Clinical Trial: Peristeen Bowel Irrigation System in Cauda Equina

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary: 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.
Sponsor: University of Manitoba

Current Primary Outcome:

  • 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: University of Manitoba

Dates:
Date Received: January 30, 2013
Date Started: March 2013
Date Completion:
Last Updated: July 4, 2016
Last Verified: July 2016