New Study Offers More Than a Decade of Evidence for Minimally-Invasive Surgery to Treat Female In...( Results add to body of clinical evi...),Health

Results add to body of clinical evidence demonstrating the efficacy and

safety of synthetic mesh slings for treatment of stress urinary

incontinence in women.

SOMERVILLE, N.J., Sept. 8 /PRNewswire/ -- A new study published in the August issue of International Urogynecology Journal analyzes data of an 11-year follow up study on the safety and effectiveness of tension-free vaginal tape (TVT) as a treatment for stress urinary incontinence (SUI) in women. Researchers followed women treated with GYNECARE TVT(TM) Retropubic System Tension-free Support for Incontinence and found that after 11 years, 90% were objectively cured and 97% considered themselves subjectively cured or improved. This study represents the most extensive follow up for modern mid-urethral sling operations to date.

The three-center prospective observational cohort study led by Professor Carl G. Nilsson, Department of Obstetrics and Gynecology, Helsinki University Central Hospital, Finland, reports on 90 women suffering from urinary stress incontinence who were treated with GYNECARE TVT. Pre-operative assessment included a 24-hour pad test, a stress test, physical examination and a visual analog scale for assessing how bothersome the condition was to each patient. Of the original cohort, 69 women were available for post-operative follow-up 11.5 years after surgery. These women were evaluated using a stress test, a pad test, the patient's overall impression of the cure and a questionnaire administered to assess the patient's quality of life. More than 11 years after surgery, 97% of women assessed subjectively considered themselves cured or improved and researchers determined that 90% of patients were objectively cured based on 24-hour pad tests and stress tests.

"Our results substantiate the evidence showing that the TVT procedure is a safe, effective solution that offers excellent long-term cure rates for women suffering with SUI," said Prof
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