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

September 20, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mehmet Serkan S ÖZKENT, MD
  • Phone Number: +90 5059364155
  • Email: msozkent@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: CASE_CONTROL
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: 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.
Other: No Intervention

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary Microplastic Burden
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association Between Urinary Microplastic Burden and Stone Size
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konya City Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

September 20, 2026

First Submitted That Met QC Criteria

September 20, 2026

First Posted (Actual)

September 25, 2026

Study Record Updates

Last Update Posted (Actual)

September 25, 2026

Last Update Submitted That Met QC Criteria

September 20, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSH-2026/166

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe