Status:
COMPLETED
A Randomised, Cross-over, Open-labelled Test Catheter Acceptance Study
Lead Sponsor:
Coloplast A/S
Conditions:
Spinal Cord Injuries
Eligibility:
MALE
18+ years
Phase:
NA
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
Eligibility Criteria
Inclusion
- 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
- Has a symptomatic urinary tract infection as assessed by the investigator
- Is mentally unstable as assessed by the investigator
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00990093
Start Date
November 1 2009
End Date
March 1 2010
Last Update
September 5 2012
Active Locations (1)
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1
Klinik for Rygmarvsskader
Hornbæk, Denmark, 3100