Clinical trial NCT00286520: Treatment of Fecal Incontinence and Constipation in Patients With Spinal Cord Injury
Official title: Treatment of Fecal Incontinence and Constipation in Patients With Spinal Cord Injury - a Prospective, Randomized, Controlled, Multicentre Trial of Transanal Irrigation Vs. Conservative Bowel Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Constipation
Fecal Incontinence
Spinal Cord Injury
Keywords: Constipation
Fecal incontinence
Spinal cord injury
transanal irrigation
quality of life
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Coloplast A/S
name: Montecatone Rehabilitation Institute S.p.A.
name: National Spinal Injuries Centre, Stoke Mandeville Hospital, United Kingdom,
name: Orthopädische Universitätsklinik Heidelberg, Germany,
name: Karolinska University Hospital
name: Central Jutland Regional Hospital
First posted: 2006-02-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, randomized trial in spinal cord lesion patients (SCL- patients) with faecal incontinence and/or constipation.

Population; 80 SCL- patients with faecal incontinence and/or constipation from five countries.

Focus on:

Bowel symptom score Neurogenic Bowel Dysfunction score Symptom related quality of life questionnaire Time expenditure for performance of bowel care ans side effects

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 leading to constipation, fecal incontinence or a combination of both. Although these symptoms are not life-threatening, they may have a severe impact on quality of life as well as increase levels of anxiety and depression.

Various bowel management programs have been empirical, and individual solutions have been sought on a trial-and-error basis. Transanal irrigation has been used in selected patients with constipation or fecal incontinence. The majority of spinal cord injured patients in a recent study benefited from the treatment. However, there is limited evidence in the literature supporting any bowel management program in spinal cord injury in favor of another and well-designed controlled trials are still lacking. Therefore, the present study aims to compare transanal irrigation with conservative bowel management, defined as best supportive bowel care without irrigation, in a prospective, randomized, controlled, multicentre study among spinal cord injured patients with neurogenic bowel dysfunction.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Cleveland Clinic Constipaton Scoring System
measure: St. Mark's Fecal Incontinence Grading System
Secondary outcomes:
measure: Neurogenic Bowel Dysfunction Score
measure: American Society of Colorectal Surgeon Fecal Incontinence Score
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
Study officials:
affiliation: Surgical Research Unit, Department of Surgery P, Aarhus University Hospital, Denmark
name: Soeren Laurberg, professor, D.M.Sci
role: STUDY_CHAIR
References:
citation: Christensen P, Olsen N, Krogh K, Bacher T, Laurberg S. Scintigraphic assessment of retrograde colonic washout in fecal incontinence and constipation. Dis Colon Rectum. 2003 Jan;46(1):68-76. doi: 10.1007/s10350-004-6498-0.
citation: Christensen P, Kvitzau B, Krogh K, Buntzen S, Laurberg S. Neurogenic colorectal dysfunction - use of new antegrade and retrograde colonic wash-out methods. Spinal Cord. 2000 Apr;38(4):255-61. doi: 10.1038/sj.sc.3100991.
citation: Krogh K, Olsen N, Christensen P, Madsen JL, Laurberg S. Colorectal transport during defecation in patients with lesions of the sacral spinal cord. Neurogastroenterol Motil. 2003 Feb;15(1):25-31. doi: 10.1046/j.1365-2982.2003.00381.x.