Peristeen Bowel Irrigation System in Cauda Equina

University of Manitoba

Status: Completed

Conditions: Cauda Equina Syndrome

Treatments: Device: Peristeen Bowel Irrigation System

Study type: Interventional

Funder types: Other

Identifiers

NCT01784328

2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Use of a bowel irrigation system

Other group

Description:

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.

Treatment:

Device: Peristeen Bowel Irrigation System