CompletedNot Applicable

Urinary NGAL and KIM-1 After ESWL

Turkey (Türkiye)50 participantsStarted 2025-06-01

Plain-language summary

The goal of this prospective observational study is to evaluate the effect of different time intervals between extracorporeal shock wave lithotripsy (ESWL) sessions on renal injury using urinary biomarkers in patients with urinary system stone disease. The main questions it aims to answer are: Does the interval between consecutive ESWL sessions affect the degree of renal injury? Are urinary NGAL and KIM-1 levels reliable biomarkers for detecting ESWL-related renal damage? What is the optimal time interval between ESWL sessions to minimize renal injury? If there is a comparison group, researchers will compare patients undergoing ESWL with different inter-session time intervals to determine whether shorter or longer intervals are associated with higher levels of renal injury biomarkers. Participants will: Undergo ESWL treatment for urinary system stones Be assigned to one of two groups based on the time interval between ESWL sessions Provide urine samples before ESWL and after three ESWL sessions Have urinary NGAL and KIM-1 levels measured to assess renal injury

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged 18 years and older * Patients with an indication for extracorporeal shock wave lithotripsy (SWL) for urinary system stone disease Exclusion Criteria: * Positive nitrite on urinalysis prior to SWL * Positive urine culture prior to SWL, defined as \>10⁵ CFU/mL bacterial growth * Suspected struvite stone, based on previous or partial stone analysis * Presence of a nephrostomy tube * Presence of urinary diversion * History of bleeding disorders * Pregnancy * Use of anticoagulant therapy * History of cardiac arrhythmia

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in urinary NGAL level

Timeframe: Within 2 weeks after completion of the third SWL session

Change in urinary KIM-1 levels

Timeframe: Within 2 weeks after completion of the third SWL session

Trial details

NCT IDNCT07341269

SponsorMarmara University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-08-01

View on ClinicalTrials.gov More Urinary Stone trials