NCT01784328

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2013

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

3.1 years

First QC Date

January 30, 2013

Last Update Submit

July 4, 2016

Conditions

Cauda Equina Syndrome

Keywords

Peristeen Bowel Irrigation SystemCauda Equina SyndromeLower Motor Neuron Neurogenic Bowel

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (5)

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

    At baseline and again after 10 weeks of treatment

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

    At baseline and again after 10 weeks of treatment

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

    At baseline and again after 10 weeks of treatment.

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

    At baseline and after 10 weeks of treatment.

  • Measurement of Influence of Current Bowel Management on Quality of Life

    After 10 weeks of treatment

Study Arms (1)

Use of a bowel irrigation system

OTHER

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.

Device: Peristeen Bowel Irrigation System

Interventions

Peristeen Bowel Irrigation SystemDEVICE

A complete system for bowel Irrigation to manage bowel dysfunction

Use of a bowel irrigation system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WRHA Health Sciences Centre Rehabilitation Hospital

Winnipeg, Manitoba, R3A 1M4, Canada

Location

MeSH Terms

Conditions

Cauda Equina Syndrome

Condition Hierarchy (Ancestors)

Nerve Compression SyndromesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPolyradiculoneuropathyPolyneuropathies

Study Officials

  • Karen Ethans, MD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Spinal Cord Injury Rehabilitation Program

Study Record Dates

First Submitted

January 30, 2013

First Posted

February 5, 2013

Study Start

March 1, 2013

Primary Completion

April 1, 2016

Study Completion

July 1, 2016

Last Updated

July 6, 2016

Record last verified: 2016-07

Locations

CA(1)