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

Spinal Cord Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00286520
• Other study ID #: DK021CC
• Status: Completed
• Phase: Phase 4
• First received: January 30, 2006
• Last updated: February 2, 2006
• Start date: December 2003
• Est. completion date: August 2005

Study information

• Verified date: February 2006
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Fecal Incontinence
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Procedure:
• Transanal irrigation with Peristeen Anal Irrigation

Locations

Country	Name	City	State
Denmark	Surgical Research Unit, Department of Surgery P, Aarhus University Hospital	Aarhus

Sponsors (7)

Lead Sponsor	Collaborator
University of Aarhus	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,, Orthopädische Universitätsklinik Heidelberg, Germany,

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cleveland Clinic Constipaton Scoring System
Primary	St. Mark's Fecal Incontinence Grading System
Secondary	Neurogenic Bowel Dysfunction Score
Secondary	American Society of Colorectal Surgeon Fecal Incontinence Score