A phase I efficacy study of ureteroscopy-assisted flexible negative pressure Suction sheath in the treatment of renal stones larger than 4 cm
摘要
This study aims to investigate the feasibility, safety, and efficacy attributes of one-stage treatment of ≥ 4 cm renal stones using flexible ureteroscopy (FURS)-assisted head-end flexible negative pressure suction sheath (TFS-UAS). Initially, we retrospectively analyzed the samples from a total of 161 patients with renal stones (≥ 4 cm) who underwent surgical treatment at the Department of Urology of the First Affiliated Hospital of Fujian Medical University from October 2022 to November 2024. Accordingly, the subjects were initially divided into minimally invasive percutaneous nephrolithotripsy (mPNL, n = 80) and TFS-UAS-combined FURS lithotripsy (TFS-UAS, n = 81) groups. Further, the demographic characteristics, laboratory tests, stone parameters, surgical information, SFR, and perioperative complications were analyzed. The findings showed no statistically significant differences in demographic characteristics, inflammatory indicators, changes in serum creatinine (Scr) and glomerular filtration rate (GFR), maximum stone diameter, maximum width, CT values, and degree of hydronephrosis between the two groups. The one-stage complete stone-free rate (SFR) in the TFS-UAS group (49.4% vs. 20.0%) (P < 0.001) and relative SFR (61.7% vs. 45.0%) (P = 0.033) were significantly higher in the TFS-UAS group than in the mPNL group. After phase II treatment, the complete SFR (65.4% vs. 46.3%, P = 0.014) and relative SFR (75.3% vs. 58.8%, P = 0.025) in the TFS-UAS group were still significantly higher than those in the mPNL group of patients. The TFS-UAS-combined FURS method effectively treated kidney stones (≥ 4 cm) during phase I. Nevertheless, further investigations are required to explore postoperative infections.