Efficacy Study of Antimicrobial Catheters to Avoid Urinary Infections in Spinal Cord Injured Patients (ESCALE)

Multicentric, Controlled, Randomized Clinical Trial to Assess the Efficacy and Cost-effectiveness of Urinary Catheters With Silver Alloy Coating Versus Conventional Catheters in Spinal Cord Injured Patients

The purpose of this trial is to make a comparison between the use of antiseptic silver alloy-coated silicone urinary catheters and the use of conventional silicone urinary catheters in spinal cord injured patients to prevent urinary infections.

Study Overview

• Status: Terminated
• Conditions: Urinary Tract Infection
• Intervention / Treatment: Device: Silver Alloy-Coated Urinary Catheters; Device: Conventional Urinary Catheter

Detailed Description

Antiseptic Silver Alloy-Coated Silicone Urinary Catheters seems to be a promising intervention to reduce urinary tract infections; however, research evidence cannot be extrapolated to spinal cord injured patients.

The study is an open, randomized, multicentric, and parallel clinical trial with blinded assessment. The study includes spinal cord injured patients who require at least seven days of urethral catheterization as a method of bladder voiding. Participants are on-line centrally randomized and allocated to one of the two interventions (Antiseptic Urinary Catheters or Conventional Catheters). Catheters are used for a maximum period of 30 days or removed earlier at the clinician criteria.

The main outcome is the incidence of urinary tract infections 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.

The aim of this study is to assess whether silver alloy-coated silicone urinary catheters reduce urinary infections in spinal cord injured patients.

• Study Type: Interventional
• Enrollment (Actual): 489
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Santiago de Chile, Chile, 4848
    • Mutual de la Seguridad Chilena
• Italy
  • Ancona, Italy
    • Azienda Ospedaliero-Universitaria - Ospedali Riuniti di Ancona - Unità Spinale
  • Bari, Italy, 70124
    • Azienda Ospedaliero-Universitaria Policlinico di Bari- Unità Operativa di Medicina Fisica e Riabilitazione e Unità Spinale Unipolare
  • Ceglie Messapica, Italy, 72013
    • Unità Operative Recupero e Riabilitazione Funzionale e Gravi Cerebrolesioni Acquisite
  • Rome, Italy, 00142
    • Unità Spinale Unipolare
• Portugal
  • Braga, Portugal, 4710-243
    • Centro Clínico Académico - Braga, Associação (2CA-Braga)
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto
  • Alcabideche
    • Alcoitão, Alcabideche, Portugal, 2649-506
      • Centro de Medicina de Reabilitação de Alcoitão
• Spain
  • A Coruña, Spain
    • Complexo Hospitalario Universitario A Coruña
  • Cadiz, Spain
    • Hospital Universitario Puerta Del Mar
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Sevilla, Spain
    • Hospital Universitario Virgen del Rocío
  • Toledo, Spain
    • Hospital Nacional de Parapléjicos
  • Zaragoza, Spain
    • Hospital Universitario Miguel Servet
  • Asturias
    • Oviedo, Asturias, Spain
      • Hospital Universitario Central de Asturias
  • Barcelona
    • Badalona, Barcelona, Spain
      • Hospital de Neurorrehabilitación Instituto Guttmann
  • Las Palmas
    • Las Palmas de Gran Canaria, Las Palmas, Spain
      • Complejo Hospitalario Universitario Insular - Materno Infantil de Canarias
  • Vizcaya
    • Barakaldo, Vizcaya, Spain
      • Hospital Universitario Cruces
• Turkey
  • Izmir
    • Alsancak, Izmir, Turkey, 35210
      • Dokuz Eylul University Dept. of Physical Medicine and Rehabilitation
  • İzmir
    • Bornova, İzmir, Turkey, 35040
      • Ege University Dept. of Physical Medicine and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female patients with traumatic or medical spinal cord injury
• Age of 18 years or above
• Patients who need an indwelling urinary catheter as a method of bladder drainage for at least 7 days.
• Patients who are willing to participate in the study and give their written informed consent (If a patient is unable to give written consent because of physical or mental disability, an affirmation of consent will be taken in his presence from his relative or legal guardian).

Exclusion Criteria:

• Patients who can benefit from other method of bladder drainage such as intermittent catheterization, suprapubic drainage, reflex voiding or use of an external collector.
• Patients with urinary tract infection at the moment of inclusion
• Current antibiotic use or use within 7 days prior to inclusion
• Outpatients with sporadic medical examinations (less than one per month)
• Known allergy to latex, silver salts or hydrogels.
• Patients with surgical interventions in the urinary tract that may interfere, at the investigator criteria, with the study results.
• Pregnant or breastfeeding woman.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Silver Alloy-Coated Urinary Catheters; Bactiguard® Infection Protection coating consists of noble metals such as gold, palladium and silver. Trained health staff performs urethral catheterization and select the most adequate catheter size. To ensure aseptic conditions they are asked to strictly follow the current protocol in their respective centers. Indwelling urethral catheters are periodically replaced about 30 days of use; to not interfere with current clinical practice, the policy of each center (or the investigator criteria) for catheter replacement and removal is considered valid for this study.	Device: Silver Alloy-Coated Urinary Catheters; Other Names: BIP Foley catheter - Silicone Bactiguard Infection Protection
OTHER: Conventional Urinary Catheter; Conventional or standard urinary catheters are those commonly used in each study center, most of them made of silicone or silicone-latex. Trained health staff performs urethral catheterization and select the most adequate catheter size. To ensure aseptic conditions they are asked to strictly follow the current protocol in their respective centers. Indwelling urethral catheters are periodically replaced about 30 days of use; to not interfere with current clinical practice, the policy of each center (or the investigator criteria) for catheter replacement and removal is considered valid for this study.	Device: Conventional Urinary Catheter; Other Names: Foley silicona 100% (16 or 18 Ch); Foley Rüsch (16 or 18 Ch); Foley Bardex (16 or 18 Ch); Folysil (16 or 18 Ch); Foley Rochester (16 or 18 Ch); Foley Euromedical (16 or 18 Ch)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of catheter associated urinary tract infection	Is considered that a patient suffer a urinary tract infection if they have at least one suggestive sign or symptom with no other recognized cause and a positive urine culture with no more than 2 species of microorganisms. An urinary tract infection is considered catheter associated if the specimen collection is performed at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first).	at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asymptomatic urinary tract infection	A positive urine culture with no more than 2 species of microorganisms(collected at any time from catheterization procedure and 30th day, catheter removal or catheter replacement, whichever occurs first), and no signs or symptoms.	at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)
Bacteremic urinary tract infection	Those with the primary outcome and with a positive blood culture with at least 1 matching uropathogen microorganism to the urine culture.	at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Direct costs	Calculation of direct costs attributable to the use of intervention or control urinary catheters and their complications	From catheterization procedure and 30th day, catheter removal or catheter replacement or finalization of complication(s) or related treatment(s), whichever last longer.
Number of participants with adverse events related to catheterization as a Measure of Safety and Tolerability	Any untoward medical occurrence related to urinary catheterization	at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborators: European Clinical Research Infrastructure Network; Asociacion Colaboracion Cochrane Iberoamericana
• Investigators: Principal Investigator: Xavier Bonfill, MD, PhD, Asociación Colaboración Cochrane Iberoamericana

Publications and helpful links

General Publications

• Bonfill X, Rigau D, Jauregui-Abrisqueta ML, Barrera Chacon JM, de la Barrera SS, Aleman-Sanchez CM, Bea-Munoz M, Moraleda Perez S, Borau Duran A, Espinosa Quiros JR, Ledesma Romano L, Fuertes ME, Araya I, Martinez-Zapata MJ. 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. BMC Urol. 2013 Jul 30;13:38. doi: 10.1186/1471-2490-13-38.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): January 1, 2016

Study Registration Dates

• First Submitted: February 26, 2013
• First Submitted That Met QC Criteria: March 1, 2013
• First Posted (ESTIMATE): March 4, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): September 20, 2016
• Last Update Submitted That Met QC Criteria: September 19, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Randomized clinical trial; Urinary tract infection; Protocol; Spinal cord injuries; Urinary catheters
• Additional Relevant MeSH Terms: Urologic Diseases; Infections; Urinary Tract Infections
• Other Study ID Numbers: IIBSP-SUR-2011-68; 112210 (OTHER_GRANT: La Fundació La Marató de TV3)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES