Diagnostic Performance of PIC Cystogram vs VCUG in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PIC cystography, VCUG.
- Who it may be relevant to
- Registry conditions: Pediatric Urology. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of the Effectiveness of PIC Cystogram and VCUG in the Diagnosis of Vesicoureteral Reflux in Children
Overview
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 test PIC 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 test VCUG
VCUG performed
Primary outcome measures
- Detection of vesicoureteral reflux (VUR) by PIC cystography compared with VCUG [Time frame: During endoscopic surgery (single intraoperative assessment)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Turkey (Türkiye) · 1 center
- Marmara University School of Medicine Urology Department — Istanbul
Identifiers
NCT: NCT07334821 · MAR.UAD.0028