A prospective randomized study comparing suction evacuation ureteral access sheath versus standard ureteral access sheath in flexible ureteroscopy for upper urinary tract stones lithotripsy

Background Flexible ureteroscopy (FURS) has become a standard treatment for upper urinary tract stones. However, stone evacuation efficiency remains a concern. Novel suction evacuation ureteral access sheaths (FANS-UAS) with bendable tips may improve outcomes.Objective To compare the feasibility and efficacy of suction evacuation ureteral access sheath versus standard ureteral access sheath during FURS for upper urinary tract stone lithotripsy.Methods This prospective randomized comparative study was conducted from April 2024 to April 2025 at Tanta University Hospital. Seventy patients with upper urinary tract stones ≤20 mm were randomly allocated into two groups: Group A (n = 35) using suction evacuation UAS (ClearPetra 11/13 Fr) and Group B (n = 35) using standard UAS (11/13 Fr). Primary endpoint was 1-month NCCT stone-free rate. Secondary endpoints included immediate stone free rate, operative time, surgeon satisfaction, and complications.Results Of the 70 randomized patients, 60 were included in the per-protocol analysis (29 in Group A and 31 in Group B). Regarding the primary endpoint, Group A achieved a significantly superior one-month NCCT stone-free rate compared to Group B (93% vs 71%, p = 0.043). Concerning secondary endpoints, Group A demonstrated significantly higher immediate stone clearance rates assessed by both endoscopic vision (86% vs 61%, p = 0.029) and C-arm fluoroscopy (97% vs 74%, p = 0.015). Additionally, Group A had a significantly shorter mean operative time compared to Group B (77.59 ± 9.32 vs 87.74 ± 12.51 min, p = 0.001). Surgeon satisfaction scores were significantly higher in Group A across all assessed domains, including visualization, fragmentation, maneuverability, and suction (all p < 0.001). No significant differences were observed between the two groups regarding complications, hospital stay, or pain scores.Conclusions Suction evacuation ureteral access sheaths with bendable tips significantly improve operative efficiency, immediate and one-month stone-free rates, and surgeon satisfaction compared to standard sheaths, while maintaining similar safety profiles.