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

NCT06474845 | Suspended

• 1 other identifier: RM-TCONTROL-2024-05
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 6

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.

Conditions

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

Keywords

Catheterization; CAUTI; Foley catheter; QoL

Outcome Measures

Primary Outcomes (2)

• Rate of Catheter-Associated Urinary Tract Infections (symptomatic and asymptomatic)

  Number of infections divided by number of patients. The presence of pathogenic microorganisms in quantities greater than or equal to 1,000 CFU/ml will determine the presence of infection, while, in the absence of symptoms of infection, a determination of microorganisms greater than or equal to 100,000 CFU/ml will indicate asymptomatic infection.

  4 weeks

• Magnitude of Catheter-Associated Urinary Tract Infections (symptomatic and asymptomatic)

  Amount of pathogenic microorganisms present in urine (in CFU/ml) divided by number of patients

  4 weeks

Secondary Outcomes (6)

• Health Related Quality of Life (HRQoL)

  4 weeks

• Catheter Related Quality of Life

  4 weeks

• Adverse events

  4 weeks

• Antibiotic treatments

  4 weeks

• Cost-effectiveness

  4 weeks

Study Arms (2)

Experimental arm (T-Control®)

EXPERIMENTAL

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

Device: T-Control® catheter

Control arm (Foley)

ACTIVE COMPARATOR

Patients catheterized with a conventional urinary catheter with continuous drainage

Device: Foley-type catheter

Interventions

T-Control® catheter DEVICE

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

Experimental arm (T-Control®)

Foley-type catheter DEVICE

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

Control arm (Foley)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rethink Medical SL: lead
• Evidenze Health España (CRO): collaborator
• Centro para el Desarrollo Tecnológico y la Innovación (CDTI), Spain: collaborator

Study Sites (6)

Prof. Doutor Fernando Fonseca Hospital

Amadora, 2720-276, Portugal

Location

Egas Moniz Hospital

Lisbon, 1349-019, Portugal

Location

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

Lisbon, 1649-028, Portugal

Location

Regional University Hospital of Malaga

Málaga, Andalucía/Spain, 29010, Spain

Location

Rey Juan Carlos University Hospital

Móstoles, Madrid/Spain, 28933, Spain

Location

La Fe University and Polytechnic Hospital

Valencia, Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Infections

Study Officials

• Jose Medina-Polo, Dr.

  Hospital Universitario 12 de Octubre

  STUDY CHAIR

• Salvador Arlandis Guzmán, Dr.

  La Fe University and Polytechnic Hospital

  PRINCIPAL INVESTIGATOR

• Raúl Vozmediano Chicharro, Dr.

  Carlos Haya Regional University Hospital

  PRINCIPAL INVESTIGATOR

• David Carracedo Calvo, Dr.

  Rey Juan Carlos University Hospital

  PRINCIPAL INVESTIGATOR

• Jose Carlos Santos, Dr.

  Hospital Egas Moniz

  PRINCIPAL INVESTIGATOR

• Alberto Marques Silva, Dr.

  Prof. Doutor Fernando Fonseca Hospital

  PRINCIPAL INVESTIGATOR

• José Manuel Palma dos Reis, Dr.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, it is not possible to blind the patient or the healthcare professional; however, the professional who analyses the data will be unaware of the type of catheter used for each patient.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Comparative, randomized, controlled, multicentric clinical study with two arms

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 26, 2024
• Study Start: February 10, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Within one year from the completion of the clinical investigation or three months after its early termination or temporary cessation. When, for scientific reasons, would not possible to submit the clinical research report within one year after completion of the research, it will be submitted as soon as it is available.
• Access Criteria: Available from the Sponsor upon reasonable request.

Locations

ES (3); PT (3)