Exploratory Study of a New Urine Collection Device for Men

Coloplast

Status: Completed

Conditions: Urinary Incontinence

Treatments: Device: Urine collection device for men

Study type: Interventional

Funder types: Industry

Identifiers

NCT04672993

CP326

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Urine Collection Device for Men

Experimental group

Description:

Test of Urine Collection Device for Men for 7 (+/- 3/0 days).

Treatment:

Device: Urine collection device for men