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

NCT ID: NCT06474845

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-10
• Study Completion Date: 2026-08-01

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Experimental arm (T-Control®)

Patients catheterized with a catheter with a control valve for intermittent drainage

Group Type: EXPERIMENTAL

T-Control® catheter

Intervention Type: DEVICE

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

Control arm (Foley)

Patients catheterized with a conventional urinary catheter with continuous drainage

Group Type: ACTIVE_COMPARATOR

Foley-type catheter

Intervention Type: DEVICE

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

Interventions

T-Control® catheter

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

Intervention Type: DEVICE

Foley-type catheter

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

Intervention Type: DEVICE

Eligibility Criteria

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

Exclusion Criteria

• Use of current antibiotic treatment or in the 2 weeks prior to the study inclusion.
• Patients undergoing chemotherapy, radiotherapy, immunosuppressants or retroviral treatment.
• 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 during the course of this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Evidenze Health España (CRO)

UNKNOWN

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

Rethink Medical SL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose Medina-Polo, Dr.

Role: STUDY_CHAIR

Hospital Universitario 12 de Octubre

Salvador Arlandis Guzmán, Dr.

Role: PRINCIPAL_INVESTIGATOR

La Fe University and Polytechnic Hospital

Raúl Vozmediano Chicharro, Dr.

Role: PRINCIPAL_INVESTIGATOR

Carlos Haya Regional University Hospital

David Carracedo Calvo, Dr.

Role: PRINCIPAL_INVESTIGATOR

Rey Juan Carlos University Hospital

Jose Carlos Santos, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hospital Egas Moniz

Alberto Marques Silva, Dr.

Role: PRINCIPAL_INVESTIGATOR

Prof. Doutor Fernando Fonseca Hospital

José Manuel Palma dos Reis, Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Countries

Portugal; Spain

Other Identifiers

RM-TCONTROL-2024-05

Identifier Type: -

Identifier Source: org_study_id