At-Home Feasibility Trial of Genital Nerve Stimulation to Modulate Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury

What this Trial Is About

Researchers are evaluating genital nerve stimulation (GNS) as a possible new way to manage bowel problems caused by spinal cord injuries (SCI). The study focuses on whether electrical stimulation applied to the skin near the genitals can reduce reflexes that lead to bowel accidents. This research aims to find out if GNS can be a feasible alternative to current bowel treatments like diet, medication, or surgery in people with different severities of SCI. The study uses an FDA-approved Transcutaneous Electrical Nerve Stimulation (TENS) device applied off-label. Participants will be randomly assigned to receive either target GNS or a sham (placebo) stimulation. Stimulation involves biphasic square pulses delivered through surface electrodes placed differently for men and women. The treatment is applied for 6-8 hours daily over four weeks, with increasing stimulation intensity each week. The sham group will receive a low-frequency, low-intensity stimulation for the same duration. Participants will use the stimulation at home and visit the research center three times for exams and questionnaires. They will keep daily diaries tracking bowel symptoms and stimulation use. The study will measure feasibility of daily GNS application, assess bowel function through clinical exams and manometry, and evaluate quality of life related to bowel management. The total study duration is six weeks including baseline and follow-up assessments.

At-Home Genital Nerve Stimulation for SCI Bowel