N/A
N=2
Stimulation for Colonic Motility
Neurogenic Bowel Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT02641483 ↗Enrolled (actual)
2
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Compare Changes in Number of Interventions Used to Complete Bowel Routine, Including Electrical Rectal Stimulation (Treatment) Versus Mechanical Rectal Distension (Control) — 4; 1 bouts of stimulation
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Electrical Rectal Stimulation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compare Changes in Number of Interventions Used to Complete Bowel Routine, Including Electrical Rectal Stimulation (Treatment) Versus Mechanical Rectal Distension (Control) |
4; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Diagnosed neurogenic bowel dysfunction and using digital rectal stimulation
- Neurologically stable
- Skeletally mature
- Suprasacral spinal cord injury, stroke, or multiple sclerosis
- At least 6 months post neurological injury or disease diagnosis
Exclusion Criteria
- Active sepsis
- Open pressure sores on or around pelvis
- Significant colon trauma or colostomy
- History of autonomic dysreflexia
Data sourced from ClinicalTrials.gov (NCT02641483). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.