Neurogenic Bowel Dysfunction
Conditions
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.
Interventions
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.
Sponsors
VA Office of Research and Development
Cleveland Functional Electrical Stimulation Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time required to complete bowel emptying | 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. |
Countries
United States
Contacts
CONTACTCesar Colasante-Garrido, MD
PRINCIPAL_INVESTIGATORCesar Colasante-Garrido, MD
Syracuse VA Medical Center, Syracuse, NY
PRINCIPAL_INVESTIGATORDennis Bourbeau, PhD
Louis Stokes VA Medical Center, Cleveland, OH
Outcome results
None listed