Urinary InfectionPUCESNCT01862822
Position of Children During Urine Collection: Evaluation Study
A study testing upright position in people with Urinary Infection, run by University Hospital, Limoges at 1 site in France.
Trial summary
Urinary tract infection (UTI) is a frequently suspected cause of fever in young children, justifying urine cultures. Sampling procedures are decisive for the reliability of UTI diagnosis. Read more about this study
- Who is it for?
- Ages 2 to 36 months
- Conditions the study is for
- Urinary Infection
- What is being tested?
- upright position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 803 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Dec 2017
- 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 2 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2 - 36 months
- Non-toilet-trained children
- Indication to bag urine collection with the following criteria :
- fever ≥ 38.5 °C
- unexplained fever
- and at least 1 of the following criteria for girls and uncircumcised boys, at least 2 criteria for circumcised boys :
Show all 10Show fewer
- age ≤ 12 months
- fever ≥ 48 hours
- poorly tolerated fever (chills ± cyanosis ± pronounced weakness…)
- preceding episode of tract urine infection
Who cannot join
- Parents opposed to the participation of their children in the study
- Diarrhea
- Current antibiotic treatment or during the 8 preceding days of the urine collection
- Genitals / perineal anomaly
Trial locations and contacts
1 site in 1 country.
About this study
Urinary tract infection (UTI) is a frequently suspected cause of fever in young children, justifying urine cultures. Sampling procedures are decisive for the reliability of UTI diagnosis. Even though official guidelines recommend clean catch method, catheterization or suprapubic aspiration, urine bag collection remains widely used. In our experience, the rate of contaminated bag-obtained cultures reaches 30.2 %. In a recent study, the investigators have noticed that the rate of contaminated urine cultures was lower when children were kept in an upright position at the time of urine collection. The upright position could explain this decrease, perineum being less in contact with urine. These results are borderline significant, the investigators would like to confirm them with a specific study.
- Conditions
- Urinary Infection
- Being tested
- upright position
- Keywords
- Paediatrics, Urinary tract infection, Urine collection
- 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.
upright positionOther
Also called the impact of an upright position on the number of contaminated urine cultures during urine bag collection
| Study group | Role | What they receive |
|---|---|---|
| upright position | Experimental | Upright position during urine bag collection Receives: Other: upright position |
| usual position | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of polybacterial urine analysis in each group
Measured: 1 hour
Secondary outcomes (1)
The failure rate in upright position in private practice
Measured: 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2017
- Study completionDec 2017
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 InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 803 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862822
- Sponsor's protocol ID
- I11 016
- Acronym
- PUCES
- Status last verified
- Aug 2016
- First submitted
- 22 May 2013
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Bahans C, Dallocchio A, Tran A, Dubos F, Soto B, Schoder G, Blanc P, Messager V, Demonchy D, Labrunie A, Garnier F, Guigonis V. The position during urine sample collection from young precontinent children through a bag does not limit contamination rates: Results from a randomized controlled trial: Does infant position influence quality of urine collection? Arch Pediatr. 2022 Jul;29(5):359-363. doi: 10.1016/j.arcped.2022.03.007. Epub 2022 May 2.
PubMed 35513967
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Position of Children During Urine Collection: Evaluation Study
- ClinicalTrials.gov ID
- NCT01862822
- Acronym / sponsor ID
- PUCES / I11 016
- Conditions
- Urinary Infection
- Keywords
- Paediatrics, Urinary tract infection, Urine collection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 803 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 27 May 2013 (estimated)
- 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 a frequently suspected cause of fever in young children, justifying urine cultures. Sampling procedures are decisive for the reliability of UTI diagnosis. Even though official guidelines recommend clean catch method, catheterization or suprapubic aspiration, urine bag collection remains widely used. In our experience, the rate of contaminated bag-obtained cultures reaches 30.2 %. In a recent study, the investigators have noticed that the rate of contaminated urine cultures was lower when children were kept in an upright position at the time of urine collection. The upright position could explain this decrease, perineum being less in contact with urine. These results are borderline significant, the investigators would like to confirm them with a specific study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| upright position | Experimental | Other: upright positionUpright position during urine bag collection |
| usual position | No intervention | – |
Who may qualify
- Ages
- 2 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Children aged 2 - 36 months
- Non-toilet-trained children
- Indication to bag urine collection with the following criteria :
- fever ≥ 38.5 °C
- unexplained fever
Key exclusion criteria (4 listed)
- Parents opposed to the participation of their children in the study
- Diarrhea
- Current antibiotic treatment or during the 8 preceding days of the urine collection
- Genitals / perineal anomaly
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 |
|---|---|---|
| upright positionAlso: the impact of an upright position on the number of contaminated urine cultures during urine bag collection | Other | upright position |
Primary outcome
Proportion of polybacterial urine analysis in each group
Time frame: 1 hour
1 secondary outcome
The failure rate in upright position in private practice
Time frame: 1 hour.
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 30 Jul 2025.
- Results publication: PubMed 35513967Bahans C, Dallocchio A, Tran A, Dubos F, Soto B, Schoder G, Blanc P, Messager V, Demonchy D, Labrunie A, Garnier F, Guigonis V. The position during urine sample collection from young precontinent children through a bag does not limit contamination rates: Results from a randomized controlled trial: Does infant position influence quality of urine collection? Arch Pediatr. 2022 Jul;29(5):359-363. doi: 10.1016/j.arcped.2022.03.007. Epub 2022 May 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing upright position in people with Urinary Infection, run by University Hospital, Limoges at 1 site 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 10 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 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Proportion of polybacterial urine analysis in each group (time frame: 1 hour). 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 NCT01862822, 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 30 Jul 2025.