Urinary IncontinenceNCT04672993
Exploratory Study of a New Urine Collection Device for Men
A study testing Urine collection device for men in people with Urinary Incontinence, run by Coloplast A/S at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Urine collection device for men
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Nov 2020to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- If experiencing incontinence less than once per week
- Bedridden, using wheelchair or using a walking aids regularly
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Urine collection device for men
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine collection device for menDevice
Use of urine collection device for men
| Study group | Role | What they receive |
|---|---|---|
| Urine Collection Device for Men | Experimental | Test of Urine Collection Device for Men for 7 (+/- 3/0 days). Receives: Device: Urine collection device for men |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start2 Nov 2020
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Rasmussen, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672993
- Sponsor's protocol ID
- CP326
- Status last verified
- Feb 2024
- First submitted
- 3 Sep 2020
- Last updated
- 8 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of a New Urine Collection Device for Men
- ClinicalTrials.gov ID
- NCT04672993
- Acronym / sponsor ID
- CP326
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Posted 8 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urine Collection Device for Men | Experimental | Device: Urine collection device for menTest of Urine Collection Device for Men for 7 (+/- 3/0 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- If experiencing incontinence less than once per week
- Bedridden, using wheelchair or using a walking aids regularly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine collection device for menUse of urine collection device for men | Device | Urine Collection Device for Men |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Rasmussen principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urine collection device for men in people with Urinary Incontinence, run by Coloplast A/S at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants That Found the Product to be Comfortable to Wear (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.