Urinary Calculi After Bladder Augmentation in Children

NCT06734403 | Completed

• 1 other identifier: M24DC1104
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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..)

Conditions

Calculi, Urinary; Neurogenic Bladder Disorder; Spina Bifida; Child, Only

Keywords

Urinary Calculus; Bladder Augmentation; Child; Retrospective Study

Outcome Measures

Primary Outcomes (2)

• Rate of participants with urinary calculi

  Rate of participants with urinary calculi After bladder augmentation

  Through study completion, an average of 2 years

• 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

Secondary Outcomes (3)

• Time frame between surgery and occurence of urinary calculi in the participants After bladder augmentation

  Through study completion, an average of 2 years

• Management of urinary calculi after bladder augmentation in the participants

  Through study completion, an average of 2 years

• Risk factors of urinary calculi after bladder augmentation in the participants

  Through study completion, an average of 2 years

Study Arms (2)

Ileocystoplasty

Urinary Calculi After Ileocystoplasty in Children

Other: Bladder Augmentation

Sigmoidocystoplasty

Urinary Calculi After Sigmoidocystoplasty in Children

Other: Bladder Augmentation

Interventions

Bladder Augmentation OTHER

Bladder Augmentation using bowel loop (ileal or sigmoid loop)

Ileocystoplasty; Sigmoidocystoplasty

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Central Hospital, Nancy, France: collaborator

Study Sites (1)

University Hospital, Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

Location

MeSH Terms

Conditions

Urinary Calculi; Urinary Bladder, Neurogenic; Spinal Dysraphism

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Signs and Symptoms; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: November 20, 2022
• Primary Completion: January 31, 2023
• Study Completion: April 10, 2023
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)