Comparison of Extracorporeal Shock Wave Lithotripsy Versus Retrograde Intrarenal Surgery in the Management of Renal Calculi

Recruiting now · Not applicable

Conditions studied: Nephrolithiasis, Renal Calculi

In brief

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.

Key facts

Study ID: NCT07261995
Run by: Ziauddin Hospital
People needed: 98
Starts: 2025-09-05
Expected to finish: 2026-02-05
Last updated by the study team: 2025-12-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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).

You may not qualify if…

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.

Where it is running

Ziauddin Hospital — Karachi, Sindh, Pakistan (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.