Clinical trial NCT04633291: Investigation of New Intermittent Catheter Swelling Media in Healthy Volunteers
Official title: Clinical Study in Healthy Volunteers Evaluating the Performance and Handling of a Urinary Intermittent Catheter With a Newly Developed Swelling Media.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter Site Pain
Catheter Site Discomfort
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2020-11-18
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Discomfort During Nurse Catheterization
timeFrame: Immediately after the procedure/catheterization, up to 5 min.
Secondary outcomes:
measure: Insertion Discomfort During Nurse Catheterization
timeFrame: Immediately after the procedure/catheterization, up to 5 min.
measure: Withdrawal Discomfort During Nurse Catheterization
timeFrame: Immediately after the procedure/catheterization, up to 5 min.
measure: Urination Discomfort After Catheterization
timeFrame: Immediately after first normal void, up to 5 min.
measure: Catheter Handling During Insertion
timeFrame: Immediately after the procedure/catheterization, up to 5 min.
measure: Catheter Handling During Withdrawal
timeFrame: Immediately after the procedure/catheterization, up to 5 min.
measure: Touch of Catheter Coating
timeFrame: Immediately after the procedure/catheterization, up to 5 min.
measure: Visual Blood During Catheterization
timeFrame: Immediately after the procedure/catheterization, up to 5 min.
measure: Microscopic Blood in Catheter-collected Urine
timeFrame: Immediately after the procedure/catheterization, up to 30 min.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark
state: København Ø
Study officials:
affiliation: Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark
name: Per Bagi, MD
role: PRINCIPAL_INVESTIGATOR
References: