NCT07334821

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

January 12, 2026

Status Verified

December 1, 2025

Enrollment Period

28 days

First QC Date

December 31, 2025

Last Update Submit

December 31, 2025

Conditions

Pediatric Urology

Keywords

PIC CystogramVCUGVesicoureteral RefluxChildren

Outcome Measures

Primary Outcomes (1)

  • 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.

    During endoscopic surgery (single intraoperative assessment)

Study Arms (2)

PIC cystography

EXPERIMENTAL
Diagnostic Test: PIC cystographyDiagnostic Test: VCUG

VCUG Group

OTHER
Diagnostic Test: VCUG

Interventions

PIC cystographyDIAGNOSTIC_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

PIC cystography
VCUGDIAGNOSTIC_TEST

VCUG performed

PIC cystographyVCUG Group

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine Urology Department

Istanbul, Pendik, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vesico-Ureteral Reflux

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Turker Altuntas

CONTACT

+905344525700turkeraltuntas@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Single-blind (physician blinded to VCUG results)
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

December 31, 2025

First Posted

January 12, 2026

Study Start

February 1, 2026

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

January 12, 2026

Record last verified: 2025-12

Locations

TU(1)