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

NCT00286520 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2006-02-03

No results posted yet for this study

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

Conditions

Interventions

PROCEDURE

Transanal irrigation with Peristeen Anal Irrigation

Sponsors & Collaborators

  • Coloplast A/S

    collaborator INDUSTRY

  • Montecatone Rehabilitation Institute S.p.A.

    collaborator OTHER

  • National Spinal Injuries Centre, Stoke Mandeville Hospital, United Kingdom,

    collaborator UNKNOWN

  • Orthopädische Universitätsklinik Heidelberg, Germany,

    collaborator UNKNOWN

  • Karolinska University Hospital

    collaborator OTHER

  • Central Jutland Regional Hospital

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Completion
2005-08-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00286520 on ClinicalTrials.gov