Study Confirms Safety, Efficacy of Overactive Bladder Control Solution

Avation Medical Inc. is sharing encouraging safety and efficacy results from a multi-center study of its Vivally System.

The FREEOAB study results demonstrated significant reductions in three-day diary parameters for daily void, incontinence, and urgency episodes at 12 weeks. Quality of life (QOL) measures exceeded the minimal clinically important difference in all questionnaires. Long-term efficacy results remained robust at 12 months, with sustained improvement in diary parameters. Device-related adverse events were mild and there were no device-related significant adverse events. Mean therapy compliance at 12 weeks was 88.5%. High satisfaction rates were also reported for the device overall, including device ease of use.
 
“The Vivally System represents a significant advancement in bladder control therapy as a non-invasive, patient-centered therapy providing patients with effective treatment, performed in the home, without the need for surgery or drugs,” Principal FREEOAB Study Investigator Dr. Colin Goudelocke said. “In our study, significant reductions in symptom burden were observed at 12 weeks which, notably, persisted out to 12 months, even with a reduction in frequency of therapy sessions.”

The Vivally System is a non-invasive bladder control therapy device and companion mobile application to treat patients with urge urinary incontinence (UUI) and urinary urgency caused by overactive bladder (OAB), without the need for surgery, drugs, or needle-electrodes. Vivally is the only noninvasive, wearable neuromodulation system for bladder control with personalized calibration and automated closed-loop adjustment through electromyographic (EMG) monitoring cleared for sale in the United States. Worn on the ankle, Vivally is used at-home with therapy sessions lasting only 30 minutes, as little as once per week.
 
“Physician and patient response to Vivally has been overwhelmingly positive. Vivally will bring meaningful relief to millions of patients seeking treatment for symptoms of OAB that do not want the risks of surgery, or the side-effects of drug therapies,” Avation CEO Jill Schiaparelli stated. “We are grateful to the investigators and patients that participated in the study for helping us bring the Vivally System to market.”
 
Vivally is cleared by the U.S. Food and Drug Administration and available by prescription in select U.S. geographies.
 
Avation Medical is a neuromodulation and digital health company whose Vivally System combines a patient-friendly, closed-loop neuromodulation system with a companion mobile application, offering a comprehensive therapy and support system. Prescribed by a clinician, the company’s smart ankle wearable objectively confirms activation of the target nerve, sets a personalized therapeutic range for each patient, and delivers clinically effective therapy in just 30 minutes as little as once per week.