Urinary Calculi After Bladder Augmentation in Children

Child, Only Clinical Trial

— LITAVPED  

Official title:

Management of Urinary Calculi After Bladder Augmentation in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05861024
• Other study ID #: ULorilith
• Secondary ID: 2023PI005
• Status: Completed
• Start date: November 20, 2022
• Est. completion date: April 10, 2023

Study information

• Verified date: May 2023
• Source: University of Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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..)

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 10, 2023
• Est. primary completion date: January 31, 2023
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Calculi, Urinary
• Child, Only
• Neurogenic Bladder
• Spina Bifida
• Spinal Dysraphism
• Urinary Bladder, Neurogenic
• Urinary Calculi
• Urolithiasis

Intervention

Other:
• Bladder Augmentation
Bladder Augmentation using bowel loop (ileal or sigmoid loop)

Locations

Country	Name	City	State
France	ULorraine	Vandœuvre-lès-Nancy	Grand-Est

Sponsors (1)

Lead Sponsor	Collaborator
University of Lorraine

Country where clinical trial is conducted

France, 

References & Publications (3)

Mathoera RB, Kok DJ, Nijman RJ. Bladder calculi in augmentation cystoplasty in children. Urology. 2000 Sep 1;56(3):482-7. doi: 10.1016/s0090-4295(00)00663-4. — View Citation

Salama AK, Misseri R, Hollowell N, Hahney B, Whittam B, Kaefer M, Cain MP, Rink RC, Szymanski KM. Incidence of nephrolithiasis after bladder augmentation in people with spina bifida. J Pediatr Urol. 2021 Aug;17(4):521.e1-521.e7. doi: 10.1016/j.jpurol.2021.03.012. Epub 2021 Mar 19. — View Citation

Szymanski KM, Misseri R, Whittam B, Lingeman JE, Amstutz S, Ring JD, Kaefer M, Rink RC, Cain MP. Bladder stones after bladder augmentation are not what they seem. J Pediatr Urol. 2016 Apr;12(2):98.e1-6. doi: 10.1016/j.jpurol.2015.06.021. Epub 2015 Sep 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of participants with urinary calculi	After bladder augmentation	Through study completion, an average of 2 years
Primary	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	Time frame between surgery and occurence of urinary calculi in the participants	After bladder augmentation	Through study completion, an average of 2 years
Secondary	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
Secondary	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