Have you or your loved ones been diagnosed with overactive bladder?

You may be eligible to participate in a overactive bladder clinical trial.

Have you or your loved ones been diagnosed with overactive bladder? You may be eligible to participate in a overactive bladder clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Overactive Bladder Clinical Trial in Savannah GA
NCT02873312 | Interventional
Bioness Inc
Sponsored by
Bioness Inc

Have you or your loved ones been diagnosed with overactive bladder?

You may be eligible to participate in a overactive bladder clinical trial.

Have you or your loved ones been diagnosed with overactive bladder? You may be eligible to participate in a overactive bladder clinical trial.

Recruiting

Male & Female

22 Years +

This study is looking to recruit 180 Participants

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.