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Minimally-Invasive Surgery for Female Incontinence Appears to Offer Good Long-Term Cure Rates

SOMERVILLE, NJ -- December 1, 2004 -- A new study published in the December issue of the Journal of Obstetrics and Gynecology (Vol 104, Number 6) reports that 97 percent of women undergoing treatment for stress urinary incontinence (SUI) with GYNECARE TVT* Tension-free Support for Incontinence remained dry or significantly improved seven years postoperatively.

"The TVT procedure represents a significant advance in the treatment of female SUI," said lead study author Dr. Carl Gustaf Nilsson, Helsinki University Central Hospital. "It can be performed in under 30 minutes, using local anesthesia, with minimal postoperative complications. And, as our study shows, it offers excellent long-term cure rates."

The study reports on 80 women who underwent the TVT procedure at three centers in Finland and Sweden between January 1995 and October 1996. Of these women, 64 were available to return to the clinics to be objectively evaluated using pad and stress tests. Of these women, 81.3 percent were determined to be objectively cured. In addition, all 80 women were interviewed by telephone or during their evaluation. The same percentage of women said they were cured and 16.3 percent said their condition had improved since having the procedure.

"In the past, surgery for incontinence usually involved major surgery," said Dr. Nilsson. "Today treatments like TVT offer cure rates comparable to the best traditional surgeries, but with the added benefit of a minimally- invasive procedure and short recovery time."

Female SUI or urine leakage is caused predominantly by an improperly functioning urethra, the tube by which urine exits the bladder. Normally the urethra maintains a tight seal to prevent involuntary urine loss. However, childbirth, estrogen loss, obesity and age can weaken the muscles and tissues of the pelvic floor and, as a result, the urethra doesn't maintain a tight seal during exercise or other movement and urine escapes.

GYNECARE TVT is the only mid-urethral sling device with seven years of clinical efficacy data. It combines the use of a safe material, PROLENE* polypropylene mesh, and a variation of a traditional operation known as a sling procedure to correct SUI. The PROLENE mesh is inserted through the vagina and positioned underneath the urethra, creating a supportive sling. During movement or exercise, the mesh supports the urethra, allowing it to maintain its seal to prevent urine loss. The tape, therefore, provides support only when needed, without any unnecessary tension on the urethra (tension-free). To date, more than 600,000 patients worldwide have been treated with GYNECARE TVT, and the device has more published clinical data than any other mid-urethral sling device on the market.

The treatment is not appropriate for pregnant women or women with future plans for pregnancy.



* Trademark

SOURCE: ETHICON, Inc.

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