Status:
COMPLETED
Exploratory Study of a New Urine Collection Device for Men
Lead Sponsor:
Coloplast A/S
Conditions:
Urinary Incontinence
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The aim of the investigation is to evaluate the subjects experience of a new collection device for men. An open-labelled, single arm study design was chosen for this investigation with a duration of ...
Eligibility Criteria
Inclusion
- Have given written informed consent
- Male
- Be at least 18 years of age and have full le-gal capacity
- Suffering from urinary incontinence equiva-lent to using up to 6 pads or 2 diapers per day
- Have had current incontinence issues for at least 3 months
- Able to understand patient information and able to change the product himself
- Up to 6 of the subjects can be users who are using an intermittent catheter due to re-tention, but who are also dribble inconti-nent in-between catheterizations, and hence need a product to handle the inconti-nence.
- Able to fit the test product.
Exclusion
- If experiencing incontinence less than once per week
- Bedridden, using wheelchair or using a walking aids regularly
Key Trial Info
Start Date :
November 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04672993
Start Date
November 2 2020
End Date
December 1 2020
Last Update
February 8 2024
Active Locations (1)
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1
Flying Nurses
Hillerød, Denmark, 3400