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Completed

NCT Number: NCT07585435

Acoustic Impedance Matching in ESWL Coupling

The purpose of this study is to investigate the effect of different salt concentrations (tonicity) in the coupling fluid used during Extracorporeal Shock Wave Lithotripsy (ESWL). The study compares three types of coupling fluids: hypotonic (degassed water), isotonic (0.9% NaCl), and hypertonic (3% NaCl) solutions. Researchers aim to determine which solution provides the best stone fragmentation success while minimizing procedure-related pain and skin complications.

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Key information

Conditions

Kidney Stones Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences, Konya City Hospital

Konya, 42020, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients with kidney stones measuring 5-20 mm.

Patients scheduled for ESWL treatment.

Age 18 and older

Exclusion criteria

Pregnancy.

Uncorrected bleeding disorders.

Active urinary tract infection.

Anatomical abnormalities preventing ESWL.

Treatment and study plan

Hypotonic degassed water coupling

Procedure

Hypotonic degassed water was used as the coupling fluid during the ESWL procedure.

Isotonic (0.9% NaCl) coupling

Procedure

0.9% NaCl (isotonic) solution was used as the coupling fluid during the ESWL procedure.

Hypertonic (3% NaCl) coupling

Procedure

3% NaCl (hypertonic) solution was used as the coupling fluid during the ESWL procedure.

Primary outcomes

  1. Stone Fragmentation Success Rate

    Time frame: 2-4 weeks after the ESWL procedure

    The percentage of patients achieving successful stone fragmentation, defined as residual fragments smaller than 4 mm.

  2. Post-ESWL Pain Scores

    Time frame: Immediately after the ESWL procedure

    Pain intensity assessed using the Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the worst imaginable pain.

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

Acoustic Impedance Matching in ESWL: A Comparative Analysis of Hypotonic, Isotonic and Hypertonic Coupling Fluids

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 13, 2026
Registry last updated
May 13, 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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