Status:
COMPLETED
Treatment of Fecal Incontinence and Constipation in Patients With Spinal Cord Injury
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Coloplast A/S
Montecatone Rehabilitation Institute S.p.A.
Conditions:
Constipation
Fecal Incontinence
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The study aims to compare a newly developed system for transanal colonic irrigation (Peristeen Anal Irrigation) with a bowel management regime that does not include irrigation in a prospective, random...
Detailed Description
The magnitude of bowel dysfunction in spinal cord injury patients has been documented in several studies. Spinal cord injury affects colorectal motility, transit times, and bowel emptying often leadin...
Eligibility Criteria
Inclusion
- Aged 18 or over
- Spinal cord lesion at any level at least 3 months from injury
- At least one or more of the following symptoms:
- Spending ½ hour or more attempting to defecate each day or every second day
- Symptoms of autonomic dysreflexia before or during defecation
- Abdominal discomfort before or during defecation
- Episodes of faecal incontinence once or more per month
- The patient is able to understand the treatment and is willing to comply with the prescribed regimen
- The patient is able to perform transanal colonic irrigation seated on a toilet commode with or without assistance
- Signed informed consent has been obtained
Exclusion
- Co-existing major unsolved physical problems due to the injury
- Perform transanal retrograde irrigation on a regular basis
- Evidence of bowel obstruction
- Evidence of inflammatory bowel disease
- History of cerebral palsy or cerebral apoplexy
- Multiple sclerosis
- Diabetic polyneuropathy
- Previous abdominal or perianal surgery (not including minor surgery as appendectomy or haemorrhoidectomy)
- Pregnant or lactating
- Evidence of spinal chock
- Mentally unstable
- Treatment with more than 5 mg prednisolon per day.
- PNS implant (sacral nerve stimulation)
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00286520
Start Date
December 1 2003
End Date
August 1 2005
Last Update
February 3 2006
Active Locations (1)
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1
Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
Aarhus, Denmark, 8000