accepting
Karpman E, Sadeghi-Nejad H, Henry GD, Khera M, Morey AF. Current opinions on alternative reservoir placement for
inflatable penile prosthesis among members of the Sexual Medicine Society of North America. J Sex Med 2013;10: 2115–20.
Rogue Reservoir Patients
Patient Anatomy
“Hostile” pelvis
o Multiple/Combined/Repeated ABD procedures
o Bladder reconstruction
o Bilateral hernia repair +/- mesh
 Organ transplant (kidney)
 Thin habitus
 Surgery on anticoagulation
 Reconstruction/plastics: Neophallus
Best Patient Outcome
Surgeon Comfort + Patient Comfort
Need the right implant for the right patient = options
Patient vs Patient
Patient vs Patient
Patient vs Patient
?
 Goal of IPP placement is to improve quality of
life by resumption of sexual activity
 Device/technique adjustment vs compromise
for complications
 Preoperative counseling, assessment of all
patient qualities, proper device selection =
higher patient satisfaction
Two-Piece Prosthesis
 Safe
 Effective
 Mechanically reliable
 Low revision rate
 Low infection rate
 Good patient and partner satisfaction
 Cost
There continues to be a valuable role for the 2 piece
Do not underestimate the role of SIMPLICITY


Placement, Performance, Use
Especially in complicated patients
LONG LIVE THE 2-PIECE