Antibiotic Prophylaxis for Ureteroscopy With a Negative Pressure Suction Sheath
An International Multicenter Study on the Antimicrobial Prophylaxis Strategy for Flexible Ureteroscopic Lithotripsy Combined With a Flexible Negative Pressure Suction Sheath
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
500 participants
Feb 1, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- Age 18-75 years.
- Diagnosed by CT with renal and/or upper ureteral stones, with the longest stone diameter being ≤2cm.
- Scheduled to undergo fURS lithotripsy.
- No preoperative symptoms of infection such as chills and fever, and the most recent preoperative urine culture is negative.
- No immunosuppressive status and no urinary flow obstruction caused by anatomical abnormalities.
- No use of long-acting antimicrobial agents within 7 days prior to surgery, and no use of intermediate or short-acting antimicrobial agents within 72 hours prior to surgery.
- Has signed and dated an informed consent form, indicating that the patient or their legal representative has been fully informed about the study-related information and has agreed to participate.
Exclusion Criteria18
- Pregnant or lactating women.
- Allergy to the investigational drug(s).
- Participation in other clinical trials within 30 days.
- Presence of other active infection foci requiring antimicrobial treatment.
- Concomitant severe systemic diseases, such as cardiac or pulmonary disease, malignant tumors, and immunodeficiency states.
- Congenital malformations of the urinary tract.
- History of kidney transplantation or urinary diversion surgery.
- Unable to provide samples or complete follow-up according to the study protocol.
- Unable to provide informed consent.
- Inability to achieve complete placement of the flexible negative-pressure suction sheath.
- Any other conditions that the investigator deems unsuitable for participation in this study.
- History of diabetes mellitus, immunocompromised.
- Renal insufficiency, neurogenic bladder.
- Recent preoperative history of stone-related fever.
- Long-term indwelling urinary drainage tube.
- Urine white blood cells >5/HPF (High Power Field) or positive for urine nitrites.
- Large stone burden (e.g., staghorn calculus) or moderate to severe hydronephrosis.
- Imaging findings showing turbid urine in the renal pelvis where pyonephrosis or infectious stones cannot be excluded.
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Interventions
The experimental group will undergo surgery without the use of any prophylactic antimicrobials; therapeutic antimicrobials will only be administered postoperatively to patients who develop signs or symptoms of infection. The control group will receive a single dose of intravenous prophylactic antimicrobials 30-60 minutes before surgery, followed by the same standardized surgical procedure.
Receive a single dose of intravenous prophylactic antimicrobials (e.g., a second-generation cephalosporin or levofloxacin) 30-60 minutes before surgery, followed by the same standardized flexible negative-pressure sheath ureteroscopic surgery.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07246967