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Quick-Wee Versus Bladder Stimulation System to Collect Midstream Urine From Pre-continent Infants (ES-Stimquick U)

F

Fondation Lenval

Status

Completed

Conditions

Urinary Tract Infections

Treatments

Other: bladder stimulation
Other: Quick wee

Study type

Interventional

Funder types

Other

Identifiers

NCT04587999
20-HPNCL-04

Details and patient eligibility

About

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 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

Enrollment

230 patients

Sex

All

Ages

Under 1 year old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Infants under the age of 1 year, pre-continent, before walking
  • For whom an urine sample is required for the diagnosis of a urinary tract infection, uropathy, nephropathy, metabolic disease
  • Obtaining the authorization by one of the two parents or the holder of parental authority
  • Affiliation to a national social security scheme

Exclusion criteria

  • Do exhibiting signs of vital distress
  • Withdrawal of informed consent by parents or holders of parental authority
  • External genitalia or urinary tract malformation
  • Bladder dysfunction

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

230 participants in 2 patient groups

bladder stimulation
Experimental group
Treatment:
Other: bladder stimulation
Quick wee
Active Comparator group
Treatment:
Other: Quick wee

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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