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

This trial accepts healthy volunteers

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

Design model

Single group

Treatments tested in this trial

PIC cystography
Diagnostic test
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
VCUG
Diagnostic test
VCUG performed

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: PIC cystographyExperimental treatment 2 interventions

Group B: VCUG GroupOther 1 intervention

Trial outcomes

Primary outcomes

Detection of vesicoureteral reflux (VUR) by PIC cystography compared with VCUG

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.

Time frame

During endoscopic surgery (single intraoperative assessment)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tarik Emre Sener

Lead sponsor

Marmara University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: