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Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Short-term Genital Nerve Stimulation to Modulate Anorectal Reflex Activity in Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Traumatic SCI * Minimum 6 months post-injury * Aged 18 years or older * Neurological level of injury T12 or higher AIS grade A-D defined by ISNCSCI * Response to genital nerve stimulation upon screening * Able to understand and provide informed consent Exclusion Criteria: * Currently enrolled in another functional electrical stimulation (FES) research trial * Females who are pregnant or planning to become pregnant during the trial * Presence of cardiac pacemaker, implanted defibrillator or other implanted FES device if, upon clinical exam, it may have an interaction with GNS. * In the judgement of the PI or Co-Investigators, presence of medical complications that may interfere with the execution of the study.
About the study
Bowel issues occur in nearly all people after spinal cord injury (SCI) and one major complication is fecal incontinence (accidents). This complication has been repeatedly highlighted by people living with SCI as particularly life-limiting and in need of more options for interventions. This study will test the effect of genital nerve stimulation (GNS), with non-invasive electrodes, on the activity of the anus and rectum of persons after SCI. Recording anorectal manometry (ARM) endpoints tells us the function of those tissues and our study design (ARM without stim, ARM with stim, ARM without stim) will allow us to conclude the GNS effect and whether it is likely to reduce fecal incontinence. The study will also collect medical, demographic, and bowel related functional information. The combination of all of these data should help predict who will respond to stimulation, what will happen when stimulation is applied, and if that stimulation is likely to provide an improvement in fecal continence for people living with SCI.
What is being tested
- Genital Nerve Stimulation (device)
- Clinical exam (diagnostic test)
- Collection of SCI common data elements (diagnostic test)
- Bowel function survey completion (diagnostic test)
- International Standard for Neurological Classification of SCI (ISNCSCI) (diagnostic test)
- Response to genital nerve stimulation (GNS) (diagnostic test)
Sponsor: MetroHealth Medical Center · Participants: 52 · Started: Mar 21, 2023
Contact the study team
- Mayson Moore · Phone: 2169573558
- Rob Hoey, PhD · Phone: 2169573665
Official record on ClinicalTrials.gov — NCT05626816
Locations in the U.S.
| Ohio | MetroHealth Medical System Old Brooklyn Campus, Cleveland |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.