Urinary Calculi After Bladder Augmentation in Children

Completed

• Conditions: Neurogenic Bladder; Child, Only; Calculi, Urinary; Spina Bifida
• Interventions: Other: Bladder Augmentation

• Registration Number: NCT05861024
• Lead Sponsor: University of Lorraine

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
• Study First Submitted: 2023-04-13
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-14
• Study First Posted: 2023-05-16
• Last Update Submitted: 2023-05-16
• Last Update Posted: 2023-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Arm && Interventions

Group	Intervention	Description
Sigmoidocystoplasty	Bladder Augmentation	Urinary Calculi After Sigmoidocystoplasty in Children
Ileocystoplasty	Bladder Augmentation	Urinary Calculi After Ileocystoplasty in Children

Primary Outcome Measures

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

Trial Locations

Locations (1)

ULorraine; 🇫🇷 Vandœuvre-lès-Nancy, Grand-Est, France