Assessment of Urinary Microplastic Concentration in Patients With Urolithiasis: A Prospective Case-Control Study (Microplastics)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Mehmet Serkan S ÖZKENT, MD
- Telefonnummer: +90 5059364155
- E-post: msozkent@gmail.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: CASE_CONTROL
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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. |
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. |
This is an observational study. No study-specific intervention will be assigned to participants. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Urinary Microplastic Burden
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Association Between Urinary Microplastic Burden and Stone Size
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Mehmet Serkan Özkent, MD, Konya City Hospital
- Huvudutredare: Batuhan Ağrulu, MD, Konya City Hospital
Publikationer och användbara länkar
Allmänna publikationer
- https://doi.org/10.1186/s12989-026-00661-0
- Agarwal DK, Lulich JP, Furrow E, Simcik M. Microplastic Particles Are Present in Mammalian Urolithiasis. Journal of Urology. doi:10.1097/01.JU.0001109956.38240.97.13.
- O'Callaghan L, Olsen M, Tajouri L, Beaver D, Hudson C, Alghafri R, McKirdy S, Goldsworthy A. Plastic induced urinary tract disease and dysfunction: a scoping review. J Expo Sci Environ Epidemiol. 2025 Sep;35(5):770-784. doi: 10.1038/s41370-024-00709-3. Epub 2024 Aug 31.
- de Oliveira RB, Pelepenko LE, Masaro DA, Lustosa GMMM, de Oliveira MC, Roza NAV, Marciano MA, Dos Reis LM, Kamel S, Louvet L, Mazon T. Effects of microplastics on the kidneys: a narrative review. Kidney Int. 2024 Sep;106(3):400-407. doi: 10.1016/j.kint.2024.05.023. Epub 2024 Jun 18.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Manliga urogenitala sjukdomar
- Calculi
- Patologiska tillstånd, anatomiska
- Njursjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Urinvägar
- Nefrolitiasis
- Patologiska tillstånd, tecken och symtom
- Njure Calculi
- Urolithiasis
Andra studie-ID-nummer
- KSH-2026/166
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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