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

ConditionUrolithiasis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKonya City Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • No Intervention

    Other intervention

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Urinary Stone Group1 intervention
Group B: Healthy Control Group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At enrollment
2

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.

Time frame
At enrollment

Secondary outcomes

1

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.

Time frame
At enrollment
2

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.

Time frame
At enrollment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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