Clinical trial NCT04587999: Quick-Wee Versus Bladder Stimulation System to Collect Midstream Urine From Pre-continent Infants
Official title: Quick-Wee Versus Bladder Stimulation to Collect Midstream Urine From Pre-continent Infants: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 230
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: volume of urine collection to measure the effectiveness of two techniques
timeFrame: at the end of intervention completion, an average 30 minutes
Secondary outcomes:
measure: time needed to obtain urines
timeFrame: at the end of intervention completion, an average 30 minutes
measure: patient comfort
timeFrame: through intervention completion, an average 30 minutes
measure: Bacterial contamination rates of urine samples
timeFrame: at 48 hours after inclusion
measure: collection of patient data to define risk factors associated with the failure of the bladder stimulation techniques
timeFrame: through intervention completion, an average 30 minutes
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier Universitaire de Sainte-Justine
city: Antibes
country: France
facility: Centre Hospitalier Antibes Juan les Pins
city: Nice
country: France
facility: Hôpitaux Pédiatriques de Nice CHU-Lenval
Study officials:
References:
citation: Marchal S, Janicot J, Salicis J, Demonchy D, Herisse AL, Olla M, Rancurel A, Haas H, Berard E, Breaud J, Bernardor J, Ribet C, Freyssinet E, Donzeau D, Desmontils J, Schori-Fortier C, Fontas E, Tran A. Quick-Wee versus bladder stimulation to collect midstream urine from precontinent infants under 1 year of age: a study protocol for a randomised controlled trial (ES.Stimquick.U). BMJ Open. 2021 Sep 16;11(9):e046324. doi: 10.1136/bmjopen-2020-046324.