Status:
COMPLETED
Intermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Prototype Micro Hole Zone Catheter
Lead Sponsor:
Coloplast A/S
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
18-110 years
Phase:
NA
Brief Summary
This investigation is a randomized, single-blinded, parallel, single-center investigation. In total, up to 50 subjects (40 completers) were included and each subject had two test visits overseen by th...
Detailed Description
This investigation was a randomized, single-blinded, parallel, single-center investigation. Up to 50 subjects (40 completers) will be included and each subject will have two test visits overseen by th...
Eligibility Criteria
Inclusion
- Has given written informed consent
- Is at least 18 years and have full legal capacity
- Is female
- Has a negative urine Multistix dipstick test for erythrocytes (haematuria)
Exclusion
- Has used an internal urinary catheter or cystoscopy within the past month
- Has prior history of bladder surgery
- Is symptomatic and/or on medication for overactive bladder
- Has evidence of ongoing, active, symptomatic urinary tract infection (UTI) (assessed by PI, or delegate)
- Is pregnant and/or breast-feeding
- Is participating in other clinical investigations during this investigation
- Is menstruating during study period
Key Trial Info
Start Date :
January 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT05224544
Start Date
January 31 2022
End Date
March 31 2022
Last Update
December 12 2025
Active Locations (1)
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1
American Health Research
Charlotte, North Carolina, United States, 28277