At-Home Use of Genital Nerve Stimulation to Manage Bowel Problems in Adults with Spinal Cord Injury

What this Trial Is About

Researchers are evaluating whether electrical stimulation of the skin in the pelvic area near the genitals can reduce bowel reflexes that cause accidents in people with spinal cord injuries. This study aims to provide an alternative to current bowel treatments like diet, medications, or surgery by testing genital nerve stimulation GNS in individuals with neurogenic bowel dysfunction due to spinal cord injury. The study focuses on feasibility and how GNS modulates bowel function across different injury severities. Participants will use a non-invasive device with surface electrodes placed on genital areas to deliver electrical stimulation daily for 6-8 hours over four weeks at home. The study compares target stimulation levels to a placebo sham stimulation. Stimulation intensity gradually increases over the study weeks, starting from threshold levels to higher intensities. Participants will receive either the experimental or sham stimulation in a randomized, single-blind design. During the study, participants visit the research center three times for exams and questionnaires. They will keep daily diaries of bowel symptoms and stimulation times. Researchers will measure feasibility of daily GNS use, anorectal function via manometry, clinical exam results, and bowel function questionnaires over six weeks. Baseline data include spinal cord injury characteristics. This study monitors adherence and responses to evaluate GNS as a bowel management option.

At-Home Genital Nerve Stimulation for SCI Bowel