Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2013-03-31
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Use of a bowel irrigation system
Open label. No placebo use in this study. All volunteers will trial the bowel irrigation system. Eligible volunteers will be those patients who have failed conventional supportive bowel care.
Peristeen Bowel Irrigation System
A complete system for bowel Irrigation to manage bowel dysfunction
Interventions
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Peristeen Bowel Irrigation System
A complete system for bowel Irrigation to manage bowel dysfunction
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Manitoba Spinal Cord Injury Research Committee
UNKNOWN
Canadian Paraplegic Association
OTHER
University of Manitoba
OTHER
Responsible Party
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Dr. Karen Ethans
Director, Spinal Cord Injury Rehabilitation Program
Principal Investigators
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Karen Ethans, MD
Role: PRINCIPAL_INVESTIGATOR
University of Manitoba
Locations
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WRHA Health Sciences Centre Rehabilitation Hospital
Winnipeg, Manitoba, Canada
Countries
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Other Identifiers
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2013
Identifier Type: -
Identifier Source: org_study_id
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