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Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
NCT05626816 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Clinical exam
- DEVICE Genital Nerve Stimulation
- DIAGNOSTIC_TEST Collection of SCI common data elements
- DIAGNOSTIC_TEST Bowel function survey completion
- DIAGNOSTIC_TEST International Standard for Neurological Classification of SCI (ISNCSCI)
Study Locations (1)
Ohio
- MetroHealth Medical System Old Brooklyn Campus — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2023-03-21 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05626816
The ClinicalTrials.gov registry entry for NCT05626816 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MetroHealth Medical Center, which has 29 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Fecal Incontinence appearing as the primary indexed condition, and to 5 interventions — of which Clinical exam is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05626816 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05626816 about?
NCT05626816 is a clinical study titled "Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury". 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 wil...
What is the current status of trial NCT05626816?
This trial is currently recruiting. It is a NA study. The enrollment target is 52 participants. The study started on 2023-03-21. Estimated completion is 2025-12-31.
What conditions does trial NCT05626816 study?
This clinical trial studies the following conditions: Fecal Incontinence. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05626816?
The interventions under investigation include: Clinical exam (DIAGNOSTIC_TEST), Genital Nerve Stimulation (DEVICE), Collection of SCI common data elements (DIAGNOSTIC_TEST), Bowel function survey completion (DIAGNOSTIC_TEST), International Standard for Neurological Classification of SCI (ISNCSCI) (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05626816?
This trial is sponsored by MetroHealth Medical Center, which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05626816 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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