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More info
You can access this
clinical trial
if you have
Overactive Bladder
and you are
over 22
years old
-
The phase for this study is not defined.
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The purpose

Approximately 20 Study Sites will participate over total 24 months. Study population will consist of adults age 22 or over, reporting overactive bladder (OAB) symptoms for at least 3 months. Primary Study Objectives: 1. To assess efficacy of the StimRouter stimulation 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 for the indication of OAB Secondary Study Objective: To evaluate efficacy of the StimRouter therapy in addressing urinary urge incontinence as measured by the 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, where Responder is defined as having ≥50% improvement in average voiding frequency above the normal value of 8 (those returning to normal voiding based on 7-day average voids/leak episodes < 9, will be categorized as achieving half or more reduction) AND having ≥50% improvement in average number of moderate to severe urgency episodes, at approximately three months after programming. Secondary Endpoint: Secondary endpoint will be the difference between the investigational and control groups in proportion of patients with reduction by half or more in urinary urge incontinence as measured by the average number of urge incontinence episodes per day.

Provided treatments

  • Device: StimRouter
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Locations near you

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Tris trial is registered with FDA with number: NCT02873312. The sponsor of the trial is Bioness Inc and it is looking for 180 volunteers for the current phase.
Official trial title:
Prospective, Multi-Center, Randomized, Double-Blinded Trial of Percutaneous Tibial Nerve Stimulation With the Bioness StimRouter Neuromodulation System Versus Sham in the Treatment of Overactive Bladder (OAB)