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NCT Number: NCT07341269

Urinary NGAL and KIM-1 After ESWL

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

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Key information

Conditions

Urinary Stone Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Injury Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University School of Medicine Urology Department

Istanbul, 34854, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No interventions

Other

No study-specific intervention; patients receive standard-of-care SWL.

No intervention

Other

No study-specific intervention; patients receive standard-of-care SWL.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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