NephrolithiasisNCT07261995
Comparison of Extracorporeal Shock Wave Lithotripsy Versus Retrograde Intrarenal Surgery in the Management of Renal Calculi
A study testing Extracorporeal Shock Wave Lithotripsy (ESWL) and Retrograde Intrarenal Surgery (RIRS) in people with Nephrolithiasis and Renal Calculi, run by Ziauddin Hospital at 1 site in Pakistan.
Trial summary
This study is being carried out in patients with kidney stones measuring between 1 and 2 centimeters. Kidney stones are common in Pakistan and can cause severe pain, infection, and repeated hospital visits. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nephrolithiasis, Renal Calculi
- What is being tested?
- Extracorporeal Shock Wave Lithotripsy (ESWL) and Retrograde Intrarenal Surgery (RIRS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Sep 2025to 5 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 65 years.
- Patients diagnosed with a single renal calculus measuring between 1 cm and 2 cm, confirmed on imaging (ultrasound or non-contrast CT KUB).
Who cannot join
- Presence of multiple renal stones or bilateral renal stones.
- Patients with anatomical abnormalities such as horseshoe kidney, ureteropelvic junction obstruction, or calyceal diverticulum based on medical history or radiological findings.
- Active urinary tract infection at the time of intervention.
- Pregnant women.
- Patients with bleeding disorders or on anticoagulation therapy that cannot be safely stopped.
- Patients with chronic kidney disease (eGFR < 30 mL/min/1.73 m²).
- Patients with morbid obesity (BMI > 40 kg/m²).
- Patients with solitary kidney.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Ziauddin Hospital
Karachi, Sindh, 75000
Muhammad Waqas Arshad, +9221358629379, info@zu.edu.pk
About this study
Official title: Comparison of Outcomes of Extracorporeal Shock Wave Lithotripsy Versus Retrograde Intrarenal Surgery in the Management of Renal Calculi Measuring 1 to 2 Centimeters
This study is being carried out in patients with kidney stones measuring between 1 and 2 centimeters. Kidney stones are common in Pakistan and can cause severe pain, infection, and repeated hospital visits. Two commonly used treatments for stones of this size are extracorporeal shock wave lithotripsy (ESWL) and retrograde intrarenal surgery (RIRS). ESWL uses shock waves applied from outside the body to break the stone into small fragments that can pass in the urine. RIRS is a minimally invasive endoscopic procedure in which a thin flexible scope is passed through the urinary passage into the kidney and a laser is used to break the stone.
Adult patients aged 18 to 65 years with a single kidney stone of 1-2 cm will be included. According to the urologist's clinical judgment and patient preference, individuals will undergo either ESWL (Group A) as a day-care shock wave procedure or RIRS (Group B) under general anesthesia using a laser. All patients will receive standard care before and after the procedure and will be followed for 28 days.
The study will compare how completely the stone is cleared (based on a CT scan), how long patients stay in hospital, how much pain they feel after the procedure, and whether they develop visible blood in the urine or signs of infection such as fever and raised white cell count. The need for any further procedure for the same stone will also be recorded. The central hypothesis is that there is a meaningful difference between ESWL and RIRS in stone clearance, safety, pain, and need for retreatment. The findings are expected to help doctors and patients choose the most suitable treatment for kidney stones of this size in routine practice.
- Conditions
- Nephrolithiasis, Renal Calculi
- Being tested
- Extracorporeal Shock Wave Lithotripsy (ESWL), Retrograde Intrarenal Surgery (RIRS)
- Keywords
- Kidney stones, Nephrolithiasis, Urolithiasis, Extracorporeal shock wave lithotripsy, Retrograde intrarenal surgery
- Medical subject headings
- Nephrolithiasis, Kidney Calculi, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock Wave Lithotripsy (ESWL)Procedure or surgery
Also called Shock wave lithotripsy
Extracorporeal shock wave lithotripsy delivered as an outpatient procedure under sedation, using a standard lithotripter. Shock waves are applied at 60-100 impulses per minute, up to a maximum of 3000 shocks per session, to fragment a 1-2 centimeter renal calculus. Patients receive standard analgesia, hydration counselling, and antibiotic prophylaxis according to hospital protocol.
Retrograde Intrarenal Surgery (RIRS)Procedure or surgery
Retrograde intrarenal surgery performed under general anesthesia after prior placement of a 5 Fr double-J ureteral stent. A flexible ureteroscope introduced via the urethra and ureteral access sheath is used to visualise the renal stone. Stone disintegration is achieved with a Holmium:YAG laser (0.5-1.2 Joules, 20-40 Hertz) using dusting or fragmentation, followed by placement of a double-J stent for three weeks. Standard postoperative analgesia, antibiotics, and hydration advice are given.
| Study group | Role | What they receive |
|---|---|---|
| Group ESWL | Active comparator | Patients with a single renal stone measuring 1-2 centimeters receive extracorporeal shock wave lithotripsy (ESWL) as a day-care outpatient procedure under sedation. Shock waves are delivered starting at 60 impulses per minute and titrated up to 100 impulses per minute according to patient tolerance, with a maximum of 3000 shocks per session. Standard peri-procedural care, analgesia, hydration advice, and antibiotic prophylaxis according to institutional protocol are provided. Receives: Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL) |
| Group RIRS | Active comparator | Patients with a single renal stone measuring 1-2 centimeters undergo retrograde intrarenal surgery (RIRS) under general anesthesia. All patients are pre-stented with a 5 Fr double-J ureteral stent 2-3 weeks prior to the definitive procedure. A flexible ureteroscope is advanced to the renal collecting system through a ureteral access sheath, and the stone is fragmented using a Holmium:YAG laser with energy 0.5-1.2 Joules and frequency 20-40 Hertz (dusting or fragmentation technique as appropriate). A double-J stent is left in situ at the end of the procedure and scheduled for removal after three weeks. Standard postoperative care is provided. Receives: Procedure: Retrograde Intrarenal Surgery (RIRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone clearance rate
Proportion of participants in each treatment group who achieve successful stone clearance, defined as absence of visible stone or presence of a clinically insignificant residual fragment measuring ≤4 mm on non-contrast computed tomography of kidneys, ureters and bladder (CT-KUB). All scans will be interpreted and reported by a consultant radiologist blinded to treatment allocation. Stone clearance will be analysed as a binary variable (cleared/not cleared) for comparison between extracorporeal shock wave lithotripsy and retrograde intrarenal surgery.
Measured: 28 days after the procedure
Secondary outcomes (1)
Postoperative pain intensity (VAS score)
Patient-reported pain severity measured on a 10-cm Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents worst imaginable pain. Scores will be recorded by trained nursing staff and compared between groups as a continuous variable.
Measured: At 24 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start5 Sep 2025
- Primary completion5 Feb 2026 (estimated)
- Study completion5 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NephrolithiasisStudies 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
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziauddin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Waqas Arshad, Ziauddin Hospital
- Investigators
- Muhammad Waqas Arshad, Principal investigator, Ziauddin Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261995
- Sponsor's protocol ID
- Ziauddin Uro1
- Status last verified
- Sep 2025
- First submitted
- 21 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arshad MW, Javed A, Ahadi S, Ghayoor Yousaf A. Comparison of outcomes of extracorporeal shock wave lithotripsy versus retrograde intrarenal surgery in the management of renal calculi measuring one to two centimeters. Pak J Med Sci. 2026 Sep;42(9):2581-2587. doi: 10.12669/pjms.42.9.16588.
PubMed 42819572
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes of Extracorporeal Shock Wave Lithotripsy Versus Retrograde Intrarenal Surgery in the Management of Renal Calculi Measuring 1 to 2 Centimeters
- ClinicalTrials.gov ID
- NCT07261995
- Acronym / sponsor ID
- Ziauddin Uro1
- Conditions
- Nephrolithiasis, Renal Calculi
- Keywords
- Kidney stones, Nephrolithiasis, Urolithiasis, Extracorporeal shock wave lithotripsy, Retrograde intrarenal surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Ziauddin HospitalUniversity, hospital or other
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 5 Feb 2026 (estimated)
- Study completion
- 5 Feb 2026 (estimated)
- First posted
- 3 Dec 2025 (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.
This study is being carried out in patients with kidney stones measuring between 1 and 2 centimeters. Kidney stones are common in Pakistan and can cause severe pain, infection, and repeated hospital visits. Two commonly used treatments for stones of this size are extracorporeal shock wave lithotripsy (ESWL) and retrograde intrarenal surgery (RIRS). ESWL uses shock waves applied from outside the body to break the stone into small fragments that can pass in the urine. RIRS is a minimally invasive endoscopic procedure in which a thin flexible scope is passed through the urinary passage into the kidney and a laser is used to break the stone.
Adult patients aged 18 to 65 years with a single kidney stone of 1-2 cm will be included. According to the urologist's clinical judgment and patient preference, individuals will undergo either ESWL (Group A) as a day-care shock wave procedure or RIRS (Group B) under general anesthesia using a laser. All patients will receive standard care before and after the procedure and will be followed for 28 days.
The study will compare how completely the stone is cleared (based on a CT scan), how long patients stay in hospital, how much pain they feel after the procedure, and whether they develop visible blood in the urine or signs of infection such as fever and raised white cell count. The need for any further procedure for the same stone will also be recorded. The central hypothesis is that there is a meaningful difference between ESWL and RIRS in stone clearance, safety, pain, and need for retreatment. The findings are expected to help doctors and patients choose the most suitable treatment for kidney stones of this size in routine practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group ESWL | Active comparator | Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL)Patients with a single renal stone measuring 1-2 centimeters receive extracorporeal shock wave lithotripsy (ESWL) as a day-care outpatient procedure under sedation. Shock waves are delivered starting at 60 impulses per minute and titrated up to 100 impulses per minute according to patient tolerance, with a maximum of 3000 shocks per session. Standard peri-procedural care, analgesia, hydration advice, and antibiotic prophylaxis according to institutional protocol are provided. |
| Group RIRS | Active comparator | Procedure: Retrograde Intrarenal Surgery (RIRS)Patients with a single renal stone measuring 1-2 centimeters undergo retrograde intrarenal surgery (RIRS) under general anesthesia. All patients are pre-stented with a 5 Fr double-J ureteral stent 2-3 weeks prior to the definitive procedure. A flexible ureteroscope is advanced to the renal collecting system through a ureteral access sheath, and the stone is fragmented using a Holmium:YAG laser with energy 0.5-1.2 Joules and frequency 20-40 Hertz (dusting or fragmentation technique as appropriate). A double-J stent is left in situ at the end of the procedure and scheduled for removal after three weeks. Standard postoperative care is provided. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged between 18 and 65 years.
- Patients diagnosed with a single renal calculus measuring between 1 cm and 2 cm, confirmed on imaging (ultrasound or non-contrast CT KUB).
Key exclusion criteria (8 listed)
- Presence of multiple renal stones or bilateral renal stones.
- Patients with anatomical abnormalities such as horseshoe kidney, ureteropelvic junction obstruction, or calyceal diverticulum based on medical history or radiological findings.
- Active urinary tract infection at the time of intervention.
- Pregnant women.
- Patients with bleeding disorders or on anticoagulation therapy that cannot be safely stopped.
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 Lithotripsy (ESWL)Also: Shock wave lithotripsyExtracorporeal shock wave lithotripsy delivered as an outpatient procedure under sedation, using a standard lithotripter. Shock waves are applied at 60-100 impulses per minute, up to a maximum of 3000 shocks per session, to fragment a 1-2 centimeter renal calculus. Patients receive standard analgesia, hydration counselling, and antibiotic prophylaxis according to hospital protocol. | Procedure or surgery | Group ESWL |
| Retrograde Intrarenal Surgery (RIRS)Retrograde intrarenal surgery performed under general anesthesia after prior placement of a 5 Fr double-J ureteral stent. A flexible ureteroscope introduced via the urethra and ureteral access sheath is used to visualise the renal stone. Stone disintegration is achieved with a Holmium:YAG laser (0.5-1.2 Joules, 20-40 Hertz) using dusting or fragmentation, followed by placement of a double-J stent for three weeks. Standard postoperative analgesia, antibiotics, and hydration advice are given. | Procedure or surgery | Group RIRS |
Primary outcome
Stone clearance rate
Time frame: 28 days after the procedure
Proportion of participants in each treatment group who achieve successful stone clearance, defined as absence of visible stone or presence of a clinically insignificant residual fragment measuring ≤4 mm on non-contrast computed tomography of kidneys, ureters and bladder (CT-KUB). All scans will be interpreted and reported by a consultant radiologist blinded to treatment allocation. Stone clearance will be analysed as a binary variable (cleared/not cleared) for comparison between extracorporeal shock wave lithotripsy and retrograde intrarenal surgery.
1 secondary outcome
Postoperative pain intensity (VAS score)
Time frame: At 24 hours after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Derived from this study: PubMed 42819572Arshad MW, Javed A, Ahadi S, Ghayoor Yousaf A. Comparison of outcomes of extracorporeal shock wave lithotripsy versus retrograde intrarenal surgery in the management of renal calculi measuring one to two centimeters. Pak J Med Sci. 2026 Sep;42(9):2581-2587. doi: 10.12669/pjms.42.9.16588.
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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.
Muhammad Waqas Arshad principal investigator
Ziauddin Universty
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 (ESWL) and Retrograde Intrarenal Surgery (RIRS) in people with Nephrolithiasis and Renal Calculi, run by Ziauddin Hospital 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 2 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 3 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Waqas Arshad Arshad (+9221358629379, waqasarshad617@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone clearance rate (time frame: 28 days after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07261995, which also lists 1 linked publication.
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 3 Dec 2025.