In-clinic Study – completed
The initial clinical trial was a blinded, randomized, sham-controlled crossover study conducted at two clinical centers. Clinical results were presented at the American Urology Association (AUA) Annual Meeting in San Francisco and at the International Urogynecological Association (IUGA) Annual Meeting in Vienna, Austria. Suzette Sutherland, M.D., chief of the Division of Female Urology at the University of Washington, confirmed that primary goals related to fit, comfort and safety were met, as were secondary goals related to patient preference, a reduction in incontinence events and an increase in the time between bladder emptying.
In-home Study – completed
The EVANESCE-I ™ (Evaluation of a Non-Implanted Electrical Stimulation Continence Device for Overactive Bladder) was a prospective, randomized, sham-controlled, double-blind clinical trial with a parallel group design. The study enrolled 21 patients at three sites to evaluate the treatment of adult women diagnosed with overactive bladder as outpatients. The primary objectives of the study were to assess safety, describe fit and comfort, and evaluate the potential clinical benefit of the therapy system developed by FemPulse. The positive results of the study were presented by the principal investigator at the 2020 American Urology Association (AUA) Annual Meeting. Improvements in daily bladder emptying and other validated measures with The FemPulse System compared favorably with published clinical outcomes for the leading drugs.
EVANESCE-II™ – in planning
The EVANESCE-II study is planned to start in September 2024 and follows the already conducted and completed two previous clinical studies, one conducted in the clinic and the other in the home setting. The objective of the prospective, multicenter, randomized controlled trial will be to confirm the safety of The Fempulse System and to establish non-inferiority to drug therapy with tolterodine.