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A Multicenter Prospective Sham-controlled Trial Evaluating a Physiologic Closed-loop Wearable Tibial Neuromodulation
Colin Goudelocke1, Rohit Dhir2, Eve Shapiro3
1Ochsner Health System, New Orleans, LA.
Urology
|September 19, 2024
Summary
The Vivally System effectively treated overactive bladder (OAB) symptoms, showing a higher response rate than sham therapy. This wearable neuromodulation device is safe and user-friendly for OAB management.
Area of Science:
- Urology
- Neuromodulation
- Medical Devices
Background:
- Overactive bladder (OAB) significantly impacts quality of life.
- Current OAB treatments have limitations and side effects.
- Home-based wearable systems offer a potential alternative for OAB management.
Purpose of the Study:
- To assess the efficacy and safety of the Vivally System, a wearable tibial neuromodulation device, for OAB treatment.
- To compare the Vivally System against a sham control in a randomized, double-blind trial.
Main Methods:
- A multicenter, prospective, randomized, double-blind, sham-controlled trial was conducted.
- 125 adult subjects with OAB were randomized to receive active or sham therapy.
- The primary endpoint was responder rate (≥50% reduction in urgency leaks or ≥30% reduction in voids).
Main Results:
- The active therapy group showed a significantly higher responder rate (83.6%) versus sham (57.7%; P=.032).
- The Vivally System exhibited a favorable safety profile with no serious adverse events.
- Patient satisfaction was high (97.8%), and compliance exceeded 92%.
Conclusions:
- The Vivally System demonstrated significant improvement in OAB symptoms compared to sham therapy.
- The device offers a high responder rate and an excellent safety profile.
- This neuromodulation system presents a user-friendly and effective option for OAB management.
