Peristeen Bowel Irrigation System in Cauda Equina
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|ClinicalTrials.gov Identifier: NCT01784328|
Recruitment Status : Completed
First Posted : February 5, 2013
Last Update Posted : July 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cauda Equina Syndrome||Device: Peristeen Bowel Irrigation System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of the Peristeen Bowel Irrigation System for People With Cauda Equina Syndrome|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||July 2016|
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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784328
|WRHA Health Sciences Centre Rehabilitation Hospital|
|Winnipeg, Manitoba, Canada, R3A 1M4|
|Principal Investigator:||Karen Ethans, MD||University of Manitoba|