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Clinical Trial of New Intermittent Single-use Catheter

Urinary Incontinence Clinical Trial

Official title:
A Randomized, Open-labelled, Crossover Study Confirming Performance of a New Single-use Compact Intermittent Catheter in a Population of Adult Female Intermittent Catheter Users

Clinical Trial Summary

A multi-centre, open-labelled, randomised, crossover design. The total study duration for the individual subject will be approximately 4 weeks, consisting of four site visits and two 2-week test periods at home. Visits 0 and 1 can be performed on the same day. For visit 2 and 3, 2 catheterisations will be performed in a hospital setting (one HCP catheterisation and one self-catheterisation) for bladder emptying and user experience assessments. Visit 1 and 2 are followed by a home-use test period, followed by visit 3 which terminates the study.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05814211
Study type Interventional
Source Coloplast A/S
Contact
Status Completed
Phase N/A
Start date August 4, 2023
Completion date November 29, 2023
View Details
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