What is it about?

The study compares the effectiveness and comfort of a new silicone Foley catheter with an integrated fluid control valve (T-Control) to a conventional Foley catheter in patients with long-term catheterization. The primary endpoints are the comfort and acceptability of the T-Control device and the quality of life related to self-perceived health, while secondary endpoints include infection rates, adverse events, healthcare resource use, and satisfaction of both patients and health professionals. The study is a mixed-method trial comprising a two-arm, pilot comparative study and a qualitative study through discussion groups. The sample size is 50 patients, and the study is approved by the Research Ethics Committee. T-Control has undergone biocompatibility and usability studies, which show its potential to reduce infections, improve safety during insertion, and be easier to use. Another pilot clinical study is currently being carried out with T-Control in patients with acute urinary retention. [Some of the content on this page has been created by AI]

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Why is it important?

This research is important because it aims to determine the effectiveness, comfort, and experience of patients catheterized with the new silicone Foley catheter, T-Control ®, compared to patients with a conventional Foley catheter. The study also aims to reduce the risks associated with bladder catheterization by adopting a multifactorial approach. By using objective and subjective tools to evaluate different aspects of bladder catheterization, the study seeks to improve the work environment for health personnel, reduce occupational risks, and promote an active and healthy lifestyle for users. Furthermore, the development of this clinical study could help improve the sustainability of the healthcare system by reducing infections, emergency visits, and personnel costs. Key Takeaways: 1. The study aims to determine the effectiveness, comfort, and experience of patients catheterized with the new silicone Foley catheter, T-Control ®, compared to patients with a conventional Foley catheter. 2. The study uses objective and subjective tools to evaluate different aspects of bladder catheterization, aiming to improve the work environment for health personnel, reduce occupational risks, and promote an active and healthy lifestyle for users. 3. The development of this clinical study could help improve the sustainability of the healthcare system by reducing infections, emergency visits, and personnel costs.

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This page is a summary of: A study protocol of a comparative mixed study of the T‐Control catheter, BJUI Compass, January 2024, Wiley,
DOI: 10.1002/bco2.313.
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