Watkins-Conti Products, an Edmond-based leader in women’s pelvic health solutions, announces the official launch of the Yōni.Fit Bladder Support (“Yōni.Fit”), starting immediately with its home market in Oklahoma and national distribution anticipated in the fourth quarter, following its recent 510(k) clearance from the U.S. Food and Drug Administration (FDA).
The Yōni.Fit and its FDA clearance represents a substantial milestone as a non-surgical option for the temporary management of stress urinary incontinence (SUI) in women aged 18 and older.
The Yōni.Fit is available by prescription starting Aug. 26 through primary healthcare providers and may be covered by insurance.
“Lakeside holds a special place in my heart. It’s where I delivered both of my children, and the challenges I faced after my second delivery directly inspired the creation of the Yōni.Fit,” said Allison L. Watkins, founder and CEO of Watkins-Conti. “Bringing this product to market in partnership with Lakeside is a full-circle moment. We are thrilled to launch the Yōni.Fit first in Oklahoma and work alongside such respected healthcare and pharmacy institutions.”
“Educating providers about the Yōni.Fit has been incredibly rewarding. Providers are excited to hear that they will now have an FDA approved, accessible way to treat stress urinary incontinence in the office,” said Dr. Kate Arnold, Watkins-Conti Chief Medical Officer. “Before the Yōni.Fit, treatment options were limited in what OBGYNs and family medicine providers could do. Now, providers can prescribe the Yōni.Fit to treat patients immediately without the need for additional appointments or invasive procedures. Providers are excited to help women reclaim their lives.”
“I look forward to having this new solution for my patients who leak urine with exercise, laughing, or coughing,” said Dr. Dana Stone, OBGYN, Lakeside Doctors. “Controlling urine loss gives women back their confidence and favorite activities.”
“I understand that the more informed the patient is, the better decisions they can make about their health,” said Dr. Arielle Allen, Urogynecology Female Pelvic Medicine at INTEGRIS Health and Urogynecology of Oklahoma. “As a urogynecologist specializing in female pelvic medicine, I am looking forward to having another non-invasive, FDA-cleared option for women experiencing stress urinary incontinence.”
The Yōni.Fit is crafted in the U.S. from 100% medical-grade silicone. This soft, flexible vaginal insert effectively reduces urine leaks without inhibiting voluntary urination. It is self-administered and can be used during specific activities, after recently giving birth, going through menopause, or for up to 12 hours for broad symptom management.
“I already have a patient ready for this…just saw her last week and as soon as we have it, she will be ready for her device,” said Lydia D. Nightingale, MD, Vice President Medical Affairs at Variety Care. “She wants it for when she plays pickleball. Can’t wait! This will be so great for the women of Oklahoma (and others as well).”
The Yōni.Fit is thoughtfully designed to comfortably and effectively meet the needs of women of all shapes and sizes, as well as women residing in rural areas and medically underserved communities, for whom access to surgical treatments may be challenging. By providing a convenient, non-invasive solution, the Yōni.Fit ensures that more women can manage their pelvic health effectively, regardless of their geographic location or healthcare access limitations.
The launch of the Yōni.Fit follows a rigorous randomized, controlled, single-blind, multi-center clinical study, and was conducted by urogynecologists at top medical centers, including Stanford Health Care, NYU Langone, and Thomas Jefferson Health. Results showed a significant reduction in 12-hour pad weights among users of the Yōni.Fit compared to a control device, with mild to moderate adverse events reported and no serious adverse events related to the product. Further ongoing support, including plenary sessions at scientific conferences, was provided by the American Urogynecologic Society (AUGS) and Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU).
