Abdominal Transcutaneous Electrical Stimulation to Alleviate Neurogenic Bowel Dysfunction in People With Chronic Spinal Cord Injury
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- University of Alberta
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Mean defecation time at 2 weeks
Study Overview
Brief Summary
Many people with spinal cord injury (SCI) have bowel problems resulting in constipation and need a long time to empty the bowel. Some people spend an hour or more to empty their bowel. The investigators want test if using a small device to deliver electrical pulses to the belly (abdomen), would improve bowel function. The investigators hope that electrical stimulation will shorten the time needed to evacuate the bowel (defecation), improve stool consistency, and speed up food passing through the bowel. A pilot study found that electrical stimulation of the belly can speed up defecation if stimulation is making the abdominal muscles contract and squeeze the belly, which is what the investigators expected. However, some results suggested that people may benefit from low stimulation levels without making the muscles contract.
Therefore, the investigators will do small study at the University of Alberta on 12 people who lived with SCI for more than 1 year, to find out the best way to apply the electrical stimulation, and to better understand how it works. The participants will use an electrical stimulator at home, to stimulate the skin with 4 sticky pads attached over the abdomen, without causing the muscles to contract. During a 2-month period, they will use the stimulator for 30 minutes before every bowel routine. The investigators will compare how long it takes to empty the bowel, stool consistency, and how long it takes for food to pass through the bowel, with and without using the electrical stimulator.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Traumatic or non-traumatic SCI
- •>1 year post injury
- •Injury level C2 - S5 (NLI, neurological level of injury)
- •AIS A, B, C, D (American Spinal Injury Association Impairment Scale)
- •Feels defecation takes too long and wants to do something about it
- •Defecation takes > 30 minutes
Exclusion Criteria
- •Bladder stimulator
- •Inflammatory bowel disease
- •Unable to give consent
Arms & Interventions
Abdominal TES
Abdominal transcutaneuous electrical stimulation (TES)
Intervention: Abdominal transcutaneous electrical stimulation (TES) (Device)
Outcomes
Primary Outcomes
Mean defecation time at 2 weeks
Time Frame: 2 weeks after enrollment (after 2 weeks of usual bowel routine)
Mean defecation time for all bowel routines from 0 to 2 weeks (2 weeks of usual bowel routine). Defecation time = time from initiation of bowel movement to the end of stool evacuation.
Mean defecation time at 6 weeks
Time Frame: 6 weeks after enrollment (after 4 weeks of optimized bowel routine)
Mean defecation time for all bowel routines from 2 to 6 weeks (4 weeks of optimized bowel routine). Defecation time = time from initiation of bowel movement to the end of stool evacuation.
Mean defecation time at 14 weeks
Time Frame: 14 weeks after enrollment (after 8 weeks of abdominal TES)
Mean defecation time for all bowel routines from 6 to 14 weeks (8 weeks of abdominal TES). Defecation time = time from initiation of bowel movement to the end of stool evacuation.
Mean defecation time at 18 weeks
Time Frame: 18 weeks after enrollment (after 4 weeks of usual bowel routine)
Mean defecation time for all bowel routines from 14 to 18 weeks (4 weeks of usual bowel routine). Defecation time = time from initiation of bowel movement to the end of stool evacuation.
Secondary Outcomes
- Bristol Stool Form(Every bowel routine)
- Bowel Transit Time at 2 weeks(2 weeks after enrollment (after 2 weeks of usual bowel routine))
- Bowel Transit Time at 14 weeks(14 weeks after enrollment (after 8 weeks of abdominal TES))
- Neurogenic Bowel Dysfunction Score (NBDS) at 6 weeks(6 weeks after enrollment (after 4 weeks of optimized bowel routine))
- Participant Feedback(18 weeks after enrollment (end of study))
- Bowel Transit Time at 6 weeks(6 weeks after enrollment (after 4 weeks of optimized bowel routine))
- Bowel Transit Time at 18 weeks(18 weeks after enrollment (after 4 weeks of usual bowel routine))
- Neurogenic Bowel Dysfunction Score (NBDS) at 18 weeks(18 weeks after enrollment (after 4 weeks of usual bowel routine))
- Neurogenic Bowel Dysfunction Score (NBDS) at 2 weeks(2 weeks after enrollment (after 2 weeks of usual bowel routine))
- Neurogenic Bowel Dysfunction Score (NBDS) at 14 weeks(14 weeks after enrollment (after 8 weeks of abdominal TES))