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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)

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® catheterDevice

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

Experimental arm (T-Control®)

Foley-type catheterDevice

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

Control arm (Foley)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Study Sites (6)

Prof. Doutor Fernando Fonseca Hospital

Amadora, 2720-276, Portugal

Egas Moniz Hospital

Lisbon, 1349-019, Portugal

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

Lisbon, 1649-028, Portugal

Regional University Hospital of Malaga

Málaga, Andalucía/Spain, 29010, Spain

Rey Juan Carlos University Hospital

Móstoles, Madrid/Spain, 28933, Spain

La Fe University and Polytechnic Hospital

Valencia, Valencia, 46026, Spain

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

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

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

Sponsor Type

INDUSTRY

Responsible Party

SPONSOR

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (6)

Study Arms (2)

Experimental arm (T-Control®)

Control arm (Foley)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Conditions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (6)

Study Arms (2)

Experimental arm (T-Control®)

Control arm (Foley)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Conditions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations