Investigation of New Intermittent Catheter Swelling Media in Healthy Volunteers

Not Applicable

Completed

Conditions: Catheter Site Discomfort
Catheter Site Pain

Interventions: Device: Novel swelling media
Device: Comparator swelling media

Registration Number: NCT04633291

Lead Sponsor: Coloplast A/S

Brief 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 22

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Novel swelling media	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.
Comparator swelling media	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.

Primary Outcome Measures

Name	Time	Method
Overall Discomfort During Nurse Catheterization	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.

Secondary Outcome Measures

Name	Time	Method
Urination Discomfort After Catheterization	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.
Catheter Handling During Insertion	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.
Touch of Catheter Coating	Immediately after the procedure/catheterization, up to 5 min.	Nurse evaluation of whether or not it was needed to touch the catheter coating during handling and/or catheterization (yes/no).
Catheter Handling During Withdrawal	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.
Insertion Discomfort During Nurse Catheterization	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.
Withdrawal Discomfort During Nurse Catheterization	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.
Visual Blood During Catheterization	Immediately after the procedure/catheterization, up to 5 min.	Nurse evaluation of if he/she experienced visual blood on either the catheter or in the urine during catheterization (yes/no).
Microscopic Blood in Catheter-collected Urine	Immediately after the procedure/catheterization, up to 30 min.	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).