Effectiveness of T-Control Catheter in Reducing Infections and Adverse Events in AUR Patients

What is it about?

This study aims to evaluate the effectiveness and cost-effectiveness of the T-Control catheter versus the conventional Foley-type catheter in patients with Acute Urine Retention (AUR). The trial design is a pragmatic, open, multicentre, controlled clinical trial with random allocation to either catheter type. The primary endpoint is the magnitude of infections, with secondary endpoints including rate of symptomatic and asymptomatic infections, days free of infection, quality of life, adverse events, catheter-related healthcare resources, patient and health professional satisfaction, and acceptability of the T-Control device. The study will recruit male adults aged ≥50 years with AUR and an indication for bladder catheterisation for at least 2 weeks. The estimated sample size is 50 patients, who will be followed from catheter insertion to removal or change 2 weeks later, plus 2 weeks after for an in-depth interview. [Some of the content on this page has been created by AI]

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Why is it important?

This research is important as it is the first clinical trial to investigate the T-Control catheter, which has an integrated fluid control valve designed to reduce the risks associated with bladder catheterization. The study aims to evaluate the effectiveness and cost-effectiveness of the T-Control catheter versus the conventional Foley-type catheter in patients with acute urine retention, and its potential to improve health outcomes, reduce complications, and promote patient autonomy. Key Takeaways: 1. The study aims to evaluate the effectiveness and cost-effectiveness of the T-Control catheter versus the conventional Foley-type catheter in patients with acute urine retention. 2. The study uses both objective and subjective tools to evaluate different aspects of bladder catheterization related to patients, health professionals, and the impact on the health system. 3. The study is limited in that neither patients nor health professionals will be blinded, but it is a strength that the research team will be blinded. 4. The study is the first clinical trial to investigate the T-Control catheter, which has an integrated fluid control valve designed to reduce the risks associated with bladder catheterization. 5. The study could contribute to improving health and social well-being among patients who use permanent bladder catheters, although the results cannot be extrapolated to other cohorts or conditions for the use of T-Control.