Antibiotic Prophylaxis for Ureteroscopy With a Negative Pressure Suction Sheath

This study, as a prospective, randomized, controlled, non-inferiority, international multicenter clinical trial, aims to evaluate whether a strategy of no antimicrobial prophylaxis is non-inferior to the traditional single-dose prophylaxis regimen in patients with a low risk of infection undergoing single-use flexible ureteroscopic lithotripsy combined with a flexible negative-pressure suction sheath. It is anticipated that this will have a substantial impact on infection prevention strategies in urological surgery.

NCT Number	NCT07246967
Lead Sponsor	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions	Urolithiasis, Antibiotics
Enrollment	500 participants
Start Date	2026-02-01
Primary Completion	2027-03 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-04-23