This randomized controlled trial aims to compare the efficacy and safety of two suction techniques during retrograde flexible ureteroscopy (FURS) for lower calyceal renal stones measuring 1.5-2 cm. The study evaluates Flexible \& Navigable Suction Ureteral Access Sheath (FANS) versus Antegrade Suction (via percutaneous access) in improving stone-free rates (SFR), reducing operative time, and minimizing complications such as bleeding, ureteral injury, and infection. A total of 120 adult patients will be randomized into two groups, undergoing either flexible ureteroscopy (FURS) with Flexible \& Navigable Suction Ureteral Access Sheath (FANS) or flexible ureteroscopy (FURS) with antegrade suction, at Banha University Faculty of Medicine.
Adult patients (≥18 years old)
Patients diagnosed with renal stones (1.5-2 cm) confirmed by non-contrast computed tomography (NCCT)
Patients undergoing flexible ureteroscopy (FURS) as the primary treatment approach
Patients with no active urinary tract infection (UTI) at baseline
Patients with anatomical anomalies (e.g., horseshoe kidney, PUJ obstruction)
Patients with a single functioning kidney
Pregnant women
Patients with a history of urological malignancy
Parallel
Flexible & Navigable Suction Ureteral Access Sheath (FANS)
Procedure/SurgeryThe Flexible \& Navigable Suction Ureteral Access Sheath (FANS) is used during retrograde flexible ureteroscopy (FURS) for renal stones (1.5-2 cm). It allows continuous active suctioning, improving stone fragment evacuation, reducing operative time, lowering intrarenal pressure, and optimizing stone-free rates (SFR). The procedure involves inserting the Navigator 10F, 55 cm YIGAOMED FANS over a guidewire, followed by flexible ureteroscopy with PUSEN® 9.2 Fr ureteroscope and laser lithotripsy using Holmium Laser (JenaSurgical® MultiPulse HoPLUS™ 150W).
Antegrade Suction via Percutaneous Nephrostomy
Procedure/SurgeryThis technique involves antegrade suction from the kidney during flexible ureteroscopy (FURS) without the use of a ureteral access sheath. A percutaneous nephrostomy (PCN) tract is created using an 18G needle, and a 6F renal dilator is placed and fixed to the skin, allowing for direct suctioning from the collecting system. Following this, retrograde flexible ureteroscopy (FURS) is performed using the PUSEN® 9.2 Fr ureteroscope and Holmium Laser (JenaSurgical® MultiPulse HoPLUS™ 150W) for stone fragmentation. This technique aims to improve stone clearance while minimizing ureteral trauma associated with access sheaths.
Stone-Free Rate (SFR)
The stone-free rate (SFR) will be assessed one month postoperatively using non-contrast computed tomography (NCCT) to determine the presence or absence of residual stone fragments ≥4 mm. A higher SFR indicates better effectiveness of the intervention.
Operative Time
The total operative time will be recorded from the initial endoscopic access to procedure completion. This includes access sheath insertion, ureteroscopy, lithotripsy, and final stone evacuation. A shorter operative time is indicative of a more efficient technique.
Intraoperative Bleeding Requiring Intervention
The incidence of ureteral injuries, including mucosal damage, perforation, or full-thickness injury, will be documented. The severity will be graded based on endoscopic findings and clinical impact.
Ureteral Injury
The incidence of ureteral injuries, including mucosal damage, perforation, or full-thickness injury, will be documented. The severity will be graded based on endoscopic findings and clinical impact.
Postoperative Hematuria
The presence of postoperative hematuria (macroscopic bleeding) will be assessed. It will be classified as mild (self-limited), moderate (requiring irrigation), or severe (requiring intervention such as transfusion or embolization).
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