Open Access Highly Accessed Study protocol

A randomized controlled trial to assess the efficacy and cost-effectiveness of urinary catheters with silver alloy coating in spinal cord injured patients: trial protocol

Xavier Bonfill12345, David Rigau23*, María Luisa Jáuregui-Abrisqueta6, Juana María Barrera Chacón7, Sebastián Salvador de la Barrera8, Carolina María Alemán-Sánchez9, Manuel Bea-Muñoz10, Susana Moraleda Pérez11, Albert Borau Duran12, Juan Ramón Espinosa Quirós13, Luís Ledesma Romano14, Manuel Esteban Fuertes15, Ignacio Araya16 and Ma José Martínez-Zapata234

Author Affiliations

1 Service of Clinical Epidemiology, Hospital de la Santa Creu i Sant Pau, Calle Sant Antoni M. Claret, 167, PO: 08025, Barcelona, Spain

2 Iberoamerican Cochrane Centre, Calle Sant Antoni M. Claret, 167, PO: 08025, Barcelona, Spain

3 Institute of Biomedical Research (IIB Sant Pau), Barcelona, Spain

4 CIBERESP (CIBER de Epidemiología y Salud Pública), Barcelona, Spain

5 Department of Paediatrics, Obstetrics and Gynaecology and Preventive Medicine, Universitat Autònoma de Barcelona, Bellaterra, Spain

6 Hospital Universitario Cruces, Plaza de Cruces s/n, PO: 48903, Barakaldo Bizkaia, Spain

7 Hospital Universitario Virgen del Rocío, Avenida Manuel Siurot s/n, PO: 41013, Sevilla, Spain

8 Complexo Hospitalario Universitrio A Coruña, Avenida As Xubias s/n, PO: 15006, A Coruña, Spain

9 Complejo Hospitalario Universitario Insular Materno Infantil, Avenida Marítima del Sur, s/n. PO: 35016, Las Palmas de Gran Canaria, Spain

10 Hospital Universitario Central de Astúrias, Calle Celestino Villamil, s/n. PO: 33006, Oviedo, Spain

11 Hospital Universitario La Paz, Paseo de la Castellana, 261, PO: 28046, Madrid, Spain

12 Hospital de Neurorrehabilitación - Instituto Guttmann, Camí de Can Ruti, s/n, PO: 08916, Badalona, Spain

13 Hospital Universitario Puerta del Mar, Avenida Ana de Viya, 21, PO: 11500, Cádiz, Spain

14 Hospital Universitario Miguel Servet, Calle Isabel la Católica, 1-3, PO: 50009, Zaragoza, Spain

15 Hospital Nacional de Parapléjicos de Toledo, Finca de La Peraleda, s/n, PO: 45071, Toledo, Spain

16 Departamento de Cirugía y Traumatología Maxilofacial, Facultad de Odontología - Universidad de Chile, Calle Sergio Livingstone Pohlhammer 943, Independencia, PO: 8380–492, Santiago de Chile, Chile

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BMC Urology 2013, 13:38  doi:10.1186/1471-2490-13-38

Published: 30 July 2013

Abstract

Background

Patients with non-acute spinal cord injury that carry indwelling urinary catheters have an increased risk of urinary tract infection (UTIs). Antiseptic Silver Alloy-Coated Silicone Urinary Catheters seems to be a promising intervention to reduce UTIs; however, actual evidence cannot be extrapolated to spinal cord injured patients. The aim of this trial is to make a comparison between the use of antiseptic silver alloy-coated silicone urinary catheters and the use of standard urinary catheters in spinal cord injured patients to prevent UTIs.

Methods/Design

The study will consist in an open, randomized, multicentre, and parallel clinical trial with blinded assessment. The study will include 742 spinal cord injured patients who require at least seven days of urethral catheterization as a method of bladder voiding. Participants will be online centrally randomized and allocated to one of the two study arms (silver alloy-coated or standard catheters). Catheters will be used for a maximum period of 30 days or removed earlier if the clinician considers it necessary. The main outcome will be the incidence of UTIs by the time of catheter removal or at day 30 after catheterization, the event that occurs first. Intention-to-treat analysis will be performed, as well as a primary analysis of all patients.

Discussion

The aim of this study is to assess whether silver alloy-coated silicone urinary catheters improve ITUs in spinal cord injured patients. ESCALE is intended to be the first study to evaluate the efficacy of the silver alloy-coated catheters in spinal cord injured patients.

Trial registration

NCT01803919

Keywords:
Spinal cord injuries; Urinary tract infection; Urinary catheters; Protocol; Randomized clinical trial