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NCT Number: NCT06078176

Stimulation for Bowel Emptying

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.

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Key information

Conditions

Neurogenic Bowel Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210-2716, United States

Location status: Recruiting

Location contact

Cesar Colasante-Garrido, MD

CONTACT

[email protected]

315-325-4400

Cesar Colasante-Garrido, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrical Rectal Stimulation

Other

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 outcomes

  1. 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 contacts

Contact information is provided by the study sponsor or research team.

Cesar Colasante-Garrido, MD

CONTACT

[email protected]

(315) 325-4400

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Cleveland Functional Electrical Stimulation Center

Registry information

Official study title

Electrical Rectal Stimulation to Promote Bowel Emptying After Spinal Cord Injury

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 11, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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