N/A
N=42
Performance of a Single-use Intermittent Micro-hole Zone Catheter
Urinary Incontinence · Retention, Urinary
Bottom Line
View on ClinicalTrials.gov: NCT05485922 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Number of Flow-stop Episodes — 0.17; 1.09 Flow stop episodes — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Investigational device - intermittent catheter with a micro-hole zone (Device); Comparator device -VaPro intermittent catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Coloplast A/S
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Flow-stop Episodes |
0.17; 1.09 | 0.05 |
| PRIMARY Residual Urine at 1st Flow-stop |
5.10; 39.40 | 0.05 |
| PRIMARY Number of Flow-stop Episodes |
0.17; 1.09 | 0.05 |
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.
Eligibility Criteria
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
- Has any known allergies towards ingredients in the investigational device
Data sourced from ClinicalTrials.gov (NCT05485922). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.