Diagnostic Performance of PIC Cystogram vs VCUG in Children

NCT ID: NCT07334821

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2026-04-01

Brief Summary

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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

Detailed Description

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Conditions

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Pediatric Urology

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators
Single-blind (physician blinded to VCUG results)

Study Groups

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PIC cystography

Group Type EXPERIMENTAL

PIC cystography

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

VCUG performed

VCUG Group

Group Type OTHER

VCUG

Intervention Type DIAGNOSTIC_TEST

VCUG performed

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

VCUG

VCUG performed

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tarik Emre Sener

OTHER

Sponsor Role lead

Responsible Party

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Tarik Emre Sener

Associated Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Marmara University School of Medicine Urology Department

Istanbul, Pendik, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Turker Altuntas

Role: CONTACT

+905344525700

Facility Contacts

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Turker Altuntas

Role: primary

9005344525700

Other Identifiers

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MAR.UAD.0028

Identifier Type: -

Identifier Source: org_study_id

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