Antibiotics versus no antibiotics for flexible 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

This trial will test whether adults at low risk of infection having single-use flexible ureteroscopy with a negative-pressure suction sheath can safely skip the usual single-dose antibiotic before surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07246967 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–75 with renal or upper ureteral stones ≤2 cm who are scheduled for single-use flexible ureteroscopic lithotripsy with a negative-pressure suction sheath, have no preoperative infection symptoms and a negative preoperative urine culture, and are not immunosuppressed are the intended participants.

Not a fit: Patients with active infection or positive urine culture, immunosuppression, urinary tract obstruction from anatomic causes, pregnancy or lactation, recent antibiotic use, or other exclusion criteria are unlikely to benefit from the no-antibiotic approach and are excluded.

Why it matters

Potential benefit: If successful, the approach could safely reduce unnecessary antibiotic use, lowering side effects and antibiotic resistance while maintaining low post-operative infection rates.

How similar studies have performed: Previous trials have suggested withholding prophylaxis can be safe in selected low-risk ureteroscopy cases, but using a flexible negative-pressure suction sheath in this randomized international non-inferiority setting is relatively novel and large definitive evidence is limited.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• 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

Conditions Urolithiasis; Antibiotics