WVU Medicine Urologists Participate in Multicenter Urinary Incontinence Device Study

WVU Medicine was one of seven centers invited to participate in a trial of a home wearable device to improve the symptoms of urinary incontinence and overactive bladder.

The multicenter study, published in the January 2024 issue of Urology, offers encouraging results for the Vivally System, a novel closed-loop wearable tibial neuromodulation system developed by Avation Medical for the treatment of overactive bladder (OAB) and urgency urinary incontinence (UUI). The system combines non-invasive bladder control neuromodulation therapy with a digitally enabled behavioral support mobile app offering a comprehensive treatment solution.

OAB and UUI are common conditions affecting millions of people worldwide, significantly impacting quality of life. Prior treatment options can be limited in effectiveness or have undesirable side effects.

“Urinary incontinence and urgency aren’t just inconvenient conditions,” Stanley Zaslau, MD, chair of WVU Medicine Urology, said. “They can have a significant impact on quality of life, as well. Patients often report avoiding social situations or extended outings out of fear that they might have an embarrassing accident. By offering a non-invasive treatment patients can do themselves in the comfort of their own home, we are able to help restore their confidence in social situations.”

Neuromodulation has been used for more than 20 years to treat urinary incontinence and urgency by delivering a targeted stimulus, such as an electrical pulse, to specific sites on the body to re-establish normal nerve communication to the detrusor muscle, which forms a layer in the wall of the bladder.

“The device works by sending pulses through the tibial nerve in the leg to regulate nerve signals and retrain the detrusor muscle, reducing incontinence and urgency with no negative side effects and greater patient safety,” Dr. Zaslau said.

Participants used the device, which delivers mild electrical pulses to the tibial nerve, either once or three times weekly for 12 weeks. They also tracked their voids, urgency, and other symptoms in a journal, recording any changes or progress they observed.

The study included 96 participants between 47 and 73 years of age and found significant reductions in daily voids, incontinence episodes, and urgency compared to their baseline. Patients reported a significant improvement in quality of life and high satisfaction with the device at the end of the initial 12 weeks of the study, and those findings remained robust one year later.

The Avation Medical Vivally system is cleared by the U.S. Food and Drug Administration to treat the bladder conditions of urge urinary incontinence and urinary urgency caused by overactive bladder syndrome.