At-Home Genital Nerve Stimulation for SCI Bowel
Start Date
3/1/2025
Completion Date
9/30/2026
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
Detailed Description
The objective of this proposal is to determine how genital nerve stimulation (GNS) acutely modulates neurogenic bowel dysfunction (NBD) in individuals with different severities of spinal cord injury (SCI) and to determine the key study design and methodology parameters of daily at-home administration of GNS. This study will determine the feasibility of daily application of GNS as an intervention for NBD. Key feasibility measures related to dosage and adherence will be evaluated.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Genital nerve stimulation
Conditions
Locations
MetroHealth Center for Rehabilitation Research
Cleveland, Ohio 44109
United States