Treatment of Fecal Incontinence and Constipation in Patients With Spinal Cord Injury

• ClinicalTrials.gov Identifier: NCT00286520
• Recruitment Status: Completed
• First Posted: February 3, 2006
• Last Update Posted: February 3, 2006
• Sponsor: University of Aarhus
• Collaborators: Coloplast A/S; Montecatone Rehabilitation Institute S.p.A.; National Spinal Injuries Centre, Stoke Mandeville Hospital, United Kingdom,; Orthopädische Universitätsklinik Heidelberg, Germany,; Karolinska University Hospital; Central Jutland Regional Hospital
• Information provided by: University of Aarhus

Study Description

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

Condition or disease	Intervention/treatment	Phase
Constipation; Fecal Incontinence; Spinal Cord Injury	Procedure: Transanal irrigation with Peristeen Anal Irrigation	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: December 2003
• Study Completion Date: August 2005

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Cleveland Clinic Constipaton Scoring System
2. St. Mark's Fecal Incontinence Grading System

Secondary Outcome Measures :

1. Neurogenic Bowel Dysfunction Score
2. American Society of Colorectal Surgeon Fecal Incontinence Score

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

Denmark

Surgical Research Unit, Department of Surgery P, Aarhus University Hospital

Aarhus, Denmark, 8000

Sponsors and Collaborators

University of Aarhus

Coloplast A/S

Montecatone Rehabilitation Institute S.p.A.

National Spinal Injuries Centre, Stoke Mandeville Hospital, United Kingdom,

Orthopädische Universitätsklinik Heidelberg, Germany,

Karolinska University Hospital

Central Jutland Regional Hospital

Investigators

• Study Chair: Soeren Laurberg, professor, D.M.Sci; Surgical Research Unit, Department of Surgery P, Aarhus University Hospital, Denmark

More Information

Publications:

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.

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.

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.

• ClinicalTrials.gov Identifier: NCT00286520
• Other Study ID Numbers: DK021CC
• First Posted: February 3, 2006
• Last Update Posted: February 3, 2006
• Last Verified: February 2006

Keywords provided by University of Aarhus:

Constipation; Fecal incontinence; Spinal cord injury; transanal irrigation; quality of life

Additional relevant MeSH terms:

Fecal Incontinence; Spinal Cord Injuries; Constipation; Wounds and Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Signs and Symptoms, Digestive; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases