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Assessment of Urinary Microplastic Concentration in Patients With Urolithiasis: A Prospective Case-Control Study (Microplastics)

20 september 2026 bijgewerkt door: Mehmet Serkan Ozkent, Konya City Hospital

Quantitative and Qualitative Evaluation of Urinary Microplastic Load in Patients With Kidney/Ureteral Stones: A Single-Center Prospective Case-Control Study

This prospective observational case-control study aims to evaluate the presence and burden of microplastic particles in urine samples from patients with kidney and ureteral stones and to compare these findings with healthy controls. The study will also investigate the associations between urinary microplastic burden and clinical characteristics of urinary stone disease, including stone size, stone density measured in Hounsfield units (HU), localization, and stone composition.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Urinary stone disease is a common urological condition with a multifactorial etiology. Although established metabolic, dietary, genetic, and environmental factors contribute to stone formation, the potential role of microplastic exposure in urinary stone disease remains insufficiently understood.

In this prospective observational case-control study, patients diagnosed with kidney or ureteral stones and healthy control participants will be evaluated. Following informed consent, demographic and clinical data will be collected. A midstream urine sample will be obtained from each participant for laboratory analysis.

Urine samples will undergo laboratory processing for the detection and characterization of suspected microplastic particles. The analytical process will include centrifugation, Proteinase K treatment, membrane filtration, microscopic examination, image analysis using ImageJ, and Fourier-transform infrared (FTIR) spectroscopy for polymer identification.

In participants with urinary stones, available stone specimens will also be analyzed for stone composition. Imaging-derived stone characteristics, including stone size, localization, and density in Hounsfield units, will be recorded.

The primary objective is to compare urinary microplastic burden between participants with urinary stones and healthy controls. Secondary analyses will investigate the relationships between urinary microplastic burden and stone characteristics, including stone size, density, localization, and composition.

The study does not involve administration of investigational drugs, use of investigational medical devices, or additional invasive procedures. Participation will involve collection of a urine sample and collection of clinical data obtained during routine clinical care.

Studietype

Observationeel

Inschrijving (Geschat)

100

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Mehmet Serkan S ÖZKENT, MD
  • Telefoonnummer: +90 5059364155
  • E-mail: msozkent@gmail.com

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

The study population will consist of adult participants with kidney or ureteral stones and healthy control participants. Participants in the urinary stone group will have a diagnosis of kidney or ureteral stone disease. Healthy controls will have no current or previous diagnosis of urinary stone disease. Participants will be recruited prospectively from the study center and will provide informed consent before enrollment. Midstream urine samples will be collected from all participants for microplastic detection and characterization. Clinical and demographic data will be recorded for the urinary stone group, including stone size, localization, and stone density measured in Hounsfield units.

Beschrijving

Inclusion Criteria:

  • Participants will be eligible if they are 18 years of age or older, are able to provide informed consent, and meet the criteria for either the urinary stone group or the healthy control group. Participants in the urinary stone group will have a diagnosis of kidney or ureteral stone disease. Healthy controls will have no current or previous diagnosis of urinary stone disease.

Exclusion Criteria:

  • Participants will be excluded if they are unable or unwilling to provide informed consent, have an active urinary tract infection at the time of urine sample collection, are pregnant, or are unable to provide an adequate urine sample for laboratory analysis. Participants will also be excluded if the urine sample is considered unsuitable or significantly contaminated during laboratory processing.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: CASE_CONTROL
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Urinary Stone Group

Participants diagnosed with kidney or ureteral stones will be included in this group. Demographic and clinical data, including age, sex, body mass index, stone size, stone localization, and stone density measured in Hounsfield units, will be recorded. Midstream urine samples will be collected for microplastic detection and characterization. When available, stone specimens obtained during routine clinical treatment will be analyzed for stone composition.
Ander: No Intervention

This is an observational study. No study-specific intervention will be assigned to participants.
Healthy Control Group

Participants without current or previous urinary stone disease will be included in this group. Demographic and relevant clinical data will be recorded. Midstream urine samples will be collected and analyzed using the same laboratory procedures as those applied to the urinary stone group for detection and characterization of microplastic particles.
Ander: No Intervention

This is an observational study. No study-specific intervention will be assigned to participants.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Urinary Microplastic Burden
Tijdsspanne: At enrollment

Urinary microplastic burden will be assessed as the number of confirmed microplastic particles detected per milliliter of urine (particles/mL). Microplastic particles will be identified by microscopic examination and confirmed by FTIR spectroscopy based on polymer characteristics. The urinary microplastic burden will be compared between the urinary stone group and the healthy control group.
At enrollment
Microplastic Polymer Type
Tijdsspanne: At enrollment

The polymer types of confirmed microplastic particles detected in urine samples will be identified by FTIR spectroscopy and reported according to polymer type, including polyethylene, polypropylene, polyethylene terephthalate, polystyrene, and other identified polymers.
At enrollment

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Association Between Urinary Microplastic Burden and Stone Size
Tijdsspanne: At enrollment

The association between urinary microplastic burden and maximum urinary stone diameter will be evaluated in participants with kidney or ureteral stones.
At enrollment
Association Between Urinary Microplastic Burden and Stone Density
Tijdsspanne: At enrollment

The association between urinary microplastic burden and urinary stone density measured in Hounsfield units (HU) on computed tomography will be evaluated in participants with kidney or ureteral stones.
At enrollment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Konya City Hospital

Onderzoekers

  • Hoofdonderzoeker: Mehmet Serkan Özkent, MD, Konya City Hospital
  • Hoofdonderzoeker: Batuhan Ağrulu, MD, Konya City Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 september 2027

Studie voltooiing (Geschat)

1 september 2027

Studieregistratiedata

Eerst ingediend

20 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

20 september 2026

Eerst geplaatst (Werkelijk)

25 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 september 2026

Laatste update ingediend die voldeed aan QC-criteria

20 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • KSH-2026/166

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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