Clinical Trial of New Single-use Compact Intermittent Catheter

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Urinary Incontinence

Clinical Trial Details

NCT number	NCT05841004
Study type	Interventional
Source	Coloplast A/S
Contact
Status	Completed
Phase	N/A
Start date	June 20, 2023
Completion date	September 14, 2023

View Details

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