Back to resultsA Randomised, Cross-over, Open-labelled Test Catheter Acceptance Study
Primary Purpose
Spinal Cord Injuries
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
test intermittent catheter
Intermittent catheterization
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries
Eligibility Criteria
Inclusion Criteria:
- At least 18 years of age
- Has normal/impaired sensation in the urethra
- Self-catheterises at least 4 times per day
- Has used clean self-intermittent catheterisation for at least 14 days
- Is able to open and prepare the catheters for catheterisation
- Has signed the informed consent before any study related-activities.
Exclusion Criteria:
- Has a symptomatic urinary tract infection as assessed by the investigator
- Is mentally unstable as assessed by the investigator
Sites / Locations
- Klinik for Rygmarvsskader
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
test intermittent catheter
intermittent catheter
Arm Description
CH 12 hydrophilic coated catheter
CH 12 hydrophilic coated catheter
Outcomes
Primary Outcome Measures
Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort.
Participants were to test the catheter by self-catheterising a minimum of 4 catheters each day for 14 days.
At the end of each study period participants were asked to indicate how they would rate the discomfort experienced during the catheterisation procedures. Discomfort was measured by the participants own rating of discomfort on a VAS scale from 0 (no discomfort) to 10 (worst imaginable discomfort)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00990093
Brief Title
A Randomised, Cross-over, Open-labelled Test Catheter Acceptance Study
Official Title
A Randomised, Cross-over, Open-labelled Study Evaluating the Acceptance of Test Catheters Compared to SpeediCath Catheters
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coloplast A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate that the test catheter is no less accepted than the SpeediCath (SC) catheter.
Detailed Description
See brief summary
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
test intermittent catheter
Arm Type
Experimental
Arm Description
CH 12 hydrophilic coated catheter
Arm Title
intermittent catheter
Arm Type
Experimental
Arm Description
CH 12 hydrophilic coated catheter
Intervention Type
Device
Intervention Name(s)
test intermittent catheter
Other Intervention Name(s)
Test catheter
Intervention Description
CH 12 hydrophilic coated catheter
Intervention Type
Device
Intervention Name(s)
Intermittent catheterization
Other Intervention Name(s)
SpeediCath
Intervention Description
CH 12 hydrophilic catheter
Primary Outcome Measure Information:
Title
Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort.
Description
Participants were to test the catheter by self-catheterising a minimum of 4 catheters each day for 14 days.
At the end of each study period participants were asked to indicate how they would rate the discomfort experienced during the catheterisation procedures. Discomfort was measured by the participants own rating of discomfort on a VAS scale from 0 (no discomfort) to 10 (worst imaginable discomfort)
Time Frame
14 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 18 years of age
Has normal/impaired sensation in the urethra
Self-catheterises at least 4 times per day
Has used clean self-intermittent catheterisation for at least 14 days
Is able to open and prepare the catheters for catheterisation
Has signed the informed consent before any study related-activities.
Exclusion Criteria:
Has a symptomatic urinary tract infection as assessed by the investigator
Is mentally unstable as assessed by the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fin Biering-Sørensen, MD
Organizational Affiliation
Klinik for Rygmarvsskader, Rigshospitalet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik for Rygmarvsskader
City
Hornbæk
ZIP/Postal Code
3100
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
34699062
Citation
Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database Syst Rev. 2021 Oct 26;10(10):CD006008. doi: 10.1002/14651858.CD006008.pub5.
Results Reference
derived
PubMed Identifier
21339763
Citation
Chartier-Kastler E, Lauge I, Ruffion A, Goossens D, Charvier K, Biering-Sorensen F. Safety of a new compact catheter for men with neurogenic bladder dysfunction: a randomised, crossover and open-labelled study. Spinal Cord. 2011 Jul;49(7):844-50. doi: 10.1038/sc.2011.5. Epub 2011 Feb 22.
Results Reference
derived
Learn more about this trial
A Randomised, Cross-over, Open-labelled Test Catheter Acceptance Study
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