Urinary Incontinence
Conditions
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 1 week + up to 3 days extra.
Interventions
DEVICEUrine collection device for men
Use of urine collection device for men
Sponsors
Coloplast A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have given written informed consent 2. Male 3. Be at least 18 years of age and have full le-gal capacity 4. Suffering from urinary incontinence equiva-lent to using up to 6 pads or 2 diapers per day 5. Have had current incontinence issues for at least 3 months 6. Able to understand patient information and able to change the product himself 7. 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. 8. Able to fit the test product.
Exclusion criteria
1. If experiencing incontinence less than once per week 2. Bedridden, using wheelchair or using a walking aids regularly
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants That Found the Product to be Comfortable to Wear | One week | 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. |
Countries
Denmark
Participant flow
Pre-assignment details
There was no pre-assignment period.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Urine Collection Device for Men | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 15 Participants | — |
| Age, Categorical Between 18 and 65 years | 5 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Denmark | 20 participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 20 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 13 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Percentage of Participants That Found the Product to be Comfortable to Wear
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.
Time frame: One week
Population: ITT (electronic data from one subject was lost)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Urine Collection Device for Men | Percentage of Participants That Found the Product to be Comfortable to Wear | 53 percentages of participants |