RecruitingNot Applicable

At-Home Genital Nerve Stimulation for SCI Bowel

United States12 participantsStarted 2025-03-01

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD.

Timeframe: From baseline to the end of 6 weeks

The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD.

Timeframe: From baseline to the end of 6 weeks

The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD.

Timeframe: From baseline to the end of 6 weeks

Trial details

NCT IDNCT06836739

SponsorMetroHealth Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Mayson Moore

216-957-3518 mmoore12@metrohealth.org

View on ClinicalTrials.gov More Spinal Cord Injury trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

What they're measuring

The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD.

Timeframe: From baseline to the end of 6 weeks

The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD.

Timeframe: From baseline to the end of 6 weeks

The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD.

Timeframe: From baseline to the end of 6 weeks