Catheter Site PainNCT04633291
Investigation of New Intermittent Catheter Swelling Media in Healthy Volunteers
A study testing Novel swelling media and Comparator swelling media in people with Catheter Site Pain and Catheter Site Discomfort, run by Coloplast A/S at 1 site in Denmark.
Trial summary
Investigation of novel swelling media for CE marked intermittent urinary catheters. The study was a randomized, single blinded, cross-over investigation comparing a novel swelling media with a comparator swelling media in 22 adult, healthy, male 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
- Catheter Site Pain, Catheter Site Discomfort
- What is being tested?
- Novel swelling media and Comparator swelling media
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Nov 2019to 28 Nov 2019
- 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
- Written informed consent given
- Minimum 18 years of age and with full legal capacity
- Male gender
- Willing to refrain from using analgesics up to 24 hours prior to catheterization visits
- Negative urine multistix analysis for erythrocytes (microscopic hematuria)
- Negative urine multistix analysis for leukocytes and 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 previously participation in this investigation
- Known hypersensitivity toward any of the investigational device
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark
Copenhagen, København Ø, 2100
About this study
Official title: Clinical Study in Healthy Volunteers Evaluating the Performance and Handling of a Urinary Intermittent Catheter With a Newly Developed Swelling Media.
Investigation of novel swelling media for CE marked intermittent urinary catheters. The study was a randomized, single blinded, cross-over investigation comparing a novel swelling media with a comparator swelling media in 22 adult, healthy, male volunteers.
Read the detailed description
The CP279 study investigated a novel swelling media for male intermittent urinary catheters. The study was conducted in Denmark and was a single-site, randomized, single blinded, cross-over investigation, testing inferiority of a novel catheter swelling media against a comparator swelling media in 22 adult, healthy, male volunteers.
Each participant was randomized to one of two treatment arms, using a randomization sequence of two (i.e., with two different random options for the order in which the participants tested the two swelling media). The study thus contained two test visits, for which the 22 participants tested the two different swelling media, respectively. There was 4-14 days between the test visits and all catheterizations were performed by trained nurses. Due to a visual difference between the products, it was only possible to blind the subjects.
- Conditions
- Catheter Site Pain, Catheter Site Discomfort
- Being tested
- Novel swelling media, Comparator swelling media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel swelling mediaDevice
Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
Comparator swelling mediaDevice
Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
| Study group | Role | What they receive |
|---|---|---|
| Novel swelling media | Experimental | Participants underwent catheterization with the SpeediCath standard male catheter containing the novel swelling media. The catheterization was performed by a trained nurse. Receives: Device: Novel swelling media |
| Comparator swelling media | Active comparator | Participants underwent catheterization with CE-marked SpeediCath® standard male containing the original swelling media. The catheterization was performed by a trained nurse. Receives: Device: Comparator swelling media |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Secondary outcomes (8)
Insertion 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.
Withdrawal 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.
Urination Discomfort After 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 first normal void, up to 5 min.
Catheter Handling During Insertion
Nurse evaluation of how he/she experienced catheter insertion on a 5-point likert scale including the options: Very difficult, difficult, neither difficult nor easy, easy or very easy.
Measured: Immediately after the procedure/catheterization, up to 5 min.
Catheter Handling During Withdrawal
Nurse evaluation of how he/she experienced catheter withdrawal on a 5-point likert scale including the options: Very difficult, difficult, neither difficult nor easy, easy or very easy.
Measured: Immediately after the procedure/catheterization, up to 5 min.
Touch of Catheter Coating
Nurse evaluation of whether or not it was needed to touch the catheter coating during handling and/or catheterization (yes/no).
Measured: Immediately after the procedure/catheterization, up to 5 min.
Visual Blood During Catheterization
Nurse evaluation of if he/she experienced visual blood on either the catheter or in the urine during catheterization (yes/no).
Measured: Immediately after the procedure/catheterization, up to 5 min.
Microscopic Blood in Catheter-collected Urine
Dipstick analysis of hematuria (erythrocytes) after catheterization using a semi-quantitative color scale with five categories ranging from negative to 3+:
Negative (-). 10 erythrocytes/μL (+/-). 25 erythrocytes/μL (1+). 80 erythrocytes/μL (2+). 200 erythrocytes/μL (3+).
At least one fully positive response (i.e., either 1+, 2+ or 3+), the endpoint was considered positive and the outcome was analyzed as a binary response (positive/negative).
Measured: Immediately after the procedure/catheterization, up to 30 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start5 Nov 2019
- Primary completion28 Nov 2019
- Study completion28 Nov 2019
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 Catheter Site PainStudies 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
- 22 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, Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633291
- Sponsor's protocol ID
- CP279
- Status last verified
- Aug 2022
- First submitted
- 5 Nov 2020
- Last updated
- 17 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 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study in Healthy Volunteers Evaluating the Performance and Handling of a Urinary Intermittent Catheter With a Newly Developed Swelling Media.
- ClinicalTrials.gov ID
- NCT04633291
- Acronym / sponsor ID
- CP279
- Conditions
- Catheter Site Pain, Catheter Site Discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 28 Nov 2019 (actual)
- Study completion
- 28 Nov 2019 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Posted 17 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 swelling media for CE marked intermittent urinary catheters. The study was a randomized, single blinded, cross-over investigation comparing a novel swelling media with a comparator swelling media in 22 adult, healthy, male volunteers.
Detailed description
The CP279 study investigated a novel swelling media for male intermittent urinary catheters. The study was conducted in Denmark and was a single-site, randomized, single blinded, cross-over investigation, testing inferiority of a novel catheter swelling media against a comparator swelling media in 22 adult, healthy, male volunteers.
Each participant was randomized to one of two treatment arms, using a randomization sequence of two (i.e., with two different random options for the order in which the participants tested the two swelling media). The study thus contained two test visits, for which the 22 participants tested the two different swelling media, respectively. There was 4-14 days between the test visits and all catheterizations were performed by trained nurses. Due to a visual difference between the products, it was only possible to blind the subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel swelling media | Experimental | Device: Novel swelling mediaParticipants underwent catheterization with the SpeediCath standard male catheter containing the novel swelling media. The catheterization was performed by a trained nurse. |
| Comparator swelling media | Active comparator | Device: Comparator swelling mediaParticipants underwent catheterization with CE-marked SpeediCath® standard male containing the original swelling media. The catheterization was performed by a trained nurse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent given
- Minimum 18 years of age and with full legal capacity
- Male gender
- Willing to refrain from using analgesics up to 24 hours prior to catheterization visits
- Negative urine multistix analysis for erythrocytes (microscopic hematuria)
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 previously participation in this investigation
- Known hypersensitivity toward any of 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 |
|---|---|---|
| Novel swelling mediaIntermittent catheterization through the urethra draining the bladder, performed by a trained nurse. | Device | Novel swelling media |
| Comparator swelling mediaIntermittent catheterization through the urethra draining the bladder, performed by a trained nurse. | Device | Comparator swelling media |
Primary outcome
Overall Discomfort During Nurse Catheterization
Time frame: Immediately after the procedure/catheterization, up to 5 min.
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.
8 secondary outcomes
Insertion 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.
Urination Discomfort After Catheterization
Time frame: Immediately after first normal void, up to 5 min.
Catheter Handling During Insertion
Time frame: Immediately after the procedure/catheterization, up to 5 min.
Catheter Handling During Withdrawal
Time frame: Immediately after the procedure/catheterization, up to 5 min.
Touch of Catheter Coating
Time frame: Immediately after the procedure/catheterization, up to 5 min.
Visual Blood During Catheterization
Time frame: Immediately after the procedure/catheterization, up to 5 min.
Microscopic Blood in Catheter-collected Urine
Time frame: Immediately after the procedure/catheterization, up to 30 min.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 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
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 Novel swelling media and Comparator swelling media in people with Catheter Site Pain and Catheter Site Discomfort, 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 6 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 17 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 17 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?
Overall Discomfort During Nurse Catheterization (time frame: Immediately after the procedure/catheterization, up to 5 min.). 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 17 Jul 2023.