DefluxTM for Stress Urinary Incontinence. A simple, safe and natural

Deflux for Stress Urinary Incontinence.
TM
A simple, safe and natural treatment
for an improved quality of life.
Deflux / Inject Control / For Stress Urinary Incontinence
Inject Control
The Natural Solution
Stress urinary incontinence (SUI)
is characterised by the involuntary
leakage of urine, typically upon
exercise, coughing or sneezing.
It is a common condition that may
affect 10- 40% of women across
all age groups1.
Deflux gel is a viscous substance
consisting of two components:
dextranomer (Dx) microspheres
and stabilized hyaluronic acid of
non-animal origin (NASHA™).
SUI can have a significant impact
on the quality of life for people
with the condition which can
include social isolation and poor
self-esteem. Many women just
accept the condition as part of
the ageing process and rely on
pads and changes to their lifestyle
to manage the condition2.
There are a number of treatment
options for SUI. Urethral bulking
is a minimally invasive option
and offers an effective and safe
alternative to open surgery3.
Studies show that quality of
life improvements after urethral
injection are comparable to those
obtained with surgery4. It is an
ideal first line treatment option
for mild to moderate SUI.
Deflux can be administered
under local sedation or general
anaesthetic and the patient can
quickly return to normal activity
within 24 – 48 hours.
(Dx) beads act as the bulking agent
and have been shown to remain at
the injection site for up to 4 years5.
The stabilized hyaluronic gel is
the carrier gel which disappears
from the body. Data shows there
are no significant long term safety
concerns or reactions to Deflux6.
The dextranomer (Dx) component
promotes in-growth of collagen
and connective tissue creating
a lasting effect.
Deflux is completely safe and
has been successfully used for
over a decade to treat more than
200,000 children affected with
vesicoureteral reflux.
In the treatment of SUI, Deflux
is injected into the urethra
endoscopically to obtain a
bulking affect. The dextranomer
When you choose Deflux you
can rely on safety, efficacy
and durability7.
Benefits
•Deflux can be administered
under general anaesthetic or
local sedation
•It is a minimally invasive procedure
•Deflux is proven to have minimal side effects8
•There is a return to normal activity within 24 – 48 hours9
•Studies demonstrate a success
rate of 74%9
•It does not affect more major surgery at a later stage, if required10
Email / international@oceanathera.com Durability
•Deflux has been shown to remain
in place for over 4 years
•On average if patients require a repeat injection it is administered
at 5 years11
Suitability
•Women who prefer a minimally invasive option
•Women not suitable for a general anaesthetic
•Women with residual incontinence post a surgical procedure such as sling insertion
•Women of childbearing age
Tel / +353 1 293 0153 Fax / +353 1 293 0166
For Stress Urinary Incontinence / Inject Control / Deflux
The Procedure
1 A standard cystoscope with a working channel
is inserted into the urethra.
2 Deflux is injected into the submucosa approximately one centimetre back from the bladder neck.
3 Deflux can be injected at the 3, 6, 9, or 12 o’clock position dependent on the patient.
4 The needle should be held in place for 30 seconds
at each injection to allow the gel to settle.
The desired amount of Deflux gel varies between 1 – 3 mls, the number of injections depends upon the visible bulking effect.
The open urethra is closed with swelling towards
the midline observed after injection.
Post Operative Advice
•
•
Patients may experience some dysuria
and haematuria for 24 – 48 hours
Most patients return to normal activities
within 48 hours
•
•
There are no limitations to normal activities
although patients are advised to avoid sexual
intercourse, bicycle and horse riding for 1 month
At review, up to 10% of patients may require a
‘top up’ injection
Oceana Therapeutics Ltd / Suite 602 / Q House Sandyford / Sandyford Industrial Estate / Dublin 18 / Ireland
Deflux for Stress Urinary Incontinence.
TM
A simple, safe and natural treatment
for an improved quality of life.
For more information please contact us.
Email. international@oceanathera.com
Tel. +353 1 293 0153
Fax. +353 1 293 0166
Oceana Therapeutics Ltd
Suite 602, Q House Sandyford
76 Furze Road
Sandyford Industrial Estate
Dublin 18
Ireland
Clinical References
1. Hannestad YS, Rortveit G, Hunskar S: Help
seeking and associated factors in female urinary
incontinence. The Norwegian EPIN-CONT Study.
Epidemiology of Incontinence in the county
of Nord-Trondelag. Scand J Prim Health Care
2002;20:102-107
2. Andersson G, Johansson JE, Garpenholt O,
Nilsson K: Urinary Incontinence-prevalence,
impact on daily living and desire for treatment:a
population based study.Scand J of Nephrology
2004;38:125-130
OTL10066
3. Herschorn S. Current role of injectable
agents for female stress urinary incontinence.
The Canadian Journal of Urology.13
(Supplement 1): 5-12
4. Chapple C, Brubaker L, Haab F, van
Kerrebroeck P, Robinson D. Patient perceived
outcomes in the treatment of stress urinary
incontinence: focus on urtheral injection therapy.
Int Urogynecol J (2007) 18:199-205
5. Appell R, Dmochowski r, Herscorn
S. Urethral injections for female stress
incontinence. 2006 BJU International 98,
Supplement 1, 27 – 30
6. Stenberg A, Larsson E, Lackgren G,:
Endoscopic Treatment with dextranomerhyaluronic acid for vesicoureteral
reflux:histological findings. J Urol
2003;169:1109-1113
7. Stenberg A, Lackgren G. Treatment of
Vesicoureteral Reflux in Children Using Non
– Animal Hyaluronic Acid/Dextranomer Gel
(NASHA/Dx): A Long Term Observational
Study. J Pediat Urol. 2007;3:80-85
8. Foley. S et al. The use of Deflux™ to treat
stress urinary incontinence: 3 year results.
ICS 2011 Poster Presentation
9. Blick C, Marsh H, Muneer A, Tokaca N, Foley
SJ,: NASHA/Dx Gel (Zuidex™) for Stress Urinary
Incontinence: Results from a Single – Centre
Study of 150 Patients. Curr Urol 2008; 194 – 199
10. Blick C, Patel N, Foley SJ: Do Periurethral
Zuidex Injections Alter the Performance of
Tension-Free Tapes in the Treatment of Stress
Urinary Incontinence? Curr Urol 2010;4:15-17
11. Personal communication has not
been published