Peer-reviewed article

Stimulation methods for collecting urine from hospitalised precontinent infants: study protocol for a prospective, multicentre, open-label, three-arm, parallel-group randomised controlled trial.

Li F, Yuan C, Cao F, Feng P, Li S et al. · 12 Mar 2026

Abstract

Introduction Obtaining clean-catch urine (CCU) samples from non-continent infants is a common clinical challenge due to low urine volume and irregular urination. Non-invasive stimulation techniques, such as the bladder stimulation technique (BST) and the Quick-Wee method, have been proposed to improve success rates and reduce contamination. However, the supporting evidence remains inconsistent, and no multicentre randomised trials have directly compared the effectiveness and safety of Quick-Wee, BST and standard CCU. Methods and analysis The study will enrol 342 infants aged 1-12 months requiring urinalysis, recruited from paediatric wards across three tertiary hospitals in China. Eligible participants will be randomly assigned in a 1:1:1 ratio to one of three intervention groups: BST, Quick-Wee or standard CCU. The primary endpoint is the success rate of urine collection within 5 min of intervention. Secondary endpoints include time to urination, 5 min urination rate, infant discomfort scores, parental and clinician satisfaction, and urine contamination rates. Safety will be evaluated by monitoring the incidence of adverse events. Ethics and dissemination This study was approved by the Biomedical Ethics Review Committee of West China Hospital, Sichuan University (No. 114/2025). Written informed consent will be obtained from all participants' parents prior to enrolment. Study findings will be published in peer-reviewed journals and presented at relevant conferences. Individual participant data will be kept strictly confidential and securely stored in compliance with data protection regulations. Trial registration number ChiCTR2500098691.