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

Not Applicable

Completed

Interventions: Device: Comparator device -VaPro intermittent catheter
Device: Investigational device - intermittent catheter with a micro-hole zone

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.

Recruitment & Eligibility

Inclusion Criteria

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
Has any known allergies towards ingredients in the investigational device

Arm && Interventions

Group	Intervention	Description
Comparator device - VaPro intermittent catheter	Comparator device -VaPro intermittent catheter	Hollister VaPro, a single-use hydrophilic sleeved soft/flexible catheters in the sizes CH12 or CH14. The catheterization was performed by a trained nurse.
Investigational device - intermittent catheter with a micro-hole zone	Investigational device - intermittent catheter with a micro-hole zone	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.

Primary Outcome Measures

Name	Time	Method
Number of Flow-stop Episodes	Immediately after catheterisation	Flow-stop episodes were determined as instances where the flow rate decreased to less than 0.8 mL/s for a period of at least two seconds. All episodes were detected by automatic thresholding, followed by manual inspection, where the intra-catheter pressure readings were used to support the assessment of a flow stop.
Residual Urine at 1st Flow-stop	When the first flow-stop appeared, the amount of voided urine was measured.	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 \[g\].

Secondary Outcome Measures