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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.

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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.

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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.