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