Status:
COMPLETED
New Coating for Urinary Intermittent Catheters
Lead Sponsor:
Coloplast A/S
Conditions:
Retention, Urinary
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The goal is to confirm, that the newly developed coating is non-inferior to the comparator with respect to the overall discomfort of the catheterisation (assessed by participant). Participants will a...
Detailed Description
The primary objective of the study is to confirm that the newly developed investigational coating is non-inferior to the comparator coating with respect to the overall discomfort of catheterisation. ...
Eligibility Criteria
Inclusion
- Has given written informed consent
- Is at least 18 years old
- Has full legal capacity
- Has self-assessed intact male anatomy with no abnormalities or disease of the lower urinary tract or any surgical procedures performed in the lower urinary tract
- Is able (assessed by investigator) and willing to adhere to study procedures during study duration.
- Is able to refrain from using analgesics up to 24 hours prior to catheterisation visits
- Is negative for haematuria, measured by urine dipstick test of erythrocytes
Exclusion
- Is participating in any other clinical investigation during this investigation, which could affect the results of this investigation, as assessed by investigator.
- Has previously been randomized in this investigation.
- Has known hypersensitivity towards any of the devices used in the investigation
- Is currently experiencing symptoms associated with UTI, as assessed by investigator.
- Has known impaired sensation of the urethra
Key Trial Info
Start Date :
May 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06985888
Start Date
May 6 2025
End Date
June 30 2025
Last Update
August 14 2025
Active Locations (1)
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1
Department of Urology, Rigshospitalet
Copenhagen, Denmark, 2100