Extracorporeal Shock Wave Lithotripsy Versus Ureteroscopy for Upper Ureteric Stones

NCT07772635 | Completed

• 2 other identifiers: TERC/SC/INT/2025/570Technical and Ethical Review C
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ureteral Calculi

Keywords

Upper ureteric stone; Proximal ureteral stone; Extracorporeal shock wave lithotripsy; ESWL; Semirigid ureteroscopy; URS; Stone clearance; Urolithiasis

Outcome Measures

Primary Outcomes (1)

• Complete Stone Clearance

  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 Outcomes (1)

• Number of ESWL Sessions Required

  Immediately after completion of the final ESWL treatment session

Study Arms (2)

Extracorporeal Shock Wave Lithotripsy

ACTIVE COMPARATOR

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

Semirigid Ureteroscopy

ACTIVE COMPARATOR

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

Interventions

Extracorporeal Shock Wave Lithotripsy PROCEDURE

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.

Extracorporeal Shock Wave Lithotripsy

Semirigid Ureteroscopy PROCEDURE

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.

Semirigid Ureteroscopy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanzla Arshad: lead

Study Sites (1)

Sheikh Zayed Hospital

Lahore, 54810, Pakistan

Location

MeSH Terms

Conditions

Ureteral Calculi; Ureterolithiasis; Urolithiasis

Interventions

Lithotripsy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Ultrasonic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomized in a 1:1 ratio to receive either extracorporeal shock wave lithotripsy or semirigid ureteroscopy.

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 19, 2026
• Study Start: December 1, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Beginning 3 months after publication of the study results and available for 5 years.
• 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.

Locations

PA (1)