Published data support safety, efficacy of vaginal insert for SUI

The Yōni.Fit bladder support, a soft vaginal insert for women with stress urinary incontinence (SUI), significantly reduced pad weights and SUI events compared with a sham device, according to findings from a recent study (NCT03978741) published in Urogynecology.¹

The responder rate was 53.0% in the Yōni.Fit arm vs 23.3% in the comparator arm.

According to the authors, Yōni.Fit is “a translucent, flexible, cone-shaped, 100% silicone vaginal insert device.”

The device was granted 510(k) clearance by the FDA in May 2024 for the temporary management of urine leakage due to SUI. The clearance was supported by data from the recently published randomized controlled study.

"Among participants who completed the evaluation phase, significantly more achieved a meaningful reduction in 12-hour pad weights spanning 7 days Yōni.Fit compared to the control device—highlighting Yōni.Fit’s superior performance," said co-author Karolynn T. Echols, MD, director and associate professor of female pelvic medicine and reconstructive surgery at Thomas Jefferson University in Philadelphia, Pennsylvania.

Specifically, data showed that the responder rate, defined as those with a meaningful reduction in 12-hour pad weights, was 53.0% in the Yōni.Fit arm vs 23.3% in the comparator arm (P = .013; absolute difference, 29.6%; 95% CI, 7.4% to 51.8%).

The percent change in pad weight and SUI episodes were also higher among those in the Yōni.Fit arm. The percent reduction in pad weight was 56.2% in the treatment arm vs 17.7% in the sham arm (P = .003). Similarly, the percent reduction in SUI episode was 88.8% in the treatment arm vs 8.3% in the comparator arm (P < .001).

Additionally, 96.3% of patients in the treatment arm experienced a greater than 50% reduction in SUI episodes from baseline, compared with 27.2% of patients in the control arm (P < .001).

More patients who received treatment with the Yōni.Fit device felt that their status was ‘much improved’ or ‘better’ vs those who received treatment with a comparator device (82.8% vs 38.5%; P = .001). Those who used the Yōni.Fit device also scored higher on the USE Questionnaire subdomain of usefulness (5.95 vs 4.13; P = 0.008).

There was no significant difference between the 2 arms regarding pad dry days nor change in I-QOL scores (both total and subscale scores) from baseline to treatment assessment.

Treatment adherence was good in both groups, according to the authors. The average daily/weekly use of device for patients in the treatment arm was 13.1 hours per day for an average of 6.6 days. In the sham arm, the average use was 12.3 hours per day for an average of 6.7 days.

No patients who received treatment with the Yōni.Fit device experienced a device-related serious adverse event (AE). Overall, 54.8% of patients who received the Yōni.Fit device experienced a treatment-emergent AE compared with 29.6% of patients who received a comparator device. All AEs reported were of mild to moderate intensity. The most common AEs were vaginal discomfort, bleeding, pain, itching, yeast infection, bruising, discharge, and dryness.

About the study

In total, the single-blind study enrolled 56 adult women with SUI through 3 clinical trials sites in the US.

To be included in the trial, patients must have had a body mass index lower than 35 kg/m² and SUI as determined through the cough supine test and at least a 3-month history of experiencing SUI symptoms.³ Further, women of childbearing potential needed to agree to acceptable forms of contraception for the duration of the study.

The primary outcome measure for the study was the responder rate, defined as at least a 50% reduction in 12-hour pad weight test from baseline to the end of the treatment phase. Secondary outcome measures included the percent change in mean pad weight, the percent change in the frequency of SUI events, and the responder rate for the frequency of SUI events.

Allison L. Watkins, founder and CEO of Watkins-Conti, added in the news release,² “With multiple national distribution partners and the availability of self-sizing kits, we are focused on bringing Yōni.Fit to women across the country as a convenient, easy, and tariff-proof solution for SUI. The Very Important Provider (VIP) kit assists in integrating Yōni.Fit seamlessly into primary care, OB-GYN, urology, or urogynecology practices.”

REFERENCES

1. Escobar C, Sokol ER, Rosenblum N, Milikien D, Echols K. A randomized controlled trial of a novel device for stress incontinence. Urogynecology (Phila). 2025. doi:10.1097/SPV.0000000000001676

2. Healthcare company Watkins-Conti announces publication of positive clinical trial results for FDA-cleared Yōni.Fit bladder support. News release. Watkins-Conti Products, Inc. May 13, 2025. Accessed May 14, 2025. https://www.eurekalert.org/news-releases/1083796

3. Study evaluating the efficacy and safety of Yoni.Fit in women with stress urinary incontinence. ClinicalTrials.gov. Last updated May 8, 2023. Accessed May 14, 2025. https://clinicaltrials.gov/study/NCT03978741