Intermittent Urethral CatheterizationNCT01800903
Safety and Performance of a New Coating for Urinary Intermittent Catheters
A study testing ZN-D catheter, ZN-C catheter and SpeediCath catheter in people with Intermittent Urethral Catheterization, run by Coloplast A/S at 1 site in Denmark.
Trial summary
The aim of the study is to evaluate safety and performance of a new catheter coating,compared to the current SpeediCath coating. 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
- Intermittent Urethral Catheterization
- What is being tested?
- ZN-D catheter, ZN-C catheter and SpeediCath catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2013to Apr 2013
- 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
- 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
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 interventional clinical investigations during this investigation (inclusion to termination) or have previously participated in this investigation (including run-in period)
- Known hypersensitivity toward any of the test products -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study Investigating Safety and Performance of a New Coating for Urinary Intermittent Catheters in Healthy Volunteers
The aim of the study is to evaluate safety and performance of a new catheter coating,compared to the current SpeediCath coating.
- Conditions
- Intermittent Urethral Catheterization
- Being tested
- ZN-D catheter, ZN-C catheter, SpeediCath catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZN-D catheterDevice
ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
ZN-C catheterDevice
ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
SpeediCath catheterDevice
The Speedicath cathere is CE-marked and commercially available.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Active comparator | SpeediCath catheter then ZN-D catheter then ZN-C catheter Receives: Device: ZN-D catheter; Device: ZN-C catheter; Device: SpeediCath catheter |
| Sequence 2 | Experimental | SpeediCath catheter then ZN-C catheter then ZN-D catheter Receives: Device: ZN-D catheter; Device: ZN-C catheter; Device: SpeediCath catheter |
| Sequence 3 | Experimental | ZN-D catheter then SpeediCath catheter then ZN-C catheter Receives: Device: ZN-D catheter; Device: ZN-C catheter; Device: SpeediCath catheter |
| Sequence 4 | Experimental | ZN-D catheter then ZN-C catheter then SpeediCath catheter Receives: Device: ZN-D catheter; Device: ZN-C catheter; Device: SpeediCath catheter |
| Sequence 5 | Experimental | ZN-C catheter then SpeediCath catheter then ZN-D catheter Receives: Device: ZN-D catheter; Device: ZN-C catheter; Device: SpeediCath catheter |
| Sequence 6 | Experimental | ZN-C catheter then ZN-D catheter then SpeediCath catheter Receives: Device: ZN-D catheter; Device: ZN-C catheter; Device: SpeediCath catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Discomfort During Catheterization
Evaluated by the subject on a 10 cm Visual Analog Scale (VAS), where 0 cm is no discomfort and 10 cm is the worst possible discomfort.
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 posted28 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2013
- Study completionApr 2013
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 Intermittent Urethral CatheterizationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Per Bagi, MD, PhD, Principal investigator, Department of Urology, Rigshospitalet Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800903
- Sponsor's protocol ID
- CP235
- Other IDs
- CP235
- Status last verified
- Aug 2020
- First submitted
- 22 Feb 2013
- Last updated
- 10 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Investigating Safety and Performance of a New Coating for Urinary Intermittent Catheters in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01800903
- Acronym / sponsor ID
- CP235
- Conditions
- Intermittent Urethral Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 28 Feb 2013 (estimated)
- Results
- Posted 14 Mar 2014
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 evaluate safety and performance of a new catheter coating,compared to the current SpeediCath coating.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Active comparator | Device: ZN-D catheter, Device: ZN-C catheter, Device: SpeediCath catheterSpeediCath catheter then ZN-D catheter then ZN-C catheter |
| Sequence 2 | Experimental | Device: ZN-D catheter, Device: ZN-C catheter, Device: SpeediCath catheterSpeediCath catheter then ZN-C catheter then ZN-D catheter |
| Sequence 3 | Experimental | Device: ZN-D catheter, Device: ZN-C catheter, Device: SpeediCath catheterZN-D catheter then SpeediCath catheter then ZN-C catheter |
| Sequence 4 | Experimental | Device: ZN-D catheter, Device: ZN-C catheter, Device: SpeediCath catheterZN-D catheter then ZN-C catheter then SpeediCath catheter |
| Sequence 5 | Experimental | Device: ZN-D catheter, Device: ZN-C catheter, Device: SpeediCath catheterZN-C catheter then SpeediCath catheter then ZN-D catheter |
| Sequence 6 | Experimental | Device: ZN-D catheter, Device: ZN-C catheter, Device: SpeediCath catheterZN-C catheter then ZN-D catheter then SpeediCath catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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
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 interventional clinical investigations during this investigation (inclusion to termination) or have previously participated in this investigation (including run-in period)
- 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 |
|---|---|---|
| ZN-D catheterZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating. | Device | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| ZN-C catheterZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating. | Device | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| SpeediCath catheterThe Speedicath cathere is CE-marked and commercially available. | Device | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
Overall Discomfort During Catheterization
Time frame: 1 day
Evaluated by the subject on a 10 cm Visual Analog Scale (VAS), where 0 cm is no discomfort and 10 cm is the worst possible discomfort.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- 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.
Per Bagi, MD, PhD principal investigator
Department of Urology, Rigshospitalet Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZN-D catheter, ZN-C catheter and SpeediCath catheter in people with Intermittent Urethral Catheterization, 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 4 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 10 Sep 2020. 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 14 Mar 2014). 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?
Overall Discomfort During Catheterization (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 10 Sep 2020.