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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after the procedure/catheterization, up to 5min
Awards & highlights
No Placebo-Only Group

Summary

This trial tested a new type of catheter with tiny holes to help male patients who need to use catheters regularly. The goal was to see if this new catheter could keep urine flowing better and empty the bladder more completely compared to a standard catheter.

Eligible Conditions
  • Urinary Incontinence
  • Urinary Retention

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after the procedure/catheterization, up to 5min
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after the procedure/catheterization, up to 5min for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Flow-stop episodes
Residual urine

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
154 Previous Clinical Trials
14,739 Total Patients Enrolled
20 Trials studying Urinary Incontinence
2,466 Patients Enrolled for Urinary Incontinence
Cecilie Rovsing, MDPrincipal InvestigatorSanos
~14 spots leftby Dec 2025
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