Safety and Usability of the T-Control® Catheter in Cytostatics Management: a Pilot Study
The goal of this pilot clinical trial is to know if this study is feasable in terms of design, recruitment and interventions, as well as gather preliminary data to determine if the T-Control® catheter is safer than the conventional Foley-type catheter during intravesical therapy with oncological patients. It will also learn about the usability and workload of T-Control®. The main questions it aims to answer are:
* Does T-Control® lower the rate of spillages occurred during intravesical treatments?
* Is T-Control® a better device in terms of usability during intravesical treatments?
* Does T-Control reduce the workload perceived by healthcare professionals during intravesical treatment?
Researchers will compare T-Control® catheter to a conventional Foley-type catheter (Folysil® Silicone catheter, Coloplast) to see if T-Control® reduce the rate of accidental spillages.
Participants will:
* Undergo intravesical therapy with one of the 2 devices used in the study: T-Control® catheter (intervention arm) or Folysil® silicone catheter (control arm).
* At the end of the procedure (1-2 hours), the catheter will be removed or changed.
* Healthcare professionals involved in the procedure will take note of spillages and others adverse events occurred during the intravesical instillation.
Multicentre International Randomized Clinical Study to Assess the Efficacy of the T-Control® Catheter vs. a Conventional Foley-type Catheter
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.
Comparative Mixed Study of the Foley Catheter With the T-Control® Catheter in Patients With Long-term Catheterization
This is a comparative, randomized, controlled pilot study. The main objective of this study is to evaluate the efficacy, comfort, and patient experience in people with long-term bladder catheterization with T-Control® versus patients with a conventional Foley-type catheter.
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