Urinary IncontinenceNCT05485922
Performance of a Single-use Intermittent Micro-hole Zone Catheter
A study testing Investigational device - intermittent catheter with a micro-hole zone and Comparator device -VaPro intermittent catheter in people with Urinary Incontinence and Retention, Urinary, run by Coloplast A/S at 1 site in Denmark.
Trial summary
The goal of this randomized, controlled crossover study was to assess the performance of a new micro-hole zone catheter compared to a conventional 2-eyelet catheter in 42 male intermittent catheter users. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Incontinence, Retention, Urinary
- What is being tested?
- Investigational device - intermittent catheter with a micro-hole zone and Comparator device -VaPro intermittent catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Sep 2022to 4 Nov 2022
- 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
- Is Male
- Is at least 18 years of age and has full legal capacity
- Has given written informed consent
- Has signed letter of authority (only DK)
- Has used clean intermittent catheterisation CH12 or CH14 for at least one month
- Use intermittent catheterisation as the primary bladder emptying method
- Is able (assessed by investigator) and willing to follow study procedures
Who cannot join
- Is participating in any other clinical study during this investigation
- Has previous participated in this study
- Has symptoms of urinary tract infection as judged by the investigator 4 Is an individual with history, suspected or showing signs of producing urine with excessive amount of mucus or large/clustered sediments or debris
- 5. Has any known allergies towards ingredients in the investigational device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-labelled, Crossover Study Confirming Performance of a Single-use Intermittent Micro-hole Zone Catheter in a Population of Adult Male Intermittent Catheter Users
The goal of this randomized, controlled crossover study was to assess the performance of a new micro-hole zone catheter compared to a conventional 2-eyelet catheter in 42 male intermittent catheter users.
The main objective of this study was to demonstrate superiority of the micro-hole zone catheter in terms of number of flow-stop episodes and residual volume at first flow-stop, with the catheterization performed by a health care professional in a hospital setting compared to a conventional two-eyelet catheter.
Read the detailed description
The investigation was a single-centre, randomized, controlled crossover study including 42 male participants comparing the performance of two intermittent catheters (IC).
The study included an information visit (visit 0) and two test visits (visit 1 and 2) in which one catheterization with either the investigational device or the comparator device, according to a randomization scheme, was performed by a health care professional in a hospital setting assessing flow stop episodes, bladder emptying and hematuria. There were 4-14 days between each test visit (visit 1 and 2) and visit 0 and 1 could be held on the same day.
- Conditions
- Urinary Incontinence, Retention, Urinary
- Being tested
- Investigational device - intermittent catheter with a micro-hole zone, Comparator device -VaPro intermittent catheter
- Medical subject headings
- Urinary Incontinence, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational device - intermittent catheter with a micro-hole zoneDevice
The investigational device was a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.
Comparator device -VaPro intermittent catheterDevice
The comparator device is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.
| Study group | Role | What they receive |
|---|---|---|
| Investigational device - intermittent catheter with a micro-hole zone | Experimental | A ready-to-use, sterile, hydrophilic-coated male catheter for intermittent catheterisation with a flexible tip and a micro-hole zone for urinary drainage in sizes CH12 and CH14. The catheterization was performed by a trained nurse. Receives: Device: Investigational device - intermittent catheter with a micro-hole zone |
| Comparator device - VaPro intermittent catheter | Active comparator | Hollister VaPro, a single-use hydrophilic sleeved soft/flexible catheters in the sizes CH12 or CH14. The catheterization was performed by a trained nurse. Receives: Device: Comparator device -VaPro intermittent catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Flow-stop Episodes
Flow-stops were measured with a pressure sensor, which is an electronic device used for monitoring the hydrostatic pressure at the outlet of an intermittent urinary catheter during emptying.
From a sensor curve, flow-stops were identified by two individually trained evaluators as a hydrostatic pressure peak coinciding with a urine flow-stop/ urine dripping (flowrate lower than 0,8 ml/sec).
Results from both evaluators were compared and in case of discrepancy a discussion was performed to extenuate discrepancies and agree on a final interpretation of the curves.
Measured: Immediately after the procedure/catheterization
Residual Urine at 1st Flow-stop
The residual urine at 1st flow-stop during catheterization (performed by a nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying.
Hence, the residual volume at 1st flow-stop was calculated as the total volume post catheterisation minus the volume at 1st flow-stop, derived from a catheterisation profile which was connected to a time-logged weighing [g].
Measured: When the first flow-stop appeared, the amount of voided urine was measured.
Number of Flow-stop Episodes
Flow-stop episodes were determined as instances where the flow rate decreased to less than 0.8 mL/s for a period of at least two seconds. All episodes were detected by automatic thresholding, followed by manual inspection, where the intra-catheter pressure readings were used to support the assessment of a flow stop.
Measured: Immediately after catheterisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start23 Sep 2022
- Primary completion4 Nov 2022
- Study completion4 Nov 2022
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 Urinary IncontinenceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cecilie Rovsing, MD, Principal investigator, Sanos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485922
- Sponsor's protocol ID
- CP353
- Status last verified
- Feb 2025
- First submitted
- 1 Jul 2022
- Last updated
- 5 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-labelled, Crossover Study Confirming Performance of a Single-use Intermittent Micro-hole Zone Catheter in a Population of Adult Male Intermittent Catheter Users
- ClinicalTrials.gov ID
- NCT05485922
- Acronym / sponsor ID
- CP353
- Conditions
- Urinary Incontinence, Retention, Urinary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 4 Nov 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 3 Aug 2022 (actual)
- Results
- Posted 5 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized, controlled crossover study was to assess the performance of a new micro-hole zone catheter compared to a conventional 2-eyelet catheter in 42 male intermittent catheter users.
The main objective of this study was to demonstrate superiority of the micro-hole zone catheter in terms of number of flow-stop episodes and residual volume at first flow-stop, with the catheterization performed by a health care professional in a hospital setting compared to a conventional two-eyelet catheter.
Detailed description
The investigation was a single-centre, randomized, controlled crossover study including 42 male participants comparing the performance of two intermittent catheters (IC).
The study included an information visit (visit 0) and two test visits (visit 1 and 2) in which one catheterization with either the investigational device or the comparator device, according to a randomization scheme, was performed by a health care professional in a hospital setting assessing flow stop episodes, bladder emptying and hematuria. There were 4-14 days between each test visit (visit 1 and 2) and visit 0 and 1 could be held on the same day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational device - intermittent catheter with a micro-hole zone | Experimental | Device: Investigational device - intermittent catheter with a micro-hole zoneA ready-to-use, sterile, hydrophilic-coated male catheter for intermittent catheterisation with a flexible tip and a micro-hole zone for urinary drainage in sizes CH12 and CH14. The catheterization was performed by a trained nurse. |
| Comparator device - VaPro intermittent catheter | Active comparator | Device: Comparator device -VaPro intermittent catheterHollister VaPro, a single-use hydrophilic sleeved soft/flexible catheters in the sizes CH12 or CH14. The catheterization was performed by a trained nurse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Is Male
- Is at least 18 years of age and has full legal capacity
- Has given written informed consent
- Has signed letter of authority (only DK)
- Has used clean intermittent catheterisation CH12 or CH14 for at least one month
Key exclusion criteria (4 listed)
- Is participating in any other clinical study during this investigation
- Has previous participated in this study
- Has symptoms of urinary tract infection as judged by the investigator 4 Is an individual with history, suspected or showing signs of producing urine with excessive amount of mucus or large/clustered sediments or debris
- 5. Has any known allergies towards ingredients in the investigational device
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 |
|---|---|---|
| Investigational device - intermittent catheter with a micro-hole zoneThe investigational device was a urinary catheter for bladder drainage through the urethra. The product is for intermittent use. | Device | Investigational device - intermittent catheter with a micro-hole zone |
| Comparator device -VaPro intermittent catheterThe comparator device is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use. | Device | Comparator device - VaPro intermittent catheter |
Primary outcome
Number of Flow-stop Episodes
Time frame: Immediately after the procedure/catheterization
Flow-stops were measured with a pressure sensor, which is an electronic device used for monitoring the hydrostatic pressure at the outlet of an intermittent urinary catheter during emptying. From a sensor curve, flow-stops were identified by two individually trained evaluators as a hydrostatic pressure peak coinciding with a urine flow-stop/ urine dripping (flowrate lower than 0,8 ml/sec). Results from both evaluators were compared and in case of discrepancy a discussion was performed to extenuate discrepancies and agree on a final interpretation of the curves.
Residual Urine at 1st Flow-stop
Time frame: When the first flow-stop appeared, the amount of voided urine was measured.
The residual urine at 1st flow-stop during catheterization (performed by a nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying. Hence, the residual volume at 1st flow-stop was calculated as the total volume post catheterisation minus the volume at 1st flow-stop, derived from a catheterisation profile which was connected to a time-logged weighing [g].
Number of Flow-stop Episodes
Time frame: Immediately after catheterisation
Flow-stop episodes were determined as instances where the flow rate decreased to less than 0.8 mL/s for a period of at least two seconds. All episodes were detected by automatic thresholding, followed by manual inspection, where the intra-catheter pressure readings were used to support the assessment of a flow stop.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Cecilie Rovsing, MD principal investigator
Sanos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational device - intermittent catheter with a micro-hole zone and Comparator device -VaPro intermittent catheter in people with Urinary Incontinence and Retention, 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 7 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 5 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 5 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?
Number of Flow-stop Episodes (time frame: Immediately after the procedure/catheterization). The study lists 3 primary outcomes in all. 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 5 Mar 2025.