Trial Outcomes & Findings for Exploratory Study of a New Urine Collection Device for Men (NCT NCT04672993)
NCT ID: NCT04672993
Last Updated: 2024-02-08
Results Overview
Questionnaire used to measure the frequency of success in support of "comfortable": "How comfortable was the product to wear?". The question was asked at the end of the trial.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
One week
Results posted on
2024-02-08
Participant Flow
There was no pre-assignment period.
Participant milestones
| Measure |
Urine Collection Device for Men
Test of Urine Collection Device for Men for 7 (+/- 3/0 days).
Urine collection device for men: Use of urine collection device for men
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Urine Collection Device for Men
n=20 Participants
Test of Urine Collection Device for Men for 7 (+/- 3/0 days).
Urine collection device for men: Use of urine collection device for men
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=20 Participants
|
|
Region of Enrollment
Denmark
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: One weekPopulation: ITT (electronic data from one subject was lost)
Questionnaire used to measure the frequency of success in support of "comfortable": "How comfortable was the product to wear?". The question was asked at the end of the trial.
Outcome measures
| Measure |
Urine Collection Device for Men
n=19 Participants
Test of Urine Collection Device for Men for 7 (+/- 3/0 days).
Urine collection device for men: Use of urine collection device for men
|
|---|---|
|
Percentage of Participants That Found the Product to be Comfortable to Wear
|
53 percentages of participants
Interval 29.0 to 76.0
|
Adverse Events
Urine Collection Device for Men
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Urine Collection Device for Men
n=20 participants at risk
Test of Urine Collection Device for Men for 7 (+/- 3/0 days).
Urine collection device for men: Use of urine collection device for men
|
|---|---|
|
Skin and subcutaneous tissue disorders
mild skin irritation
|
50.0%
10/20 • Number of events 10 • 1 week
Definition of adverse events are from ISO Standard 14155:2021. Collection of AEs happened during the 1 week trial and when the subjects terminated their participations by the study nurse and by use of specific forms.
|
|
Skin and subcutaneous tissue disorders
Mild pain
|
15.0%
3/20 • Number of events 3 • 1 week
Definition of adverse events are from ISO Standard 14155:2021. Collection of AEs happened during the 1 week trial and when the subjects terminated their participations by the study nurse and by use of specific forms.
|
Additional Information
Senior Scientific Manager Marianne Raff Dambæk
Coloplast
Phone: 004549112562
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place