Pediatric UrologyNCT07334821
Diagnostic Performance of PIC Cystogram vs VCUG in Children
A study testing PIC cystography and VCUG in people with Pediatric Urology, run by Tarik Emre Sener at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Urology
- What is being tested?
- PIC cystography and VCUG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Marmara University School of Medicine Urology Department
Istanbul, Pendik, 34854
Turker Altuntas, 9005344525700, turkeraltuntas@hotmail.com
About this study
Official title: Comparison of the Effectiveness of PIC Cystogram and VCUG in the Diagnosis of Vesicoureteral Reflux 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:
Read more
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
- Conditions
- Pediatric Urology
- Being tested
- PIC cystography, VCUG
- Keywords
- PIC Cystogram, VCUG, Vesicoureteral Reflux, Children
- Medical subject headings
- Vesico-Ureteral Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
VCUGDiagnostic test
VCUG performed
| Study group | Role | What they receive |
|---|---|---|
| PIC cystography | Experimental | Not described Receives: Diagnostic Test: PIC cystography; Diagnostic Test: VCUG |
| VCUG Group | Other | Not described Receives: Diagnostic Test: VCUG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During endoscopic surgery (single intraoperative assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric UrologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarik Emre Sener
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tarik Emre Sener, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334821
- Sponsor's protocol ID
- MAR.UAD.0028
- Status last verified
- Dec 2025
- First submitted
- 31 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of PIC Cystogram and VCUG in the Diagnosis of Vesicoureteral Reflux in Children
- ClinicalTrials.gov ID
- NCT07334821
- Acronym / sponsor ID
- MAR.UAD.0028
- Conditions
- Pediatric Urology
- Keywords
- PIC Cystogram, VCUG, Vesicoureteral Reflux, Children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tarik Emre SenerUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PIC cystography | Experimental | Diagnostic Test: PIC cystography, Diagnostic Test: VCUG |
| VCUG Group | Other | Diagnostic Test: VCUG |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIC cystographyPIC 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 | Diagnostic test | PIC cystography |
| VCUGVCUG performed | Diagnostic test | PIC cystography, VCUG Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIC cystography and VCUG in people with Pediatric Urology, run by Tarik Emre Sener at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Turker Altuntas (+905344525700, turkeraltuntas@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of vesicoureteral reflux (VUR) by PIC cystography compared with VCUG (time frame: During endoscopic surgery (single intraoperative assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.