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Peristeen Bowel Irrigation System in Cauda Equina | Clinical Trials | Clareo Health

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Peristeen Bowel Irrigation System in Cauda Equina

The Use of the Peristeen Bowel Irrigation System for People With Cauda Equina Syndrome

NCT01784328•University of Manitoba

Summary

To compare the Peristeen Anal Irrigation System with conservative bowel management in a prospective study among spinal cord injured patients with lower motor neuron neurogenic bowel dysfunction.

Detailed Description

People with spinal cord injury (SCI) often have severe problems with management of bowel function, including incontinence, impaction, lengthy bowel routines and extremely slow transit times.The anal irrigation system is a recently available system to help patients with bowel dysfunction empty their bowels by using pulse water irrigation. The system consists of a rectal balloon catheter, manual pump and water container.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female \>18 years or older
•Cauda equina spinal injury at least 12 months previously, with lower motor neuron bowel dysfunction and at least one of the following symptoms:
•Spending 30 minutes or more attempting to defecate each day or every second day
•Episodes of fecal incontinence once or more per month
•Abdominal discomfort before or during defecation

Exclusion Criteria

•Coexisting major unresolved physical problems due to the injury
•Performance of transanal irrigation on a regular basis
•Evidence of bowel obstruction or active inflammatory bowel disease
•History of cerebral palsy, stroke, multiple sclerosis or diabetic polyneuropathy
•Previous colorectal or perineal surgery(excluding minor surgery such as hemorrhoidectomy)
•Pregnancy or lactation
•Immunosuppression
•Prior implant for sacral nerve stimulation

Locations (1)

WRHA Health Sciences Centre Rehabilitation Hospital

Winnipeg, Manitoba, Canada

Key Dates

Start Date

March 1, 2013

Primary Completion Date

April 1, 2016

Completion Date

July 1, 2016

Last Updated

July 6, 2016

Enrollment

ACTUAL participants

Conditions

Cauda Equina Syndrome

Interventions

Peristeen Bowel Irrigation System

DEVICE

BLB Study Back or Leg Pain and Bladder Symptoms Study

NCT03325374

Cauda Equina SyndromeFunctional Neurological Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 6, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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