Comparison of two negative pressure ureteral access sheaths combined with day-case flexible ureteroscopy for renal stones randomized trial

Abstract To compare the safety and effectiveness of the combination of intelligent intrarenal pressure control platforms and flexible end ureteral access sheath combined with flexible ureteroscopic lithotripsy (FURL) for the treatment of renal stones less than 2 cm with day case mode. From November 2023 to July 2024, a prospective, randomized, double-blind, parallel-controlled study was conducted to recruit 60 patients with upper urinary tract calculi measuring ≤ 2 cm in longest diameter. A total of 60 eligible patients were consecutively enrolled. Based on a pre-generated random number table and allocation scheme using SPSS 27.0, patients were assigned to either the intelligent pressure control group (IFURL, n = 30) or the head bending group (BFURL, n = 30). Blinding measures were implemented for patients, data collectors, statisticians, and analysts, with the allocation results disclosed to the surgeons prior to the start of the procedure in the operating room. The operation duration for IFURL and BFURL was 52.50 (48.00, 60.00) vs. 46.00 (36.00, 56.25), respectively ( p = 0.047). Stone free rate (SFR) on the first postoperative day was 73.33% vs. 93.33% for IFURL and BFURL, respectively ( p = 0.038). While, SFR was no significant difference between the two groups after two months(90.00% vs. 96.67%, p = 0.301). One patient in IFURL was readmitted after discharge due to fever 2 days post-discharge, and improved after 2 days of anti-infection treatment. One patient in BFURL was readmitted due to lumbar and abdominal pain from urine extravasation, which improved after 3 days of anti-infection treatment. SFR of one-month post-surgery for renal calculi ≤ 2 cm treated with intelligent pressure control and flexible UAS combined with FURL in day surgery mode was similar, with low infection-related complications and rehospitalization rates, showing no statistical difference. However, the overall hospitalization costs for the BFURL was lower than IFURL.