The Effectiveness of Prophylactic Antibiotics with Oral Levofloxacin against Post-Shock Wave Lithotripsy Infectious Complications: A Randomized Controlled Trial

Abstract

Abstract

Objective:

To evaluate the efficacy of prophylactic antibiotics in reduction of infections after shock wave lithotripsy (SWL) in patients undergoing shock wave lithotripsy (SWL).

Methods:

The study was a randomized control trial. Between 2012 and 2014, patients with pre-operative sterile urine undergoing SWL were randomly assigned by the randomization ratio of 1:1 to receive prophylactic antibiotics with single-dose oral levofloxacin (500 mg) or no treatment (control group), respectively. Urinalysis and urine cultures were obtained between post-operative day five and seven, respectively. Pyuria was defined as ≥10 white blood cells per high power field (WBC/hpf). Significant bacteriuria was defined as ≥10⁵ colony forming units per milliliter (CFU/mL) uropathogens. Febrile urinary tract infection (fUTI) was defined as body temperature higher than 38.0°C with pyuria or significant bacteriuria within seven days after SWL treatment.

Results:

Initially, 274 patents underwent randomization with 135 and 139 patients in the levofloxacin and control group, respectively. A total of 206 patients (106 with placebo and 100 with levofloxacin) with complete follow-up of urinalysis were eligible for analysis. The rates of post-operative pyuria were not significantly different in patients with and without prophylaxis (8% versus 4.7%, p = 0.33). Moreover, there was also no significant difference in rates of bacteriuria in patients with and without prophylaxis (1% versus 0%, p = 0.49). Patients without follow-up urinalysis and urine culture received telephone survey. Among them, there was only one patient reporting post-SWL fever in the levofloxacin group (0.7%) compared with none (0%) in the control group (p = 0.49). As the results of the interim analysis revealed no benefit of levofloxacin in preventing post-SWL pyuria, bacteriuria, and fUTI, we terminated the study early before the pre-planned sample size was achieved.

Conclusions:

The incidence of asymptomatic and fUTI is low in patients with pre-SWL sterile urine undergoing SWL. Therefore, prophylactic antibiotics may be unnecessary in this cohort of patients.