RECRUITING

Stimulation for Bowel Emptying

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Electrical Rectal Stimulation to Promote Bowel Emptying After Spinal Cord Injury

Quick Facts

Study Start:2024-05-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06078176

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Suprasacral spinal cord injury
  2. * Diagnosed neurogenic bowel dysfunction and using digital rectal stimulation
  3. * Bowel routine requires at least 30 minutes or at least 3 cycles of digital rectal stimulation
  4. * Neurologically stable
  5. * At least 18 years old
  6. * At least 12 months post neurological injury or disease diagnosis
  1. * Active sepsis
  2. * Open pressure sores on or around pelvis
  3. * Significant colon trauma or colostomy
  4. * Crohn's disease
  5. * Colonic obstruction or gastrointestinal surgery within last 3 months
  6. * Significant history of autonomic dysreflexia

Contacts and Locations

Study Contact

Cesar Colasante-Garrido, MD
CONTACT
(315) 325-4400
cesar.colasante@va.go

Principal Investigator

Cesar Colasante-Garrido, MD
PRINCIPAL_INVESTIGATOR
Syracuse VA Medical Center, Syracuse, NY

Study Locations (Sites)

Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, 13210-2716
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Cesar Colasante-Garrido, MD, PRINCIPAL_INVESTIGATOR, Syracuse VA Medical Center, Syracuse, NY

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-05-01
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Neurogenic Bowel Dysfunction