Peristeen Bowel Irrigation System in Cauda Equina

Cauda Equina Syndrome Clinical Trial

Official title:

The Use of the Peristeen Bowel Irrigation System for People With Cauda Equina Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01784328
• Other study ID #: 2013
• Status: Completed
• Phase: N/A
• First received: January 30, 2013
• Last updated: July 4, 2016
• Start date: March 2013
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cauda Equina Syndrome
• Polyradiculopathy
• Syndrome

Intervention

Device:
• Peristeen Bowel Irrigation System
A complete system for bowel Irrigation to manage bowel dysfunction

Locations

Country	Name	City	State
Canada	WRHA Health Sciences Centre Rehabilitation Hospital	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
University of Manitoba	Canadian Paraplegic Association, Manitoba Spinal Cord Injury Research Committee

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At baseline Visit and again after 10 weeks of treatment	No
Primary	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.	At baseline and again after 10 weeks of treatment	No
Secondary	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.	At baseline and again after 10 weeks of treatment	No
Secondary	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	At baseline and again after 10 weeks of treatment	No
Secondary	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.	At baseline and again after 10 weeks of treatment.	No
Secondary	Change from baseline on a numeric box scale to measure bowel function, influence on daily activities, and general satisfaction after 10 weeks of treatment.	Numeric box scales with a range of 1-10	At baseline and after 10 weeks of treatment.	No
Secondary	Measurement of Influence of Current Bowel Management on Quality of Life	A numeric box scale with a range of 0-10, with 0 representing great reduction and 10 representing great improvement.	After 10 weeks of treatment	No