Clinical Trial

Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury

Recruiting
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Record status
This record was last updated December 2, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
Bowel issues occur in nearly all people after spinal cord injury (SCI) and one major complication is fecal incontinence (accidents). This complication has been repeatedly highlighted by people living with SCI as particularly life-limiting and in need of more options for interventions. This study will test the effect of genital nerve stimulation (GNS), with non-invasive electrodes, on the activity of the anus and rectum of persons after SCI. Recording anorectal manometry (ARM) endpoints tells us the function of those tissues and our study design (ARM without stim, ARM with stim, ARM without stim) will allow us to conclude the GNS effect and whether it is likely to reduce fecal incontinence. The study will also collect medical, demographic, and bowel related functional information. The combination of all of these data should help predict who will respond to stimulation, what will happen when stimulation is applied, and if that stimulation is likely to provide an improvement in fecal continence for people living with SCI.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2022-11-15; most recent amendment 2025-11-24.
Trial Details
NCT Number NCT05626816
Lead Sponsor MetroHealth Medical Center
Collaborators: VA of Northeast Ohio Health System, Congressionally Directed Medical Research Programs
Conditions Fecal Incontinence
Enrollment 52 participants
Start Date 2023-03-21
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-02