An interventional study of Extracorporeal Shock Wave Lithotripsy and Semirigid Ureteroscopy in Ureteral Calculi, sponsored by Hanzla Arshad. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Hanzla Arshad · Not applicable, Interventional, and Treatment
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.
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.
50 studies on the registry are indexed under Ureteral Calculi; 14 are open to participants now.
This study's enrollment of 100 is close to the median of 100 across 42 interventional studies indexed under Ureteral Calculi.
Browse Ureteral Calculi studies →Hanzla Arshad is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: 4 weeks after completion of the assigned treatment
Number of ESWL Sessions Required
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.
Time frame: Immediately after completion of the final ESWL treatment session
Plan to share: Yes — 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.
Supporting information: Informed consent form
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.
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hanzla Arshad