DefluxTM for Stress Urinary Incontinence.

A simple, safe and natural treatment for an improved quality of life.

Deflux / Inject Control / For Stress Urinary Incontinence

Inject Control

Email / international@oceanathera.com Tel / +353 1 293 0153 Fax / +353 1 293 0166

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.

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.

Deflux gel is a viscous substance consisting of two components: dextranomer (Dx) microspheres and stabilized hyaluronic acid of non-animal origin (NASHA™).

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

(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.

When you choose Deflux you can rely on safety, efficacy and durability7.

The Natural Solution

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

• 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

• 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

Durability

Suitability

For Stress Urinary Incontinence / Inject Control / Deflux

The Procedure

Oceana Therapeutics Ltd / Suite 602 / Q House Sandyford / Sandyford Industrial Estate / Dublin 18 / Ireland

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.

The desired amount of Deflux gel varies between 1 – 3 mls, the number of injections depends upon the visible bulking effect.

4 The needle should be held in place for 30 seconds at each injection to allow the gel to settle.

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

Clinical References1. 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

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 dextranomer-hyaluronic 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

DefluxTM for Stress Urinary Incontinence.

A simple, safe and natural treatment for an improved quality of life.

For more information please contact us.

Email. international@oceanathera.comTel. +353 1 293 0153Fax. +353 1 293 0166

Oceana Therapeutics LtdSuite 602, Q House Sandyford76 Furze RoadSandyford Industrial EstateDublin 18Ireland

OTL

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