Renovia, a digital women’s health company, recently completed enrollment for a large clinical trial intended to validate the company’s signature product, the leva Digital Therapeutic System. The system is designed to help treat women with bladder control. The virtual trial, initiated in October 2020, involves 350 women age 18-83. Twenty-five percent of participants are from Black, Latina, and other medically underserved communities, reflecting Renovia’s commitment to breaking down traditional barriers to equitable participation in women’s health research.
An estimated 50% of adult women in the US have experienced bladder control problems, also known as urinary incontinence (UI). Pregnancy, childbirth, declining hormones due to menopause, and female anatomy structure contribute to stress incontinence, urge incontinence, and other types of bladder control issues.
These conditions occur largely due to the weakening of the pelvic floor: a hammock-like network of small muscles that cradles the bladder and reproductive organs within the pelvis. UI can severely diminish quality of life for many women, yet it frequently goes undiagnosed and untreated due to the social stigma and lack of understanding regarding the loss of bladder control.
Research shows that pelvic floor exercises, sometimes referred to as “Kegels,” can improve UI and help women avoid adult diapers and pelvic surgical procedures. But the private nature of these exercises makes it difficult for women to know if they’re performing them correctly or if the exercises are actually helping. Too often, this can lead to patient non-compliance with treatment exercises.
The FDA-cleared leva System involves a special probe designed to monitor pelvic floor muscle contraction and an integrated mobile app, used daily in 5-minute sessions. The app’s user-friendly interface displays data from the probe that helps the user learn to perform the exercises properly, track progress, and discreetly connect with a personal health coach to help patients meet their goals.
In a six-week pilot study of 23 women, 50% of participants had significant symptom improvement after using leva for just one week. In the final week, 87% of participants reported zero leakage. All participants experienced some improvement and said that leva improved their quality of life. The results of that study were published in the journal Neurology and Urodynamics in 2019.