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.
Subject(s)
Catheter-Related Infections/economics , Catheter-Related Infections/prevention & control , Silver/administration & dosage , Spinal Cord Injuries/economics , Urinary Catheters/economics , Urinary Incontinence/economics , Urinary Incontinence/therapy , Adolescent , Adult , Aged , Aged, 80 and over , Alloys/administration & dosage , Alloys/chemistry , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/chemistry , Bacterial Infections/economics , Bacterial Infections/epidemiology , Bacterial Infections/prevention & control , Catheter-Related Infections/epidemiology , Coated Materials, Biocompatible/administration & dosage , Coated Materials, Biocompatible/chemistry , Comorbidity , Cost-Benefit Analysis , Equipment Design , Equipment Failure Analysis , Female , Humans , Incidence , Male , Middle Aged , Research Design , Risk Factors , Silver/chemistry , Single-Blind Method , Spain/epidemiology , Spinal Cord Injuries/epidemiology , Spinal Cord Injuries/therapy , Treatment Outcome , Urinary Catheters/statistics & numerical data , Urinary Incontinence/epidemiology , Young AdultABSTRACT
OBJECTIVES: To determine the prevalence of radiologic images suggestive of urethral diverticula (UD) in men with spinal cord injury (SCI) and to study the interobserver diagnostic reproducibility. METHODS: Radiological studies (i.e. voiding cystourethrography and retrograde urethrography) performed over 1 year on men with SCI were independently reviewed by 3 researchers (1 urologist and 2 radiologists). RESULTS: The prevalence of UD was found to be between 4.2 and 9.8% of the patients, the higher figure obtained when including also the doubtful images. The kappa index of agreement between the researchers was low (between 0.15 and 0.40). The factors that significantly influenced agreement were localization in the prostatic urethra (p = 0.021), localization in the penile urethra (p = 0.000) and fusiform morphology (p = 0.004). Logistic regression analysis showed that the variables that independently influenced diagnostic agreement were the following: localization in the penile urethra (in favor of agreement) and fusiform morphology (against agreement). CONCLUSIONS: Radiologic images suggestive of UD constitute a frequent finding in men with SCI and raise important diagnostic problems.
