Overactive Bladder Treatment Using StimRouter Neuromodulation System: A Prospective Randomized Trial
Public ClinicalTrials.gov record NCT02873312. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02873312
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 180 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 22 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 9, 2017
- Primary completion
- Jul 29, 2021
- Completion
- Jul 29, 2021
- Last update posted
- Jan 28, 2021
2017 – 2021
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Del Sol Research | Tucson | Arizona | 85710 | Withdrawn |
| Kaiser Permanente Reserach | Irvine | California | 92618 | Recruiting |
| University of Southern California | Los Angeles | California | 90089 | Recruiting |
| Providence St. John's Health Center | Santa Monica | California | 90404 | Recruiting |
| Skyline Urology | Sherman Oaks | California | 91411 | Recruiting |
| Barrett Cowan, MD, Urology Associates | Englewood | Colorado | 80113 | Completed |
| Clinical Research Center of Florida | Pompano Beach | Florida | 33060 | Completed |
| Meridian Clinical Research, LLC/Urology Associates Savannah | Savannah | Georgia | 31405 | Recruiting |
| Comprehensive Urologic Care | Barrington | Illinois | 60010 | Completed |
| Sheldon Freedman, MD LTD | Las Vegas | Nevada | 89144 | Completed |
| University of North Carolina Urogynecology | Chapel Hill | North Carolina | 27514 | Completed |
| Cleveland Clinic Glickman Urologic and Kidney Institute | Cleveland | Ohio | 44195 | Recruiting |
| Basel Hassoun | Oklahoma City | Oklahoma | 73120 | Completed |
| Michael England, MD, Texas Health Care | Fort Worth | Texas | 76104 | Withdrawn |
| Michael DeBakey VA Med Ctr | Houston | Texas | 77030 | Withdrawn |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02873312, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 28, 2021 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02873312 live on ClinicalTrials.gov.