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Clinical Trial Summary

Male self catherterisng observational study.


Clinical Trial Description

This is a multicentre, prospective international observational study. Male patients in the UK, USA and France performing self-catheterisation will be asked to participate in this study. The subjects will be asked to use the GentleCath™ Intermittent Catheter with FeelClean™ Technology as per their normal routine. They will be asked to record when and where they catheterise. At the baseline, during and on completion of the study, the subjects will be asked to complete Difficulty in Catheterisation plus Intermittent Catheter related Quality of Life Questionnaires. Difficulty during catheterisation and quality of life will be assessed using the ICDQ and ISC-Q validated questionnaires during catheterisation at the start of the study before use of GentleCath™ Air has commenced (D0) and on day 1 (D1), day 15 (D15), day 30 (D30), day 45 (D45) and day 60 (D60) transcribed in a collecting record provided for this purpose. Compliance and catheter use will also be assessed. Patient confidence regarding reduced stickiness plus related risk of urethral injury and resultant bleeding or infection will also be recorded. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05470751
Study type Observational
Source ConvaTec Inc.
Contact
Status Completed
Phase
Start date February 2, 2023
Completion date April 6, 2024

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