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

This study has been completed.
Sponsor:
Collaborators:
Coloplast A/S
Montecatone Rehabilitation Institute, University of Bologna, Italy,
National Spinal Injuries Centre, Stoke Mandeville Hospital, United Kingdom,
Orthopädische Universitätsklinik Heidelberg, Germany,
Spinalis, Karolinska Sjukhuset, Stockholm, Sweden,
Viborg Hospital
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00286520
First received: January 30, 2006
Last updated: February 2, 2006
Last verified: February 2006

January 30, 2006
February 2, 2006
December 2003
Not Provided
  • Cleveland Clinic Constipaton Scoring System
  • St. Mark's Fecal Incontinence Grading System
Same as current
Complete list of historical versions of study NCT00286520 on ClinicalTrials.gov Archive Site
  • Neurogenic Bowel Dysfunction Score
  • American Society of Colorectal Surgeon Fecal Incontinence Score
Same as current
Not Provided
Not Provided
 
Treatment of Fecal Incontinence and Constipation in Patients With Spinal Cord Injury
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

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Constipation
  • Fecal Incontinence
  • Spinal Cord Injury
Procedure: Transanal irrigation with Peristeen Anal Irrigation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
August 2005
Not Provided

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00286520
DK021CC
Not Provided
Not Provided
University of Aarhus
  • Coloplast A/S
  • Montecatone Rehabilitation Institute, University of Bologna, Italy,
  • National Spinal Injuries Centre, Stoke Mandeville Hospital, United Kingdom,
  • Orthopädische Universitätsklinik Heidelberg, Germany,
  • Spinalis, Karolinska Sjukhuset, Stockholm, Sweden,
  • Viborg Hospital
Study Chair: Soeren Laurberg, professor, D.M.Sci Surgical Research Unit, Department of Surgery P, Aarhus University Hospital, Denmark
University of Aarhus
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP