Investigation of New Intermittent Catheter Swelling Media in Healthy Volunteers

Catheter Site Discomfort Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04633291
• Other study ID #: CP279
• Status: Completed
• Phase: N/A
• Start date: November 5, 2019
• Est. completion date: November 28, 2019

Study information

• Verified date: August 2022
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 28, 2019
• Est. primary completion date: November 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Catheter Site Discomfort
• Catheter Site Pain

Intervention

Device:
• Novel swelling media
Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.
• Comparator swelling media
Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.

Locations

Country	Name	City	State
Denmark	Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark	Copenhagen	København Ø

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.