FemPulse is preparing to complete a pivotal clinical study in support of an application for FDA clearance as a De Novo device for the overactive bladder (OAB) indication. The pivotal study follows successful achievement of primary and secondary endpoints in two previous clinical studies, one in-clinic and the other in-home.
In-clinic study completed
The first clinical study was an IRB-approved, blinded, randomized, sham-controlled crossover study conducted in two clinical centers. Clinical results were presented at the American Urology Association (AUA) annual meeting in San Francisco and the International Urogynecological Association (IUGA) annual meeting in Vienna, Austria. Dr. Suzette Sutherland, Director of Female Urology at University of Washington, presented that primary objectives regarding fit, comfort and safety were met, as well as positive secondary outcomes regarding patient preference, a reduction in incontinence events, and an increase in time between voids.
In-home study completed
The EVANESCE-OAB™ (Evaluation of a Non-Implanted Electrical Stimulation Continence Device for Overactive Bladder) trial was an IRB-approved, prospective, randomized, sham-controlled, double-blind, parallel group design clinical investigation. The study enrolled 21 patients across three sites to assess in an ambulatory setting the treatment in adult women with a diagnosis of overactive bladder. The primary objectives of the trial were to evaluate safety, describe fit and comfort and assess the potential clinical utility of FemPulse’s proprietary device therapy. The positive results of the trial were again presented by the Principal Investigator at an American Urology Association (AUA) annual meeting, in 2020. The improvements in voids per day as well as on questionnaires related to bother and quality of life using the FemPulse device were encouraging compared to published clinical results for the leading medications.
Articles on FemPulse
The promise of FemPulse’s wearable bioelectronic medicine has been welcomed in numerous industry articles, such as MD+DI “Finally, a Wearable Neuromodulation Device for Overactive Bladder”, MedTech Insight “Neuromodulation Devices Stimulate Opportunities in Urology”, Start Up “FemPulse Pioneers on Multiple Fronts”, and Urology Times “Wearable Neuromodulation Device Shows Promise for Overactive Bladder” (linked also by the American Urogynecologic Society weekly news), as well as in more popular publications such as The Daily Mail “Could a Doughnut-Shaped Nerve Zapper Cure Overactive Bladders in Women?”