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Trial record 1 of 2 for:
"Glanders"
Peristeen Bowel Irrigation System in Cauda Equina
This study has been completed.
Sponsor:
University of Manitoba
Collaborators:
Manitoba Spinal Cord Injury Research Committee
Canadian Paraplegic Association
Information provided by (Responsible Party):
Dr. Karen Ethans, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01784328
First received: January 30, 2013
Last updated: July 4, 2016
Last verified: July 2016
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Purpose
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.
| Condition | Intervention |
|---|---|
| Cauda Equina Syndrome | Device: Peristeen Bowel Irrigation System |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Use of the Peristeen Bowel Irrigation System for People With Cauda Equina Syndrome |
Resource links provided by NLM:
Further study details as provided by Dr. Karen Ethans, University of Manitoba:
Primary Outcome Measures:
- Change from baseline on Cleveland Clinic Constipation Scoring System after 10 weeks of treatment [ Time Frame: At baseline Visit and again 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. [ Time Frame: At baseline and again 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 [ Time Frame: At baseline and again 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. [ Time Frame: At baseline and again 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 [ Time Frame: At baseline and again 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. [ Time Frame: At baseline and 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 [ Time Frame: After 10 weeks of treatment ]A numeric box scale with a range of 0-10, with 0 representing great reduction and 10 representing great improvement.
| Enrollment: | 12 |
| Study Start Date: | March 2013 |
| Study Completion Date: | July 2016 |
| Primary Completion Date: | April 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Device: Peristeen Bowel Irrigation System
A complete system for bowel Irrigation to manage 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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01784328
Please refer to this study by its ClinicalTrials.gov identifier: NCT01784328
Locations
| Canada, Manitoba | |
| WRHA Health Sciences Centre Rehabilitation Hospital | |
| Winnipeg, Manitoba, Canada, R3A 1M4 | |
Sponsors and Collaborators
University of Manitoba
Manitoba Spinal Cord Injury Research Committee
Canadian Paraplegic Association
Investigators
| Principal Investigator: | Karen Ethans, MD | University of Manitoba |
More Information
| Responsible Party: | Dr. Karen Ethans, Director, Spinal Cord Injury Rehabilitation Program, University of Manitoba |
| ClinicalTrials.gov Identifier: | NCT01784328 History of Changes |
| Other Study ID Numbers: |
2013 |
| Study First Received: | January 30, 2013 |
| Last Updated: | July 4, 2016 |
Keywords provided by Dr. Karen Ethans, University of Manitoba:
|
Peristeen Bowel Irrigation System Cauda Equina Syndrome Lower Motor Neuron Neurogenic Bowel |
Additional relevant MeSH terms:
|
Glanders Syndrome Polyradiculopathy Disease Pathologic Processes Burkholderia Infections Gram-Negative Bacterial Infections |
Bacterial Infections Polyradiculoneuropathy Polyneuropathies Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on July 14, 2017