ClinicalTrials.gg
CompletedNCT06734403LITAPEDUpdated Dec 16, 2024

Urinary Calculi After Bladder Augmentation in Children

An observational study in Calculi, Urinary, Neurogenic Bladder Disorder and Spina Bifida, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 0 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-12-16.

Sponsored by University Hospital, Clermont-Ferrand · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
34
Ages
0 Years to 17 Years
Sex
All
01

Study 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..)
Read the detailed description

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

02

Conditions studied

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

Keywords

  • Urinary Calculus
  • Bladder Augmentation
  • Child
  • Retrospective Study
03

In context

Urinary Calculi

94 studies on the registry are indexed under Urinary Calculi; 20 are open to participants now.

This study's enrollment of 34 is below the median of 200 across 31 observational studies indexed under Urinary Calculi.

Browse Urinary Calculi studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients older than 18 years old, with urinary calculi, after bladder augmentation
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
34 participants (actual)
Patient registry
No

Groups and cohorts

  • Ileocystoplasty

    Urinary Calculi After Ileocystoplasty in Children

    Other: Bladder Augmentation

  • Sigmoidocystoplasty

    Urinary Calculi After Sigmoidocystoplasty in Children

    Other: Bladder Augmentation

Interventions

  • OtherBladder Augmentation

    Bladder Augmentation using bowel loop (ileal or sigmoid loop)

06

What researchers measure

Primary outcomes

  1. Rate of participants with urinary calculi

    Rate of participants with urinary calculi After bladder augmentation

    Time frame: Through study completion, an average of 2 years

  2. 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.

    Time frame: Through study completion, an average of 2 years

Secondary outcomes

  1. 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

    Time frame: Through study completion, an average of 2 years

  2. 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.

    Time frame: Through study completion, an average of 2 years

  3. Risk factors of urinary calculi after bladder augmentation in the participants

    Age, sex, type of bladder augmentation...

    Time frame: Through study completion, an average of 2 years

07

Study locations

1 site
  • University Hospital, Clermont-Ferrand
    Clermont-Ferrand, Auvergne 63003, France
08

References and documents

Individual participant data

Plan to share: No — In the name of anonymization the investigators won't share individual participant data

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06734403
Responsible party
Destinval Christelle (M.D., University Hospital, Clermont-Ferrand) — Principal investigator
First posted
Dec 16, 2024
Start date
Nov 20, 2022
Primary completion
Jan 31, 2023
Completion
Apr 10, 2023
Last update
Dec 16, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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