Stone Disease of the Urinary Tract in Children

Urinary Lithiasis Clinical Trial

— Ped-Urolithia  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06032364
• Other study ID #: 9020
• Status: Recruiting
• Start date: August 23, 2023
• Est. completion date: August 23, 2024

Study information

• Verified date: August 2023
• Source: University Hospital, Strasbourg, France
• Contact: Isabelle TALON, MD
• Phone: 33 3 88 12 72 96
• Email: Isabelle.TALON[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: August 23, 2024
• Est. primary completion date: August 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lithiasis
• Urinary Calculi
• Urinary Lithiasis
• Urolithiasis

Locations

Country	Name	City	State
France	Service de Pédiatrie 1 - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	This study is retrospective on already existing data	Files analysed retrospectively from January 01, 2010 to December 31, 2022 will be examined