Stimulation for Colonic Motility

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VA Office of Research and Development

Status

Completed

Conditions

Neurogenic Bowel Dysfunction

Treatments

Other: Electrical Rectal Stimulation

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT02641483
B1962-W

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

2 participants in 1 patient group

Colonic Motility
Experimental group
Description:
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.
Treatment:
Other: Electrical Rectal Stimulation

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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