Efficacy and Safety of a Novel Disposable Intravaginal Device for Treating Stress Urinary Incontinence

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

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.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Disposable Equipment
  • Equipment Design
  • Female
  • Humans
  • Incontinence Pads
  • Middle Aged
  • Pain / epidemiology
  • Patient Satisfaction
  • Pessaries*
  • Prostheses and Implants
  • Quality of Life
  • Treatment Outcome
  • Urinary Incontinence, Stress / therapy*