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 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 < 0.0001). Seventy-one percent of the study population experienced a more than 50% reduction in leakage volume, leakage episodes, or both. The quality of life scores improved from baseline to posttreatment phase by 4.35 points on average (P < 0.0001). A total of 40 adverse events were recorded, and only 4 subjects withdrew due to adverse events.

Conclusions: The self-deployable pessary device evaluated in this study is an alternative option for women seeking an over-the-counter method to manage symptoms of SUI. Further studies are required to determine the long-term effects and compliance using the device.

Trial registration: ClinicalTrials.gov NCT03323723.

FIGURE 1.

Parts of the device are shown in the image. A, Image shows the reusable bladder support pessary-like device. The strings of the device should aim the caudal aspect of the patient allowing its removal. B, Image shows the reusable applicator that is made of 2 pieces; the white is the advancer to deploy the device and the blue sheet is to allow the insertion. C, Image illustrates the fully assemble applicator with the device inside ready to be used.

FIGURE 2.

Participant disposition summary. ⁺Patients were excluded because they did not complete the diaries on day-by-day basis.