More than 60% of women in the United States will experience incontinence at some point during their lives. Often presenting after childbirth, stress urinary incontinence is the leakage of urine during any activities that increase pressure in the abdominal cavity, like exercise, sneezing or coughing. Women experiencing urinary incontinence endure discomfort and embarrassment, significantly decreasing quality of life. The pelvic floor is a network of muscles that support all pelvic organs, including the bladder, bowel, and uterus. Sphincters within the pelvic floor contract to provide voluntary control over urination and defecation. Urinary incontinence is the involuntary leaking of urine often caused by the weakening of these muscles.
After the birth of her children, Allison Watkins, founder of Watkins-Conti Products, struggled with stress urinary incontinence. She noticed that wearing a menstrual tampon during exercise classes helped prevent leakage. Watkins used her experience to design the Yõni.Fit device; an intravaginal insert that applies a small amount of pressure to the urethral sphincter. This pressure stops the involuntary flow of urine from the urethra. Similar in shape to a menstrual cup, the Yõni.Fit expands after placement inside the vaginal canal. The Yõni.Fit device is made of medical-grade silicone making it flexible; contouring to the unique shape of each person. It does not occlude the urethra; thus, users retain the ability to voluntarily urinate.
Watkins-Conti products is currently executing a randomized, comparator-controlled, single-blind, multicenter study to assess the product’s effectiveness and safety. Data collection was completed in August 2022 and the Yõni.Fit device is currently awaiting 510(k) clearance with the Food and Drug Administration (FDA). Watkins-Conti Products initially plans to market the device by prescription for women experiencing urinary incontinence. However, if additional clinical trials demonstrate successful long-term safety, Watkins-Conti Products hopes to deliver direct-to-consumer.
The Yõni.Fit device appeals to the large market segment of women affected by urinary incontinence. The company plans to keep the re-usable product priced under $100, making it affordable for many people. Because urinary incontinence often impacts women after childbirth, the device will likely be prescribed by urogynecologists and obstetrics-gynecologists.
Similar to the Yõni.Fit device, pessaries are intra-vaginal devices that apply pressure to the urethra to treat prolapse of the uterus. About 40% of women experience some degree of uterine prolapse; when the uterus drops into the vagina. About 60% of these women have concurrent urinary incontinence. Pessaries are prescribed, and initially applied, by a provider in the office. This non-surgical device does improve urinary incontinence for women affected by uterine prolapse. However, the Yõni.Fit device will market to a broader range of women that experience stress urinary incontinence but may not have uterine prolapse. When released, the Yõni.Fit will be the first patient-designed, non-surgical device on the market to relieve symptoms of stress incontinence. Ultimately, if the Yõni.Fit is delivered direct-to-consumer, it will be more accessible to women who may not have access to medical care, or those that are embarrassed to seek treatment.
Other available options for women experiencing urinary incontinence include pelvic floor physical therapy and surgical options, like the mid-urethral sling. The goal of pelvic floor physical therapy is to re-strengthen the muscles controlling urination. This intervention is between 50-69% effective in reducing incontinence episodes but takes at least six months to see results. The Yõni.Fit device provides immediate relief in symptoms and could be used simultaneously with pelvic floor physical therapy. The mid-urethral sling is a surgically- applied mesh that provides support for the urethra and bladder during periods of stress, like laughing and coughing. This effective option improves symptoms in 80-90% of women but involves an invasive procedure, takes time to schedule with a provider, and requires a recovery period. The Yõni.Fit device provides immediate relief of symptoms and, in a 2016 feasibility study, relieved symptoms for 87% of women.
With 15 million adult women experiencing stress urinary incontinence, the demand for Yõni.Fit will likely be high. Watkins-Conti Products may face challenges meeting that demand and will require significant funding. Users may also face challenges during menstruation because the Yõni.Fit device does not create a full seal around the cervix. However, the founder of the product, Allison Watkins, recommends using both a panty liner and the Yõni.Fit device during menstruation.
Always an entrepreneur, Watkins started her career in radio sales and has a strong background in marketing and advertising. While running a plumbing and construction business, she designed, patented, and manufactured the Yõni.Fit device. Watkins bootstrapped initial fundraising efforts until the initial feasibility study attracted Medical Doctors to support her product. Allison Watkins has since been recognized in Business Times’ Top 20 under 40, Disrupt magazine’s Top 10 Influential Women, and Journal Record’s Achievers under 40.
Since completing the 2016 feasibility study demonstrating 87% effectiveness, the Yõni.Fit device has undergone clinical trials at Stanford, New York University and Thomas Jefferson University under the direction of urogynecologists. The trial completed data collection in August 2022 and the product is now awaiting approval from the FDA. Legally, Watkins-Conti Products carries intellectual property protection to secure exclusive rights to the patented design of Yõni.Fit. The device has been named the “most promising new venture” in 2021 by the Oklahoma Venture Forum and a top ten nephrology and urology company by MedTech Outlook.