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NCT02641483 · ClinicalTrials.gov registry record · NA
Stimulation for Colonic Motility
A NA study of Neurogenic Bowel Dysfunction, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 2
- Enrollment target
- 2
- Study locations
NCT02641483: Completed NA study of Neurogenic Bowel Dysfunction, sponsored by VA Office of Research and Development.
NCT02641483 is a NA study of Neurogenic Bowel Dysfunction that has completed, run by VA Office of Research and Development. The registered enrollment target is 2 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02641483, a NA study of Neurogenic Bowel Dysfunction, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
- 2
- Study locations
Study Summary
The investigators are testing the effect of electrical stimulation of the rectum on colonic motility. Most individuals with spinal cord injury develop neurogenic bowel dysfunction, which includes slowed colonic motility, which means that stools take longer than normal to pass through the colon. This slowed movement may result in chronic constipation and difficulty emptying the bowels. Individuals typically (without or without caregiver assistance) insert a gloved finger into the rectum and gently stretch it to improve colonic motility for a brief period to empty the bowels. The investigators hypothesize that electrically stimulating the rectum, instead of mechanically stretching it, will produce the same beneficial effect of improving colonic motility. Therefore, this study will compare the two methods. If electrical stimulation effectively improves colonic motility, then the investigator shall develop the approach as a therapeutic intervention in future studies.
Primary Outcome
Two interventions will be tested, including the clinical standard of digital rectal stimulation and a novel approach using electrical stimulation of rectal sensory afferents, to determine the effect on colonic pressure. Typically several bouts of digital rectal stimulation are required to achieve complete bowel emptying. We will compare the number of bouts of digital rectal stimulation (control) with electrical rectal stimulation (treatment) required to achieve complete bowel emptying.
Conditions Studied
Interventions
- OTHER Electrical Rectal Stimulation
Study Locations (2)
New York
- Syracuse VA Medical Center, Syracuse, NY - Syracuse
Ohio
- Louis Stokes VA Medical Center, Cleveland, OH - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2019-01-01 |
| Est. Completion | 2021-12-31 |
| Phase | NA |
What the finished NCT02641483 record still lists
NCT02641483 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Neurogenic Bowel Dysfunction appearing as the primary indexed condition, and to 1 intervention - of which Electrical Rectal Stimulation is the first listed.
NCT02641483 reports a single indexed study location in New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT02641483 about?
NCT02641483 is a clinical study titled "Stimulation for Colonic Motility". The investigators are testing the effect of electrical stimulation of the rectum on colonic motility. Most individuals with spinal cord injury develop neurogenic bowel dysfunction, which includes slowed colonic motility, which means that stools take longer than normal to pass through the colon. This...
What is the current status of trial NCT02641483?
This trial is currently completed. It is a NA study. The enrollment target is 2 participants. The study started on 2019-01-01. Estimated completion is 2021-12-31.
What conditions does trial NCT02641483 study?
This clinical trial studies the following conditions: Neurogenic Bowel Dysfunction.
What interventions are being tested in trial NCT02641483?
The interventions under investigation include: Electrical Rectal Stimulation (OTHER).
Who is sponsoring clinical trial NCT02641483?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02641483 being conducted?
This trial has 2 study locations across New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02641483's enrollment target sits among peer trials
2 1997th of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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