Clinical trial NCT01784328: Peristeen Bowel Irrigation System in Cauda Equina
Official title: The Use of the Peristeen Bowel Irrigation System for People With Cauda Equina Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cauda Equina Syndrome
Keywords: Peristeen Bowel Irrigation System
Cauda Equina Syndrome
Lower Motor Neuron Neurogenic Bowel
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Manitoba Spinal Cord Injury Research Committee
name: Canadian Paraplegic Association
First posted: 2013-02-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change from baseline on Cleveland Clinic Constipation Scoring System after 10 weeks of treatment
timeFrame: At baseline Visit and again after 10 weeks of treatment
measure: Change from baseline on the St. Mark's Fecal Incontinence Grading System after 10 weeks of treatment.
timeFrame: At baseline and again after 10 weeks of treatment
Secondary outcomes:
measure: Change from baseline in The Neurogenic Bowel Dysfunction Score after 10 weeks of treatment
timeFrame: At baseline and again after 10 weeks of treatment
measure: Change from baseline in a modified American Society of Colon and Rectal Surgeons fecal incontinence score after 10 weeks of treatment.
timeFrame: At baseline and again after 10 weeks of treatment
measure: Change from baseline measurement of Colonic Transit Time (CTT)after 10 weeks of treatment
timeFrame: At baseline and again after 10 weeks of treatment.
measure: Change from baseline on a numeric box scale to measure bowel function, influence on daily activities, and general satisfaction after 10 weeks of treatment.
timeFrame: At baseline and after 10 weeks of treatment.
measure: Measurement of Influence of Current Bowel Management on Quality of Life
timeFrame: After 10 weeks of treatment
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: WRHA Health Sciences Centre Rehabilitation Hospital
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Karen Ethans, MD
role: PRINCIPAL_INVESTIGATOR
References: