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Exploratory Study of a New Urine Collection Device for Men

Primary Purpose

Urinary Incontinence

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Urine collection device for men

About this trial

This is an interventional other trial for Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Have given written informed consent
Male
Be at least 18 years of age and have full le-gal capacity
Suffering from urinary incontinence equiva-lent to using up to 6 pads or 2 diapers per day
Have had current incontinence issues for at least 3 months
Able to understand patient information and able to change the product himself
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.
Able to fit the test product.

Exclusion Criteria:

If experiencing incontinence less than once per week
Bedridden, using wheelchair or using a walking aids regularly

Sites / Locations

Flying Nurses

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Urine Collection Device for Men

Arm Description

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

Outcomes

Primary Outcome Measures

Questionnaire used to measure the frequency of success in support of "comfortable": "How comfortable was the product to wear?"

Questionnaire

Secondary Outcome Measures

Full Information

NCT ID

NCT04672993

First Posted

September 3, 2020

Last Updated

December 16, 2020

Sponsor

Coloplast A/S

1. Study Identification

Unique Protocol Identification Number

NCT04672993

Brief Title

Exploratory Study of a New Urine Collection Device for Men

Official Title

Exploratory Study of a New Urine Collection Device for Men

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

November 2, 2020 (Actual)

Primary Completion Date

December 1, 2020 (Actual)

Study Completion Date

December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Coloplast A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Incontinence

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Urine Collection Device for Men

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Urine collection device for men

Intervention Description

Use of urine collection device for men

Primary Outcome Measure Information:

Title

Questionnaire used to measure the frequency of success in support of "comfortable": "How comfortable was the product to wear?"

Description

Questionnaire

Time Frame

One week

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have given written informed consent Male Be at least 18 years of age and have full le-gal capacity Suffering from urinary incontinence equiva-lent to using up to 6 pads or 2 diapers per day Have had current incontinence issues for at least 3 months Able to understand patient information and able to change the product himself 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. Able to fit the test product. Exclusion Criteria: If experiencing incontinence less than once per week Bedridden, using wheelchair or using a walking aids regularly

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susan Rasmussen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Flying Nurses

City

Hillerød

ZIP/Postal Code

3400

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Exploratory Study of a New Urine Collection Device for Men

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