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

February 2, 2006 updated by: University of Aarhus

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Surgical Research Unit, Department of Surgery P, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Neurogenic Bowel Dysfunction Score
American Society of Colorectal Surgeon Fecal Incontinence Score

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Karolinska University Hospital
Coloplast A/S
Central Jutland Regional Hospital
Montecatone Rehabilitation Institute S.p.A.
National Spinal Injuries Centre, Stoke Mandeville Hospital, United Kingdom,
Orthopädische Universitätsklinik Heidelberg, Germany,

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Study Completion

August 1, 2005

Study Registration Dates

First Submitted

January 30, 2006

First Submitted That Met QC Criteria

February 2, 2006

First Posted (Estimate)

February 3, 2006

Study Record Updates

Last Update Posted (Estimate)

February 3, 2006

Last Update Submitted That Met QC Criteria

February 2, 2006

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK021CC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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