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At-Home Genital Nerve Stimulation for SCI Bowel

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 28, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Re-verified, no change to tracked fieldsv7
  2. Collaborators expanded, about 5 wordsv6
  3. 2 versions Re-verified since Aug 14, 2025, no change to tracked fieldsv4-v5
  4. Site contact updatedv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06836739
Lead Sponsor MetroHealth Medical Center
Collaborators: Congressionally Directed Medical Research Programs
Conditions
(from sponsor)		 Spinal Cord Injury
Related terms Fecal Incontinence, Neurogenic Bowel, Paralysis, Paraplegia, Quadriplegia, Spinal Cord Injuries
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov