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

ABSTRACT:

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 cond

SUBMITTER: Duenas-Garcia OF 

PROVIDER: S-EPMC7720247 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature