A Randomized Controlled Trial of a Novel Device for Stress Incontinence.

Abstract

Importance: There is a need for safe and efficacious nonsurgical options for women with stress urinary incontinence (SUI).

Objective: This study compared the safety and efficacy of Yōni.Fit, a novel intravaginal insert, with a sham device in treating women's SUI.

Study design: In a multicenter, single-blind, randomized, sham-controlled trial, women with SUI for ≥3 months with a positive cough stress test result were enrolled. Participants, using either Yōni.Fit or a sham device, self-fitted from 6 sizes wore the insert daily for 12 hours. The primary outcome was responder rate defined as a ≥ 50% reduction in pad weights. Secondary endpoints were change in pad weight, frequency of SUI episodes, Patient Global Impression of Change, Incontinence-Quality of Life Assessment, proportion of pad dry days, and Usefulness, Satisfaction, and Ease of Use Questionnaire.

Results: Fifty-six women completed the treatment phase. The responder rate based on pad weights was higher for Yōni.Fit (53.0% vs 23.3%, P = 0.013). Among Yōni.Fit participants, a greater proportion achieved SUI responder status compared to sham (96.3% vs 27.2%, P < 0.001). Participants using Yōni.Fit rated it higher in usefulness than sham (5.95 vs 4.13, P = 0.008). Although the adverse event rate was 54.8% in Yōni.Fit and 29.6% in sham, most adverse events were mild, with vaginal discomfort reported as most common.

Conclusions: Yōni.Fit significantly reduced pad weights and SUI events and was evaluated as more useful when compared to sham. Although adverse events were higher with Yōni.Fit, they were generally mild. Further research is necessary to evaluate long-term safety and efficacy.