NCT05485922

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Incontinence
• Retention, Urinary

Interventions

Type	Name	Description
DEVICE	Investigational device - intermittent catheter with a micro-hole zone	The investigational device was a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.
DEVICE	Comparator device -VaPro intermittent catheter	The comparator device is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.

Timeline

• Start date: 2022-09-23
• Primary completion: 2022-11-04
• Completion: 2022-11-04
• First posted: 2022-08-03
• Last updated: 2025-03-05
• Results posted: 2025-03-05

Locations

1 site across 1 country: Denmark