An interventional study of Extracorporeal Shock Wave Lithotripsy (ESWL) and Retrograde Intrarenal Surgery (RIRS) in Nephrolithiasis and Renal Calculi, sponsored by Ziauddin Hospital. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-03.
Sponsored by Ziauddin Hospital · Not applicable, Interventional, and Treatment
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.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's planned enrollment of 98 is above the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Ziauddin Hospital is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Compared within Kidney Calculi, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Nephrolithiasis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL)
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.
Procedure: Retrograde Intrarenal Surgery (RIRS)
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.
Also known as: Shock wave lithotripsy
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.
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.
Time frame: 28 days after the procedure
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.
Time frame: At 24 hours after the procedure
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