Watkins-Conti Products, a women’s pelvic health company, has announced the peer-reviewed publication of clinical trial results for its Yōni.Fit Bladder Support device, which received FDA 510(k) clearance in 2024 for managing stress urinary incontinence in women.
The study, “A Randomized Controlled Trial of a Novel Device for Stress Incontinence,” was published in Urogynecology, the official journal of the American Urogynecologic Society. The randomized, controlled, single-blind, multi-center study was conducted by urogynecologists at Stanford, NYU Langone, and Jefferson Health.
“Among participants who completed the evaluation phase, significantly more achieved a meaningful reduction in 12-hour pad weights spanning seven days with Yoni.Fit compared to the control device — highlighting Yoni.Fit’s superior performance,” said Dr. Karolynn T. Echols, Director and Associate Professor of Female Pelvic Medicine and Reconstructive Surgery at Thomas Jefferson University, who was an investigator in the study.
Watkins-Conti’s device is a self-administered, soft vaginal insert made from 100% medical-grade silicone that can be used during specific activities or up to 12 hours for general symptom control. According to the study, participants who experienced adverse events reported only mild to moderate severity, with no serious adverse events related to the device.
“Many of my post-partum patients develop SUI, but they’re not necessarily ready for surgery, especially if they plan to have more children,” said Dr. Darren Walter Goff, MD OB-GYN. “With just one office or telehealth visit, I can prescribe Yōni.Fit and bring immediate relief to these patients.”
Stress urinary incontinence involves leaking urine when pressure is applied to the bladder during activities such as exercising, laughing, or coughing. Urinary incontinence is estimated to affect approximately two in three women in the United States at some point in their lives.
“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,” said Allison L. Watkins, founder and CEO of Watkins-Conti.
The device is available by prescription through in-person or telehealth consultations and is covered by most major commercial and government insurance plans.
