Exploratory Study of a New Urine Collection Device for Men

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-02

Study Completion Date

2020-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Urinary Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Urine Collection Device for Men

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

Group Type EXPERIMENTAL

Urine collection device for men

Intervention Type DEVICE

Use of urine collection device for men

Interventions

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Urine collection device for men

Use of urine collection device for men

Intervention Type DEVICE

Eligibility Criteria

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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.