Clinical trial NCT04543136: Investigation of Non-CE Marked Intermittent Catheters.
Official title: Exploratory Investigation on Performance and Safety of Newly Developed Intermittent Catheters in Male Users of Intermittent Catheters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retention, Urinary
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2020-09-09
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for males with a comparator catheter

Detailed description: The CP323 study investigated a novel non-CE marked intermittent catheter, designed in two different variants, Variant 1 and Variant 2, respectively, and was conducted in Denmark. The study was a randomized, single blinded, cross-over investigation, comparing the two new variant catheters with a comparator catheter in 15 male IC users.

For each participant, the study thus contains three test visits/treatment arms (Comparator, Variant 1 and Variant 2, respectively), to which the 15 participants were randomized using a randomization sequence of six (i.e., there were six different random options for the order in which the participants tested the three catheters). There were 4-14 days between the test visits.

Eligibility criteria: Inclusion Criteria:

* Male
* Minimum 18 years of age and with full legal capacity
* Daily intermittent catheterization for bladder management, with at least two catheters used on average pr. day, during the last 3 months
* Ability to self-catheterize
* Written informed consent, signed letter of authority and signed secrecy agreement given

Exclusion Criteria:

* Participation in any other clinical study during this investigation
* Symptoms of urinary tract infection as judged by the investigator
* Any know allergies towards ingredients in the products
* Relevant medical history that would prevent the subject from participation in the investigation (investigators judgement)

Primary outcomes:
measure: Residual Urine at 1st Flow-stop During Nurse Catheterization
timeFrame: Immediately after the procedure/catheterization, up to 5 min.
measure: Residual Urine at 1st Flow-stop During Self-catheterization
timeFrame: Immediately after the procedure/catheterization, up to 5 min.
Secondary outcomes:
measure: Post-void Residual Urine After Nurse Catheterization
timeFrame: Immediately after the procedure/catheterization, up to 15 min.
measure: Post-void Residual Urine After Self-catheterization
timeFrame: Immediately after the procedure/catheterization, up to 15 min.
measure: Insertion Discomfort During Nurse Catheterization
timeFrame: Immediately after the procedure/catheterization, up to 5 min.
measure: Urination 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: Overall Discomfort During Nurse Catheterization
timeFrame: Immediately after the procedure/catheterization, up to 5 min.
measure: Insertion Discomfort During Self-catheterization
timeFrame: Immediately after the procedure/catheterization, up to 5 min.
measure: Urination Discomfort During Self-catheterization
timeFrame: Immediately after the procedure/catheterization, up to 5 min.
measure: Withdrawal Discomfort During Self-catheterization
timeFrame: Immediately after the procedure/catheterization, up to 5 min.
measure: Overall Discomfort During Self-catheterization
timeFrame: Immediately after the procedure/catheterization, up to 5 min.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet
Study officials:
affiliation: Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark
name: Per Bagi, MD
role: PRINCIPAL_INVESTIGATOR
References: