Overactive Bladder Treatment Using StimRouter Neuromodulation System: A Prospective Randomized Trial

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen byHoward Goldman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Bioness Inc

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Keith McBride

Principal Investigator

Bioness Inc

Howard Goldman, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

Inclusion Criteria

Male or female age ≥22 years and competent to provide consent

Minimum 3 months of self-reported OAB symptoms

A mean score of ≥4.0 on the OAB-q symptom questions 1-8

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Treatment Details

Interventions

StimRouter (Neuromodulation System)

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: StimRouter TreatmentExperimental Treatment1 Intervention

The Treatment group will receive therapeutic level StimRouter electrical stimulation. At the end of the Month 3 visit the Treatment group will continue to receive therapeutic level StimRouter electrical stimulation for an additional 3 months.

Group II: StimRouter ControlPlacebo Group1 Intervention

The Control group will receive sham (sub-therapeutic level only) StimRouter stimulation. At the end of the Month 3 visit the Control group will be allowed to receive therapeutic level StimRouter electrical stimulation for 3 months.