Stone Disease of the Urinary Tract in Children (Ped-Urolithia)

November 4, 2024 updated by: University Hospital, Strasbourg, France

Stone Disease of the Urinary Tract in Children: Clinical Presentation, Diagnostic Methods, Therapeutic Management, Evolution and Prognosis

The incidence of stone disease of the urinary tract in children is increasingly increasing with a remarkable economic impact for its management.

This incidence is variable according to race, geographic region, socio-economic status and dietary habits.

Oxalo-calcium stones are the most common but the biochemical nature of urinary stones varies depending on the region where those of a phosphatic nature are characterized by a higher incidence in Europe.

The diagnosis is confirmed by imaging. The unprepared abdomen (ASP) has low diagnostic accuracy. The scanner is the reference tool but remains an irradiating examination.

Risk factors for disease recurrence include primarily the presence of an underlying urinary metabolic abnormality and young age. Urinary metabolic abnormalities vary from one study to another.

The understanding of lithogenesis, its evaluation as well as the therapeutic options is essential for adequate and adapted management in the pediatric population.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

140

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de pédiatrie 1 - CHU de Strasbourg - France
        • Principal Investigator:
          • Isabelle Talon, MD
        • Contact:
        • Principal Investigator:
          • Kamal EL HAISSOUFI, MD
        • Principal Investigator:
          • Ciro ANDOLFI, MD

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

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged less than 18 years presenting with lithiasis of the urinary tree in one of the two departments concerned between 01/01/2010 and 12/31/2022

Description

Inclusion criteria:

  • Patients aged less than 18 years.
  • Both sexes.
  • Subjects presenting with lithiasis of the urinary tree in one of the two departments concerned between 01/01/2010 and 12/31/2022
  • Subject not opposing, after information, the reuse of their data for the purposes of this research.
  • Holders of parental authority who do not object, after being informed, to the reuse of their child's data for the purposes of this research.

Exclusion criteria:

  • Subject or holder of parental authority having expressed opposition to participating in the study.
  • Non-usable patient files: insufficient data.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study of the modalities of the therapeutic management of children with urinary stones, retrospective description of the evolutionary aspects and the risk factors associated with recurrence.
Time Frame: Files analysed retrospectively from January 01, 2010 to December 31, 2022 will be examined
This study is retrospective on already existing data
Files analysed retrospectively from January 01, 2010 to December 31, 2022 will be examined

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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)

August 23, 2023

Primary Completion (Estimated)

June 23, 2025

Study Completion (Estimated)

June 23, 2025

Study Registration Dates

First Submitted

August 31, 2023

First Submitted That Met QC Criteria

September 4, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9020 (CTEP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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