Extracorporeal Shock Wave Lithotripsy Versus Ureteroscopy for Upper Ureteric Stones

August 18, 2026 updated by: Hanzla Arshad

Comparison of Treatment Efficacy of Extracorporeal Shock Wave Lithotripsy Versus Ureteroscopy in Patients With Upper Ureteric Stones: A Randomized Controlled Trial

Upper ureteric stones can be treated using extracorporeal shock wave lithotripsy or ureteroscopy. Extracorporeal shock wave lithotripsy breaks the stone using shock waves delivered from outside the body, whereas ureteroscopy involves passing a small instrument through the urinary tract to locate and fragment the stone.

This randomized controlled trial compared the effectiveness and safety of these two treatments in adults with a single upper ureteric stone smaller than 10 mm and a stone density of 1000 Hounsfield units or less. Participants were assigned to receive either extracorporeal shock wave lithotripsy or semirigid ureteroscopy. The main outcome was complete stone clearance on non-contrast computed tomography four weeks after completion of the assigned treatment. Pain relief, number of treatment sessions and treatment-related complications were also assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This single-centre, randomized, parallel-group controlled trial was conducted in the Department of Urology, Federal Postgraduate Medical Institute, Shaikh Zayed Hospital, Lahore, Pakistan. The objective was to compare the treatment efficacy and short-term safety of extracorporeal shock wave lithotripsy (ESWL) with semirigid ureteroscopy (URS) in patients presenting with an upper ureteric stone.

A total of 100 participants aged 18-75 years were enrolled. Eligible participants had a single unilateral upper ureteric stone located above the sacroiliac joint. The stone was confirmed on non-contrast computed tomography of the kidneys, ureters and bladder, measured less than 10 mm in maximum diameter and had a density of 1000 Hounsfield units or less. Participants were randomized in a 1:1 ratio by lottery, with 50 participants assigned to each treatment group.

Participants assigned to ESWL were treated using the MODULITH SLX-F2 lithotripter. Shock waves were delivered at a rate of 60-120 shocks per minute, with an energy setting of 1-9 kV and approximately 2500-3000 shocks per session. Each session lasted approximately 30-60 minutes. A maximum of three sessions was permitted, with an interval of at least 48 hours between successive sessions.

Participants assigned to URS underwent semirigid ureteroscopy under general anesthesia using a 6.5-7.5 Fr semirigid ureteroscope. Stones were fragmented using the Swiss LithoClast Master pneumatic lithotripsy system with a 1-1.2 Fr probe. Stone fragments were removed using a Dormia basket or grasping forceps when required. A double-J ureteric stent was inserted in every participant undergoing URS and was subsequently removed according to clinical assessment.

The primary outcome was complete stone clearance, assessed using non-contrast computed tomography four weeks after completion of the assigned treatment. Complete stone clearance was defined as the absence of any residual stone or stone fragment in the ipsilateral kidney or ureter. A participant requiring an additional stone-removal procedure before the four-week assessment was classified as having treatment failure.

Secondary outcomes included the number of ESWL sessions required, pain relief, immediate procedure-related complications and complications occurring during the four-week follow-up period.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Lahore, Pakistan, 54810
        • Sheikh Zayed Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female participant aged 18 to 75 years Single unilateral upper ureteric stone located above the sacroiliac joint Stone confirmed by non-contrast computed tomography of the kidneys, ureters and bladder Stone maximum diameter less than 10 mm Stone density of 1000 Hounsfield units or less Written informed consent provided Willing and able to complete the assigned treatment and four-week follow-up

Exclusion Criteria:

  • Solitary functioning kidney Bilateral ureteric stones Active urinary tract infection Deranged renal function Stone maximum diameter of 10 mm or greater Stone density greater than 1000 Hounsfield units Unable or unwilling to complete the assigned treatment or four-week follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Extracorporeal Shock Wave Lithotripsy
Participants received extracorporeal shock wave lithotripsy using the MODULITH SLX-F2 lithotripter. A maximum of three sessions was permitted, with an interval of at least 48 hours between sessions.
Procedure: Extracorporeal Shock Wave Lithotripsy
ESWL was performed using the MODULITH SLX-F2 lithotripter at 60-120 shocks per minute, an energy setting of 1-9 kV and approximately 2500-3000 shocks per session. Each session lasted approximately 30-60 minutes. Up to three sessions were permitted, with at least 48 hours between sessions.
Active Comparator: Semirigid Ureteroscopy
Participants underwent semirigid ureteroscopy under general anesthesia with pneumatic stone fragmentation. Stone fragments were removed when required, and a double-J ureteric stent was inserted in all participants.
Procedure: Semirigid Ureteroscopy
Semirigid ureteroscopy was performed under general anesthesia using a 6.5-7.5 Fr ureteroscope. Stones were fragmented using the Swiss LithoClast Master pneumatic lithotripsy system with a 1-1.2 Fr probe. Fragments were removed using a Dormia basket or grasping forceps when required. A double-J ureteric stent was inserted in every participant and subsequently removed according to clinical assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Stone Clearance
Time Frame: 4 weeks after completion of the assigned treatment
Number of participants with complete stone clearance on non-contrast computed tomography of the kidneys, ureters and bladder. Complete stone clearance was defined as the absence of any residual stone or stone fragment in the ipsilateral kidney or ureter. Participants requiring an additional stone-removal procedure before assessment were classified as treatment failures.
4 weeks after completion of the assigned treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of ESWL Sessions Required
Time Frame: Immediately after completion of the final ESWL treatment session
Number of extracorporeal shock wave lithotripsy sessions received by each participant assigned to the ESWL arm. Participants could receive a maximum of three sessions, with an interval of at least 48 hours between successive sessions.
Immediately after completion of the final ESWL treatment session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanzla Arshad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Actual)

June 1, 2026

Study Completion (Actual)

June 1, 2026

Study Registration Dates

First Submitted

August 13, 2026

First Submitted That Met QC Criteria

August 18, 2026

First Posted (Actual)

August 19, 2026

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 18, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TERC/SC/INT/2025/570
  • Technical and Ethical Review C (Other Identifier: Shaikh Zayed Federal Postgraduate Medical Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual participant data underlying the results reported in the final publication will be available upon reasonable request. Data will be shared only after approval of a scientifically sound proposal and completion of a data-use agreement. Information that could identify individual participants will not be shared.

IPD Sharing Time Frame

Beginning 3 months after publication of the study results and available for 5 years.

IPD Sharing Access Criteria

Researchers with a methodologically sound proposal may request access from the principal investigator. Requests must describe the research objectives, proposed analyses and data-security arrangements. Access will require approval by the principal investigator and completion of a data-use agreement. Data may be used only for the analyses specified in the approved proposal.

IPD Sharing Supporting Information Type

  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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