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Clinical Trials/NCT06078176
NCT06078176
Recruiting
Not Applicable

Electrical Rectal Stimulation to Promote Bowel Emptying After Spinal Cord Injury

VA Office of Research and Development2 sites in 1 country12 target enrollmentMay 1, 2024

Overview

Phase
Not Applicable
Intervention
Electrical Rectal Stimulation
Conditions
Neurogenic Bowel Dysfunction
Sponsor
VA Office of Research and Development
Enrollment
12
Locations
2
Primary Endpoint
Time required to complete bowel emptying
Status
Recruiting
Last Updated
19 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2024
End Date
December 31, 2026
Last Updated
19 days ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: Electrical Rectal Stimulation

Outcomes

Primary Outcomes

Time required to complete bowel emptying

Time Frame: 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.

Study Sites (2)

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