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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cauda Equina Syndrome Device: Peristeen Bowel Irrigation System Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. 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.

  2. 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

  3. 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.

  4. 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

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

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


Locations
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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
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Principal Investigator: Karen Ethans, MD University of Manitoba
More Information
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Responsible Party: Dr. Karen Ethans, Director, Spinal Cord Injury Rehabilitation Program, University of Manitoba
ClinicalTrials.gov Identifier: NCT01784328    
Other Study ID Numbers: 2013
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 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:
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Glanders
Cauda Equina Syndrome
Syndrome
Disease
Pathologic Processes
Burkholderia Infections
Gram-Negative Bacterial Infections
 Bacterial Infections
Nerve Compression Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Polyradiculoneuropathy
Polyneuropathies