Ureteral CalculiNCT07772635
Extracorporeal Shock Wave Lithotripsy Versus Ureteroscopy for Upper Ureteric Stones
A study testing Extracorporeal Shock Wave Lithotripsy and Semirigid Ureteroscopy in people with Ureteral Calculi, run by Hanzla Arshad at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ureteral Calculi
- What is being tested?
- Extracorporeal Shock Wave Lithotripsy and Semirigid Ureteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ureteral Calculi
- Being tested
- Extracorporeal Shock Wave Lithotripsy, Semirigid Ureteroscopy
- Keywords
- Upper ureteric stone, Proximal ureteral stone, Extracorporeal shock wave lithotripsy, ESWL, Semirigid ureteroscopy, URS, Stone clearance, Urolithiasis
- Medical subject headings
- Ureteral Calculi, Ureterolithiasis, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock Wave LithotripsyProcedure or surgery
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 UreteroscopyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Semirigid Ureteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks after completion of the assigned treatment
Secondary outcomes (1)
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.
Measured: Immediately after completion of the final ESWL treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Dec 2025
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized in a 1:1 ratio to receive either extracorporeal shock wave lithotripsy or semirigid ureteroscopy.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanzla Arshad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hanzla Arshad, Shaikh Zayed Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772635
- Sponsor's protocol ID
- TERC/SC/INT/2025/570
- Other IDs
- Technical and Ethical Review C
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treatment Efficacy of Extracorporeal Shock Wave Lithotripsy Versus Ureteroscopy in Patients With Upper Ureteric Stones: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07772635
- Acronym / sponsor ID
- TERC/SC/INT/2025/570
- Conditions
- Ureteral Calculi
- Keywords
- Upper ureteric stone, Proximal ureteral stone, Extracorporeal shock wave lithotripsy, ESWL, Semirigid ureteroscopy, URS, Stone clearance, Urolithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hanzla ArshadUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized in a 1:1 ratio to receive either extracorporeal shock wave lithotripsy or semirigid ureteroscopy.
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal Shock Wave Lithotripsy | Active comparator | Procedure: Extracorporeal Shock Wave LithotripsyParticipants 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. |
| Semirigid Ureteroscopy | Active comparator | Procedure: Semirigid UreteroscopyParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal Shock Wave LithotripsyESWL 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. | Procedure or surgery | Extracorporeal Shock Wave Lithotripsy |
| Semirigid UreteroscopySemirigid 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. | Procedure or surgery | Semirigid Ureteroscopy |
Primary outcome
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.
1 secondary outcome
Number of ESWL Sessions Required
Time frame: Immediately after completion of the final ESWL treatment session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock Wave Lithotripsy and Semirigid Ureteroscopy in people with Ureteral Calculi, run by Hanzla Arshad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Stone Clearance (time frame: 4 weeks after completion of the assigned treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.