Incontinence, UrinaryNCT02965105
Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheters in Healthy Volunteers
A study testing Coloplast Test Catheter and 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 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 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
- Nov 2016to Dec 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
- 1. Have given written informed consent and signed letter of authority 2. Be at least 18 years of age and have full legal capacity 3. Be a male 4. Willing to refrain from using analgetics up to 24 hours prior to catheterization visits 5. Have a negative urine multistix - erythrocytes (Microscopic haematuria) 6. 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
- Conditions
- Incontinence, Urinary
- Being tested
- Coloplast Test Catheter, 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
This is a newly developed intermittent catheter
SpeedicathDevice
This is a marketed Catheter which is used as comparator
| Study group | Role | What they receive |
|---|---|---|
| First Coloplast Test Catheter; then Speedicath | Experimental | The subjects allocated to this arm first test Coloplast Test Catheter and then after cross over test the comparator Speedicath Catheter Receives: Device: Coloplast Test Catheter; Device: Speedicath |
| First Speedicath; then Coloplast Test Catheter | Experimental | The subjects allocated to this arm first test Speedicath Catheter and then after cross over test Coloplast Test Catheter Receives: Device: Coloplast Test Catheter; Device: Speedicath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain experienced by the subjects at catheterisation is measure with the VAS scale
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 startNov 2016
- Primary completionDec 2016
- Study completionDec 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 for urology at Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965105
- Sponsor's protocol ID
- CP271
- Status last verified
- Feb 2017
- First submitted
- 11 Nov 2016
- Last updated
- 1 Mar 2017
- 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 1 Mar 2017. 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 Catheters in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02965105
- Acronym / sponsor ID
- CP271
- Conditions
- Incontinence, Urinary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 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
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 | Experimental | Device: Coloplast Test Catheter, Device: SpeedicathThe subjects allocated to this arm first test Coloplast Test Catheter and then after cross over test the comparator Speedicath Catheter |
| First Speedicath; then Coloplast Test Catheter | Experimental | Device: Coloplast Test Catheter, Device: SpeedicathThe subjects allocated to this arm first test Speedicath Catheter and then after cross over test 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 (3 listed)
- 1. Have given written informed consent and signed letter of authority 2. Be at least 18 years of age and have full legal capacity 3. Be a male 4. Willing to refrain from using analgetics up to 24 hours prior to catheterization visits 5. Have a negative urine multistix - erythrocytes (Microscopic haematuria) 6. Have a negative urine multistix:
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 CatheterThis is a newly developed intermittent catheter | Device | First Coloplast Test Catheter; then Speedicath, First Speedicath; then Coloplast Test Catheter |
| SpeedicathThis is a marketed Catheter which is used as comparator | Device | First Coloplast Test Catheter; then Speedicath, First Speedicath; then Coloplast Test Catheter |
Primary outcome
Pain
Time frame: 1 day
Pain experienced by the subjects at catheterisation is measure with the VAS scale
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 1 Mar 2017.
- 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 for 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 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 3 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 1 Mar 2017. 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 1 Mar 2017.