Antibiotics versus no antibiotics for flexible ureteroscopy with a negative-pressure suction sheath

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an international, multicenter, prospective, randomized, controlled non-inferiority trial comparing no antimicrobial prophylaxis to a single-dose prophylactic antibiotic in low-infection-risk patients undergoing single-use flexible ureteroscopic lithotripsy with a flexible negative-pressure suction sheath. Eligible participants are randomized 1:1 with stratification by center and stone size (≤1.5 cm versus >1.5 cm and ≤2 cm). Surgeries are performed by surgeons experienced with the negative-pressure sheath and recorded using a standardized surgical form. The trial compares post-operative infection-related outcomes between the two groups to determine if withholding prophylaxis is not worse than standard single-dose prophylaxis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-75 years.
2. Diagnosed by CT with renal and/or upper ureteral stones, with the longest stone diameter being ≤2cm.
3. Scheduled to undergo fURS lithotripsy.
4. No preoperative symptoms of infection such as chills and fever, and the most recent preoperative urine culture is negative.
5. No immunosuppressive status and no urinary flow obstruction caused by anatomical abnormalities.
6. 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.
7. 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 Criteria:

1. Pregnant or lactating women.
2. Allergy to the investigational drug(s).
3. Participation in other clinical trials within 30 days.
4. Presence of other active infection foci requiring antimicrobial treatment.
5. Concomitant severe systemic diseases, such as cardiac or pulmonary disease, malignant tumors, and immunodeficiency states.
6. Congenital malformations of the urinary tract.
7. History of kidney transplantation or urinary diversion surgery.
8. Unable to provide samples or complete follow-up according to the study protocol.
9. Unable to provide informed consent.
10. Inability to achieve complete placement of the flexible negative-pressure suction sheath.
11. Any other conditions that the investigator deems unsuitable for participation in this study.
12. History of diabetes mellitus, immunocompromised.
13. Renal insufficiency, neurogenic bladder.
14. Recent preoperative history of stone-related fever.
15. Long-term indwelling urinary drainage tube.
16. Urine white blood cells \>5/HPF (High Power Field) or positive for urine nitrites.
17. Large stone burden (e.g., staghorn calculus) or moderate to severe hydronephrosis.
18. Imaging findings showing turbid urine in the renal pelvis where pyonephrosis or infectious stones cannot be excluded.

Where it's running

• Shanghai General Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Yi Shao — Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Study coordinator: Ziyang Zheng
• Email: zhengzzy0116@163.com
• Phone: 18861968196

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.