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

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ClinicalTrials.gov Identifier: NCT00286520
Recruitment Status : Completed
First Posted : February 3, 2006
Last Update Posted : February 3, 2006
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE January 30, 2006
First Posted Date  ICMJE February 3, 2006
Last Update Posted Date February 3, 2006
Study Start Date  ICMJE December 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2006)
  • Cleveland Clinic Constipaton Scoring System
  • St. Mark's Fecal Incontinence Grading System
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2006)
  • Neurogenic Bowel Dysfunction Score
  • American Society of Colorectal Surgeon Fecal Incontinence Score
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Fecal Incontinence and Constipation in Patients With Spinal Cord Injury
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Constipation
  • Fecal Incontinence
  • Spinal Cord Injury
Intervention  ICMJE Procedure: Transanal irrigation with Peristeen Anal Irrigation
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: February 2, 2006)
80
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00286520
Other Study ID Numbers  ICMJE DK021CC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE
  • 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  ICMJE
Study Chair: Soeren Laurberg, professor, D.M.Sci Surgical Research Unit, Department of Surgery P, Aarhus University Hospital, Denmark
PRS Account University of Aarhus
Verification Date February 2006

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