Comment on “A Randomized Controlled Trial of a Novel Device for Stress Incontinence”

Up to 35% of women are affected by stress urinary incontinence (SUI), which is characterized by the involuntary loss of urine when sneezing, coughing, or during other physical exertion. Treatments include pelvic floor muscle training, incontinence pessaries, and other support devices or surgical options such as urethral bulking, urethropexy, midurethral slings, and autologous fascial slings. Surgical treatment has been shown to be more effective, but with higher complication rates. There is a need for increased nonsurgical options for the treatment of SUI; current research has focused on vaginal inserts, but those that are available require insertion by a health care provider or have unknown safety and efficacy. This study was designed to compare the safety and efficacy of a self-fitted novel intravaginal insert (Yoni.Fit) to a sham device for the treatment of SUI. This was a multicenter, randomized, sham-controlled, single blind trial of women with SUI conducted between January 2020 and August 2022. Inclusion criteria were female patients over the age of 18, self-reporting SUI for at least 3 months and a positive cough stress test. Exclusion criteria are detailed in the supplemental material. Randomization was 1:1 to the device group and the sham group. Outcomes of interest included 12-hour pad weight tests, voiding diaries, Patient Global Impression of Change (PGIC), Usefulness, Satisfaction, and Ease of Use (USE) Questionnaire, and Incontinence-Quality of Life (I-QOL) assessment questionnaire. The primary outcome associated with efficacy was responder rate, with responders defined as those who had a 50% or more reduction in mean 12-hour pad weight at the end of treatment. Secondary efficacy-associated outcomes included percent change in mean pad weight, frequency of SUI events, and the responder rate for SUI events. Final analysis included 58 patients. Analysis showed a higher responder rate for the device compared to controls ( P <0.05), as well as an increased reduction in pad weight and SUI episodes ( P =0.003 and <0.001, respectively). Per protocol analysis showed similar results, with patients in the device group showing significantly better outcomes overall compared with controls. PGIC scores indicated more improvement in the device group ( P =0.001), and there were no significant differences in pad dry days or quality of life (I-QOL) between the two groups. The USE questionnaire did show significantly higher scores for the device group in the subdomain of usefulness compared with controls (=0.008). Treatment adherence was high in both groups, and there were no device-related serious adverse events. Mild to moderate adverse events that occurred included vaginal discomfort, bleeding, pain, itching, yeast infection, bruising, discharge, and dryness. These results indicate that the Yoni.Fit device is both safe and effective for SUI treatment compared with controls. These results are similar to those published regarding other intravaginal devices, though these results indicate longer-lasting efficacy for the Yoni.Fit device. Future studies should assess applicability for other types of incontinence, and patient counseling should expand to include this as a nonsurgical treatment option for SUI. (Summarized from Escobar C, Sokol ER, Rosenbaum N, et al. A randomized controlled trial of a novel device for stress incontinence. Urogynecology (Phila). 2026;32:105-115. doi: 10.1097/SPV.0000000000001676).