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

NCT07841834 | Not Yet Recruiting

• 1 other identifier: KSH-2026/166
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Urolithiasis

Keywords

Microplastics; Urolithiasis; Ureteral stones; Urinary microplastics; Kidney stones; Urinary stone disease; FTIR spectroscopy

Outcome Measures

Primary Outcomes (2)

• Urinary Microplastic Burden

  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

  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 Outcomes (2)

• Association Between Urinary Microplastic Burden and Stone Size

  At enrollment

• Association Between Urinary Microplastic Burden and Stone Density

  At enrollment

Study Arms (2)

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

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

Interventions

No Intervention OTHER

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

Healthy Control Group; Urinary Stone Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Konya City Hospital: lead

Related Publications (4)

• https://doi.org/10.1186/s12989-026-00661-0

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 39217203 BACKGROUND

• 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.

  PMID: 38901606 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Midstream urine samples will be collected from all participants for microplastic detection and characterization. Urine samples will be processed by centrifugation, Proteinase K treatment, membrane filtration, microscopic examination, ImageJ analysis, and FTIR spectroscopy. Stone specimens obtained during routine clinical treatment will be analyzed for stone composition when available. No biological samples will be collected specifically for genetic analysis, and DNA will not be extracted or retained.

MeSH Terms

Conditions

Urolithiasis; Kidney Calculi

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephrolithiasis; Kidney Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Mehmet Serkan Özkent, MD

  Konya City Hospital

  PRINCIPAL INVESTIGATOR

• Batuhan Ağrulu, MD

  Konya City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehmet Serkan S ÖZKENT, MD

CONTACT

+90 5059364155; msozkent@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Doctor

Study Record Dates

• First Submitted: September 20, 2026
• First Posted: September 25, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share