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Completed

NCT Number: NCT01784328

Peristeen Bowel Irrigation System in Cauda Equina

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.

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Key information

Conditions

Cauda Equina Syndrome Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

WRHA Health Sciences Centre Rehabilitation Hospital

Winnipeg, Manitoba, R3A 1M4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peristeen Bowel Irrigation System

Device

A complete system for bowel Irrigation to manage bowel dysfunction

Primary outcomes

  1. Change from baseline on Cleveland Clinic Constipation Scoring System after 10 weeks of treatment

    Time frame: At baseline Visit and again 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.

  2. Change from baseline on the St. Mark's Fecal Incontinence Grading System after 10 weeks of treatment.

    Time frame: At baseline and again 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.

Secondary outcomes

  1. Change from baseline in The Neurogenic Bowel Dysfunction Score after 10 weeks of treatment

    Time frame: At baseline and again 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.

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

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

    Symptom-related Quality of Life Score

  3. Change from baseline measurement of Colonic Transit Time (CTT)after 10 weeks of treatment

    Time frame: At baseline and again 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.

  4. Change from baseline on a numeric box scale to measure bowel function, influence on daily activities, and general satisfaction after 10 weeks of treatment.

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

    Numeric box scales with a range of 1-10

  5. Measurement of Influence of Current Bowel Management on Quality of Life

    Time frame: After 10 weeks of treatment

    A numeric box scale with a range of 0-10, with 0 representing great reduction and 10 representing great improvement.

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Canadian Paraplegic Association
  • Manitoba Spinal Cord Injury Research Committee

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 5, 2013
Registry last updated
Jul 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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