Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence
Completed · Not applicable
Conditions studied: Overactive Bladder, Urge Incontinence, Incontinence, Urinary, Urinary Urge Incontinence
In brief
This trial is a prospective, multicenter, single-arm study of the safety and effectiveness of eCoinTM tibial nerve stimulation in subjects having overactive bladder (OAB) with urgency urinary incontinence (UUI). The study will evaluate changes from baseline in OAB symptoms as measured by voiding diaries and patient reported-outcomes through 48 weeks of eCoinTM therapy or 52 weeks of implantation.
Key facts
- Study ID
- NCT03556891
- Run by
- Valencia Technologies Corporation
- People needed
- 133
- Starts
- 2018-09-04
- Expected to finish
- 2024-09-18
- Last updated by the study team
- 2025-10-02
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Kaiser Permanente — Downey, California, United States
- Sequoia Urology Center — Redwood City, California, United States
- Kaiser Permanente — San Diego, California, United States
- Sansum Clinic — Santa Barbara, California, United States
- SurgOne PC — Englewood, Colorado, United States
- Urology Associates of Norwalk — Norwalk, Connecticut, United States
- Florida Bladder Institute — Naples, Florida, United States
- North Shore Medical Group — Skokie, Illinois, United States
- UnityPoint Clinic — Waterloo, Iowa, United States
- Chesapeake Urology — Owings Mills, Maryland, United States
- Adult & Pediatric Urology — Omaha, Nebraska, United States
- Manhattan Medical Research — New York, New York, United States
- Alliance Urology Specialists — Greensboro, North Carolina, United States
- The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute) — Allentown, Pennsylvania, United States
- South Carolina OB/GYN — Columbia, South Carolina, United States
Full record on ClinicalTrials.gov
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