Exploratory Study of a New Urine Collection Device for Men

Urinary Incontinence Clinical Trial

Official title:

Exploratory Study of a New Urine Collection Device for Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04672993
• Other study ID #: CP326
• Status: Completed
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: February 2024
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Device:
• Urine collection device for men
Use of urine collection device for men

Locations

Country	Name	City	State
Denmark	Flying Nurses	Hillerød

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	One week