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OpenTrials
Completed

NCT Number: NCT04672993

Exploratory Study of a New Urine Collection Device for Men

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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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Flying Nurses

Hillerød, 3400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urine collection device for men

Device

Use of urine collection device for men

Primary outcomes

  1. Percentage of Participants That Found the Product to be Comfortable to Wear

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 17, 2020
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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