Primary Obstructive Megaureter Management in Eastern Interregional Area (POMME)

Primary Obstructive Megaureter Management in Eastern Interregional Area : Current Status and Perspectives

Congenital obstructive megaureter is a urinary malformation affecting the ureterovesical junction and causing obstruction to the flow of urine. It is the second most common cause of hydronephrosis. This malformation affects four times more boys than girls and is bilateral in 25% of cases. It is also associated with contralateral renal dysplasia in 15% of cases. The obstruction is linked to aperistalsis and hypertrophy of the circular muscle bundles and increased collagen 1 level. This malformation is accessible to antenatal screening from the second trimester. It falls within the scope of CAKUT and requires regular monitoring. Indeed, this uropathy can cause repeated pyelonephritis, kidney scarring and affected kidney function.

Study Overview

• Status: Completed
• Conditions: Congenital Obstructive Megaureter

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Service de Chirurgie Pédiatrique - CHU de Strasbourg - France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Minor patient (from 1 to 17 years old) treated between January 2010 and December 2017 for an obstructive congenital mega-ureter

Description

Inclusion Criteria:

• Minor patient (from 1 to 17 years old)
• Patient treated between January 2010 and December 2017 in one of the participating centers for an obstructive congenital mega-ureter
• Subject (and/or his parental authority) not having expressed, after information, his opposition to the reuse of his data for the purposes of this research

Exclusion Criteria:

• Subject (and/or his parental authority) having expressed, after information, his opposition to the reuse of his data for the purposes of this research

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine over the past seven years, the operability factors of patients aged 0 to 5 years regardless of the surgical technique used	This study aims to make a retrospective inventory and perspective on the management of congenital obstructive mega ureter	Files analysed retrospectively from January 01, 2010 to December 31, 2017 will be examined

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2020
• Primary Completion (Actual): March 2, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Actual): December 6, 2022

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Congenital obstructive megaureter; Urinary malformation; Ureterovesical junction; Hydronephrosis; Renal dysplasia
• Other Study ID Numbers: 7978

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No