- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04633291
Investigation of New Intermittent Catheter Swelling Media in Healthy Volunteers
Clinical Study in Healthy Volunteers Evaluating the Performance and Handling of a Urinary Intermittent Catheter With a Newly Developed Swelling Media.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
København Ø
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Copenhagen, København Ø, Denmark, 2100
- Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Novel swelling media
Participants underwent catheterization with the SpeediCath standard male catheter containing the novel swelling media.
The catheterization was performed by a trained nurse.
|
Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
|
Active Comparator: Comparator swelling media
Participants underwent catheterization with CE-marked SpeediCath® standard male containing the original swelling media.
The catheterization was performed by a trained nurse.
|
Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Immediately after the procedure/catheterization, up to 5 min.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insertion 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.
|
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.
|
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.
|
Immediately after the procedure/catheterization, up to 5 min.
|
Urination Discomfort After Catheterization
Time Frame: Immediately after first normal void, 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.
|
Immediately after first normal void, up to 5 min.
|
Catheter Handling During Insertion
Time Frame: Immediately after the procedure/catheterization, up to 5 min.
|
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.
|
Immediately after the procedure/catheterization, up to 5 min.
|
Catheter Handling During Withdrawal
Time Frame: Immediately after the procedure/catheterization, up to 5 min.
|
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.
|
Immediately after the procedure/catheterization, up to 5 min.
|
Touch of Catheter Coating
Time Frame: Immediately after the procedure/catheterization, up to 5 min.
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Nurse evaluation of whether or not it was needed to touch the catheter coating during handling and/or catheterization (yes/no).
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Immediately after the procedure/catheterization, up to 5 min.
|
Visual Blood During Catheterization
Time Frame: Immediately after the procedure/catheterization, up to 5 min.
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Nurse evaluation of if he/she experienced visual blood on either the catheter or in the urine during catheterization (yes/no).
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Immediately after the procedure/catheterization, up to 5 min.
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Microscopic Blood in Catheter-collected Urine
Time Frame: Immediately after the procedure/catheterization, up to 30 min.
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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). |
Immediately after the procedure/catheterization, up to 30 min.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Per Bagi, MD, Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CP279
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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