Urinary Calculi After Bladder Augmentation in Children

Completed

• Conditions: Calculi, Urinary; Neurogenic Bladder Disorder; Spina Bifida; Child, Only

• Registration Number: NCT06734403
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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..)

Detailed Description

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

Study Timeline

• Study Start: 2022-11-20
• Primary Completion: 2023-01-31
• Study Completion: 2023-04-10
• Status Verified: 2024-12
• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-11
• Last Update Submitted: 2024-12-11
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of participants with urinary calculi	Through study completion, an average of 2 years	Rate of participants with urinary calculi After bladder augmentation
Location of urinary calculi in the participants	Through study completion, an average of 2 years	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.

Secondary Outcome Measures

Name	Time	Method
Time frame between surgery and occurence of urinary calculi in the participants After bladder augmentation	Through study completion, an average of 2 years	Time frame between surgery and occurence of urinary calculi in the participants After bladder augmentation
Management of urinary calculi after bladder augmentation in the participants	Through study completion, an average of 2 years	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.
Risk factors of urinary calculi after bladder augmentation in the participants	Through study completion, an average of 2 years	Age, sex, type of bladder augmentation...

Trial Locations

Locations (1)

University Hospital, Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, Auvergne, France