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NCT05626816 · ClinicalTrials.gov registry record · NA
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
A NA study of Fecal Incontinence, sponsored by MetroHealth Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT05626816: Recruiting NA study of Fecal Incontinence, sponsored by MetroHealth Medical Center.
NCT05626816 is a NA study of Fecal Incontinence that is actively recruiting participants, run by MetroHealth Medical Center. The registered enrollment target is 52 participants, below the 333-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05626816, a NA study of Fecal Incontinence, is actively recruiting participants, sponsored by MetroHealth Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
When an organ relaxes during filling it is called compliance and is characteristic of the rectum and bladder. This allows the organ to hold more material and therefore have a larger void when emptying. After SCI, organs that have had their control systems damaged become spastic and hyperreflexive which leads to smaller volumes and incontinence issues in both bladder and bowel function. By inflating the ARM balloon with air we can slightly distend the rectum and measure the pressure (cmH20) to d
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 |
What NCT05626816 shows while recruiting
NCT05626816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 333-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (84% lower).
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.
NCT05626816 reports a single indexed study location in Ohio.
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.
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).
Who is sponsoring clinical trial NCT05626816?
This trial is sponsored by MetroHealth Medical Center, which has 76 total clinical trials registered on ClinicalTrials.gov.
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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Where NCT05626816's enrollment target sits among peer trials
52 12th of 22 higher than 11 of 22 other Fecal Incontinence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fecal Incontinence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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