Recruiting

Bowel Stimulation

Sponsor:

VA Office of Research and Development

Code:

NCT06078176

Conditions

Neurogenic Bowel Dysfunction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Electrical Rectal Stimulation

Study Details

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.

Conditions

Neurogenic Bowel Dysfunction

Study ID

NCT06078176

Start date

May 1, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Time required to complete bowel emptying [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Cesar Colasante-Garrido, MD

(315) 325-4400cesar.colasante@va.gov

Locations

Syracuse VA Medical Center, Syracuse, NY

Recruiting

Syracuse, New York, United States, 13210-2716

Contacts

Cesar Colasante-Garrido, MD

315-325-4400cesar.colasante@va.gov

Principal Investigator:

Cesar Colasante-Garrido, MD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-04-13.