Compliance, PatientNCT04231149
Explorative Clinical Study on the Performance and Acceptance of New Intermittent Catheters in Healthy Volunteers
A study testing Test product 2, Test product 3 and Comparator in people with Compliance, Patient, run by Coloplast A/S at 1 site in Denmark.
Trial summary
Performance and acceptance of new intermittent catheters tested 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
- Compliance, Patient
- What is being tested?
- Test product 2, Test product 3 and Comparator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Nov 2018to 20 Dec 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has given written informed consent and signed letter of authority Is at least 18 years of age and has full legal capacity Is a male Willing to comply without using analgetica up to 24 hours prior to catheterisation visits
Who cannot join
- Has a previous history of genitourinary disease including congenital abnormalities and surgical procedures performed in the urinary tract Has symptoms of urinary tract infections (frequent urination, stinging and pain at urination) Are participating in any other clinical investigation related to urinary tract system during this investigation (inclusion to termination) Known hypersensitivity toward any of the test products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Explorative Clinical Study Investigating the Performance and Acceptance of New Intermittent Catheters in Healthy Volunteers
Performance and acceptance of new intermittent catheters tested in healthy volunteers
Read the detailed description
This study is a single blinded, randomised, crossover study. The study period consists of an information visit, an inclusion visit, three test visits and a termination visit.
Two prototypes of intermittent catheters (Test product 2 and 3) compared to the standard catheter SpeediCath® Flex (Comparator).
In the investigation ten subjects will be included. The subjects will be catheterised once per visit. The subjects will be catheterised with the two test catheters and comparator in a randomised order. The order of the catheterisations will be randomised to prevent bias.
During the test visits the primary, secondary and explorative endpoints will be registered.
Subjects will be asked to participate in an interview in continuation of their last visit (Test Visit 3). The interviews will be performed by a Coloplast representative asking questions related to their experience with the catheter.
The subjects must sign a separate consent form for this purpose and can participate in the investigation without participating in the interview. In addition, subjects will be asked for consent to tape recording and filming during the interviews, but can participate in interviews without this.
In addition, a Coloplast representative will interview the Investigator and her representatives after LPO with questions related to their experience with the catheters.
The investigation is planned to be conducted in August 2018-Januar 2019. The visit window will be minimum five days between the visits (catheterisations), to ensure time for healing of any potential urethral trauma. However, the maximum time between visits should be adjusted to ensure the subject is terminated before LPO.
No biobank will be established for this investigation. All urine samples in the clinical investigation (for evaluating in- and exclusion criteria and for evaluating end points) will be destructed immediately after analysis.
- Conditions
- Compliance, Patient
- Being tested
- Test product 2, Test product 3, Comparator
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test product 2Device
Test catheter 2
Test product 3Device
Test catheter 3
ComparatorDevice
SpeediCath Flex
| Study group | Role | What they receive |
|---|---|---|
| Test product 2 | Experimental | Test catheter 2 Receives: Device: Test product 3; Device: Comparator |
| Test product 3 | Experimental | Test catheter 3 Receives: Device: Test product 2; Device: Comparator |
| Comparator | Active comparator | SpeediCath Flex Receives: Device: Test product 2; Device: Test product 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Flow Rate
On day of study visits 1-5 rate of urine flow through catheter measured in mL/s
Measured: 2 hour
Secondary outcomes (2)
Post-void Residual Urine
On day of study visits 1-5 rate volume of urine left in the bladder post catheterisation (in mL)
Measured: 2 hour
Number of Participants With Hematuria
On day of study visits 1-5 blood in urine post catheterisation (measured as yes/no to blood in urine)
Measured: 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start5 Nov 2018
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
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 Compliance, PatientStudies 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Birte Jakobsen, MD, Principal investigator, Coloplast A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231149
- Sponsor's protocol ID
- CP290
- Status last verified
- Mar 2025
- First submitted
- 28 May 2019
- Last updated
- 24 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explorative Clinical Study Investigating the Performance and Acceptance of New Intermittent Catheters in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04231149
- Acronym / sponsor ID
- CP290
- Conditions
- Compliance, Patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Posted 24 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Performance and acceptance of new intermittent catheters tested in healthy volunteers
Detailed description
This study is a single blinded, randomised, crossover study. The study period consists of an information visit, an inclusion visit, three test visits and a termination visit.
Two prototypes of intermittent catheters (Test product 2 and 3) compared to the standard catheter SpeediCath® Flex (Comparator).
In the investigation ten subjects will be included. The subjects will be catheterised once per visit. The subjects will be catheterised with the two test catheters and comparator in a randomised order. The order of the catheterisations will be randomised to prevent bias.
During the test visits the primary, secondary and explorative endpoints will be registered.
Subjects will be asked to participate in an interview in continuation of their last visit (Test Visit 3). The interviews will be performed by a Coloplast representative asking questions related to their experience with the catheter.
The subjects must sign a separate consent form for this purpose and can participate in the investigation without participating in the interview. In addition, subjects will be asked for consent to tape recording and filming during the interviews, but can participate in interviews without this.
In addition, a Coloplast representative will interview the Investigator and her representatives after LPO with questions related to their experience with the catheters.
The investigation is planned to be conducted in August 2018-Januar 2019. The visit window will be minimum five days between the visits (catheterisations), to ensure time for healing of any potential urethral trauma. However, the maximum time between visits should be adjusted to ensure the subject is terminated before LPO.
No biobank will be established for this investigation. All urine samples in the clinical investigation (for evaluating in- and exclusion criteria and for evaluating end points) will be destructed immediately after analysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test product 2 | Experimental | Device: Test product 3, Device: ComparatorTest catheter 2 |
| Test product 3 | Experimental | Device: Test product 2, Device: ComparatorTest catheter 3 |
| Comparator | Active comparator | Device: Test product 2, Device: Test product 3SpeediCath Flex |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Has given written informed consent and signed letter of authority Is at least 18 years of age and has full legal capacity Is a male Willing to comply without using analgetica up to 24 hours prior to catheterisation visits
Key exclusion criteria (1 listed)
- Has a previous history of genitourinary disease including congenital abnormalities and surgical procedures performed in the urinary tract Has symptoms of urinary tract infections (frequent urination, stinging and pain at urination) Are participating in any other clinical investigation related to urinary tract system during this investigation (inclusion to termination) 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 |
|---|---|---|
| Test product 2Test catheter 2 | Device | Comparator, Test product 3 |
| Test product 3Test catheter 3 | Device | Comparator, Test product 2 |
| ComparatorSpeediCath Flex | Device | Test product 2, Test product 3 |
Primary outcome
Urine Flow Rate
Time frame: 2 hour
On day of study visits 1-5 rate of urine flow through catheter measured in mL/s
2 secondary outcomes
Post-void Residual Urine
Time frame: 2 hour
Number of Participants With Hematuria
Time frame: 2 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- 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.
Birte Jakobsen, MD principal investigator
Coloplast A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test product 2, Test product 3 and Comparator in people with Compliance, Patient, 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 1 inclusion and 1 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 24 Mar 2025. 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 24 Mar 2025). 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?
Urine Flow Rate (time frame: 2 hour). 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 24 Mar 2025.