Cauda Equina SyndromeNCT01784328
Peristeen Bowel Irrigation System in Cauda Equina
A study testing Peristeen Bowel Irrigation System in people with Cauda Equina Syndrome, run by University of Manitoba at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cauda Equina Syndrome
- What is being tested?
- Peristeen Bowel Irrigation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2013to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site
WRHA Health Sciences Centre Rehabilitation Hospital
Winnipeg, Manitoba, R3A 1M4
About this study
Official title: The Use of the Peristeen Bowel Irrigation System for People With Cauda Equina Syndrome
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.
Read the detailed 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.
- Conditions
- Cauda Equina Syndrome
- Being tested
- Peristeen Bowel Irrigation System
- Keywords
- Peristeen Bowel Irrigation System, Cauda Equina Syndrome, Lower Motor Neuron Neurogenic Bowel
- Medical subject headings
- Cauda Equina Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peristeen Bowel Irrigation SystemDevice
A complete system for bowel Irrigation to manage bowel dysfunction
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Peristeen Bowel Irrigation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Symptom-related Quality of Life Score
Measured: At baseline and again after 10 weeks of treatment
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.
Measured: 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.
Numeric box scales with a range of 1-10
Measured: At baseline and after 10 weeks of treatment.
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.
Measured: After 10 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cauda Equina SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Manitoba Spinal Cord Injury Research Committee, Canadian Paraplegic Association
- Responsible party
- Principal investigator, Dr. Karen Ethans, University of Manitoba
- Investigators
- Karen Ethans, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784328
- Sponsor's protocol ID
- 2013
- Status last verified
- Jul 2016
- First submitted
- 30 Jan 2013
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of the Peristeen Bowel Irrigation System for People With Cauda Equina Syndrome
- ClinicalTrials.gov ID
- NCT01784328
- Acronym / sponsor ID
- 2013
- Conditions
- Cauda Equina Syndrome
- Keywords
- Peristeen Bowel Irrigation System, Cauda Equina Syndrome, Lower Motor Neuron Neurogenic Bowel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Manitoba Spinal Cord Injury Research Committee, Canadian Paraplegic Association
- Study start
- Mar 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 5 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of a bowel irrigation system | Other | Device: Peristeen Bowel Irrigation SystemOpen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peristeen Bowel Irrigation SystemA complete system for bowel Irrigation to manage bowel dysfunction | Device | Use of a bowel irrigation system |
Primary outcome
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.
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.
5 secondary outcomes
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
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
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.
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.
Measurement of Influence of Current Bowel Management on Quality of Life
Time frame: After 10 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Ethans, MD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peristeen Bowel Irrigation System in people with Cauda Equina Syndrome, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.