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TERMINATED
NCT06474845
NA

Efficacy of the T-Control® Catheter Compared to the Foley-type Catheter in Patients With Long-term Catheterization

Sponsor: Rethink Medical SL

View on ClinicalTrials.gov

Summary

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.

Official title: Multicentre International Randomized Clinical Study to Assess the Efficacy of the T-Control® Catheter vs. a Conventional Foley-type Catheter

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2024-02-10

Completion Date

2026-09-01

Last Updated

2026-09-04

Healthy Volunteers

No

Interventions

DEVICE

T-Control® catheter

Patients will be catheterized with T-Control® for 4 weeks

DEVICE

Foley-type catheter

Patients will be catheterized with a conventional Foley-type catheter for 4 weeks

Locations (6)

Prof. Doutor Fernando Fonseca Hospital

Amadora, Portugal

Egas Moniz Hospital

Lisbon, Portugal

Unidade Local de Saúde de Santa Maria - Centro de Investigação Clínica

Lisbon, Portugal

Regional University Hospital of Malaga

Málaga, Andalucía/Spain, Spain

Rey Juan Carlos University Hospital

Móstoles, Madrid/Spain, Spain

La Fe University and Polytechnic Hospital

Valencia, Valencia, Spain