Effectiveness of eCoin at Sensory and Subsensory Amplitudes
Completed · Not applicable
Conditions studied: Urge Incontinence
In brief
The goal of this prospective, multi-center, double-blinded randomized controlled is to learn about effectiveness and QOL with eCoin at two different amplitude settings in subjects with urge urinary incontincence (UUI). The main question it aims to answer is: * The reduction in UUI episodes per day on a 3-day voiding diary in both groups after 3 months of therapy Participants will be implanted with the eCoin device and randomized to either a sensory or subsensory stimulation group and complete voiding diaries and patient reported-outcomes through 3 months of therapy. After 3 months, subjects will be unblinded and reprogramming will be offered. Subjects will be followed for an additional month to a total of 4 months.
Key facts
- Study ID
- NCT05882318
- Run by
- Valencia Technologies Corporation
- People needed
- 38
- Starts
- 2023-06-06
- Expected to finish
- 2024-05-14
- Last updated by the study team
- 2025-11-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Genesis Research — Downey, California, United States
- Urology Associates of Central California — Fresno, California, United States
- The Iowa Clinic — Ankeny, Iowa, United States
- Cypress Medical Research Center — Wichita, Kansas, United States
- Adult & Pediatric Urology P.C. — Omaha, Nebraska, United States
- Associated Urologists of North Carolina — Raleigh, North Carolina, United States
- Institute for Female Pelvic Medicine — Allentown, Pennsylvania, United States
Full record on ClinicalTrials.gov
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