Prospective, Multi-Center, Randomized, Double-Blinded, Partial Crossover Trial of Percutaneous Tibial Nerve Stimulation with the Bioness Stimrouter Neuromodulation System Versus Sham in the Treatment of Overactive Bladder (OAB)

Sponsor

Boston Scientific

Principal Investigator

Dr. Elizabeth Geller, Obstetrics and Gynecology

Project Run Dates

5/15/2017 to 11/30/2018

 

Summary

Approximately 10 US Study Sites will participate over total 18 months Study population will consist of adults age 22 or over, reporting overactive bladder (OAB) symptoms for at least 3 months.

Primary Study Objective

  1. To assess efficacy of the StimRouter stimulation therapy in improving OAB symptoms of urgency and frequency as measured by Patient Voiding Diary when targeting the posterior tibial nerve
  2. To assess safety of the StimRouter therapy

Secondary Study Objective

To evaluate:

Efficacy of the StimRouter stimulation therapy in decreasing specific OAB symptoms of urgency, frequency, and urinary urge incontinence as measured by the Global Response Assessment (GRA) and 7-day Patient Voiding Diary

Study Design is prospective, multi-center, randomized, double-blinded

Primary Endpoint The primary efficacy endpoint will be the difference between the investigational and control groups in proportion of responders, defined as a return to normal voiding (7-day average in voids/leak episodes < 8) OR > 50% improvement in average voiding frequency above 8 that patient had at baseline OR > 50% improvement in average number of moderate to severe urgency episodes at approximately three months after programming as measured by 7-day Patient Voiding Diary.

Primary Outcomes:

  1. Proportion of responders based on Patient Voiding Diary
  2. Adverse Event Reports

Secondary Endpoints:

The secondary efficacy endpoint will be the difference in specific OAB symptoms of urgency, frequency, and urinary urge incontinence as measured based on (1) the difference in proportion of subjects in the investigational and control groups who have moderately or markedly improved overall response on a 7 level Global Response Assessment (GRA) at approximately three months after programming; and (2) the difference in responses on the 7-day Patient Voiding Diary between the baseline visit and approximately three months after programming.

Secondary Outcomes:

  1. Global Response Assessment (GRA)
  2. Urgency, frequency, and urinary urge incontinence as measured by Daily Patient Voiding Diary

 

Associated Publications and other materials

Clinical Trials.gov

 

Associated Award Numbers: A17-1478-001