Yōni.Fit expands use for menstrual discharge management

Watkins-Conti Products, Inc. ("Watkins-Conti"), a company that develops innovative solutions for women's pelvic health, today announced the Company has added a second indication for its flagship product, the Yōni.Fit Bladder Support ("Yōni.Fit"). The new label expansion, the first of its kind, is for the collection of menstrual fluid and/or vaginal discharge in women with stress urinary incontinence (SUI). Manufactured in the United States from 100% medical-grade silicone, Yōni.Fit is a soft, flexible, self-administered vaginal insert. The device comes in six sizes and is available by prescription from a provider or online at yonifit.com.

According to a study from the Harvard Chan School of Public Health, approximately 20% of menstruating women in the United States report using a menstrual cup. Usage is increasing, particularly in women age 18-35, who are drawn to the reusability, environmental sustainability, and potential cost savings.

The Yōni.Fit device was FDA-cleared in 2024 for the temporary management of SUI in women 18 years and older, for up to 12 hours at a time. SUI is the leaking of urine when pressure is applied to the bladder, as in exercising, laughing, or coughing. Urinary incontinence is a condition that is estimated to affect about 2 in 3 women in the United States at some point in their lives, negatively impacting their quality of life.

Women have inquired about using the Yōni.Fit device during their menstrual period since it was first introduced for SUI. I am thrilled to offer a device to women that essentially manages all leaks. Yōni.Fit is safe, effective, reusable and helps keep pads and tampons out of our landfills."

Allison L. Watkins, founder and CEO of Watkins-Conti

"In my medical practice, I see women in every stage of pelvic health - from young adults to pregnancy through menopause," said Darren Goff, MD, OBGYN. "With its unique, dual use, I can prescribe the Yōni.Fit device and bring immediate relief to my patients."

The clinical trial for the Yōni.Fit device demonstrated more than 96% clinically significant reduction in stress urinary incontinence bladder leaks. Study participants were enrolled in a randomized, controlled, single blind, multi-center study in women with SUI. Results were published in Urogynecology, the official journal of the American Urogynecologic Society. Among study participants experiencing adverse events, the severity was mild to moderate; there were no serious device related adverse events.

"As a urogynecologist, I am pleased to offer a non-invasive, FDA-cleared option for women experiencing stress urinary incontinence that can also be used to manage menstrual flow and vaginal discharge," said Karolynn Echols, MD, Section Chief of Urogynecology and Reconstructive Pelvic Surgery and Associate Professor of Ob/Gyn at Thomas Jefferson University and one of the principal investigators in the Yōni.Fit clinical study, "The Yōni.Fit device is an effective self-care solution for patients who want to be in control of their pelvic health."

Watkins-Conti is licensed to sell medical equipment in most states and can help women get a prescription, as well as support providers wanting to stock their practice with the device. For patients with a prescription, Yōni.Fit is HSA-eligible and may be covered under select insurance plans. Product and prescribing information are available at yonifit.com.