NCT07585435

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
294

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

2.7 years

First QC Date

May 7, 2026

Last Update Submit

May 7, 2026

Conditions

Kidney Stones

Outcome Measures

Primary Outcomes (2)

  • Stone Fragmentation Success Rate

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

    2-4 weeks after the ESWL procedure

  • Post-ESWL Pain Scores

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

    Immediately after the ESWL procedure

Study Arms (3)

Hypotonic Group

ACTIVE COMPARATOR

Patients in this group received extracorporeal shock wave lithotripsy (ESWL) using hypotonic degassed water as the coupling fluid. (n=97)

Procedure: Hypotonic degassed water coupling

Isotonic Group

EXPERIMENTAL

Patients in this group received extracorporeal shock wave lithotripsy (ESWL) using 0.9% NaCl (isotonic) solution as the coupling fluid. (n=99)

Procedure: Isotonic (0.9% NaCl) coupling

Hypertonic Group

EXPERIMENTAL

Patients in this group received extracorporeal shock wave lithotripsy (ESWL) using 3% NaCl (hypertonic) solution as the coupling fluid. (n=98)

Procedure: Hypertonic (3% NaCl) coupling

Interventions

Hypotonic degassed water couplingPROCEDURE

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

Hypotonic Group
Isotonic (0.9% NaCl) couplingPROCEDURE

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

Isotonic Group
Hypertonic (3% NaCl) couplingPROCEDURE

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

Hypertonic Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with kidney stones measuring 5-20 mm.
  • Patients scheduled for ESWL treatment.
  • Age 18 and older

You may not qualify if:

  • Pregnancy.
  • Uncorrected bleeding disorders.
  • Active urinary tract infection.
  • Anatomical abnormalities preventing ESWL.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Konya City Hospital

Konya, 42020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kidney Calculi

Interventions

Family Characteristics

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DemographyPopulation CharacteristicsSocioeconomic FactorsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Ahmet Murat Bayraktar, MD

    University of Health Sciences, Konya City Hospital, Department of Urology, Konya, Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Assistant Professor of Urology

Study Record Dates

First Submitted

May 7, 2026

First Posted

May 13, 2026

Study Start

July 1, 2023

Primary Completion

February 28, 2026

Study Completion

February 28, 2026

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

De-identified individual participant data that underlie the results reported in the article, including demographic characteristics (age, sex), stone characteristics (size, location), pain scores (Visual Analog Scale), and stone fragmentation success rates.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The data will be available beginning 6 months and ending 36 months following article publication.
Access Criteria
Data will be shared with qualified researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal. Proposals should be directed to the corresponding author's email. To gain access, data requestors will need to sign a data access agreement.

Locations

TU(1)