Renal StoneNCT07510178
Retrograde Intrarenal Surgery Versus Extracorporeal Shockwave Lithotripsy
A study testing Retrograde intrarenal surgery and Extracorporeal shock wave lithotripsy in people with Renal Stone and Stone in Calyceal Diverticulum, run by Sindh Institute of Urology and Transplantation at 1 site in Pakistan.
Trial summary
The study's aim is to determine which treatment modality, either ESWL or RIRS, is more effective in achieving stone clearance for lower calyceal calculi. Investigators hypothesize that retrograde intrarenal surgery is better as compared to extracorporeal shockwave lithotripsy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Renal Stone, Stone in Calyceal Diverticulum
- What is being tested?
- Retrograde intrarenal surgery and Extracorporeal shock wave lithotripsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Apr 2026to 30 Oct 2026
- Phase
- Interventional
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Those patients will be included with lower calyceal renal stones and size up to 1.5 cm.
- Patients' ages will be between 18 and 60 years.
- Both genders will be included.
Who cannot join
- Untreated Urine culture positive will be excluded
- Patients using anticoagulants and females with pregnancies and those lactating will be excluded.
- Anatomical abnormalities like horseshoe kidney, duplex system, pelvic kidney, malrotated kidney, calyceal diverticulum, steep infundibulopelvic angle, infundibular stenosis, long infundibular length/narrow infundibular width, pelvic ureteric junction obstruction, ureterocele, and ureteral stricture will be excluded.
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
Sindh Institute of Urology and Transplantation
Karachi, Sindh, 74200
About this study
Official title: Role Of Retrograde Intrarenal Surgery Versus Extracorporeal Shockwave Lithotripsy In Lower Calyceal Calculi
The study's aim is to determine which treatment modality, either ESWL or RIRS, is more effective in achieving stone clearance for lower calyceal calculi.
Investigators hypothesize that retrograde intrarenal surgery is better as compared to extracorporeal shockwave lithotripsy. It will target those patients suffering from kidney stones in lower calyces with sizes up to 1.5 cm in an open-label, randomized controlled trial.
Read the detailed description
After approval from the Institutional Ethical Review Committee and taking informed consent from the patients, the investigator will gather all the information related to the study. Patients will be enrolled in this study from the outpatient clinic. Total patients will be divided into two groups using the SNOSE protocol, in which patients will be randomly assigned to one of the two groups using the envelope method.
Group A will be labeled under those patients who will be treated by ESWL. Group B will be those treated by RIRS. It will be an open-label study. A Performa has been designed and finalized after a literature search. This form will gather demographic details, clinical characteristics, selection of procedure, procedure details, outcomes of procedure, and complications.
In case of ESWL, up to 3 sessions of ESWL will be given, and for RIRS, only one session will be considered. In ESWL, ultrasound- or fluoroscopy-guided 3000 shock waves per person are delivered under the supervision of an experienced consultant urologist for up to 60 - 90 minutes using lithotripsy model SLX-F2 FD21 with energy ranging from 1 to 6, and patients are discharged on proper hydration, painkillers, and alpha blockers. In RIRS, firstly, a retrograde pyelogram is performed to know the anatomy and stone position. Then, using aseptic technique, a sterile flexible 7.5/3.6 Fr ureterorenoscope of model HU30S will be passed over a Y-9-50 ureteral access sheath and advanced into the kidney, and the stone will be broken with the use of a 35-watt hyperphotonic holmium laser delivered via a 272 nm fiber. The RIRS will be performed by an experienced urologist. Later patients will be discharged with advice of hydration and empirical antibiotics. Initially the stone bulk will be defined by a CT scan, and the Hounsfield unit of stones will be noted. The infundibular pelvic angle, calyx length, diameter, and skin-to-stone distance will also be calculated using the CT scan plane. Patients managed either by RIRS or ESWL will be advised for a follow-up after four weeks with an X-ray KUB for radiopaque stones and an ultrasound and CT scan of the kidneys to look for residual radiolucent calculi. Stone clearance will be considered if residual stone size is less than 4 mm.
- Conditions
- Renal Stone, Stone in Calyceal Diverticulum
- Being tested
- Retrograde intrarenal surgery, Extracorporeal shock wave lithotripsy
- Keywords
- renal stone, lithotripsy, retrograde
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde intrarenal surgeryProcedure or surgery
Retrograde intrarenal surgery (RIRS) is a minimally invasive procedure in which a flexible ureteroscope is passed through the urethra, then the ureter, and then into the kidney, and then with the help of the laser, stones are broken down into small fragments, which can be retrieved either at the same time or flushed later in urine. Stone clearance will assessed with an X-ray of the abdomen (radiopaque) and ultrasound or CT scan of the kidneys (residual radiolucent stones) on follow-up.
Extracorporeal shock wave lithotripsyProcedure or surgery
Extracorporeal shock wave lithotripsy (ESWL) is a noninvasive procedure in which highly focused shock waves are delivered at the renal calculi, which then break down into small pieces and later pass in urine. An X-ray abdomen (radiopaque) and ultrasound or CT scan of the kidneys (residual radiolucent stone) will be used on follow-up to assess stone clearance. Up to 3 sessions of ESWL will given to the selected candidate
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A will be comprised of those patients who will be treated by ESWL (shockwave lithotripsy). Receives: Procedure: Extracorporeal shock wave lithotripsy |
| Group B | Experimental | Group B will be comprised of those patients who will be treated by RIRS (retrograde intrarenal surgery). Receives: Procedure: Retrograde intrarenal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone clearance
Stone clearance (based on follow-up with X-Ray for radio-opaque stones and ultrasound or CT Scan for radio-lucent stones)
Measured: four weeks after the intervention
Secondary outcomes (2)
Urinary tract infection
It is diagnosed if the patient starts complaining of burning micturition along with a running temperature. It will be confirmed by a urine D/R with a culture \& sensitivity report.
Measured: within 4 weeks after the intervention
Hematuria
It will be diagnosed if the patient starts complaining of burning micturition along with red discoloration of urine. It will be confirmed by the presence of numerous RBCs in a urine D/R
Measured: within 4 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StoneStudies 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
- Group A will include those patients who will be treated by ESWL, and group B will be those treated by RIRS. The primary investigator/outcome assessor will be blinded. A Performa has been designed and finalized after a literature search. This form will gather demographic details, clinical characteristics, selection of procedure, procedure details, outcomes of procedure, and complications.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sindh Institute of Urology and Transplantation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maaz Bin Nazir, Sindh Institute of Urology and Transplantation
- Investigators
- Abdul Khaliq, FCPS, Study director, Sindh Institute of Urology and Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510178
- Sponsor's protocol ID
- SIUT-ERC-2025/A-612
- Status last verified
- Apr 2026
- First submitted
- 29 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only results will be shared