Clinical trial NCT04445051: Investigation of New Intermittent Catheters in Healthy Volunteers
Official title: Exploratory Investigation on Performance and Safety of New Intermittent Catheters in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retention, Urinary
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2020-06-24
Enrollment: 30
Sex: ALL
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 non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers.

Detailed description: The CP322 study investigated a novel non-CE marked intermittent catheter for males and females, designed in two different variants, Variant 1 and Variant 2, respectively. The study was conducted in Denmark and was a randomized, single blinded, cross-over investigation comparing the two new variant catheters with a comparator catheter in 30 adult healthy volunteers.

For each participant, the study thus contained three test visits/treatment arms (Comparator, Variant 1 and Variant 2, respectively), to which the 30 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:

* Minimum 18 years of age and with full legal capacity
* Written informed consent and signed letter of authority and secrecy agreement given
* Willing to comply with not using analgesics 1 up to 24 hours prior to catheterization visits
* Urine Multistix negative for erythrocytes (hematuria)

Exclusion Criteria:

* Participation in any other clinical investigations during this investigation
* Known hypersensitivity towards any of the test products
* Symptoms of urinary tract infection (UTI) (Investigators judgement)
* Pregnancy or breastfeeding

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