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Completed

NCT Number: NCT04633291

Investigation of New Intermittent Catheter Swelling Media in Healthy Volunteers

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.

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Key information

Conditions

Catheter Site Pain Catheter Site Discomfort

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark

Copenhagen, København Ø, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Novel swelling media

Device

Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.

Comparator swelling media

Device

Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Touch of Catheter Coating

    Time frame: 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).

  7. Visual Blood During Catheterization

    Time frame: 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).

  8. Microscopic Blood in Catheter-collected Urine

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 18, 2020
Registry last updated
Jul 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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