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Electrical Rectal Stimulation for Neurogenic Bowel Dysfunction

N/A
Recruiting
Led By Dennis Bourbeau, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Bowel routine requires at least 30 minutes or at least 3 cycles of digital rectal stimulation
At least 18 years old
Must not have
Active sepsis
Open pressure sores on or around pelvis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Summary

This trial will test if electrical stimulation of the rectum can help people with spinal cord injury move stools through the colon more easily.

Who is the study for?
This trial is for adults over 18 with stable spinal cord injuries above the sacral region, diagnosed with neurogenic bowel dysfunction, and who have been using digital rectal stimulation for at least a year. It's not suitable for those with active infections, open sores near the pelvis, recent gut surgery or significant colon issues.
What is being tested?
The study tests if electrical stimulation of the rectum can improve bowel movement in people with spinal cord injuries better than manual stretching. Participants will be compared to see which method more effectively aids in emptying their bowels.
What are the potential side effects?
Potential side effects may include discomfort or pain from the electrical stimulation device, possible skin irritation at the site of electrode placement, and an unknown risk of affecting other bodily functions due to nerve interactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need significant help to have a bowel movement.
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I am 18 years old or older.
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My neurological condition is stable.
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I have a spinal cord injury above my lower back.
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I have bowel issues due to nerve problems and use a finger method for relief.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently suffering from a severe infection.
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I have open sores near my pelvis.
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I have had major injury to my colon or have a colostomy.
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I have not had a blockage in my colon or any gut surgery in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time required to complete bowel emptying

Trial Design

1Treatment groups
Experimental Treatment
Group I: Bowel emptyingExperimental Treatment1 Intervention
Study participants will act as their own controls, first providing data using their usual digital rectal stimulation intervention for bowel care, then providing data using electrical stimulation for bowel care.

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Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,360,058 Total Patients Enrolled
1 Trials studying Neurogenic Bowel Dysfunction
2 Patients Enrolled for Neurogenic Bowel Dysfunction
Dennis Bourbeau, PhDPrincipal InvestigatorLouis Stokes VA Medical Center, Cleveland, OH
3 Previous Clinical Trials
18 Total Patients Enrolled
1 Trials studying Neurogenic Bowel Dysfunction
2 Patients Enrolled for Neurogenic Bowel Dysfunction
Cesar Colasante-Garrido, MDPrincipal InvestigatorSyracuse VA Medical Center, Syracuse, NY
~8 spots leftby Dec 2026
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