Watkins-Conti Products, Inc., a pioneering company devoted to advancing women’s pelvic health, has recently announced the publication of groundbreaking peer-reviewed clinical trial results evaluating their flagship device, the Yōni.Fit® Bladder Support. This innovative device, cleared by the U.S. Food and Drug Administration (FDA) in 2024 under 510(k) for temporary management of stress urinary incontinence (SUI), offers a non-surgical, user-friendly alternative for millions of women suffering from this prevalent condition. SUI, characterized by involuntary urine leakage during activities that increase abdominal pressure, such as coughing, laughing, or exercising, affects an estimated two-thirds of women at some stage in their lives, profoundly impacting their quality of life.
The clinical trial titled “A Randomized Controlled Trial of a Novel Device for Stress Incontinence” has been published in the reputable journal Urogynecology, the official publication of the American Urogynecologic Society. This multidisciplinary journal focuses on the prevention, diagnosis, and treatment of female pelvic floor disorders, making it an ideal platform for disseminating results related to innovations in women’s pelvic health care. The study delivers rigorous evidence in support of Yōni.Fit®, reinforcing its potential as a leading front-line solution for SUI management.
Conducted at prominent medical institutions including Stanford, NYU Langone, and Jefferson Health, the randomized, controlled, single-blind, multi-center trial enrolled women over the age of 18 living with stress urinary incontinence. The methodology ensured robust data collection and analysis, with outcomes focusing on reductions in urine leakage. Specifically, the study measured 12-hour pad weights over a seven-day period to quantify leakage accurately. Participants using Yōni.Fit® demonstrated statistically significant improvements compared to those using control devices, underscoring the bladder support’s superior efficacy in managing symptoms discreetly and effectively.
One of the most compelling aspects of Yōni.Fit® is its design and material composition. Manufactured entirely in the United States from 100% medical-grade silicone, the device is soft, flexible, and self-administered. This allows women to insert and remove the support on their own, offering autonomy and convenience. Importantly, the insert can be used during targeted activities known to exacerbate SUI symptoms or for up to 12 hours for sustained control. The device’s ergonomic design is the result of extensive research and development, including patient feedback and clinical validation, positioning it as a pioneering product in the market of pelvic floor health devices.
Healthcare professionals specializing in women’s health have already endorsed Yōni.Fit®. Dr. Darren Walter Goff, an experienced OB-GYN, highlights the device’s value for postpartum patients, many of whom develop stress incontinence but may not be ready or willing to pursue surgical interventions. The ability to prescribe Yōni.Fit® following a single office or telehealth visit means that relief can be initiated promptly, reducing the burden of prolonged discomfort and improving patient outcomes. This represents a significant shift toward minimally invasive, patient-centric management of SUI.
Dr. Karolynn T. Echols, an authoritative figure in Female Pelvic Medicine and Reconstructive Surgery at Thomas Jefferson University and a lead investigator in the clinical study, emphasized the clinical advantages. According to Dr. Echols, Yōni.Fit® not only demonstrated meaningful reductions in urinary leakage but also did so safely, with no serious adverse events reported. Mild to moderate adverse effects were documented among some participants but were not directly associated with device use, reinforcing Yōni.Fit®’s strong safety profile and tolerability.
From a manufacturing and distribution standpoint, Watkins-Conti has positioned Yōni.Fit® to achieve wide accessibility. National distribution partnerships facilitate the availability of self-sizing kits, enabling women nationwide to select the appropriate device size from the comfort of their homes. These logistical strategies remove typical barriers related to pelvic health device fitting and access, such as multiple clinical visits or specialized in-person fittings, which historically limited uptake and adherence.
Moreover, the Very Important Provider (VIP) Kit concept is transforming clinical practice integration. Designed to streamline incorporation into primary care, OB-GYN, urology, and urogynecology settings, the VIP kit provides healthcare providers with education, patient materials, and the necessary tools to prescribe Yōni.Fit® effectively. This strategy supports the growing shift toward integrating preventive and conservative management of pelvic floor disorders within routine clinical care pathways.
Yōni.Fit® is also financially accessible. It is covered by most leading commercial and government insurance plans and is eligible for purchase via Health Savings Accounts (HSA). Customers can obtain the device through in-person consultations or telehealth prescriptions, and fulfillment is managed by Edgepark, a well-established healthcare supply distributor and Cardinal Health business unit. This payer coverage and streamlined purchase process enhances affordability and convenience, ensuring that cost or logistical constraints do not impede access.
Stress urinary incontinence represents a significant healthcare challenge affecting millions of women yet remains underdiagnosed and undertreated due to stigma, lack of awareness, and limited non-surgical options. Devices like Yōni.Fit® mark a pivotal advancement, providing a scientifically substantiated, user-centered solution that empowers women to regain control over their bodies without invasive treatments. The published clinical data corroborating its efficacy and safety provide an evidence-based foundation for broader clinical acceptance.
Watkins-Conti, under the leadership of founder and CEO Allison L. Watkins, continues to innovate within women’s pelvic health. Holding a broad portfolio of utility and design patents, the company exemplifies the fusion of patient-driven design and advanced biomedical technology. By focusing on non-surgical, patient-friendly management tools, Watkins-Conti envisions a future where pelvic health concerns are addressed proactively, reducing morbidity and enhancing the everyday lives of women globally.
In conclusion, the peer-reviewed validation of Yōni.Fit®’s clinical benefits heralds a significant milestone. This novel device redefines the standard of care for managing stress urinary incontinence by combining technical innovation, user-centric design, and clinical robustness. As the medical community increasingly acknowledges the impact of pelvic floor disorders, solutions like Yōni.Fit® will likely become foundational components of comprehensive women’s health strategies in the years ahead.
Subject of Research: People
Article Title: A Randomized Controlled Trial of a Novel Device for Stress Incontinence
News Publication Date: May 13, 2025
Web References:
- Clinical trial publication: https://journals.lww.com/fpmrs/fulltext/9900/a_randomized_controlled_trial_of_a_novel_device.383.aspx
- Product information: https://yonifit.com/
- FDA 510(k) clearance (implied in text)
References:
- Watkins-Conti Products, Inc. press release and clinical trial data
- Urogynecology Journal, 28-Apr-2025, DOI: 10.1097/SPV.0000000000001676
Image Credits: Watkins-Conti Products, Inc.
Keywords: Gynecology, Clinical Studies, Urology, Obstetrics, Family Medicine
