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

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.

Conditions

• Catheter; Infection (Indwelling Catheter)
• Quality of Life
• Catheter Related Complication

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

Sponsors & Collaborators

• Evidenze Health España (CRO)

  collaborator UNKNOWN

• Centro para el Desarrollo Tecnológico y la Innovación (CDTI), Spain

  collaborator UNKNOWN

• Rethink Medical SL

  lead INDUSTRY

Principal Investigators

• Jose Medina-Polo, Dr. · Hospital Universitario 12 de Octubre

• Salvador Arlandis Guzmán, Dr. · La Fe University and Polytechnic Hospital

• Raúl Vozmediano Chicharro, Dr. · Carlos Haya Regional University Hospital

• David Carracedo Calvo, Dr. · Rey Juan Carlos University Hospital

• Jose Carlos Santos, Dr. · Hospital Egas Moniz

• Alberto Marques Silva, Dr. · Prof. Doutor Fernando Fonseca Hospital

• José Manuel Palma dos Reis, Dr. · Unidade Local de Saúde de Santa Maria - Centro de Investigação Clínica

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-10

Primary Completion

2026-05-01

Completion

2026-08-01

Countries

• Portugal
• Spain

Study Locations