Urinary Tract Infection BacterialEEStiVeNNCT03801213
Evaluation of Urine Samples Obtained by Bladder Stimulation for the Diagnosis of Urinary Tract Infection in Infants
A study testing urinary catheterization and manual bladder stimulation technique in people with Urinary Tract Infection Bacterial, run by Fondation Lenval at 4 sites in France.
Trial summary
Urinary tract infection (UTI) is the most common serious bacterial infection among infants. Suprapubic aspiration and bladder catheterization are considered as the gold standard by the American Academy of Pediatrics for the diagnosis, yet it is painful and invasive. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Urinary Tract Infection Bacterial
- What is being tested?
- urinary catheterization and manual bladder stimulation technique
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 4 sitesFrance
- Study dates
- 12 Dec 2019to 12 Dec 2023
- 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 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants under the age of 6 months
- For whom an urine sample is required for the diagnosis of a urinary tract infection as follows:
- fever > 39 °C without symptoms
- fever > 38°C and uropathy or urinary tract infection
- fever > 38°C and < 3 months
- fever > 38 °C and > 48h
Show all 9Show fewer
- fever > 38 °C with sepsis signs
- Obtaining the authorization of the holders of parental authority
- Affiliation to French social security
Who cannot join
- Do exhibiting signs of vital distress (respiratory or circulatory or neurological)
- contraindication to bladder catheterization
- antibiotic therapy in the last 48 hours
- antibiotic prophylaxis in the last 48 hours
Trial locations and contacts
4 sites in 1 country.
France4 sites
CH Antibes Juans les Pins
Antibes
CH Grasse
Grasse
CHRU Lille
Lille
Hôpitaux Pédiatriques de Nice CHU-Lenval
Nice
About this study
Official title: Evaluation of the Bladder Stimulation, a Non-invasive Technique of Urine Collection, in Infant Less Than 6 Months to Diagnose Urinary Tract Infection: a Randomized Multicenter Study
Urinary tract infection (UTI) is the most common serious bacterial infection among infants. Suprapubic aspiration and bladder catheterization are considered as the gold standard by the American Academy of Pediatrics for the diagnosis, yet it is painful and invasive. In contrast, the bladder stimulation technique has been shown to be a quick and non-invasive approach to collect urine in young infants. Actually, the investigators don't have data on bacterial contamination rates for clean-catch midstream urine collections using this technique
Read the detailed description
Urinary tract infection (UTI) is common in infants and needs to be diagnosed quickly. The risk for urinary tract infection before the age of 2 years is about 1-4% in boys and 3-8% in girls. A delay in diagnosis exposes to severe complications. In infants, the symptoms are not specific. A good urinalysis quality is therefore necessary for the diagnosis of UTI. Different techniques exist to collect urine samples in these children who do not control their urination yet: supra pubic aspiration, catheterization, urine collection bag and clean catch urine. The American Academy of Pediatrics (AAP) recommends supra pubic aspiration (1-9 % bacterial contamination) and urinary catheterization (8-14 % contamination) for collecting urine but these techniques are invasive and painful. The sterile bag is a non-invasive method of urine collection, with a high bacterial contamination rates (26-62%) leading to unnecessary antibiotic treatment. Finally, clean catch urine is an accepted urine sample to diagnose UTI according to the recommendations (13-27 % of bacterial contamination) but this method is only possible for potty-trained children. Recent studies (Herreros et al, Altuntas et al, Tran et al.) have shown that bladder stimulation, which consists of pubic tapping and lumbar massage, would be a new, effective, non-invasive and safe method of collecting urine in infants.
Bladder stimulation may be performed by a nurse or a physician. The steps of the bladder stimulation technique are as follows: (a) cleaning the genital area with warm water and soap b) bladder stimulation technique, requires the presence of 3 people: infants will be held under their armpits by a parent over the bed, with legs dangling in males and hips flexed in females. The nurse or technician will then alternate between bladder stimulation maneuvers: gentle tapping in the suprapubic area at a frequency of 100 taps per minute for 30 seconds followed by lumbar paravertebral massage maneuvers for 30 seconds. These two stimulation maneuvers will be repeated until micturition begins, or for a maximum of of 3 minutes.
However, the investigators do not have data on the bacterial contamination rate for urine sample using this new technique. the investigators hypothesize that the bladder stimulation is a technique for obtaining urine with a contamination rate equivalent to those obtained by bladder catheterization, in the diagnosis of febrile urinary tract infection in infants under 6 months of age.
- Conditions
- Urinary Tract Infection Bacterial
- Being tested
- urinary catheterization, manual bladder stimulation technique
- Keywords
- Urine Specimen Collection/methods, Infant, Newborn, Feasibility Studies, Bladder stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urinary catheterizationDevice
Urinary catheterization with pain controlled
manual bladder stimulation techniqueProcedure or surgery
manual gentle tapping in the suprapubic area at a frequency of 100 taps per minute for 30 seconds followed by lumbar paravertebral massage maneuvers for 30 seconds. The renal and bladder stimulation will be performed in less than 3 minutes, with a maximum of two attempts spaced about 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Urinary catheterization | Active comparator | Not described Receives: Device: urinary catheterization |
| manual bladder stimulation Technique | Experimental | Not described Receives: Procedure: manual bladder stimulation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial contamination rates of urine samples per bladder stimulation and urinary catheterization
Bacterial contamination of urine sample is defined by:
- the growth of two or more micro-organisms,
- or the presence of a non-uropathogenic germ (lactobacilli, Staphylococcus Coagulase negative, Corynebacterium),
- or a bacteriuria> 0 colony forming unit(CFU)/ml but <104 CFU / ml for bladder catheterization and <105 CFU / ml for clean catch urine collected by bladder stimulation, or leukocyturia <104 / ml
Measured: at 48 hours after inclusion date
Secondary outcomes (4)
Pain of bladder stimulation
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 min
Pain of bladder catheterization
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 min
Diagnostic performance of the dipstick urine test
The diagnostic performance of the urinary dipstick will be established through sensitivity , specificity, positive predictive value and negative predictive value taking as Gold Standard cytobacteriological examination of the urine (ECBU). Diagnostic performance, as well as accuracy, will be established in each of the two groups.
The sensitivity and specificity will be calculated as well as their 95% confidence intervals calculated using the method of the Wilson score
Measured: through intervention completion, an average 30 min
Risk factors associated with the failure of the bladder stimulation technique
for a urinary sample quantity < 2 ml or no urinary sample collected; potential risk factors for failure will be collected (pain, Wight, sex, age, last food and time since las collect urine)
Measured: through intervention completion, an average 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start12 Dec 2019
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
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 Infection BacterialStudies 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
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DEMONCHY DIANE, MD, Principal investigator, Fondation Lenval - Nice Children Hôpitaux Pédiatriques de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801213
- Sponsor's protocol ID
- 18-HPNCL-03
- Acronym
- EEStiVeN
- Status last verified
- Sep 2023
- First submitted
- 8 Jan 2019
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Demonchy D, Ciais C, Fontas E, Berard E, Breaud J, Rohrlich PS, Dubos F, Fortier C, Desmontils J, Herisse AL, Donzeau D, Haas H, Tran A. Evaluation of bladder stimulation as a non-invasive technique for urine collection to diagnose urinary tract infection in infants under 6 months: a randomized multicenter study ("EE-Sti.Ve.N"). Trials. 2019 Dec 27;20(1):783. doi: 10.1186/s13063-019-3914-2.
PubMed 31881992
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Bladder Stimulation, a Non-invasive Technique of Urine Collection, in Infant Less Than 6 Months to Diagnose Urinary Tract Infection: a Randomized Multicenter Study
- ClinicalTrials.gov ID
- NCT03801213
- Acronym / sponsor ID
- EEStiVeN / 18-HPNCL-03
- Conditions
- Urinary Tract Infection Bacterial
- Keywords
- Urine Specimen Collection/methods, Infant, Newborn, Feasibility Studies, Bladder stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 11 Jan 2019 (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 infection (UTI) is the most common serious bacterial infection among infants. Suprapubic aspiration and bladder catheterization are considered as the gold standard by the American Academy of Pediatrics for the diagnosis, yet it is painful and invasive. In contrast, the bladder stimulation technique has been shown to be a quick and non-invasive approach to collect urine in young infants. Actually, the investigators don't have data on bacterial contamination rates for clean-catch midstream urine collections using this technique
Detailed description
Urinary tract infection (UTI) is common in infants and needs to be diagnosed quickly. The risk for urinary tract infection before the age of 2 years is about 1-4% in boys and 3-8% in girls. A delay in diagnosis exposes to severe complications. In infants, the symptoms are not specific. A good urinalysis quality is therefore necessary for the diagnosis of UTI. Different techniques exist to collect urine samples in these children who do not control their urination yet: supra pubic aspiration, catheterization, urine collection bag and clean catch urine. The American Academy of Pediatrics (AAP) recommends supra pubic aspiration (1-9 % bacterial contamination) and urinary catheterization (8-14 % contamination) for collecting urine but these techniques are invasive and painful. The sterile bag is a non-invasive method of urine collection, with a high bacterial contamination rates (26-62%) leading to unnecessary antibiotic treatment. Finally, clean catch urine is an accepted urine sample to diagnose UTI according to the recommendations (13-27 % of bacterial contamination) but this method is only possible for potty-trained children. Recent studies (Herreros et al, Altuntas et al, Tran et al.) have shown that bladder stimulation, which consists of pubic tapping and lumbar massage, would be a new, effective, non-invasive and safe method of collecting urine in infants.
Bladder stimulation may be performed by a nurse or a physician. The steps of the bladder stimulation technique are as follows: (a) cleaning the genital area with warm water and soap b) bladder stimulation technique, requires the presence of 3 people: infants will be held under their armpits by a parent over the bed, with legs dangling in males and hips flexed in females. The nurse or technician will then alternate between bladder stimulation maneuvers: gentle tapping in the suprapubic area at a frequency of 100 taps per minute for 30 seconds followed by lumbar paravertebral massage maneuvers for 30 seconds. These two stimulation maneuvers will be repeated until micturition begins, or for a maximum of of 3 minutes.
However, the investigators do not have data on the bacterial contamination rate for urine sample using this new technique. the investigators hypothesize that the bladder stimulation is a technique for obtaining urine with a contamination rate equivalent to those obtained by bladder catheterization, in the diagnosis of febrile urinary tract infection in infants under 6 months of age.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urinary catheterization | Active comparator | Device: urinary catheterization |
| manual bladder stimulation Technique | Experimental | Procedure: manual bladder stimulation technique |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Infants under the age of 6 months
- For whom an urine sample is required for the diagnosis of a urinary tract infection as follows:
- Obtaining the authorization of the holders of parental authority
- Affiliation to French social security
Key exclusion criteria (4 listed)
- Do exhibiting signs of vital distress (respiratory or circulatory or neurological)
- contraindication to bladder catheterization
- antibiotic therapy in the last 48 hours
- antibiotic prophylaxis in the last 48 hours
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 |
|---|---|---|
| urinary catheterizationUrinary catheterization with pain controlled | Device | Urinary catheterization |
| manual bladder stimulation techniquemanual gentle tapping in the suprapubic area at a frequency of 100 taps per minute for 30 seconds followed by lumbar paravertebral massage maneuvers for 30 seconds. The renal and bladder stimulation will be performed in less than 3 minutes, with a maximum of two attempts spaced about 20 minutes | Procedure or surgery | manual bladder stimulation Technique |
Primary outcome
Bacterial contamination rates of urine samples per bladder stimulation and urinary catheterization
Time frame: at 48 hours after inclusion date
Bacterial contamination of urine sample is defined by: * the growth of two or more micro-organisms, * or the presence of a non-uropathogenic germ (lactobacilli, Staphylococcus Coagulase negative, Corynebacterium), * or a bacteriuria> 0 colony forming unit(CFU)/ml but <104 CFU / ml for bladder catheterization and <105 CFU / ml for clean catch urine collected by bladder stimulation, or leukocyturia <104 / ml
4 secondary outcomes
Pain of bladder stimulation
Time frame: through intervention completion, an average 30 min
Pain of bladder catheterization
Time frame: through intervention completion, an average 30 min
Diagnostic performance of the dipstick urine test
Time frame: through intervention completion, an average 30 min
Risk factors associated with the failure of the bladder stimulation technique
Time frame: through intervention completion, an average 30 min
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 26 Feb 2024.
- Derived from this study: PubMed 31881992Demonchy D, Ciais C, Fontas E, Berard E, Breaud J, Rohrlich PS, Dubos F, Fortier C, Desmontils J, Herisse AL, Donzeau D, Haas H, Tran A. Evaluation of bladder stimulation as a non-invasive technique for urine collection to diagnose urinary tract infection in infants under 6 months: a randomized multicenter study ("EE-Sti.Ve.N"). Trials. 2019 Dec 27;20(1):783. doi: 10.1186/s13063-019-3914-2.
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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.
DEMONCHY DIANE, MD principal investigator
Fondation Lenval - Nice Children Hôpitaux Pédiatriques de Nice
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing urinary catheterization and manual bladder stimulation technique in people with Urinary Tract Infection Bacterial, run by Fondation Lenval at 4 sites in France.
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 9 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 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
Bacterial contamination rates of urine samples per bladder stimulation and urinary catheterization (time frame: at 48 hours after inclusion date). 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 NCT03801213, 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 26 Feb 2024.