CompletedNot Applicable

Peristeen Bowel Irrigation System in Cauda Equina

Canada12 participantsStarted 2013-03

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT01784328

SponsorUniversity of Manitoba

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-04

View on ClinicalTrials.gov More Cauda Equina Syndrome trials