Position of Children During Urine Collection: Evaluation Study (PUCES)

July 28, 2025 updated by: University Hospital, Limoges
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

803

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limoges, France, 87 042
        • University Hospital, Limoges

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 3 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 :
  • age ≤ 12 months
  • fever ≥ 48 hours
  • poorly tolerated fever (chills ± cyanosis ± pronounced weakness…)
  • preceding episode of tract urine infection

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: upright position
Upright position during urine bag collection
Other: upright position
Other Names:
  • the impact of an upright position on the number of contaminated urine cultures during urine bag collection
No Intervention: usual position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of polybacterial urine analysis in each group
Time Frame: 1 hour
1 hour

Secondary Outcome Measures

Outcome Measure
Time Frame
The failure rate in upright position in private practice
Time Frame: 1 hour.
1 hour.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

May 22, 2013

First Submitted That Met QC Criteria

May 24, 2013

First Posted (Estimated)

May 27, 2013

Study Record Updates

Last Update Posted (Actual)

July 30, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I11 016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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