Clinical trial NCT05485922: Performance of a Single-use Intermittent Micro-hole Zone Catheter
Official title: A Randomized, Open-labelled, Crossover Study Confirming Performance of a Single-use Intermittent Micro-hole Zone Catheter in a Population of Adult Male Intermittent Catheter Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Retention, Urinary
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2022-08-03
Enrollment: 42
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: The goal of this randomized, controlled crossover study was to assess the performance of a new micro-hole zone catheter compared to a conventional 2-eyelet catheter in 42 male intermittent catheter users.

The main objective of this study was to demonstrate superiority of the micro-hole zone catheter in terms of number of flow-stop episodes and residual volume at first flow-stop, with the catheterization performed by a health care professional in a hospital setting compared to a conventional two-eyelet catheter.

Detailed description: The investigation was a single-centre, randomized, controlled crossover study including 42 male participants comparing the performance of two intermittent catheters (IC).

The study included an information visit (visit 0) and two test visits (visit 1 and 2) in which one catheterization with either the investigational device or the comparator device, according to a randomization scheme, was performed by a health care professional in a hospital setting assessing flow stop episodes, bladder emptying and hematuria. There were 4-14 days between each test visit (visit 1 and 2) and visit 0 and 1 could be held on the same day.

Eligibility criteria: Inclusion Criteria:

1. Is Male
2. Is at least 18 years of age and has full legal capacity
3. Has given written informed consent
4. Has signed letter of authority (only DK)
5. Has used clean intermittent catheterisation CH12 or CH14 for at least one month
6. Use intermittent catheterisation as the primary bladder emptying method
7. Is able (assessed by investigator) and willing to follow study procedures

Exclusion Criteria:

1. Is participating in any other clinical study during this investigation
2. Has previous participated in this study
3. Has symptoms of urinary tract infection as judged by the investigator 4 Is an individual with history, suspected or showing signs of producing urine with excessive amount of mucus or large/clustered sediments or debris

5. Has any known allergies towards ingredients in the investigational device

Primary outcomes:
measure: Number of Flow-stop Episodes
timeFrame: Immediately after the procedure/catheterization
measure: Residual Urine at 1st Flow-stop
timeFrame: When the first flow-stop appeared, the amount of voided urine was measured.
measure: Number of Flow-stop Episodes
timeFrame: Immediately after catheterisation
Secondary outcomes:
Other outcomes:
measure: Pressure Measurement at 1st Flow-stop Derived From a Catheterisation Profile.
timeFrame: When the first flow-stop appeared, the pressure at the drainage holes was measured
measure: Post-catheterisation Volume
timeFrame: Immediately after catheterisation
Locations:
city: Gandrup
country: Denmark
facility: Sanos Clinic
Study officials:
affiliation: Sanos
name: Cecilie Rovsing, MD
role: PRINCIPAL_INVESTIGATOR
References: