Large Study Reports That 65% Of Male Patients With Stress Urinary Incontinence Were Dry At Two Years

Main Category: Urology / Nephrology
Article Date: 28 Mar 2008 - 1:00 PDT

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A condition that affects over two million men, stress urinary incontinence (SUI) is often a disturbing complication that follows the surgical removal of the prostate. Until now, there have been few options for treatment of this embarrassing condition.

A product called ProACT™ (Adjustable Continence Therapy), studied in recent clinical trials might provide an option for SUI patients. It is not yet approved by the FDA, but early clinical trial results are now becoming available. A large sample study conducted outside the United States reports that the ProACT™ (Adjustable Continence Therapy), manufactured by Uromedica, Inc., in the United States, has met study criteria used to demonstrate the safety, effectiveness and durability of the treatment for male stress urinary incontinence. The long-term study, titled International multi-center evaluation of the ProACT for male post prostatectomy stress urinary incontinence by Gilling, P. et al., and abstract accepted for presentation at the 23rd annual European Urology Association (EAU) congress, reports that 65% of patients were dry (<1 pad a day) at two years. In addition, patients reported a significant improvement in quality of life (from 41.6 before the procedure to 74.6 at two years after the procedure, on a scale from 0-100). Complications included erosion, migration, or non-response to initial surgery. Device removal was easily performed without adverse sequelae.

First used in 2000 in Austria by Dr. Wilhelm Hübner (one of the co-investigators in this study), the ProACT device was implanted in 329 male patients in four international centers between 2001 and 2005. These patients suffered from incontinence arising from multiple etiologies (but predominantly post radical prostatectomy incontinence). "The promising results reported here suggest that this may be an appropriate, effective and durable first-line treatment to offer men with stress urinary incontinence after prostatectomy", said Dr. Wilhelm Hübner, Director of the Urology Department at the Humanis Clinic in Korneuburg. Study findings will be presented at the European Association of Urology (EAU) Annual Meeting (March 26-29) in Milan, Italy. For information on this and other studies, go to http://www.uromedica-inc.com.

ProACT™ therapy and ACT® (Adjustable Continence Therapy) were developed by Uromedica and approved in Europe in 2002. Based on patented technology, the balloon volume can be percutaneously increased or decreased to meet the needs of the individual patient. The ProACT was designed to be a first-line treatment for post-prostatectomy urinary incontinence in men, and the ACT device treats stress urinary incontinence in women who have not responded to other interventions. The ProACT therapy and ACT are pending investigation in the United States and are not approved for sale by the FDA. This press release is not intended to make any claims of safety or effectiveness in the use of these devices.

About Uromedica

Uromedica, Inc. was formed in 1997 to develop minimally invasive medical devices that treat unmet medical needs in the area of urogenital and related disorders. Fourteen million people suffer from stress urinary incontinence, an embarrassing condition that produces a significant cost to society and a disturbing trend as the population increases. To date, around 6000 patients have been implanted with the ACT and ProACT minimally invasive devices which can be non-surgically adjusted to best meet the individual patient needs. The company is in the final stages of clinical studies in the United States.

http://www.uromedica-inc.com.