Incontinence, UrinaryNCT02965066
Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheter in Healthy Volunteers
A study testing Coloplast Test Catheter and Coloplast Speedicath in people with Incontinence, Urinary, run by Coloplast A/S at 1 site in Denmark.
Trial summary
The aim of the study is to test the performance and safety of a newly developed intermittent catheter in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Incontinence, Urinary
- What is being tested?
- Coloplast Test Catheter and Coloplast Speedicath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2016to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have given written informed consent and signed letter of authority
- Be at least 18 years of age and have full legal capacity
- Be a male
- Willing to refrain from using analgetics up to 24 hours prior to catheterization visits
- Have a negative urine multistix - erythrocytes (Microscopic haematuria)
- Have a negative urine multistix:
- Leukocytes
- Nitrite Or if positive, subsequent negative for bacterial growth in urine culture
Who cannot join
- Abnormalities, diseases or surgical procedures performed in the lower urinary tract
- Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)
- Participating in other clinical investigations related to urinary tracts system during this investigation (inclusion to termination) or have previously participated in this investigation
- Known hypersensitivity toward any of the test products -
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to test the performance and safety of a newly developed intermittent catheter in healthy volunteers.
- Conditions
- Incontinence, Urinary
- Being tested
- Coloplast Test Catheter, Coloplast Speedicath
- 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
Newly developed intermittent catheter
Coloplast SpeedicathDevice
Marketed Coloplast Speedicath catheter
| Study group | Role | What they receive |
|---|---|---|
| First Coloplast Test catheter; then Speedicath catheter | Experimental | The subjects allocated to this arm first test Coloplast Test catheter and after cross over test the comparator speedicath catheter Receives: Device: Coloplast Test Catheter; Device: Coloplast Speedicath |
| First Speedicath catheter; then Coloplast Test catheter | Experimental | The subjects allocated to this arm first test Speedicath catheter and after cross over test the Coloplast test catheter Receives: Device: Coloplast Test Catheter; Device: Coloplast Speedicath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
The VAS scale is used to measure the pain experienced by the subjects at catheterisation
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Per Bagi, MD, Principal investigator, MD at the clinic of urology at Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965066
- Sponsor's protocol ID
- CP269
- Status last verified
- Nov 2016
- First submitted
- 11 Nov 2016
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheter in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02965066
- Acronym / sponsor ID
- CP269
- Conditions
- Incontinence, Urinary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 16 Nov 2016 (estimated)
- Results
- Not posted in the source record
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 test the performance and safety of a newly developed intermittent catheter in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Coloplast Test catheter; then Speedicath catheter | Experimental | Device: Coloplast Test Catheter, Device: Coloplast SpeedicathThe subjects allocated to this arm first test Coloplast Test catheter and after cross over test the comparator speedicath catheter |
| First Speedicath catheter; then Coloplast Test catheter | Experimental | Device: Coloplast Test Catheter, Device: Coloplast SpeedicathThe subjects allocated to this arm first test Speedicath catheter and after cross over test the Coloplast test catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have given written informed consent and signed letter of authority
- Be at least 18 years of age and have full legal capacity
- Be a male
- Willing to refrain from using analgetics up to 24 hours prior to catheterization visits
- Have a negative urine multistix - erythrocytes (Microscopic haematuria)
Key exclusion criteria (4 listed)
- Abnormalities, diseases or surgical procedures performed in the lower urinary tract
- Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)
- Participating in other clinical investigations related to urinary tracts system during this investigation (inclusion to termination) or have previously participated in this investigation
- Known hypersensitivity toward any of the test products -
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 CatheterNewly developed intermittent catheter | Device | First Coloplast Test catheter; then Speedicath catheter, First Speedicath catheter; then Coloplast Test catheter |
| Coloplast SpeedicathMarketed Coloplast Speedicath catheter | Device | First Coloplast Test catheter; then Speedicath catheter, First Speedicath catheter; then Coloplast Test catheter |
Primary outcome
Pain
Time frame: 1 day
The VAS scale is used to measure the pain experienced by the subjects at catheterisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
- 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.
Per Bagi, MD principal investigator
MD at the clinic of urology at Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coloplast Test Catheter and Coloplast Speedicath in people with Incontinence, Urinary, 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 4 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 16 Nov 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain (time frame: 1 day). 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 16 Nov 2016.