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Clinical Data

Treatment of Fecal Incontinence and Constipation in Patients with Spinal Cord Injury
This study has been completed.

Sponsors and Collaborators: University of Aarhus
Coloplast A/S
Montecatone Rehabilitation Institute, University of Bologna, Italy, Germany, National Spinal Injuries Centre, Stoke Mandeville Hospital, United Kingdom, Orthopädische Universitätsklinik Heidelberg, Spinalis, Karolinska Sjukhuset,
Stockholm, Sweden, Viborg Hospital
Information provided by: University of Aarhus
ClinicalTrials.gov Identifier: NCT00286520

 

Purpose
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 Intervention Phase

Constipation
Fecal Incontinence
Spinal Cord Injury

Procedure: Transanal irrigation with Peristeen Anal Irrigation  Phase IV


Medline Plus related topics: Constipation Spinal Cord Injuries Urinary Incontinence

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

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

Secondary Outcome Measures:

  • Neurogenic Bowel Dysfunction Score
  • American Society of Colorectal Surgeon Fecal Incontinence Score

Estimated Enrollment: 80
Study Start Date: December 2003
Estimated Study Completion Date: August 2005

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

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00286520

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, University of Bologna, Italy,
National Spinal Injuries Centre, Stoke Mandeville Hospital, United Kingdom,
Orthopädische Universitätsklinik Heidelberg, Germany,
Spinalis, Karolinska Sjukhuset, Stockholm, Sweden,
Viborg 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.

Study ID Numbers:
DK021CC
First Received:
January 30, 2006
Last Updated:
February 2, 2006
ClinicalTrials.gov Identifier:
NCT00286520   [history]
Health Authority:
Denmark: Ethics Committee

Keywords provided by University of Aarhus:
Constipation
Fecal incontinence
Spinal cord injury
transanal irrigation
quality of life

Study placed in the following topic categories:
Fecal Incontinence
Signs and Symptoms, Digestive
Spinal Cord Diseases
Gastrointestinal Diseases
Urination Disorders
Wounds and Injuries
Quality of Life
Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System
Intestinal Diseases
Rectal Diseases
Spinal Cord Injuries
Signs and Symptoms
Digestive System Diseases
Urologic Diseases
Constipation
Urinary Incontinence

Additional relevant MeSH terms:
Urological Manifestations
Nervous System Diseases

ClinicalTrials.gov processed this record on January 05, 2009