Recruiting

Genital Nerve Stimulation

Sponsor:

MetroHealth Medical Center

Code:

NCT06836739

Conditions

Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Genital nerve stimulation

Study Details

Brief 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

Conditions

Spinal Cord Injury

Study ID

NCT06836739

Start date

Mar 1, 2025

Status verified date

Jul, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Traumatic SCI.
2. Minimum of 6 months' post-injury.
3. Aged 18 years and older.
4. Neurological level of injury T12 or higher and AIS grade A-D, as defined by the ISNCSCI.
5. Score of 14 or higher on the ISCI BF BDS v2.1.
6. Response to genital nerve stimulation able to be elicited upon screening.
7. Able to understand and provide informed consent.

Exclusion Criteria:

1. Currently enrolled in another functional electrical stimulation (FES) research trial.
2. Females who are pregnant or planning to become pregnant in the duration of the trial (identified by self-report).
3. 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.
4. In the judgment of the PI and Co-Investigators, presence of medical complications that may interfere with the execution of the study.

Study Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Target genital nerve stimulation

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.

sham comparator: Sham genital nerve stimulation

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.

Interventions

Genital nerve stimulation

Genital nerve stimulation (GNS) will be administered via non-invasive surface skin electrodes. In men, two surface electrodes (1 cm diameter) will be placed on the dorsum of the penile shaft 2 cm apart. In women, one surface electrode will be placed near the clitoris and a second surface electrode will be placed on the labia majora or inner thigh. The electrodes will be connected to an electrical stimulator device.

Primary outcome measure

  • The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: From baseline to the end of 6 weeks ]

Central Contacts and Locations

Central contacts

Mayson Moore

216-957-3518mmoore12@metrohealth.org

Megan Hammond Nechols

216-957-3562mhammond1@metrohealth.org

Locations

MetroHealth Center for Rehabilitation Research

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

Mayson Moore

216-957-3518mmoore12@metrohealth.org

Megan Hammond Nechols

216-957-3562mhammond1@metrohealth.org

More Information

Sponsor

MetroHealth Medical Center

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Keywords

  • fecal incontinence
  • neurogenic bowel
  • tetraplegia
  • paraplegia
  • paralysis
  • electrical stimulation
  • neuromodulation
  • bowel
  • feasibility
  • anorectal manometry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MetroHealth Medical Center on 2026-07-28.