First Study Participant Enrolled in Clinical Trial of Self-Managed SUI Pessary

Liv Labs Inc., a consumer healthtech company making solutions for urinary incontinence, announces that the first study participant enrolled in the Pippa Pessary Study, a pivotal clinical trial to evaluate the safety and effectiveness of a novel medical device intended to treat stress urinary incontinence (SUI) without a prescription. The trial is a multi-site study, currently recruiting at two Northwestern Medicine clinics in the Chicagoland area. Liv Labs is working with highly experienced clinicians and regulated product development experts across the US to bring this consumer-friendly, self-treatment option to market.

The clinical trial is a requirement for FDA approval. It will evaluate how reliably the Pippa Pessary reduces involuntary urine leak frequency and volume in eligible study participants diagnosed with SUI. The Pippa Pessary has already shown promising results in a first-in-human study: reducing SUI leakage by up to 98% with user-reported ease of use and physical comfort. This pivotal clinical trial is funded by a Small Business Innovation Research (SBIR) grant from the Eunice Kennedy Shriver National Institute for Child Health and Human Development (NICHD) of the National Institutes of Health under award number 5R44HD105574.

“Uncontrolled urinary leakage is a problem that limits women’s physical activity, travel, and social interaction. It negatively affects careers and psychological well-being. This device will help millions of women to confidently and freely pursue activities they have avoided,” said Dr. Jill Thompson, Clinical Instructor, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco (UCSF) and clinical advisor to Liv Labs.

Today, only a small minority of women with involuntary urine leakage receive treatment. Most symptomatic women rely on absorbents–incontinence pads, adult diapers, specialty underwear–to protect their clothing and prevent embarrassment. This practice comes with skin irritation, odor, fear of discovery, and high annual cost. Studies show that women with moderate to severe urine leakage typically wait more than six years before consulting a clinician.

Unfortunately, without treatment, urinary incontinence generally worsens over time, leaving a third of women over sixty contending with severe symptoms. According to a recent study, published in Obstetrics and Gynecology (a.k.a.: The Green Journal), the number of American women with urinary incontinence will increase 55% from 2010 to 2050 as a result of demographic changes. Liv Labs aims to support this growing need by improving and popularizing proven-effective pessary therapy for the 29 million women who need it.