N/A
Completed N=20
Exploratory Study of a New Urine Collection Device for Men
Source: ClinicalTrials.gov NCT04672993 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Percentage of Participants That Found the Product to be Comfortable to Wear — 53 percentages of participants
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 1 week + up to 3 days extra.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants That Found the Product to be Comfortable to Wear |
53 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- If experiencing incontinence less than once per week
- Bedridden, using wheelchair or using a walking aids regularly
Data sourced from ClinicalTrials.gov (NCT04672993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.