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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Mehmet Serkan S ÖZKENT, MD
- 电话号码：+90 5059364155
- 邮箱：msozkent@gmail.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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.
描述
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.
学习计划
研究是如何设计的？
设计细节
- 观测模型：CASE_CONTROL
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Urinary Microplastic Burden
大体时间：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
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Association Between Urinary Microplastic Burden and Stone Size
大体时间：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
大体时间：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
|
合作者和调查者
调查人员
- 首席研究员：Mehmet Serkan Özkent, MD、Konya City Hospital
- 首席研究员：Batuhan Ağrulu, MD、Konya City Hospital
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- KSH-2026/166
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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