Actively Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Led by MetroHealth Medical Center · Updated on 2025-12-02
52
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
Sponsors
M
MetroHealth Medical Center
Lead Sponsor
V
VA of Northeast Ohio Health System
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Traumatic spinal cord injury
- At least 6 months since injury
- Age 18 years or older
- Neurological level of injury T12 or higher with AIS grade A-D per ISNCSCI
- Response to genital nerve stimulation during screening
- Ability to understand and provide informed consent
You will not qualify if you...
- Currently enrolled in another functional electrical stimulation research trial
- Pregnant or planning pregnancy during the trial (females)
- Presence of cardiac pacemaker, implanted defibrillator, or other implanted functional electrical stimulation device that may interact with GNS
- Medical complications that may interfere with study participation, as judged by the investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MetroHealth Medical System Old Brooklyn Campus
Cleveland, Ohio, United States, 44109
Actively Recruiting
Research Team
M
Mayson Moore
CONTACT
R
Rob Hoey, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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