title: 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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  NCT01803919.
authors.forename: Xavier
authors.initials: X
authors.lastname: Bonfill
authors.forename: David
authors.initials: D
authors.lastname: Rigau
authors.forename: María Luisa
authors.initials: ML
authors.lastname: Jáuregui-Abrisqueta
authors.forename: Juana María
authors.initials: JM
authors.lastname: Barrera Chacón
authors.forename: Sebastián Salvador
authors.initials: SS
authors.lastname: de la Barrera
authors.forename: Carolina María
authors.initials: CM
authors.lastname: Alemán-Sánchez
authors.forename: Manuel
authors.initials: M
authors.lastname: Bea-Muñoz
authors.forename: Susana
authors.initials: S
authors.lastname: Moraleda Pérez
authors.forename: Albert
authors.initials: A
authors.lastname: Borau Duran
authors.forename: Juan Ramón
authors.initials: JR
authors.lastname: Espinosa Quirós
authors.forename: Luís
authors.initials: L
authors.lastname: Ledesma Romano
authors.forename: Manuel Esteban
authors.initials: ME
authors.lastname: Fuertes
authors.forename: Ignacio
authors.initials: I
authors.lastname: Araya
authors.forename: Ma José
authors.initials: MJ
authors.lastname: Martínez-Zapata
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys / Q000008:administration & dosage / Q000737:chemistry; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000737:chemistry; D001424:Bacterial Infections / Q000191:economics / Q000453:epidemiology / Q000517:prevention & control; D055499:Catheter-Related Infections / Q000191:economics* / Q000453:epidemiology / Q000517:prevention & control*; D020099:Coated Materials, Biocompatible / Q000008:administration & dosage / Q000737:chemistry; D015897:Comorbidity; D003362:Cost-Benefit Analysis; D004867:Equipment Design; D019544:Equipment Failure Analysis; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D012107:Research Design; D012307:Risk Factors; D012834:Silver / Q000008:administration & dosage* / Q000737:chemistry; D016037:Single-Blind Method; D013030:Spain / Q000453:epidemiology; D013119:Spinal Cord Injuries / Q000191:economics* / Q000453:epidemiology / Q000628:therapy; D016896:Treatment Outcome; D062885:Urinary Catheters / Q000191:economics* / Q000706:statistics & numerical data; D014549:Urinary Incontinence / Q000191:economics* / Q000453:epidemiology / Q000628:therapy*; D055815:Young Adult
chemical_list: D000497:Alloys; D000900:Anti-Bacterial Agents; D020099:Coated Materials, Biocompatible; D012834:Silver
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