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

Last updated: March 5, 2025
Sponsor: Rethink Medical SL
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Foley-type catheter

T-Control® catheter

Clinical Study ID

NCT06474845
RM-TCONTROL-2024-05
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men or women aged ≥18 years

  • Patients who require change of bladder catheter.

  • Patients with indication of bladder catheterization for at least 4 weeks.

  • Patients who maintain cognitive and physical ability for self-monitoring of thecatheter valve.

  • Patients who sign ICF prior to the performance of any study-specific procedure.

Exclusion

Exclusion Criteria:

  • Use of current antibiotic treatment or in the 2 weeks prior to the study inclusion.

  • Patients undergoing chemotherapy, radiotherapy, immunosuppressants or retroviraltreatment.

  • Patients with bilateral obstructive supravesical uropathy.

  • Inability to read and understand the language of the Hospital's country.

  • Patients who are participating in a clinical trial or intends to participate duringthe course of this study.

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Foley-type catheter
Phase:
Study Start date:
February 10, 2024
Estimated Completion Date:
September 30, 2025

Study Description

This is a comparative, randomized, controlled, multicentric clinical study with two arms in which the T-control® catheter is compared with a conventional Foley-type catheter.

The main objective of this study is to determine the efficacy of T-Control® compared to the conventional Foley-type catheter, by comparing the number of CAUTIs (both symptomatic and asymptomatic) in patients with long-term catheterization. While the secondary objectives are: to determine the Health-related QoL (HRQoL) and analyze the self-perceived QoL of catheterized patients, as well as the acceptability of the T-Control® device, patient's satisfaction and patients' experience framed in the trajectory of the disease; to compare the safety profile between T-Control® and the conventional Foley-type catheter and the antibiotics used; to determine the cost-effectiveness of T-Control® versus the conventional Foley-type catheter, from the perspective of the hospital; and to measure the level of satisfaction of healthcare professionals with the different types of urinary catheters.

Follow-up includes both the time of the catheter insertion until its removal or change, lasting 4 weeks. All the parameters collected during the follow-up visit refer to the 4 weeks during which the patient has had the catheter inserted.

Connect with a study center

  • Prof. Doutor Fernando Fonseca Hospital

    Amadora, 2720-276
    Portugal

    Site Not Available

  • Egas Moniz Hospital

    Lisboa, 1349-019
    Portugal

    Site Not Available

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

    Lisboa, 1649-028
    Portugal

    Site Not Available

  • Regional University Hospital of Malaga

    Málaga, Andalucía/Spain 29010
    Spain

    Active - Recruiting

  • La Fe University and Polytechnic Hospital

    Valencia, Comunitat Valenciana 46026
    Spain

    Active - Recruiting

  • Rey Juan Carlos University Hospital

    Móstoles, Madrid/Spain 28933
    Spain

    Active - Recruiting

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