Genital nerve stimulation for bowel issues in spinal cord injury patients
Short-term Genital Nerve Stimulation to Modulate Anorectal Reflex Activity in Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
This study is testing if genital nerve stimulation can help people with spinal cord injuries who struggle with bowel control and fecal incontinence.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MetroHealth Medical Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05626816 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of genital nerve stimulation (GNS) on fecal incontinence in individuals with spinal cord injuries (SCI). Participants will undergo a screening visit to assess their response to GNS, followed by a series of assessments including anorectal manometry to evaluate bowel function. The study aims to collect comprehensive data on bowel-related issues and the potential effectiveness of GNS in reducing fecal incontinence. The research is designed to identify which patients may benefit from this intervention and how it may improve their quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with traumatic spinal cord injuries at or above the T12 level, who are at least six months post-injury and can respond to genital nerve stimulation.
Not a fit: Patients currently enrolled in other electrical stimulation trials or those with certain medical complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce fecal incontinence and improve the quality of life for individuals living with spinal cord injuries.
How similar studies have performed: While the approach of using genital nerve stimulation is innovative, similar studies have shown promise in addressing bowel dysfunction in spinal cord injury patients.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cleveland, Ohio
- MetroHealth Medical System Old Brooklyn Campus — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Kim Anderson, PhD — MetroHealth Medical Center
- Study coordinator: Mayson Moore
- Email: MMoore12@metrohealth.org
- Phone: 2169573558
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.