At a glance
ClinicalIndex Comparison Record- ✓Adult males (≥18 years old) with full legal capacity
- ✓Established user of clean intermittent catheterization (CH12 or CH14 size) for ≥1 month
- ✓Intermittent catheterization is the primary bladder emptying method
- ✓Able and willing to follow study procedures as assessed by investigator
- ✕Active symptoms of urinary tract infection per investigator judgment
- ✕History, suspected, or signs of excessive mucus production, large/clustered sediments, or debris in urine
- ✕Known allergies to ingredients in the investigational device
- ✕Concurrent participation in another clinical study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Investigational device - intermittent catheter with a micro-hole zone and Comparator device -VaPro intermittent catheter for Urinary Incontinence and Retention, Urinary. Completed, enrolled 42 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
The investigational device was a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.
The comparator device is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.