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Am J Obstet Gynecol. 2008 May;198(5):594.e1-7. doi: 10.1016/j.ajog.2008.01.061. Epub 2008 Apr 2.

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

Author information

1
Urogynecology Service, Assuta Medical Centers, Tel Aviv, Israel. zivelan@netvision.net.il

Abstract

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.

PMID:
18377862
DOI:
10.1016/j.ajog.2008.01.061
[Indexed for MEDLINE]

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