Evaluation of bladder stimulation as a non-invasive technique for urine collection to diagnose urinary tract infection in infants under 6 months: a randomized multicenter study (“EE-Sti.Ve.N”)

Abstract

BackgroundFebrile urinary tract infection (UTI) is common in infants and needs to be diagnosed quickly. However, the symptoms are non-specific, and diagnosis can only be confirmed after high quality urinalysis. The American Academy of Pediatrics recommends suprapubic aspiration (1–9% contamination) and urinary catheterization (8–14% contamination) for urine collection but both these procedures are invasive. Recent studies have shown a new non-invasive method of collecting urine, bladder stimulation, to be quick and safe. However, few data about bacterial contamination rates have been published for this technique. We hypothesize that the contamination rate of urine collection by bladder stimulation to diagnose febrile UTI in infants under 6 months is equivalent to that of urinary catheterization.Methods/designThis trial aims to assess equivalence in terms of bacterial contamination of urinary samples collected by urinary catheterization and bladder stimulation to diagnose UTI. Seven hundred seventy infants under 6 months presenting with unexplained fever in one of four Pediatric Emergency Departments in France will be enrolled. Each child will be randomized into a bladder stimulation or urinary catheterization group. The primary endpoints will be the validity of the urine sample assessed by the presence of contamination on bacterial culture.ConclusionA high recruitment rate is achievable due to the high prevalence of suspected UTIs in infants. The medical risk is the same as that for routine clinical care as we analyze patients with isolated fever.If our hypothesis holds true and the rate of urine contamination collected by bladder stimulation is acceptable, the infants included in the study will have benefited from a non-invasive and reliable means of collecting urine.Trial registrationClinicalTrials.gov, NCT03801213. Registered on 11 January 2019.

Evaluation of the Quick Wee method of inducing faster clean catch urine collection in pre-continent infants: a randomized controlled trial

“…Of the 27 infants < 1 month old, 24 (88.9%) voided as opposed to 2 (28.6%) of the 7 participants > 1 year of age. Cohort studies can overestimate effect sizes and consequently, an RCT by Demoncy to define the impact of bladder stimulation, as a non-invasive technique to collect urine, to diagnose UTI in infants < 6 months is currently underway [ 18 ].…”

Vaginal or Fecal Contamination Which Contributes to Parasite Existence in Urine Sediment

“…There are two methods to obtain a urine specimen: non-invasive (for example, urine bags, pads, or clean catch) [43] and invasive (for example, catheter or SPA) techniques [44]. Spontaneous voiding is the main non-invasive technique, such as commonly used in cases of dysfunctional voiding [45] although other strategies may be used in children who cannot yet control their voiding, such as the use of bag urine [46].…”

Outpatient urine collection methods for paediatric urinary tract infections: Systematic review of diagnostic accuracy studies

“…However, parents prefer bags and pads to the clean‐catch method, because it is time‐consuming and messy 10 . Some studies, therefore, propose clean‐catch urine with additional bladder stimulation or cold application to accelerate urination 13–15 …”

“…10 Some studies, therefore, propose clean-catch urine with additional bladder stimulation or cold application to accelerate urination. [13][14][15] The aim of this study was to investigate which collection methods are accurate for diagnosing UTI in children presenting to the outpatient setting.…”