Safety and Efficacy of a Disposable Vaginal Device for Stress Urinary Incontinence

Objective

The aim of this study was to evaluate the efficacy and safety of an over-the-counter device for the treatment of stress urinary incontinence (SUI) in females.

Methods

A multicenter, interventional, single-arm study involving 5 different sites was conducted including women diagnosed with symptomatic SUI using a self-inserted pessary device. A 1-week baseline period was followed by a 2-week period of wearing the device. The main outcome of our study was to determine if the device was able to reduce at least 50% the number of leakage events and pad weight.

Results

Across all study sites, 73 subjects were enrolled and 51 completed the study. Efficacy analyses were conducted on the modified intent-to-treat population (n = 48), whereas the safety analysis was conducted on all consented participants. The average pad weight gain was 0.9 g/h at baseline and 0.5 g/h during the treatment phase. The number of leakage episodes per day decreased from 2 at baseline to 0.9 during the treatment phase (P

Source: Female Pelvic Medicine and Reconstructive Surgery - June 1, 2021 Category: OBGYN Tags: Original Articles Source Type: research