Renal Injury, Urinary Stone
Conditions
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
Interventions
OTHERNo Interventions
No study-specific intervention; patients receive standard-of-care SWL.
OTHERNo intervention
No study-specific intervention; patients receive standard-of-care SWL.
Sponsors
Marmara University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in urinary KIM-1 levels | 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 |
| Change in urinary NGAL level | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Turkey (Türkiye)
Outcome results
None listed