Diagnostic Performance of PIC Cystogram vs VCUG in Children

Tarik Emre Sener

Status: Not yet enrolling

Conditions: Pediatric Urology

Treatments: Diagnostic Test: PIC cystography; Diagnostic Test: VCUG

Study type: Interventional

Funder types: Other

Identifiers

NCT07334821

MAR.UAD.0028

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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60 participants in 2 patient groups

PIC cystography

Experimental group

Treatment:

Diagnostic Test: VCUG

Diagnostic Test: PIC cystography

VCUG Group

Other group

Treatment:

Diagnostic Test: VCUG