Urinary Calculi After Bladder Augmentation in Children (LITAPED)

Management of Patients Who Had Urolithiasis After Bladder Augmentation in Childhood

The goal of this observational study is to analyse the occurence of urinary calculi after bladder augmentation in children:

• location of the calculi (kidney or bladder)
• type of bladder augmentation with higher rate of urinary calculi and why
• Find risk factors of urinary calculi in bladder augmentation (age, sex, other bladder procedures..)

Study Overview

• Status: Completed
• Conditions: Child, Only; Spina Bifida; Calculi, Urinary; Neurogenic Bladder Disorder
• Intervention / Treatment: Other: Bladder Augmentation

Detailed Description

Study the data of patients younger than 18 years old, who underwent a bladder augmentation, complicated by urinary calculi.

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• France
  • Auvergne
    • Clermont-Ferrand, Auvergne, France, 63003
      • University Hospital, Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients younger than 18 years old, with urinary calculi, after bladder augmentation.

Description

Inclusion Criteria:

• Patients younger than 18 years old, with urinary calculi, after bladder augmentation

Exclusion Criteria:

• Patients older than 18 years old, with urinary calculi, after bladder augmentation

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ileocystoplasty; Urinary Calculi After Ileocystoplasty in Children	Other: Bladder Augmentation; Bladder Augmentation using bowel loop (ileal or sigmoid loop)
Sigmoidocystoplasty; Urinary Calculi After Sigmoidocystoplasty in Children	Other: Bladder Augmentation; Bladder Augmentation using bowel loop (ileal or sigmoid loop)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Location of urinary calculi in the participants	After bladder augmentation, urinary calculi can be seen on postoperative imaging such as abdominal ultrasound, CT scan, and MRI. The different locations of these calculi can be the kidneys, the ureters, the bladder, or the urethra. Each patient who has had urinary calculi will be reported, and the location of the calculi will be specified depending on the imaging results.	Through study completion, an average of 2 years
Rate of participants with urinary calculi	Rate of participants with urinary calculi After bladder augmentation	Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors of urinary calculi after bladder augmentation in the participants	Age, sex, type of bladder augmentation...	Through study completion, an average of 2 years
Management of urinary calculi after bladder augmentation in the participants	3 main procedures help getting rid off urinary calculi: extracorporeal lithotripsy, endoscopic surgery or laparotomy. The patients were divided depending on the procedure that was used to remove the urinary calculi.	Through study completion, an average of 2 years
Time frame between surgery and occurence of urinary calculi in the participants After bladder augmentation	Time frame between surgery and occurence of urinary calculi in the participants After bladder augmentation	Through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2022
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): April 10, 2023

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Child; Retrospective Study; Urinary Calculus; Bladder Augmentation
• Additional Relevant MeSH Terms: Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Congenital Abnormalities; Nervous System Malformations; Neural Tube Defects; Calculi; Spinal Dysraphism; Urinary Bladder, Neurogenic; Urinary Calculi; Urinary Bladder Diseases
• Other Study ID Numbers: M24DC1104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In the name of anonymization the investigators won't share individual participant data

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