Diagnostic Performance of PIC Cystogram vs VCUG in Children
ConditionPediatric Urology
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorTarik Emre Sener
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- PIC cystography
- VCUG
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Tarik Emre Sener
Lead sponsor
Marmara University
Sponsor institution
Source ClinicalTrials.gov