Incontinence Research - Urinary Incontinence, Bladder Control, Treatment, Causes

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Efficacy and safety of a novel disposable intravaginal device for treating stress urinary incontinence.

Ziv E, Stanton SL, Abarbanel J

Urogynecology Service, Assuta Medical Centers, Tel Aviv, Israel. zivelan@netvision.net.il

OBJECTIVE: The purpose of this study was to evaluate the efficacy and safety of a novel disposable intravaginal device for treatment of stress urinary incontinence (SUI) in women. STUDY DESIGN: Sixty women with severe SUI were recruited from 2 sites in Israel to wear preweighed pads during a 7-day control period followed by a 28-day device usage period in which the device and preweighed pads were worn daily for 8 hours. The primary endpoint was the percentage of women who achieved a > or = 70% reduction in pad weight gain (PWG) from the control period to the last 14 days of device usage. RESULTS: Sixty women who enrolled into the study and used the device for any period of time were included in the intent to treat (ITT) population. Eighty-five percent of them achieved a > or = 70% reduction in PWG (P = .01). Improvements in overall quality of life, subjective perception of incontinence, and satisfaction with the device were observed. CONCLUSION: The intravaginal device is easy to use, well-tolerated, and effective in reducing SUI.

Published 5 May 2008 in Am J Obstet Gynecol, 198(5): 594.e1-7.
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Incontinence Research Today Archive:

Volume 1 (2004)
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