[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657610":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":27,"studyPopulation":28,"armGroups":29,"interventions":39,"overallOfficials":44,"centralContacts":50,"locations":23,"responsibleParty":56,"collaborators":23,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":23,"enrollmentInfo":70,"targetDuration":23,"studyType":73,"phases":23,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":83,"whyStopped":23,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":23},{"fullName":5,"class":6},"Konya City Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":23},[9,13],{"measure":10,"description":11,"timeFrame":12},"Urinary Microplastic Burden","Urinary microplastic burden will be assessed as the number of confirmed microplastic particles detected per milliliter of urine (particles\u002FmL). 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",{"measure":14,"description":15,"timeFrame":12},"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.",[17,20],{"measure":18,"description":19,"timeFrame":12},"Association Between Urinary Microplastic Burden and Stone Size","The association between urinary microplastic burden and maximum urinary stone diameter will be evaluated in participants with kidney or ureteral stones.",{"measure":21,"description":22,"timeFrame":12},"Association Between Urinary Microplastic Burden and Stone Density","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.",null,{"allocation":23,"interventionModel":23,"interventionModelDescription":23,"primaryPurpose":23,"observationalModel":25,"timePerspective":26,"maskingInfo":23},"CASE_CONTROL","PROSPECTIVE","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.\n\nIn 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.\n\nUrine 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.\n\nIn 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.\n\nThe 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.\n\nThe 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.","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.",[30,35],{"label":31,"type":23,"description":32,"interventionNames":33},"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.",[34],"Other: No Intervention",{"label":36,"type":23,"description":37,"interventionNames":38},"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.",[34],[40],{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":23},"No Intervention","This is an observational study. No study-specific intervention will be assigned to participants.",[36,31],[45,48],{"name":46,"affiliation":5,"role":47},"Mehmet Serkan Özkent, MD","PRINCIPAL_INVESTIGATOR",{"name":49,"affiliation":5,"role":47},"Batuhan Ağrulu, MD",[51],{"name":52,"role":53,"phone":54,"phoneExt":23,"email":55},"Mehmet Serkan S ÖZKENT, MD","CONTACT","+90 5059364155","msozkent@gmail.com",{"type":47,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Mehmet Serkan Ozkent","Associate Professor Doctor","100657610","assessment-of-urinary-microplastic-concentration-in-patients-with-urolithiasis-a-prospective-case-control-study-100657610",false,"NCT07841834","Assessment of Urinary Microplastic Concentration in Patients With Urolithiasis: A Prospective Case-Control Study","Quantitative and Qualitative Evaluation of Urinary Microplastic Load in Patients With Kidney\u002FUreteral Stones: A Single-Center Prospective Case-Control Study","Microplastics","Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* 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.",true,"ALL","18 Years",{"count":71,"type":72},100,"ESTIMATED","OBSERVATIONAL","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.",[76],"Urolithiasis",[65,76,78,79,80,81,82],"Ureteral stones","Urinary microplastics","Kidney stones","Urinary stone disease","FTIR spectroscopy","NOT_YET_RECRUITING","2026-09-20",{"date":86,"type":87},"2026-09-25","ACTUAL",{"date":89,"type":72},"2026-09-01",{"date":91,"type":72},"2027-09-01",{"name":5,"class":6}]