Exploratory Study of a New Urine Collection Device for Men

Not Applicable

Completed

• Conditions: Urinary Incontinence
• Interventions: Device: Urine collection device for men

• Registration Number: NCT04672993
• Lead Sponsor: Coloplast A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-03
• Study Start: 2020-11-02
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-17
• Results First Submitted: 2022-11-01
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-06
• Last Update Submitted: 2024-02-06
• Results First Posted: 2024-02-08
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Urine Collection Device for Men	Urine collection device for men	Test of Urine Collection Device for Men for 7 (+/- 3/0 days).

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Flying Nurses; 🇩🇰 Hillerød, Denmark