Incontinence, UrinaryNCT02966015
Product Evaluation of a Newly Developed Intermittent Catheter.
A study testing Coloplast test catheter in people with Incontinence, Urinary, run by Coloplast A/S.
Trial summary
The aim of the study is to investigate the navigation of a newly developed catheter. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Incontinence, Urinary
- What is being tested?
- Coloplast test catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Jun 2016
- 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
- Male and at least 18 years
- Has used Intermittent self-catheterization at least 3 months
- Has normal to slightly reduced hand mobility
- Use catheter size CH12 or CH14 (must use same size during product evaluation)
Who cannot join
- Currently receiving treatment for urinary tract infection
- Currently receiving chemotherapy
About this study
The aim of the study is to investigate the navigation of a newly developed catheter.
- Conditions
- Incontinence, Urinary
- Being tested
- Coloplast test catheter
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coloplast test catheterDevice
This is a newly developed catheter
| Study group | Role | What they receive |
|---|---|---|
| Testing the new Coloplast Test catheter | Experimental | The subjects used the new Coloplast Test catheter for 1 week Receives: Device: Coloplast test catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Successfully Able to Insert Catheter
The subjects had to evaluate if it was possible to insert and navigate the Coloplast Test catheter through urethra by the 5-point Likert question: "How did you find the catheter navigates through the urethra during insertion" ( Very easily, Easily, Neither/nor, Difficultly, Very difficultly, Not possible). The catheterization was considered successful if it was possible to insert the catheter, meaning that ifthey selected any other answer than 'not possible'.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2016
- Study completionJun 2016
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 Incontinence, UrinaryStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Camilla F Vibjerg, Msc, Study chair, Head of clinical operation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966015
- Sponsor's protocol ID
- CP268
- Status last verified
- Feb 2018
- First submitted
- 15 Nov 2016
- Last updated
- 28 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Product Evaluation of a Newly Developed Intermittent Catheter.
- ClinicalTrials.gov ID
- NCT02966015
- Acronym / sponsor ID
- CP268
- Conditions
- Incontinence, Urinary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Posted 8 Dec 2017
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 study is to investigate the navigation of a newly developed catheter.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Testing the new Coloplast Test catheter | Experimental | Device: Coloplast test catheterThe subjects used the new Coloplast Test catheter for 1 week |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and at least 18 years
- Has used Intermittent self-catheterization at least 3 months
- Has normal to slightly reduced hand mobility
- Use catheter size CH12 or CH14 (must use same size during product evaluation)
Key exclusion criteria (2 listed)
- Currently receiving treatment for urinary tract infection
- Currently receiving chemotherapy
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 |
|---|---|---|
| Coloplast test catheterThis is a newly developed catheter | Device | Testing the new Coloplast Test catheter |
Primary outcome
Number of Participants Successfully Able to Insert Catheter
Time frame: 1 week
The subjects had to evaluate if it was possible to insert and navigate the Coloplast Test catheter through urethra by the 5-point Likert question: "How did you find the catheter navigates through the urethra during insertion" ( Very easily, Easily, Neither/nor, Difficultly, Very difficultly, Not possible). The catheterization was considered successful if it was possible to insert the catheter, meaning that ifthey selected any other answer than 'not possible'.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Camilla F Vibjerg, Msc study chair
Head of clinical operation
Questions about this trial
What is this clinical trial studying?
A study testing Coloplast test catheter in people with Incontinence, Urinary, run by Coloplast A/S.
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 4 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 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Dec 2017). 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?
Number of Participants Successfully Able to Insert Catheter (time frame: 1 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 28 Feb 2018.