Peristeen Bowel Irrigation System in Cauda Equina

University of Manitoba12 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cauda Equina Syndrome

Interventions

Peristeen Bowel Irrigation SystemDEVICE

A complete system for bowel Irrigation to manage bowel dysfunction

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

WRHA Health Sciences Centre Rehabilitation Hospital

Winnipeg, Manitoba, Canada

Outcomes

Primary Outcomes

Change from baseline on Cleveland Clinic Constipation Scoring System 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.

Time frame: At baseline Visit and again after 10 weeks of treatment

Change from baseline on the St. Mark's Fecal Incontinence Grading System 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.

Time frame: At baseline and again after 10 weeks of treatment

Secondary Outcomes

Change from baseline in The Neurogenic Bowel Dysfunction Score 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.

Time frame: At baseline and again after 10 weeks of treatment

Change from baseline in a modified American Society of Colon and Rectal Surgeons fecal incontinence score after 10 weeks of treatment.

Symptom-related Quality of Life Score

Time frame: At baseline and again after 10 weeks of treatment

Change from baseline measurement of Colonic Transit Time (CTT)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.

Time frame: At baseline and again after 10 weeks of treatment.

Data from ClinicalTrials.gov

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