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OpenTrials
Completed

NCT Number: NCT00286520

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Transanal irrigation with Peristeen Anal Irrigation

Procedure

Primary outcomes

  1. Cleveland Clinic Constipaton Scoring System

  2. St. Mark's Fecal Incontinence Grading System

Secondary outcomes

  1. Neurogenic Bowel Dysfunction Score

  2. American Society of Colorectal Surgeon Fecal Incontinence Score

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2005
First posted
Feb 3, 2006
Registry last updated
Feb 3, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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