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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-29

Study Completion Date

2022-11-17

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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bladder stimulation

Group Type EXPERIMENTAL

bladder stimulation

Intervention Type OTHER

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.

Quick wee

Group Type ACTIVE_COMPARATOR

Quick wee

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No