Quick-Wee Versus Bladder Stimulation System to Collect Midstream Urine From Pre-continent Infants (ES-Stimquick U)
Primary Purpose
Urinary Tract Infections
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
bladder stimulation
Quick wee
Sponsored by
About this trial
This is an interventional diagnostic trial for Urinary Tract Infections
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
Sites / Locations
- Centre Hospitalier Universitaire de Sainte-Justine
- Centre Hospitalier Antibes Juan les Pins
- Hôpitaux Pédiatriques de Nice CHU-Lenval
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
bladder stimulation
Quick wee
Arm Description
Outcomes
Primary Outcome Measures
volume of urine collection to measure the effectiveness of two techniques
measure of success of the urine collection technique is determined by collecting at least 2 millimeters of urine in less than 5 minutes
Secondary Outcome Measures
time needed to obtain urines
measure of times needed to obtain urines in minutes and seconds
patient comfort
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
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
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)
Full Information
NCT ID
NCT04587999
First Posted
September 25, 2020
Last Updated
September 28, 2023
Sponsor
Fondation Lenval
1. Study Identification
Unique Protocol Identification Number
NCT04587999
Brief Title
Quick-Wee Versus Bladder Stimulation System to Collect Midstream Urine From Pre-continent Infants
Acronym
ES-Stimquick U
Official Title
Quick-Wee Versus Bladder Stimulation to Collect Midstream Urine From Pre-continent Infants: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 29, 2021 (Actual)
Primary Completion Date
June 6, 2022 (Actual)
Study Completion Date
November 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Lenval
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bladder stimulation
Arm Type
Experimental
Arm Title
Quick wee
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
bladder stimulation
Intervention Description
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
Intervention Name(s)
Quick wee
Intervention Description
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.
Primary Outcome Measure Information:
Title
volume of urine collection to measure the effectiveness of two techniques
Description
measure of success of the urine collection technique is determined by collecting at least 2 millimeters of urine in less than 5 minutes
Time Frame
at the end of intervention completion, an average 30 minutes
Secondary Outcome Measure Information:
Title
time needed to obtain urines
Description
measure of times needed to obtain urines in minutes and seconds
Time Frame
at the end of intervention completion, an average 30 minutes
Title
patient comfort
Description
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.
Time Frame
through intervention completion, an average 30 minutes
Title
Bacterial contamination rates of urine samples
Description
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
Time Frame
at 48 hours after inclusion
Title
collection of patient data to define risk factors associated with the failure of the bladder stimulation techniques
Description
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)
Time Frame
through intervention completion, an average 30 minutes
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Sainte-Justine
City
Montréal
Country
Canada
Facility Name
Centre Hospitalier Antibes Juan les Pins
City
Antibes
Country
France
Facility Name
Hôpitaux Pédiatriques de Nice CHU-Lenval
City
Nice
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
34531206
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.
Results Reference
derived
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Quick-Wee Versus Bladder Stimulation System to Collect Midstream Urine From Pre-continent Infants
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