6 Page Male Incontinence Booklet 10/09/ :44 Page 1. The Natural Non-Surgical Option for Male Urinary Incontinence

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1 6 Page Male Incontinence Booklet /9/ :44 Page The Natural Non-Surgical Option for Male Urinary Incontinence

2 6 Page Male Incontinence Booklet /9/ :44 Page Stress Urinary Incontinence - A Stressful Prospect for Men Stress urinary incontinence (SUI) is an increasing problem among men, creating a huge negative impact on their quality of life. There are many risk factors, but the primary cause of male SUI is prostate surgery - in particular, radical prostatectomy for the removal of localized prostate cancer. The occurrence of urinary incontinence following radical prostatectomy ranges between 5% - 45%. The number of men who undergo prostate surgery is constantly increasing. Over 5, new prostate cancer cases are diagnosed each year worldwide. Thus, the social and hygienic inconvenience that comes with SUI is also rising. Post prostatectomy incontinence is often underestimated. In fact, the occurrence of incontinence experienced by patients is - times higher than that officially reported. It is important to remember that losing the ability to control urination or having to wear pads is distressing. Sometimes the fear is so intense that men refuse to undergo radical prostatectomy and start searching for other alternatives.

3 6 Page Male Incontinence Booklet /9/ :44 Page - The Minimally Invasive Treatment Option To treat post prostatectomy SUI there are several treatment options of varying invasiveness. One of the few minimally invasive treatments using a natural, biocompatible substance is DEFLUX. DEFLUX is a gel made from dextranomer (Dx) and stabilized nonanimal hyaluronic acid, NASHA technology. DEFLUX has been successfully used for over a decade to treat more than, children affected by vesicoureteral reflux. DEFLUX gel is injected into the urethra endoscopically to obtain a bulking effect. (Stenberg & Läckgren ). The dextranomer (Dx) component promotes ingrowth of collagen and connective tissue creating a lasting effect. Several studies demonstrate that DEFLUX is a suitable and efficient treatment for postprostatectomy incontinence. According to one study (Alloussi ), 58% of Grade patients were dry 4-8 weeks after injection, and 9% experienced a reduction in incontinence by at least one degree. Patients continent 4-8 weeks after treatment (%) SUI grade Continent SUI grading. SUI grade Number of patients Mean daily urine loss (g) < >5 Injection volume range (ml) SUI grades at baseline and volumes of NASHA/Dx gel injected SUI grade at baseline Proportion of patients continent 4-8 weeks after treatment with NASHA/Dx gel.

4 6 Page Male Incontinence Booklet /9/ :44 Page 4 The Procedure - Convenient for Everyone Involved A treatment with DEFLUX is normally preceded by local anesthesia. Observing the same sterile conditions as any other aseptic operation, the treatment is carried out transurethrally under endoscopic guidance. Figure. A standard sized cystoscope with a small caliber working channel is used, shown here entering the urethra. Figure. The cystoscope passes through the sphincter into the bladder for careful inspection and identification of the injection area. Figure. The scope is retracted, leaving the needle just above the external urethral sphincter, where the submucosal injection is made. The desired amount of DEFLUX gel varies between -4 ml, since the number of injections depends on the visible bulking effect. Figure 4. At each injection the needle should be held in place seconds to allow the gel to settle. Here the bulking effect of the injected DEFLUX gel is visualized. Immediately following treatment, patients should avoid sitting on hard surfaces, and bicycling should be avoided for 6- weeks. Patients should also be informed that a second treatment may be necessary to obtain maximum results. 4

5 6 Page Male Incontinence Booklet /9/ :44 Page 5 The Benefits Reliable and Well Documented When you use DEFLUX, you can rely on 4 5 safety, efficacy and durability. In addition to the fundamental advantages of the gel being biocompatible, nonimmunogenic, and nonmigrating, DEFLUX is also: Minimally invasive Easy to handle Proven to have minimal side effects And because the treatment has no negative influence on artificial urinary sphincter implantations, DEFLUX can be seen as a first choice alternative prior to surgery. References:. Stenberg A, Läckgren G. Treatment of Vesicoureteral Reflux in Children Using Stabilized Non-Animal Hyaluronic Acid/Dextranomer Gel (NASHA/Dx) A Long-Term Observational Study. J Pediatr Urol. 7;:8-85. Cerwinka WH, Scherz HC, Kirsch AJ. Endoscopic Treatment of Vesicoureteral Reflux with Dextranomer / Hyaluronic Acid in Children. Published online: May 4, 8 (doi :.55/8/5854). Alloussi S, Lang C, Sayegh T, Gitzhofer S, Eichel R. Preliminary Results of Non-Animal Stabilised Hyaluronic Acid/ Dextranomer (NASHA/Dx) Gel for Post-Prostatectomy Incontinence Presented at the th European Association of Urology Congress, March 5 4. Elmore JM, Kirsch AJ, Heiss EA, Gilchrist A, Scherz HC. Incidence of Urinary Tract Infections in Children after Successful Ureteral Reimplantation versus Endoscopic Dextranomer/Hyaluronic Acid Implantation. J Urol. 8;79: Chi A, Gupta A, Snodgrass W. Urinary Tract Infection Following Successful Dextranomer/Hyaluronic Acid Injection for Vesicoureteral Reflux. J Urol. 8;79:

6 6 Page Male Incontinence Booklet /9/ :44 Page 6 Oceana Therapeutics, Ltd. All rights reserved. Printed in IRELAND. OTL 4 Q House 76 Furze Road Sandyford Industrial Estate Dublin 8 Tel: +5 () 9 5 Fax: +5 () international@oceanathera.com