title: The Effectiveness of Prophylactic Antibiotics with Oral Levofloxacin against Post-Shock Wave Lithotripsy Infectious Complications: A Randomized Controlled Trial.
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 ≥10(5) 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.
authors.affiliation: 1 Division of Urology, Taipei Tzu Chi Hospital , The Buddhist Tzu Chi Medical Foundation, New Taipei, Taiwan .|2 Medical College of Buddhist Tzu Chi University , Hualien, Taiwan .
authors.forename: Cheng-Hsing
authors.initials: CH
authors.lastname: Hsieh
authors.affiliation: 1 Division of Urology, Taipei Tzu Chi Hospital , The Buddhist Tzu Chi Medical Foundation, New Taipei, Taiwan .|2 Medical College of Buddhist Tzu Chi University , Hualien, Taiwan .
authors.forename: Stephen Shei-Dei
authors.initials: SS
authors.lastname: Yang
authors.affiliation: 1 Division of Urology, Taipei Tzu Chi Hospital , The Buddhist Tzu Chi Medical Foundation, New Taipei, Taiwan .|2 Medical College of Buddhist Tzu Chi University , Hualien, Taiwan .
authors.forename: Shang-Jen
authors.initials: SJ
authors.lastname: Chang
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D019072:Antibiotic Prophylaxis; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D016905:Gram-Negative Bacterial Infections / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D016908:Gram-Positive Bacterial Infections / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D064704:Levofloxacin / Q000627:therapeutic use*; D008096:Lithotripsy / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014552:Urinary Tract Infections / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D064704:Levofloxacin