Retention, UrinaryNCT04543136
Investigation of Non-CE Marked Intermittent Catheters.
A study testing SpeediCath® Standard male, New intermittent Variant 1 catheter for males and New intermittent Variant 2 catheter for males in people with Retention, Urinary, run by Coloplast A/S at 1 site in Denmark.
Trial summary
Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for males with a comparator catheter Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Retention, Urinary
- What is being tested?
- SpeediCath® Standard male, New intermittent Variant 1 catheter for males and New intermittent Variant 2 catheter for males
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Oct 2020to 31 Jan 2021
- 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
- Male
- Minimum 18 years of age and with full legal capacity
- Daily intermittent catheterization for bladder management, with at least two catheters used on average pr. day, during the last 3 months
- Ability to self-catheterize
- Written informed consent, signed letter of authority and signed secrecy agreement given
Who cannot join
- Participation in any other clinical study during this investigation
- Symptoms of urinary tract infection as judged by the investigator
- Any know allergies towards ingredients in the products
- Relevant medical history that would prevent the subject from participation in the investigation (investigators judgement)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet
Copenhagen
About this study
Official title: Exploratory Investigation on Performance and Safety of Newly Developed Intermittent Catheters in Male Users of Intermittent Catheters
Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for males with a comparator catheter
Read the detailed description
The CP323 study investigated a novel non-CE marked intermittent catheter, designed in two different variants, Variant 1 and Variant 2, respectively, and was conducted in Denmark. The study was a randomized, single blinded, cross-over investigation, comparing the two new variant catheters with a comparator catheter in 15 male IC users.
For each participant, the study thus contains three test visits/treatment arms (Comparator, Variant 1 and Variant 2, respectively), to which the 15 participants were randomized using a randomization sequence of six (i.e., there were six different random options for the order in which the participants tested the three catheters). There were 4-14 days between the test visits.
- Conditions
- Retention, Urinary
- Being tested
- SpeediCath® Standard male, New intermittent Variant 1 catheter for males, New intermittent Variant 2 catheter for males
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpeediCath® Standard maleDevice
Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male.
New intermittent Variant 1 catheter for malesDevice
Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 catheter.
New intermittent Variant 2 catheter for malesDevice
Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 catheter.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent catheter; SpeediCath® Standard male | Active comparator | Participants underwent two catheterizations with standard of care intermittent catheter: The first was performed by a trained nurse, the second by the participant later the same day. Receives: Device: SpeediCath® Standard male |
| New intermittent catheter Variant 1 for males | Experimental | Participants underwent two catheterizations with the new intermittent catheter Variant 1 for males: The first was performed by a trained nurse, the second by the participant later the same day. Receives: Device: New intermittent Variant 1 catheter for males |
| New intermittent catheter Variant 2 for males | Experimental | Participants underwent two catheterizations with the new intermittent catheter Variant 2 for males: The first was performed by a trained nurse, the second by the participant later the same day. Receives: Device: New intermittent Variant 2 catheter for males |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual Urine at 1st Flow-stop During Nurse Catheterization
The residual urine at 1st flow-stop during nurse catheterization (i.e., catheterization performed by the nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop.
Measured: Immediately after the procedure/catheterization, up to 5 min.
Residual Urine at 1st Flow-stop During Self-catheterization
The residual urine at 1st flow-stop during nurse catheterization (i.e., catheterization performed by the participant) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop.
Measured: Immediately after the procedure/catheterization, up to 5 min.
Secondary outcomes (10)
Post-void Residual Urine After Nurse Catheterization
The volume of residual urine (urine left in the bladder) post catheterization (performed by the nurse) measured in triplicates using an ultrasound scanner.
Measured: Immediately after the procedure/catheterization, up to 15 min.
Post-void Residual Urine After Self-catheterization
The volume of residual urine (urine left in the bladder) post catheterization (performed by the participant) measured in triplicates using an ultrasound scanner.
Measured: Immediately after the procedure/catheterization, up to 15 min.
Insertion Discomfort During Nurse Catheterization
Discomfort measured at catheter insertion (performed by nurse), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.
Measured: Immediately after the procedure/catheterization, up to 5 min.
Urination Discomfort During Nurse Catheterization
Discomfort measured during catheter urination/emptying (performed by nurse), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.
Measured: Immediately after the procedure/catheterization, up to 5 min.
Withdrawal Discomfort During Nurse Catheterization
Discomfort measured during catheter withdrawal (performed by nurse), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.
Measured: Immediately after the procedure/catheterization, up to 5 min.
Overall Discomfort During Nurse Catheterization
Discomfort measured for the entire catheterization procedure (performed by nurse), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.
Measured: Immediately after the procedure/catheterization, up to 5 min.
Insertion Discomfort During Self-catheterization
Discomfort measured at catheter insertion (performed by participant), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.
Measured: Immediately after the procedure/catheterization, up to 5 min.
Urination Discomfort During Self-catheterization
Discomfort measured during catheter urination/emptying (performed by participant), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.
Measured: Immediately after the procedure/catheterization, up to 5 min.
Withdrawal Discomfort During Self-catheterization
Discomfort measured during catheter withdrawal (performed by participant), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.
Measured: Immediately after the procedure/catheterization, up to 5 min.
Overall Discomfort During Self-catheterization
Discomfort measured for the entire catheterization procedure (performed by participant), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.
Measured: Immediately after the procedure/catheterization, up to 5 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start3 Oct 2020
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
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 Retention, 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 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, Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543136
- Sponsor's protocol ID
- CP323
- Status last verified
- Aug 2022
- First submitted
- 2 Sep 2020
- Last updated
- 13 Jul 2023
- 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 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Investigation on Performance and Safety of Newly Developed Intermittent Catheters in Male Users of Intermittent Catheters
- ClinicalTrials.gov ID
- NCT04543136
- Acronym / sponsor ID
- CP323
- Conditions
- Retention, Urinary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Posted 13 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for males with a comparator catheter
Detailed description
The CP323 study investigated a novel non-CE marked intermittent catheter, designed in two different variants, Variant 1 and Variant 2, respectively, and was conducted in Denmark. The study was a randomized, single blinded, cross-over investigation, comparing the two new variant catheters with a comparator catheter in 15 male IC users.
For each participant, the study thus contains three test visits/treatment arms (Comparator, Variant 1 and Variant 2, respectively), to which the 15 participants were randomized using a randomization sequence of six (i.e., there were six different random options for the order in which the participants tested the three catheters). There were 4-14 days between the test visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intermittent catheter; SpeediCath® Standard male | Active comparator | Device: SpeediCath® Standard maleParticipants underwent two catheterizations with standard of care intermittent catheter: The first was performed by a trained nurse, the second by the participant later the same day. |
| New intermittent catheter Variant 1 for males | Experimental | Device: New intermittent Variant 1 catheter for malesParticipants underwent two catheterizations with the new intermittent catheter Variant 1 for males: The first was performed by a trained nurse, the second by the participant later the same day. |
| New intermittent catheter Variant 2 for males | Experimental | Device: New intermittent Variant 2 catheter for malesParticipants underwent two catheterizations with the new intermittent catheter Variant 2 for males: The first was performed by a trained nurse, the second by the participant later the same day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male
- Minimum 18 years of age and with full legal capacity
- Daily intermittent catheterization for bladder management, with at least two catheters used on average pr. day, during the last 3 months
- Ability to self-catheterize
- Written informed consent, signed letter of authority and signed secrecy agreement given
Key exclusion criteria (4 listed)
- Participation in any other clinical study during this investigation
- Symptoms of urinary tract infection as judged by the investigator
- Any know allergies towards ingredients in the products
- Relevant medical history that would prevent the subject from participation in the investigation (investigators judgement)
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 |
|---|---|---|
| SpeediCath® Standard maleIntermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male. | Device | Intermittent catheter; SpeediCath® Standard male |
| New intermittent Variant 1 catheter for malesIntermittent catheterization through the urethra draining the bladder, using the new Variant 1 catheter. | Device | New intermittent catheter Variant 1 for males |
| New intermittent Variant 2 catheter for malesIntermittent catheterization through the urethra draining the bladder, using the new Variant 2 catheter. | Device | New intermittent catheter Variant 2 for males |
Primary outcome
Residual Urine at 1st Flow-stop During Nurse Catheterization
Time frame: Immediately after the procedure/catheterization, up to 5 min.
The residual urine at 1st flow-stop during nurse catheterization (i.e., catheterization performed by the nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop.
Residual Urine at 1st Flow-stop During Self-catheterization
Time frame: Immediately after the procedure/catheterization, up to 5 min.
The residual urine at 1st flow-stop during nurse catheterization (i.e., catheterization performed by the participant) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop.
10 secondary outcomes
Post-void Residual Urine After Nurse Catheterization
Time frame: Immediately after the procedure/catheterization, up to 15 min.
Post-void Residual Urine After Self-catheterization
Time frame: Immediately after the procedure/catheterization, up to 15 min.
Insertion Discomfort During Nurse Catheterization
Time frame: Immediately after the procedure/catheterization, up to 5 min.
Urination Discomfort During Nurse Catheterization
Time frame: Immediately after the procedure/catheterization, up to 5 min.
Withdrawal Discomfort During Nurse Catheterization
Time frame: Immediately after the procedure/catheterization, up to 5 min.
Overall Discomfort During Nurse Catheterization
Time frame: Immediately after the procedure/catheterization, up to 5 min.
Insertion Discomfort During Self-catheterization
Time frame: Immediately after the procedure/catheterization, up to 5 min.
Urination Discomfort During Self-catheterization
Time frame: Immediately after the procedure/catheterization, up to 5 min.
Withdrawal Discomfort During Self-catheterization
Time frame: Immediately after the procedure/catheterization, up to 5 min.
Overall Discomfort During Self-catheterization
Time frame: Immediately after the procedure/catheterization, up to 5 min.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- 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.
Per Bagi, MD principal investigator
Blegdamsvej 9, Urologisk klinik Afsnit 2112, 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 SpeediCath® Standard male, New intermittent Variant 1 catheter for males and New intermittent Variant 2 catheter for males in people with 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 5 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 13 Jul 2023. 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 13 Jul 2023). 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?
Residual Urine at 1st Flow-stop During Nurse Catheterization (time frame: Immediately after the procedure/catheterization, up to 5 min.). The study lists 2 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 13 Jul 2023.