NCT05841004

Clinical Trial of New Single-use Compact Intermittent Catheter

A Randomized, Crossover Study Confirming Performance of a New Single-use Compact Intermittent Catheter vs. Infyna Chic in a Pop-ulation of Adult Female Intermittent Catheter Users.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a randomised, single-blinded, controlled crossover study. The total study duration for the individual subject will be between two days - two weeks, consisting of three site visits. Visits 0 and 1 can be performed on the same day. Visit 2 can be performed the day after visit 1. For visit 1 and 2, catheterizations will be performed in a hospital setting by a health care professional for bladder emptying assessment and collection of urine samples for haematuria assessment. A sub-group of subjects (all enrolled subjects at DK sites) will be asked to conduct a self-catheterization at visit 2 after hcp catheterization and evaluate discomfort and PVR. The total study duration for the individual subject will be up to 14 days.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Investigational device	Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The investigational device is for single use.
DEVICE	Comparator device	Hollister Infyna Chic, single-use compact catheter.

Timeline

• Start date: 2023-06-20
• Primary completion: 2023-09-14
• Completion: 2023-09-14
• First posted: 2023-05-03
• Last updated: 2025-01-23
• Results posted: 2025-01-23

Locations

1 site across 1 country: Denmark