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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
Sponsor:
Collaborators:
Manitoba Spinal Cord Injury Research Committee
Canadian Paraplegic Association
Information provided by (Responsible Party):
Dr. Karen Ethans, University of Manitoba

Tracking Information
First Submitted Date  ICMJE January 30, 2013
First Posted Date  ICMJE February 5, 2013
Last Update Posted Date July 6, 2016
Study Start Date  ICMJE March 2013
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2013)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2013)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peristeen Bowel Irrigation System in Cauda Equina
Official Title  ICMJE The Use of the Peristeen Bowel Irrigation System for People With Cauda Equina Syndrome
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cauda Equina Syndrome
Intervention  ICMJE Device: Peristeen Bowel Irrigation System
A complete system for bowel Irrigation to manage bowel dysfunction
Study Arms  ICMJE 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.
Intervention: Device: Peristeen Bowel Irrigation System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 4, 2016)
12
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2013)
10
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01784328
Other Study ID Numbers  ICMJE 2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Karen Ethans, University of Manitoba
Study Sponsor  ICMJE University of Manitoba
Collaborators  ICMJE
  • Manitoba Spinal Cord Injury Research Committee
  • Canadian Paraplegic Association
Investigators  ICMJE
Principal Investigator: Karen Ethans, MD University of Manitoba
PRS Account University of Manitoba
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP