Urinary NGAL and KIM-1 After ESWL

NCT07341269 | Completed

• 1 other identifier: MAR.UAD.0027
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Urinary Stone; Renal Injury

Outcome Measures

Primary Outcomes (2)

• Change in urinary NGAL level

  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

  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 Outcomes (1)

• Between-group difference in change of urinary NGAL and KIM-1 levels according to SWL session intervals

  Within 2 weeks after completion of the third SWL session

Study Arms (1)

Patients undergoing extracorporeal shock wave lithotripsy (SWL)

Other: No Interventions; Other: No intervention

Interventions

No intervention OTHER

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

Patients undergoing extracorporeal shock wave lithotripsy (SWL)

No Interventions OTHER

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

Patients undergoing extracorporeal shock wave lithotripsy (SWL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adults aged 18 years and older
• Patients with an indication for extracorporeal shock wave lithotripsy (SWL) for urinary system stone disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine Urology Department

Istanbul, Istanbul, 34854, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urinary NGAL and KIM-1

MeSH Terms

Conditions

Urinary Calculi

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: January 14, 2026
• Study Start: June 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: December 10, 2025
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)