Urinary Tract InfectionsES-Stimquick UNCT04587999
Quick-Wee Versus Bladder Stimulation System to Collect Midstream Urine From Pre-continent Infants
A study testing bladder stimulation and Quick wee in people with Urinary Tract Infections, run by Fondation Lenval at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- bladder stimulation and Quick wee
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 29 Jan 2021to 17 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites
Centre Hospitalier Antibes Juan les Pins
Antibes
Hôpitaux Pédiatriques de Nice CHU-Lenval
Nice
About this study
Official title: Quick-Wee Versus Bladder Stimulation to Collect Midstream Urine From Pre-continent Infants: a Randomized Controlled Trial
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.
Read more
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.
Read the 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
- Conditions
- Urinary Tract Infections
- Being tested
- bladder stimulation, Quick wee
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bladder stimulationOther
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 weeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| bladder stimulation | Experimental | Not described Receives: Other: bladder stimulation |
| Quick wee | Active comparator | Not described Receives: Other: Quick wee |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at the end of intervention completion, an average 30 minutes
Secondary outcomes (4)
time needed to obtain urines
measure of times needed to obtain urines in minutes and seconds
Measured: at the end of intervention completion, an average 30 minutes
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.
Measured: through intervention completion, an average 30 minutes
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
Measured: at 48 hours after inclusion
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)
Measured: through intervention completion, an average 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start29 Jan 2021
- Primary completion6 Jun 2022
- Study completion17 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587999
- Sponsor's protocol ID
- 20-HPNCL-04
- Acronym
- ES-Stimquick U
- Status last verified
- Sep 2023
- First submitted
- 25 Sep 2020
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34531206
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quick-Wee Versus Bladder Stimulation to Collect Midstream Urine From Pre-continent Infants: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04587999
- Acronym / sponsor ID
- ES-Stimquick U / 20-HPNCL-04
- Conditions
- Urinary Tract Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bladder stimulation | Experimental | Other: bladder stimulation |
| Quick wee | Active comparator | Other: Quick wee |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bladder stimulationThe 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 | bladder stimulation |
| Quick weeThe 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. | Other | Quick wee |
Primary outcome
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
4 secondary outcomes
time needed to obtain urines
Time frame: at the end of intervention completion, an average 30 minutes
patient comfort
Time frame: through intervention completion, an average 30 minutes
Bacterial contamination rates of urine samples
Time frame: at 48 hours after inclusion
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Derived from this study: PubMed 34531206Marchal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bladder stimulation and Quick wee in people with Urinary Tract Infections, run by Fondation Lenval at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
volume of urine collection to measure the effectiveness of two techniques (time frame: at the end of intervention completion, an average 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04587999, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.