The QuickWee trial: protocol for a randomised controlled trial of gentle suprapubic cutaneous stimulation to hasten non-invasive urine collection from infants

INTRODUCTION: Urinary tract infections (UTIs) are common in young children. Urine sample collection is required to diagnose or exclude UTI; however, current collection methods for pre-continent children all have limitations and guidelines vary. Clean catch urine (CCU) collection is a common and favoured non-invasive collection method, despite its high contamination rates and time-consuming nature. This study aims to establish whether gentle suprapubic cutaneous stimulation with cold fluid-soaked gauze can improve the rate of voiding for CCU within 5 min in young pre-continent children. METHODS AND ANALYSIS: This study is a randomised controlled trial of 354 infants (aged 1-12 months) who require urine sample collection, conducted in a single emergency department in a tertiary paediatric hospital in Melbourne, Australia. After standard urogenital cleaning, patients will be randomised to either a novel technique of suprapubic cutaneous stimulation using cold saline-soaked gauze in circular motions or no stimulation. The study period is 5 min, after which care is determined by the treating clinician if a urine sample has not been collected. PRIMARY OUTCOME: whether the child voids within 5 min (yes/no). SECONDARY OUTCOMES: parental and clinician satisfaction with the method, success in catching a urine sample if the child voids, and sample contamination rates. This trial will allow the definitive assessment of this novel technique, gentle suprapubic cutaneous stimulation with cold saline-soaked gauze, and its utility to hasten non-invasive urine collection in infants. ETHICS AND DISSEMINATION: The study has hospital ethics approval and is registered with the Australian New Zealand Clinical Trials Registry-ACTRN12615000754549. The results of the study will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ACTRN12615000754549; Pre-results.