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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 below

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

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

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~17 spots leftby Mar 2025