Retrograde Intrarenal Surgery Versus Extracorporeal Shockwave Lithotripsy

NCT07510178 | Not Yet Recruiting DMC

• 1 other identifier: SIUT-ERC-2025/A-612
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Renal Stone; Stone in Calyceal Diverticulum

Keywords

renal stone; lithotripsy; retrograde

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Urinary tract infection

  within 4 weeks after the intervention

• Hematuria

  within 4 weeks after the intervention

Study Arms (2)

Group A

ACTIVE COMPARATOR

Group A will be comprised of those patients who will be treated by ESWL (shockwave lithotripsy).

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).

Procedure: Retrograde intrarenal surgery

Interventions

Retrograde intrarenal surgery PROCEDURE

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.

Group B

Extracorporeal shock wave lithotripsy PROCEDURE

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

Group A

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sindh Institute of Urology and Transplantation: lead

Study Sites (1)

Sindh Institute of Urology and Transplantation

Karachi, Sindh, 74200, Pakistan

Location

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Lithotripsy

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ultrasonic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Abdul Khaliq, FCPS

  Sindh Institute of Urology and Transplantation

  STUDY DIRECTOR

Central Study Contacts

Maaz Nazir

CONTACT

+923122949655; maazbinnazir@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: April 3, 2026
• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)