Investigation of New Intermittent Catheter Swelling Media in Healthy Volunteers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Study in Healthy Volunteers Evaluating the Performance and Handling of a Urinary Intermittent Catheter With a Newly Developed Swelling Media.

Conditions
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Catheter Site Pain, Catheter Site Discomfort

Intervention / Treatment
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* Device: Novel swelling media
* Device: Comparator swelling media


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novel swelling media<br>Participants underwent catheterization with the SpeediCath standard male catheter containing the novel swelling media. The catheterization was performed by a trained nurse. | Device: Novel swelling media<br>* Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.<br>|
| Active Comparator: Comparator swelling media<br>Participants underwent catheterization with CE-marked SpeediCath® standard male containing the original swelling media. The catheterization was performed by a trained nurse. | Device: Comparator swelling media<br>* Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Immediately after the procedure/catheterization, up to 5 min. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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). | Immediately after the procedure/catheterization, up to 30 min. |