A Multicenter Prospective Sham-controlled Trial Evaluating a Physiologic Closed-loop Wearable Tibial Neuromodulation System for Overactive Bladder

Abstract

ObjectiveTo evaluate the effectiveness and safety of a home-based, physiologic closed-loop wearable tibial neuromodulation system in comparison to a sham control for the treatment of Overactive Bladder (OAB). MethodsThis multicenter, prospective, randomized, double-blind, sham-controlled trial included 125 adult subjects with OAB who were randomized 1:1 to receive either active therapy with the Vivally System or sham therapy. Patients were allowed to continue concomitant OAB medications if therapy was stable and the remained on a consistent regimen throughout the study. The primary efficacy endpoint was a responder rate, defined as ≥50% reduction in daily urgency leaks or a ≥30% reduction in daily voids from baseline recorded on an electronic voiding diary. Safety was evaluated through adverse event (AE) reporting and patient satisfaction with the system was recorded. ResultsIn the the modified Intent-to-Treat (mITT) population (n=107) the responder rate was significantly higher in the active therapy arm (83.6%) compared to the sham arm (57.7%; p=0.032). The system demonstrated a favorable safety profile with no serious AE. Patient satisfaction with the device and mobile application was high with 90/92 (97.8%) reporting they were moderately to extremely satisfied and therapy compliance was above 92% for both therapy and sham groups. ConclusionThe Vivally System showed significant improvement in OAB symptoms compared to sham therapy, demonstrating a high responder rate and excellent safety profile. The combination of physiologic closed-loop neuromodulation and a behavior-tracking application may offer an effective and user-friendly option for OAB management.