Stopped: Study was stopped due to issues with investigational device impacting its functionality and user handling. The sponsor decided to implement necessary design and/or material modifications to improve performance and safety before resuming recruitment.
The goal of this clinical trial is to learn if the new urinary catheter T-Control® allows a reduction in infections associated with urinary catheters and a better quality of life of urinary catheter patients compared to the conventional Foley-type catheter (the currently used in clinical practice). It will also learn about the safety profile of the T-Control® catheter and its cost-effectiveness. The main questions it aims to answer are: Does the T-Control® catheter lower the number of infections of the patients who need long-term catheterization? Does he T-Control® catheter implies a better perceived quality of life of long-term catheterization patients? Participants will: Be catheterized with T-Control® or Foley catheter. Visit the clinic after 4 weeks for checkups, fullfill questionnaires and tests. Keep a diary of their symptoms and adverse events related to the catheter.
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Rate of Catheter-Associated Urinary Tract Infections (symptomatic and asymptomatic)
Timeframe: 4 weeks
Magnitude of Catheter-Associated Urinary Tract Infections (symptomatic and asymptomatic)
Timeframe: 4 weeks