Treatment of Fecal Incontinence & Constipation in Patients With Spinal

Status Completed

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

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00286520
Study type	Interventional
Source	University of Aarhus
Contact
Status	Completed
Phase	Phase 4
Start date	December 2003
Completion date	August 2005

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02574572` - Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury	Phase 1
Recruiting	`NCT05941819` - ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury	N/A
Completed	`NCT05265377` - Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury	N/A
Recruiting	`NCT02331979` - Improving Bladder Function in SCI by Neuromodulation	N/A
Completed	`NCT02777281` - Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI	N/A
Recruiting	`NCT02978638` - Electrical Stimulation for Continence After Spinal Cord Injury	N/A
Completed	`NCT02161913` - Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers	N/A
Withdrawn	`NCT02237547` - Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury	Phase 1/Phase 2
Completed	`NCT02262234` - Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study	Phase 1/Phase 2
Completed	`NCT01884662` - Virtual Walking for Neuropathic Pain in Spinal Cord Injury	N/A
Completed	`NCT01642901` - Zoledronic Acid in Acute Spinal Cord Injury	Phase 3
Terminated	`NCT02080039` - Electrical Stimulation of Denervated Muscles After Spinal Cord Injury	N/A
Terminated	`NCT01433159` - Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury	Phase 2
Completed	`NCT01471613` - Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury	Phase 1/Phase 2
Completed	`NCT01467817` - Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI)	N/A
Completed	`NCT02149511` - Longitudinal Morphometric Changes Following SCI
Completed	`NCT01025609` - Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) Factors In Individuals With Chronic Spinal Cord Injury
Completed	`NCT00663663` - Telephone Intervention for Pain Study (TIPS)	N/A
Completed	`NCT01086930` - Early Intensive Hand Rehabilitation After Spinal Cord Injury	Phase 3
Terminated	`NCT01005615` - Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury	Phase 1/Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms