Home electrical stimulation near the genitals for bowel problems after spinal cord injury
Tests skin electrical stimulation for bowel accidents in adults with spinal cord injury.
Key facts
- Who runs it
- MetroHealth Medical Center
- Where
- Cleveland, United StatesSee the site
- Trial code
- Registry title
- At-Home Genital Nerve Stimulation for SCI Bowel
- Status
- Recruiting
- People taking part
- 12 people, planned
- Started
- 1 Mar 2025
- Expected to end
- 30 Sept 2027
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- Genital nerve stimulation
- Record updated
- 3 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a spinal cord injury caused by trauma who have bowel problems. They will use skin nerve stimulation near the genitals at home for 4 weeks.
- Age
- 18 years and older
- Sex
- All sexes
- Disease stage
- Traumatic spinal cord injury, at least 6 months since the injury. Injury level T12 or higher, AIS grade A-D (as defined by the ISNCSCI). Score of 14 or higher on the ISCI BF BDS v2.1 bowel questionnaire.
- Biomarker or test result
- A response to genital nerve stimulation must be seen at the screening visit.
Main reasons for not taking part
- Currently in another functional electrical stimulation (FES) research trial
- Pregnant or planning to become pregnant during the trial
- A cardiac pacemaker, implanted defibrillator or other implanted stimulation device that may interact with the stimulation
- Medical problems that the study doctors judge may interfere with the study
- Not able to understand and give informed consent
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Traumatic SCI
- Minimum of 6 months' post-injury
- Aged 18 years and older
- Neurological level of injury T12 or higher and AIS grade A-D, as defined by the ISNCSCI
- Score of 14 or higher on the ISCI BF BDS v2.1
- Response to genital nerve stimulation able to be elicited upon screening
- Able to understand and provide informed consent
Who cannot take part
- Presence of a cardiac pacemaker, implanted defibrillator, or other implanted functional electrical stimulation device if, upon clinical evaluation, it may have an interaction with GNS
- Currently enrolled in another functional electrical stimulation (FES) research trial
- Females who are pregnant or planning to become pregnant in the duration of the trial (identified by self-report)
- In the judgment of the PI and Co-Investigators, presence of medical complications that may interfere with the execution of the study
Where in United States
- MetroHealth Center for Rehabilitation ResearchCleveland, United StatesContact: Mayson MooreTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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
The 2 groups in the trial
- Target genital nerve stimulationTreatment being tested
Stimulation waveforms consist of biphasic, charge-balanced square pulses with a pulse width of 0.2 ms and delivered at 20 Hz. Stimuli will be applied over a range of amplitudes to determine the threshold of stimulation for producing reflex contraction of the anal sphincter (the pudendo-anal reflex). Subsequent stimulation will be applied at threshold for the first week, at 1.5 threshold for the second week, and at twice threshold (or max tolerance) for the third and fourth weeks. The typical stimulation range is 20-40 milliamps (mA) and has been shown to be well tolerated by individuals with sensation. Stimulation will be applied continuously for 6-8 hours daily for four weeks.
Treatment: Genital nerve stimulation
- Sham genital nerve stimulationSham treatment, for comparison
Sham stimulation will be applied in the same manner as target stimulation, except that the stimulation frequency will be 1 Hz and the stimulation amplitude will be set to a limit that is at the threshold of perception if individuals have sensation, or 10 mA if they do not have sensation. Stimulation will be applied continuously for 6-8 hours daily for four weeks.
Treatment: Genital nerve stimulation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- At-Home Feasibility Trial of Genital Nerve Stimulation to Modulate Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
- Plain-language title
- Home electrical stimulation near the genitals for bowel problems after spinal cord injuryGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Publications
- Record updated
- 3 November 2026