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Intermittent Catheter
Investigational device - intermittent catheter with a micro-hole zone for Urinary Incontinence
N/A
Waitlist Available
Led By Cecilie Rovsing, MD
Research Sponsored by Coloplast A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Is at least 18 years of age and has full legal capacity
Is Male
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after the procedure/catheterization, up to 5min
Awards & highlights
Study Summary
This trial is designed to show that the new micro-hole zone catheter is better than the conventional 2-eyelet catheter in terms of number of flow-stop episodes and residual volume at first flow-stop.
Eligible Conditions
- Urinary Incontinence
- Urinary Retention
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately after the procedure/catheterization, up to 5min
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after the procedure/catheterization, up to 5min
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Flow-stop episodes
Residual urine
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Investigational device - intermittent catheter with a micro-hole zoneExperimental Treatment1 Intervention
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.
Group II: Comparator device - VaPro intermittent catheterActive Control1 Intervention
Hollister VaPro, a single-use hydrophilic sleeved soft/flexible catheters in the sizes CH12 or CH14. The catheterization was performed by a trained nurse.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Investigational device - intermittent catheter with a micro-hole zone
2022
N/A
~50
Find a Location
Who is running the clinical trial?
Coloplast A/SLead Sponsor
152 Previous Clinical Trials
14,625 Total Patients Enrolled
20 Trials studying Urinary Incontinence
2,483 Patients Enrolled for Urinary Incontinence
Cecilie Rovsing, MDPrincipal InvestigatorSanos
Frequently Asked Questions
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