Back to resultsPeristeen Bowel Irrigation System in Cauda Equina
Primary Purpose
Cauda Equina Syndrome
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Peristeen Bowel Irrigation System
Sponsored by
About this trial
This is an interventional treatment trial for Cauda Equina Syndrome focused on measuring Peristeen Bowel Irrigation System, Cauda Equina Syndrome, Lower Motor Neuron Neurogenic Bowel
Eligibility Criteria
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
Sites / Locations
- WRHA Health Sciences Centre Rehabilitation Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Use of a bowel irrigation system
Arm Description
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.
Outcomes
Primary Outcome Measures
Change from baseline on Cleveland Clinic Constipation Scoring System after 10 weeks of treatment
A scoring system with a range of 0-30, with 30 representing the most severe symptoms. Will be used for volunteers whose primary complaint at baseline is constipation.
Change from baseline on the St. Mark's Fecal Incontinence Grading System after 10 weeks of treatment.
A Grading system with a range of 0-24, with 24 representing the most severe symptoms. This will be used for volunteers whose primary complaint at baseline is fecal incontinence.
Secondary Outcome Measures
Change from baseline in The Neurogenic Bowel Dysfunction Score after 10 weeks of treatment
A symptom score ranging from 0-47, where each symptom of neurogenic bowel is weighted concerning it's impact on quality of life. A score of 47 represents severe symptoms.
Change from baseline in a modified American Society of Colon and Rectal Surgeons fecal incontinence score after 10 weeks of treatment.
Symptom-related Quality of Life Score
Change from baseline measurement of Colonic Transit Time (CTT)after 10 weeks of treatment
The Metcalf method will be used.At the screening visit,eligible volunteers will be given a 7-day bowel diary and 3 SitzMark capsules with instructions on how to complete the diary and when to take the capsules. Abdominal X-rays will be obtained on Day 4 and 7. The patient will repeat the diary, SitzMark capsules and X-rays during the last week of study treatment.
Change from baseline on a numeric box scale to measure bowel function, influence on daily activities, and general satisfaction after 10 weeks of treatment.
Numeric box scales with a range of 1-10
Measurement of Influence of Current Bowel Management on Quality of Life
A numeric box scale with a range of 0-10, with 0 representing great reduction and 10 representing great improvement.
Full Information
NCT ID
NCT01784328
First Posted
January 30, 2013
Last Updated
July 4, 2016
Sponsor
University of Manitoba
Collaborators
Manitoba Spinal Cord Injury Research Committee, Canadian Paraplegic Association
1. Study Identification
Unique Protocol Identification Number
NCT01784328
Brief Title
Peristeen Bowel Irrigation System in Cauda Equina
Official Title
The Use of the Peristeen Bowel Irrigation System for People With Cauda Equina Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
Manitoba Spinal Cord Injury Research Committee, Canadian Paraplegic Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cauda Equina Syndrome
Keywords
Peristeen Bowel Irrigation System, Cauda Equina Syndrome, Lower Motor Neuron Neurogenic Bowel
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Use of a bowel irrigation system
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Peristeen Bowel Irrigation System
Intervention Description
A complete system for bowel Irrigation to manage bowel dysfunction
Primary Outcome Measure Information:
Title
Change from baseline on Cleveland Clinic Constipation Scoring System after 10 weeks of treatment
Description
A scoring system with a range of 0-30, with 30 representing the most severe symptoms. Will be used for volunteers whose primary complaint at baseline is constipation.
Time Frame
At baseline Visit and again after 10 weeks of treatment
Title
Change from baseline on the St. Mark's Fecal Incontinence Grading System after 10 weeks of treatment.
Description
A Grading system with a range of 0-24, with 24 representing the most severe symptoms. This will be used for volunteers whose primary complaint at baseline is fecal incontinence.
Time Frame
At baseline and again after 10 weeks of treatment
Secondary Outcome Measure Information:
Title
Change from baseline in The Neurogenic Bowel Dysfunction Score after 10 weeks of treatment
Description
A symptom score ranging from 0-47, where each symptom of neurogenic bowel is weighted concerning it's impact on quality of life. A score of 47 represents severe symptoms.
Time Frame
At baseline and again after 10 weeks of treatment
Title
Change from baseline in a modified American Society of Colon and Rectal Surgeons fecal incontinence score after 10 weeks of treatment.
Description
Symptom-related Quality of Life Score
Time Frame
At baseline and again after 10 weeks of treatment
Title
Change from baseline measurement of Colonic Transit Time (CTT)after 10 weeks of treatment
Description
The Metcalf method will be used.At the screening visit,eligible volunteers will be given a 7-day bowel diary and 3 SitzMark capsules with instructions on how to complete the diary and when to take the capsules. Abdominal X-rays will be obtained on Day 4 and 7. The patient will repeat the diary, SitzMark capsules and X-rays during the last week of study treatment.
Time Frame
At baseline and again after 10 weeks of treatment.
Title
Change from baseline on a numeric box scale to measure bowel function, influence on daily activities, and general satisfaction after 10 weeks of treatment.
Description
Numeric box scales with a range of 1-10
Time Frame
At baseline and after 10 weeks of treatment.
Title
Measurement of Influence of Current Bowel Management on Quality of Life
Description
A numeric box scale with a range of 0-10, with 0 representing great reduction and 10 representing great improvement.
Time Frame
After 10 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Ethans, MD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
WRHA Health Sciences Centre Rehabilitation Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M4
Country
Canada
12. IPD Sharing Statement
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Peristeen Bowel Irrigation System in Cauda Equina
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