NCT05626816 Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
| NCT ID | NCT05626816 |
| Status | Recruiting |
| Phase | — |
| Sponsor | MetroHealth Medical Center |
| Condition | Fecal Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2023-03-21 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 52 participants in total. It began in 2023-03-21 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Kim Anderson, PhD
PRINCIPAL INVESTIGATOR
MetroHealth Medical Center
Frequently Asked Questions
Who can join the NCT05626816 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fecal Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05626816 currently recruiting?
Yes, NCT05626816 is actively recruiting participants. Contact the research team at MMoore12@metrohealth.org for enrollment information.
Where is the NCT05626816 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT05626816 clinical trial?
NCT05626816 is sponsored by MetroHealth Medical Center. The principal investigator is Kim Anderson, PhD at MetroHealth Medical Center. The trial plans to enroll 52 participants.