Status:
COMPLETED
Safety and Performance of a New Coating for Urinary Intermittent Catheters
Lead Sponsor:
Coloplast A/S
Conditions:
Intermittent Urethral Catheterization
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The aim of the study is to evaluate safety and performance of a new catheter coating,compared to the current SpeediCath coating.
Eligibility Criteria
Inclusion
- Have given written informed consent and signed letter of authority
- Be at least 18 years of age and have full legal capacity
- Be a male
- Willing to refrain from using analgetics up to 24 hours prior to catheterization visits
Exclusion
- Abnormalities, diseases or surgical procedures performed in the lower urinary tract
- Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)
- Participating in other interventional clinical investigations during this investigation (inclusion to termination) or have previously participated in this investigation (including run-in period)
- Known hypersensitivity toward any of the test products -
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01800903
Start Date
February 1 2013
End Date
April 1 2013
Last Update
September 10 2020
Active Locations (1)
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1
Department of Urology
Copenhagen, Denmark, 2100