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

Abstract

Objective: To 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).

Methods: This 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.

Results: In 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 = .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.

Conclusion: The 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.