Clinical Trial

At-Home Genital Nerve Stimulation for SCI Bowel

Recruiting
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Summary
The purpose of this study is to test whether electrical stimulation of the skin in the pelvic area (near the genitals) can reduce the reflexes that cause bowel accidents in people with spinal cord injuries. Current bowel treatments either involve diet and medications or surgery. This study will evaluate whether electrical stimulation can be an alternate option for bowel management. Researchers will: * Use an FDA approved Transcutaneous Electrical Nerve Stimulation (TENS) device off-label * Compare a target stimulation level to a placebo stimulation level Participants will: * Use electrical stimulation on the skin in the pelvic area for 6-8 hours each day for 4 weeks at home * Visit the research center 3 times to participate in exams and answer questions * Keep a daily diary of their bowel symptoms and stimulation times
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2025-02-14; most recent amendment 2026-07-27.
Status change: Not Yet Recruiting → Recruiting 2025-05-06
Trial Details
NCT Number NCT06836739
Lead Sponsor MetroHealth Medical Center
Collaborators: Congressionally Directed Medical Research Programs
Conditions Spinal Cord Injury
Enrollment 12 participants
Start Date 2025-03-01
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-28