Performance of a Single-use Intermittent Micro-hole Zone Catheter

Study Overview
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Brief Summary
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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
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The investigation was a single-centre, randomized, controlled crossover study including 42 male IC users comparing the performance of two intermittent catheters. 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.

Official Title
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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

Conditions
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Urinary Incontinence, Retention, Urinary

Intervention / Treatment
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* Device: Investigational device - intermittent catheter with a micro-hole zone
* Device: Comparator device -VaPro intermittent catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is Male Is at least 18 years of age and has full legal capacity Has given written informed consent Has signed letter of authority (only DK) Has used clean intermittent catheterisation CH12 or CH14 for at least one month Use intermittent catheterisation as the primary bladder emptying method Is able (assessed by investigator) and willing to follow study procedures Exclusion Criteria: Is participating in any other clinical study during this investigation Has previous participated in this study 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational device - intermittent catheter with a micro-hole zone<br>A ready-to-use, sterile, hydrophilic-coated male catheter for intermittent catheterisation with a flexible tip and a micro-hole zone for urinary drainage in sizes CH12 and CH14. The catheterization was performed by a trained nurse. | Device: Investigational device - intermittent catheter with a micro-hole zone<br>* The investigational device was a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.<br>|
| Active Comparator: Comparator device - VaPro intermittent catheter<br>Hollister VaPro, a single-use hydrophilic sleeved soft/flexible catheters in the sizes CH12 or CH14. The catheterization was performed by a trained nurse. | Device: Comparator device -VaPro intermittent catheter<br>* The comparator device is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow-stop episodes | Flow-stops were measured with a pressure sensor, which is an electronic device used for monitoring the hydrostatic pressure at the outlet of an intermittent urinary catheter during emptying. From a sensor curve, flow-stops were identified by two individually trained evaluators as a hydrostatic pressure peak coinciding with a urine flow-stop/ urine dripping (flowrate lower than 0,8 ml/sec). Results from both evaluators were compared and in case of discrepancy a discussion was performed to extenuate discrepancies and agree on a final interpretation of the curves. | Immediately after the procedure/catheterization, up to 5min | 
| Residual urine | The residual urine at 1st flow-stop during catheterization (performed by a nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying. Hence, the residual volume at 1st flow-stop was calculated as the total volume post catheterisation minus the volume at 1st flow-stop, derived from a catheterisation profile which was connected to a time-logged weighing [g]. | Immediately after the procedure/catheterization, up to 5min |