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NCT Number: NCT07334821

Diagnostic Performance of PIC Cystogram vs VCUG in Children

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

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Key information

Conditions

Pediatric Urology Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Bladder Diseases Urogenital Diseases Urologic Diseases Vesico-Ureteral Reflux

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University School of Medicine Urology Department

Istanbul, Pendik, 34854, Turkey (Türkiye)

Location contact

Turker Altuntas

CONTACT

[email protected]

9005344525700

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Turker Altuntas

CONTACT

[email protected]

+905344525700

Sponsors and collaborators

Lead sponsor

Tarik Emre Sener

Other

Registry information

Official study title

Comparison of the Effectiveness of PIC Cystogram and VCUG in the Diagnosis of Vesicoureteral Reflux in Children

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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