Peristeen Bowel Irrigation System in Cauda Equina

Not Applicable

Completed

• Conditions: Cauda Equina Syndrome
• Interventions: Device: Peristeen Bowel Irrigation System

• Registration Number: NCT01784328
• Lead Sponsor: University of Manitoba

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 Timeline

• Study First Submitted: 2013-01-30
• Study First Submitted QC: 2013-02-01
• Study First Posted: 2013-02-05
• Study Start: 2013-03
• Primary Completion: 2016-04
• Status Verified: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-04
• Last Update Posted: 2016-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Use of a bowel irrigation system	Peristeen 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.

Primary Outcome Measures

Name	Time	Method
Change from baseline on the St. Mark's Fecal Incontinence Grading System after 10 weeks of treatment.	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 on Cleveland Clinic Constipation Scoring System after 10 weeks of treatment	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.

Secondary Outcome Measures

Name	Time	Method
Measurement of Influence of Current Bowel Management on Quality of Life	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.
Change from baseline in The Neurogenic Bowel Dysfunction Score after 10 weeks of treatment	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 on a numeric box scale to measure bowel function, influence on daily activities, and general satisfaction after 10 weeks of treatment.	At baseline and after 10 weeks of treatment.	Numeric box scales with a range of 1-10
Change from baseline in a modified American Society of Colon and Rectal Surgeons fecal incontinence score after 10 weeks of treatment.	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	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.

Trial Locations

Locations (1)

WRHA Health Sciences Centre Rehabilitation Hospital; 🇨🇦 Winnipeg, Manitoba, Canada