An observational study in Urinary Stone and Renal Injury, sponsored by Marmara University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by Marmara University · Observational
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
94 studies on the registry are indexed under Urinary Calculi; 20 are open to participants now.
This study's enrollment of 50 is below the median of 200 across 31 observational studies indexed under Urinary Calculi.
Browse Urinary Calculi studies →Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.
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The study population consists of adult patients aged 18 years and older with urinary system stone disease who are undergoing extracorporeal shock wave lithotripsy (SWL) as part of routine clinical care. Participants are prospectively observed to evaluate changes in urinary NGAL and KIM-1 levels as biomarkers of renal injury associated with SWL. Patients with active urinary tract infection, suspected struvite stones, urinary diversion, nephrostomy tube, bleeding disorders, pregnancy, anticoagulant use, or cardiac arrhythmia are excluded.
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Exclusion Criteria:
Other: No Interventions · Other: No intervention
No study-specific intervention; patients receive standard-of-care SWL.
No study-specific intervention; patients receive standard-of-care SWL.
Change in urinary NGAL level
Difference in urinary NGAL levels measured before SWL and after completion of three SWL sessions
Time frame: Within 2 weeks after completion of the third SWL session
Change in urinary KIM-1 levels
Difference in urinary KIM-1 levels measured before SWL and after completion of three SWL sessions
Time frame: Within 2 weeks after completion of the third SWL session
Between-group difference in change of urinary NGAL and KIM-1 levels according to SWL session intervals
Time frame: Within 2 weeks after completion of the third SWL session
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2025 to primary completion in Aug 2025, 2 months.
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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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