Quick-Wee Versus Bladder Stimulation System to Collect Midstream Urine From Pre-continent Infants

Overview

Urinary tract infections are common in infants. Obtaining urine from pre-continent children can be difficult and time consuming. The method of collection must balance reliability, speed, low rate of contamination, and invasiveness.

According to the American Academy of Pediatrics, midstream clean-catch urine is an acceptable method to diagnose urinary tract infections. However, it is impractical in pre-continent children.

Recently, two quick, safe and effective methods have been reported in the literature:

- The Quick-wee method: it consists in stimulating the suprapubic area with a cold and wet compress to obtain urines.

- The bladder stimulation method : the child is held under the armpits with legs dangling and a physician taps the suprapubic area and massages lumbar area alternatively.

However, advanced age, high weight, and level of discomfort during bladder stimulation were significantly associated with failure to obtain urines.

Full Title of Study: “Quick-Wee Versus Bladder Stimulation to Collect Midstream Urine From Pre-continent Infants: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2022

Detailed Description

Urinary tract infections (UTI) are common in infants. The diagnosis of a UTI has important implications for follow-up, and delayed treatment can result in morbidity, including renal scarring and serious bacterial infection.

Obtaining urine from pre-continent children can be difficult and time consuming, the method of collection must balance reliability, speed, low rate of contamination, and invasiveness The actual guidelines recommend suprapubic aspiration or bladder catheterization for collection of urine sample in pre-continent children, but these methods are invasive.

The most common way to collect urines in infants is the use of a sterile collection bag. This is an easy technique, but time consuming and responsible for high rate of contamination, leading to false positives.

According to the American Academy of Pediatrics, midstream clean-catch urine is an acceptable method to diagnose urinary tract infection. However, it is impractical in pre-continent children.

Recently, two quick, safe and effective methods have been reported in the literature:

- The Quick-wee method: it consists in stimulating the suprapubic area with a cold and wet compress to obtain urines.

- The bladder stimulation method: the child is held under the armpits with legs dangling and a physician taps the suprapubic area and massages lumbar area alternatively.

However, advanced age, high weight, and level of discomfort during bladder stimulation were significantly associated with failure to obtain urines.

Futhermore, even if urine collection in pre-continent children most often concerns urinary tract infections, these techniques could also be used to look for a metabolic abnormality, an uropathy or a nephropathy (urine electrolyte concentrations, proteinuria, hematuria).

The aim of the study is to compare the effectiveness of two non-invasive midstream urine collection methods in pre-continent children : "the Quick-Wee method" and "the Bladder stimulation method".

The investigators will also compare in the two groups the time required to obtain urine sample, the comfort of the infant during urine collection and the quality of urines.

Finally, for each technique will be analyzed the risk factors associated with failure in obtaining urine sample

Interventions

  • Other: bladder stimulation
    • The bladder stimulation technique requires the presence of 2 people: The child must be held by an adult (caregiver or parent) under the armpits, legs dangling. the first person (the investigator), performs the stimulation technique consisting of: rapid tapping (frequency of about 100 / min), over the pubic area, at the level of the bladder, alternated with external rotational movements of the pits lumbar, in the kidneys. Alternate these 2 maneuvers every 30 seconds. The second person starts the stopwatch at the start of the stimulation, and is about to collect the urine, 2nd jet in a sterile pot The maneuver ends as soon as urine is obtained, and will be stopped after 5 minutes in case of failure.
  • Other: Quick wee
    • The Quick wee technique requires the presence of only one person: Stimulation of the suprapubic area by circular movements, with a cold and wet compress held by sterile forceps. Collection of urine in a sterile container.

Arms, Groups and Cohorts

  • Experimental: bladder stimulation
  • Active Comparator: Quick wee

Clinical Trial Outcome Measures

Primary Measures

  • volume of urine collection to measure the effectiveness of two techniques
    • Time Frame: at the end of intervention completion, an average 30 minutes
    • measure of success of the urine collection technique is determined by collecting at least 2 millimeters of urine in less than 5 minutes

Secondary Measures

  • time needed to obtain urines
    • Time Frame: at the end of intervention completion, an average 30 minutes
    • measure of times needed to obtain urines in minutes and seconds
  • patient comfort
    • Time Frame: through intervention completion, an average 30 minutes
    • pain is measured by Evaluation ENfant DOuLeur (EVENDOL) scale while the technique is performed. EVENDOL is a pain scale for children under 7. A pain scale validated for children from birth to 7 years. Score ranges from 0 to 15. Treatment threshold: 4/15.
  • Bacterial contamination rates of urine samples
    • Time Frame: at 48 hours after inclusion
    • Measure of bacterial contamination of urine sample is by: numeration the growth of two or more micro-organisms, Or numeration the presence of a non-uropathogenic germ (lactobacilli, Staphylococcus Coagulase negative, Corynebacterium), or numeration a bacteriuria> 0 colony forming unit(CFU)/millimeters (mL) but <10˄4 CFU / ml for bladder catheterization and <10˄5 CFU / mL for clean catch urine collected by bladder stimulation, or leukocyturia <10˄4 / mL
  • collection of patient data to define risk factors associated with the failure of the bladder stimulation techniques
    • Time Frame: through intervention completion, an average 30 minutes
    • collection patient data : pain, weight, sex, age, last food and time since last collect urine The goal is to define potential risk factors to failure urine collection (urinary sample quantity < 2 millimeters or no urinary sample collected)

Participating in This Clinical Trial

Inclusion Criteria

  • Infants under the age of 1 year
  • For whom an urine sample is required for the diagnosis of a urinary tract infection, uropathy, nephropathy, metabolic disease
  • Obtaining the authorization of the holders of parental authority

Exclusion Criteria

  • Do exhibiting signs of vital distress
  • Withdrawal of informed consent by parents or holders of parental authority
  • Transfer of the child to a hospital unit after the 1st attempt

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 1 Year

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fondation Lenval
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Sarah MARCHAL, MD, 4 92 03 04 42, marchal.s@pediatrie-chulenval-nice.fr

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