Hsieh CH et al, 2016: The Effectiveness of Prophylactic Antibiotics with Oral Levofloxacin Against Post-Shock Wave Lithotripsy Infectious Complications: A Randomized Controlled Trial.
Hsieh CH, Yang SS, Chang SJ.
Division of Urology, Taipei Tzu Chi Hospital, The Buddhist Tzu Chi Medical Foundation, New Taipei, Taiwan.
Medical College of Buddhist Tzu Chi University, Hualien, Taiwan.
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.
Surg Infect (Larchmt). 2016 Feb 24. [Epub ahead of print]
The conclusion from this randomized study was that administration of antibiotics is of no benefit for patients with sterile urine. This finding is in agreement with my own experience based on early results from SWL with the Dornier HM3 lithotripter (1; 1989). Three groups of patients were randomized to treatment with antibiotics, methenamine hippurate, and no treatment. The conclusion was that treatment with antibiotics was not necessary. One point of specific interest from that study was that about 30% of the patients at this time were treated with a ureteral catheter.
The principles subsequently applied during more than 25 years comprised administration of antibiotics before SWL to patients with a history urinary tract infection, positive test for bacteria and/or positive urine culture, the presence of a nephrostomy catheter or suspicion of infection stones. Only presence of a ureteral stent (provided it has been inserted under sterile conditions) has not been an indication for pre-SWL antibiotics. These principles have been applied in more than 20 000 SWL-treatments and there has been no reason to change this routine. Our frequency of infection complications was in average