Retrograde Intrarenal Surgery Versus Extracorporeal Shockwave Lithotripsy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Renal Stone; Stone in Calyceal Diverticulum
• Intervention / Treatment: Procedure: Extracorporeal shock wave lithotripsy; Procedure: Retrograde intrarenal surgery

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.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maaz Nazir; Phone Number: +923122949655; Email: maazbinnazir@yahoo.com

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74200
      • Sindh Institute of Urology and Transplantation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Group A will be comprised of those patients who will be treated by ESWL (shockwave lithotripsy).	Procedure: Extracorporeal shock wave lithotripsy; 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
Experimental: Group B; Group B will be comprised of those patients who will be treated by RIRS (retrograde intrarenal surgery).	Procedure: Retrograde intrarenal 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone clearance	Stone clearance (based on follow-up with X-Ray for radio-opaque stones and ultrasound or CT Scan for radio-lucent stones)	four weeks after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	within 4 weeks after the intervention

Collaborators and Investigators

• Sponsor: Sindh Institute of Urology and Transplantation
• Investigators: Study Director: Abdul Khaliq, FCPS, Sindh Institute of Urology and Transplantation

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: March 29, 2026
• First Submitted That Met QC Criteria: March 29, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: lithotripsy; renal stone; retrograde
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Nephrolithiasis; Therapeutics; Surgical Procedures, Operative; Ultrasonic Surgical Procedures; Lithotripsy
• Other Study ID Numbers: SIUT-ERC-2025/A-612

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only results will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No