Exploratory Study of a New Urine Collection Device for Men

NCT04672993 | Completed Results

• 1 other identifier: CP326
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Urine Collection Device for Men

EXPERIMENTAL

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

Device: Urine collection device for men

Interventions

Urine collection device for men DEVICE

Use of urine collection device for men

Urine Collection Device for Men

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Flying Nurses

Hillerød, 3400, Denmark

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Senior Scientific Manager Marianne Raff Dambæk
• Organization: Coloplast

dkmr@coloplast.com

004549112562

Study Officials

• Susan Rasmussen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: December 17, 2020
• Study Start: November 2, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 8, 2024
• Results First Posted: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)