Stimulation for Bowel Emptying

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Not yet recruiting

CT.gov ID

NCT06078176

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Neurogenic Bowel Dysfunction	Other: Electrical Rectal Stimulation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Electrical Rectal Stimulation to Promote Bowel Emptying After Spinal Cord Injury

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bowel emptying 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.	Other: Electrical Rectal Stimulation Electrical stimulation of the rectum will be applied to activate sensory afferent neurons of the rectum and evoke a recto-colonic reflex to improve colonic motility and facilitate bowel emptying. This intervention will compared to individuals' usual mechanical intervention of digital rectal stimulation.

Arm

Intervention/Treatment

Experimental: Bowel emptying

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.

Other: Electrical Rectal Stimulation

Electrical stimulation of the rectum will be applied to activate sensory afferent neurons of the rectum and evoke a recto-colonic reflex to improve colonic motility and facilitate bowel emptying. This intervention will compared to individuals' usual mechanical intervention of digital rectal stimulation.

Outcome Measures

Primary Outcome Measures

Time required to complete bowel emptying [12 weeks]
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. We will compare the time required for the participant to complete their bowel emptying routine between a control period with digital rectal stimulation and a treatment period with electrical rectal stimulation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Suprasacral spinal cord injury
Diagnosed neurogenic bowel dysfunction and using digital rectal stimulation
Bowel routine requires at least 30 minutes or at least 3 cycles of digital rectal stimulation
Neurologically stable
At least 18 years old
At least 12 months post neurological injury or disease diagnosis

Exclusion Criteria:

Active sepsis
Open pressure sores on or around pelvis
Significant colon trauma or colostomy
Crohn's disease
Colonic obstruction or gastrointestinal surgery within last 3 months
Significant history of autonomic dysreflexia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Syracuse VA Medical Center, Syracuse, NY	Syracuse	New York	United States	13210-2716
2	Louis Stokes VA Medical Center, Cleveland, OH	Cleveland	Ohio	United States	44106-1702

Sponsors and Collaborators

VA Office of Research and Development

Investigators

Principal Investigator: Dennis Bourbeau, PhD, Louis Stokes VA Medical Center, Cleveland, OH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT06078176

Other Study ID Numbers:

B4529-R

First Posted:

Oct 11, 2023

Last Update Posted:

Oct 11, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Intestinal Diseases

Neurogenic Bowel

Study Results

No Results Posted as of Oct 11, 2023