Efficacy of preoperative electroacupuncture for ureteral access sheath placement during first-stage flexible...

Retrograde intrarenal surgery (RIRS) is a primary treatment for urolithiasis, with successful ureteral access sheath (UAS) placement being a critical step. Preliminary studies suggest preoperative electroacupuncture (EA) may enhance UAS placement success, reduce ureteral injury, and improve stone clearance rates. This trial evaluates the efficacy and safety of EA as an adjunct to first-stage RIRS.

This multicenter, randomized, single-blind, sham-controlled trial will enroll 120 adult patients with upper ureteral or renal stones (≥ 10 mm) scheduled for first-stage RIRS. Participants will be randomized (1:1) to receive either preoperative EA plus general anesthesia or sham EA plus general anesthesia across multiple sessions. The primary outcome is the proportion of patients with successful UAS placement during first-stage RIRS. Secondary outcomes include surgical duration, UAS insertion resistance, ureteral injury (Post-Ureteroscopic Lesion Scale [PULS]), stone clearance rate at 2 weeks post-surgery, and adverse events (AEs) up to 2 weeks post-surgery. Data will be analyzed using intention-to-treat principles.

This study is the first randomized controlled trial to investigate the efficacy of EA in improving the success rate and safety of UAS placement during first-stage RIRS. The findings will provide high-quality evidence to support the use of EA as an adjunctive therapy in clinical practice. Through a comprehensive multidimensional assessment, this study demonstrates the potential of EA for broader application in the treatment of urolithiasis. Further rigorously designed clinical trials are essential to validate and refine this promising therapeutic approach.

International Traditional Medicine Clinical Trial Registry. Identifier: ITMCTR2025001039.