Urinary NGAL and KIM-1 After ESWL

January 5, 2026 updated by: Marmara University

Prospective Evaluation of the Effect of Different Intervals Between Extracorporeal Shock Wave Lithotripsy (ESWL) Sessions on Potential Renal Injury Using Urinary NGAL and KIM-1 Biomarkers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34854
        • Marmara University School of Medicine Urology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing extracorporeal shock wave lithotripsy (SWL)
Other: No Interventions
No study-specific intervention; patients receive standard-of-care SWL.
Other: No intervention
No study-specific intervention; patients receive standard-of-care SWL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in urinary NGAL level
Time Frame: Within 2 weeks after completion of the third SWL session
Difference in urinary NGAL levels measured before SWL and after completion of three SWL sessions
Within 2 weeks after completion of the third SWL session
Change in urinary KIM-1 levels
Time Frame: Within 2 weeks after completion of the third SWL session
Difference in urinary KIM-1 levels measured before SWL and after completion of three SWL sessions
Within 2 weeks after completion of the third SWL session

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Within 2 weeks after completion of the third SWL session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Actual)

August 1, 2025

Study Completion (Actual)

December 10, 2025

Study Registration Dates

First Submitted

December 20, 2025

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAR.UAD.0027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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