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Clinical Trials/NCT02641483
NCT02641483
Completed
Not Applicable

Afferent Stimulation to Evoke Recto-colonic Reflex for Colonic Motility

VA Office of Research and Development2 sites in 1 country2 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurogenic Bowel Dysfunction
Sponsor
VA Office of Research and Development
Enrollment
2
Locations
2
Primary Endpoint
Compare Changes in Number of Interventions Used to Complete Bowel Routine, Including Electrical Rectal Stimulation (Treatment) Versus Mechanical Rectal Distension (Control)
Status
Completed
Last Updated
2 years 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
January 1, 2019
End Date
December 31, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Compare Changes in Number of Interventions Used to Complete Bowel Routine, Including Electrical Rectal Stimulation (Treatment) Versus Mechanical Rectal Distension (Control)

Time Frame: 1 month

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.

Study Sites (2)

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