Pediatric Urology
Conditions
Keywords
PIC Cystogram, VCUG, Vesicoureteral Reflux, Children
Brief summary
The goal of this interventional diagnostic clinical trial is to evaluate and compare the diagnostic effectiveness of PIC cystography and voiding cystourethrography (VCUG) for the detection of vesicoureteral reflux (VUR) in children undergoing endoscopic procedures, including those who previously underwent VCUG for urinary tract infection (UTI) or other indications, as well as children who did not require VCUG. The main questions it aims to answer are: Does PIC cystography detect VUR at a rate comparable to VCUG? How well do PIC cystography and VCUG correlate in identifying low-grade versus high-grade VUR? Researchers will compare PIC cystography findings with prior VCUG results to determine agreement between the two diagnostic methods and their ability to detect clinically relevant reflux. Participants will: Undergo PIC cystography performed during endoscopic surgery Have contrast instilled near each ureteral orifice under fluoroscopic monitoring Be evaluated for the presence and grade of vesicoureteral reflux
Interventions
DIAGNOSTIC_TESTPIC cystography
PIC cystography is performed intraoperatively during endoscopic surgery. A pediatric cystoscope is positioned adjacent to each ureteral orifice, and contrast medium is instilled by gravity from a height of 1 meter under fluoroscopic guidance. The presence and grade of vesicoureteral reflux are recorded for each renal unit. The procedure is carried out in a standardized manner by an investigator blinded to prior VCUG findings
DIAGNOSTIC_TESTVCUG
VCUG performed
Sponsors
Tarik Emre Sener
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Masking description
Single-blind (physician blinded to VCUG results)
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Children aged 0-18 years * Undergoing endoscopic urological surgery * With or without a prior VCUG performed for urinary tract infection or other clinical indications * Availability of VCUG results for participants who previously underwent VCUG * Written informed consent obtained from parents or legal guardians
Exclusion criteria
* History of previous ureteral reimplantation or anti-reflux surgery * Known neurogenic bladder or severe lower urinary tract dysfunction * Active urinary tract infection at the time of endoscopic procedure * Inability to undergo fluoroscopic imaging (e.g., contrast allergy) * Incomplete clinical or imaging data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of vesicoureteral reflux (VUR) by PIC cystography compared with VCUG | During endoscopic surgery (single intraoperative assessment) | Detection of vesicoureteral reflux (VUR) by PIC cystography compared with VCUG, assessed as the presence or absence of reflux and categorized as low-grade (Grade 1-3) or high-grade (Grade 4-5) on a renal unit basis. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactTurker Altuntas
Outcome results
None listed