Background: Percutaneous nephrolithotomy (PCNL) is the first-line treatment for renal stones larger than 2 cm according to EAU and AUA guidelines. Advances in flexible ureteroscopy, including smaller disposable ureteroscopes and suction techniques, have expanded its indications. The tip-bendable suction ureteral access sheath (S-UAS) offers improved flexibility and stone-free rates (SFR). This study compares clinical outcomes of flexible ureteroscopy (f-URS) with S-UAS and mini-PCNL in treating 2-3 cm renal stones. Objective: This study aims to determine if f-URS with S-UAS is non-inferior to mini-PCNL regarding stone-free rates. Secondary objectives include comparing complication rates, surgical time, and hospitalization duration. Methods: This multicenter, international, prospective, non-inferiority, randomized controlled trial will enroll 720 patients across 12 urological centers. Patients will be randomized to either f-URS with S-UAS or mini-PCNL. Outcomes include immediate and 3-month SFR, operative time, hospital stay, further interventions, complications, and quality of life. Results: Data will be analyzed using intention-to-treat and per-protocol approaches, with statistical analyses performed using SPSS software. Conclusion: This study will provide high-level evidence on the effectiveness of f-URS with S-UAS compared to mini-PCNL for medium-sized renal stones.
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Immediately stone-free rate (SFR)
Timeframe: Up to 72 hours.