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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
ClinicalTrials.gov Identifier: NCT00286520     History of Changes
Other Study ID Numbers: DK021CC
Study First Received: January 30, 2006
Last Updated: February 2, 2006
Health Authority: Denmark: Ethics Committee

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

Additional relevant MeSH terms:
Constipation
Fecal Incontinence
Spinal Cord Injuries
Wounds and Injuries
Signs and Symptoms, Digestive
Signs and Symptoms
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 28, 2014