Infective Complications After Prostate Biopsy: Outcome of the Global Prevalence Study of Infections in Urology (GPIU) 2010 and 2011, A Prospective Multinational Multicentre Prostate Biopsy Study

Department of Urology, Paediatric Urology and Andrology of the Justus-Liebig-University, Giessen, Germany.
European Urology (Impact Factor: 13.94). 03/2013; 63(3):521-527. DOI: 10.1016/j.eururo.2012.06.003


Infection is a serious adverse effect of prostate biopsy (P-Bx), and recent reports suggest an increasing incidence.
The aim of this multinational multicentre study was to evaluate prospectively the incidence of infective complications after P-Bx and identify risk factors.
The study was performed as an adjunct to the Global Prevalence Study of Infections in Urology (GPIU) during 2010 and 2011. Men undergoing P-Bx in participating centres during the 2-wk period commencing on the GPIU study census day were eligible. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Baseline data were collected and men were questioned regarding infective complications at 2 wk following their biopsy. The Fisher exact test, Student t test, Mann-Whitney U test, and multivariate regression analysis were used for data analysis.
A total of 702 men from 84 GPIU participating centres worldwide were included. Antibiotic prophylaxis was administered prior to biopsy in 98.2% of men predominantly using a fluoroquinolone (92.5%). Outcome data were available for 521 men (74%). Symptomatic urinary tract infection (UTI) was seen in 27 men (5.2%), which was febrile in 18 (3.5%) and required hospitalisation in 16 (3.1%). Multivariate analysis did not identify any patient subgroups at a significantly higher risk of infection after P-Bx. Causative organisms were isolated in 10 cases (37%) with 6 resistant to fluoroquinolones. The small sample size per participating site and in compared with other studies may have limited the conclusions from our study.
Infective complications after transrectal P-Bx are important because of the associated patient morbidity. Despite antibiotic prophylaxis, 5% of men will experience an infective complication, but none of the possible factors we examined appeared to increase this risk. Our study confirms a high incidence of fluoroquinolone resistance in causative bacteria.

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    • "An important point for future evaluation is the presence of levofloxacin resistance of fecal E. coli. One study showed that the presence of fecal E. coli strains resistant to levofloxacin represents an important development of infectious complications in BTRP risk [13]. To date there are few randomized studies showing the use of result of rectal swab culture for prophylactic antibiotics use in BTRP [16] [17] [18] "
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    ABSTRACT: Transrectal ultrasound-guided core prostate biopsy is a key event in the diagnosis of prostate cancer, transient side events such as local pain, haematuria, haematospermia, dysuria, and rectal bleeding are reported in a large number of patients. Antimicrobial agents lower the incidence of postbiopsy infectious complications. The timing and duration of the regimen and the route of administration remain controversial. We developed a standard prophylactic regimen, in which safety and efficiency were maximized, while costs and variability were minimized. Accordingly we prospectively evaluated 425 consecutive patients, who underwent outpatient transrectal ultrasound-guided prostate biopsy after a single dose versus three doses of levofloxacin.1. IntroductionProstate biopsy guided by transrectal ultrasound is a key element in the diagnosis of prostate cancer, but its implementation lacks in terms of safety and complications [1]. The presence of adverse events, such as local pain, hematuria, hematospermia, dysuria rectal bleeding, prostatitis, epididymitis, orchitis, and sepsis, is reported in many patients; 20–50% have bacteriuria, 3–10% had fever with lower urinary tract symptoms, and the incidence of sepsis in patients undergoing this procedure is 0.5–5% [2–6]. Antimicrobial agents reduce postinfectious biopsy complications [7, 8]. Despite performing more than one million prostate biopsies in the United States and Europe each year and although clinical guidelines exist, there is no consensus on the regime of antimicrobial prophylaxis in clinical practice. Some studies recommend the use of enemas before biopsy, but other groups question their benefit [9].Antimicrobial prophylaxis is universally accepted and multiple points of view regarding the time of drug administration, duration, and medication delivery exist [10]. Most studies use schemes ranging from prophylaxis use previous hours, to the use of antimicrobials 1–3 days before the procedure [11]. In the present study we evaluate and compare the efficacy of single dose of 500 mg of levofloxacin orally administered at the day of the procedure versus three doses of the same drug for prophylaxis in patients undergoing transrectal prostate biopsy guided by ultrasound.2. Material and Methods We evaluated 615 patients with standard indication for prostate biopsy guided by transrectal ultrasound (elevation of prostate specific antigen (PSA), abnormal digital rectal examination). All those patients with hypersensitivity to the drug, indwelling catheter, lower urinary symptoms (dysuria, suprapubic pain, urgency, and urgency), and history of febrile urinary tract infection a month before the procedure, as well as those with a history of acute retention urine and hematuria, were excluded; a total of 425 patients were eligible; patients were randomly divided into two groups using GraphPad Prism 6.0: Group A was composed of 205 patients who were administered a single dose of levofloxacin (500 mg) orally 60–120 minutes before the procedure, because the peak levofloxacin levels within the prostate were reached within one hour after oral administration of this dose and Group B consisted of 220 patients who were administered levofloxacin (500 mg) every 24 hours for two days before and on the day of the procedure. We evaluated the status of these variables: diabetes mellitus, body mass index (calculated as weight in kilograms divided by height in meters squared kg/m2) divided into normal weight 18.5–24.9 kg/m2; overweight 25.0–29.9 kg/m2; 20–34.9 kg/m2 obesity grade I; obesity grade II > 35 kg/m2 (adapted WHO-2004) [12], and prostate volume. The primary end point is the efficacy of three doses versus single dose, taking into consideration ours variables. All patients underwent bowel preparation with polyethylene glycol orally administered prior to transrectal biopsy day. The biopsy was performed using the equipment Aloka Prosound ultrasound , with intracavitary transducer 5–10 MHz with needle biopsy BARD 18 Ga-20 cm, obtaining samples of 22 mm. We applied simpre lidocaine in the periprostatic plexus for local anesthesia using a EchoTip Skinny needle chiba Tip 22 Ga/20 inch; 12 cylinders were obtained; 100% of patients underwent urinalysis after procedure but only the patients with a febrile episode underwent a urine culture. Febrile episode of urinary tract was defined as fever ≥ 38.0 degrees Celsius, accompanied by at least one symptom of urinary tract (urgency, frequency, dysuria, and pain suprapubic). Patients with this condition were hospitalized and paraclinical evaluation was complemented with general, urine, and blood culture studies. The aforementioned variables were correlated using Fisher’s exact test and Student’s -test; statistical analysis was performed using IBM SPSS statistics 19.3. ResultThe 425 patients had a prostate volume of 71.14 cc, an average age of 66.86 years (±8.11), and PSA mean of 22.13 ng/mL; they were stratified by BMI, presenting normal weight 19.04%, overweight 54.76%, obesity grade I 20.23%, and obesity grade II 5.95%; in conclusion of this, 80.92% of our patients have some degree of overweight or obesity and 36.90% have diabetes mellitus; then they were randomly divided in two groups. Group A comprised 205 patients that received a single dose of levofloxacin 500 mg orally, with an average age of 66.22 years (±7.95) and PSA mean of 23.07 ng/mL; 43.9% have DM, 4.3% presented febrile urinary tract infection with a positive culture for E. coli and Klebsiella pneumoniae and two patients had sepsis (0.97%), with average prostate volume of 65.80 cc, and 90.17% in this group had overweight. Group B comprised 220 patients that received three doses of 500 mg levofloxacin orally, with an average age of 67.45 years (±8.31) and PSA mean of 21.26 ng/mL; 31.8% of patients have DM and 4.45% presented febrile urinary tract infection, in the same manner as in Group A; the body predominant in urine culture was E. coli; no patients in this group presented sepsis; mean prostate volume was 75.61 cc, of this group of patients; 72.74% had been overweight; in both groups the antibiotic was changed according to the antibiogram. All patients are monitored at 3 weeks of the procedure, and those who had febrile infection and sepsis received two more consultations at 4 and 6 weeks. Both groups are similar and we did not find significant difference in complications () (Table 1); performing analysis considering DM, we did not identify difference in both groups regarding the risk of complications, and also when patients were analyzed with regard to body mass index and risk of complications, in both groups no difference was found (Table 2).
    Full-text · Article · Oct 2014 · International Scholarly Research Notices
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    • "Various procedure-related complications including pain on biopsy sites, hematuria, hematochezia, acute urinary retention, urinary tract infection (UTI) etc. have been reported and major complications sometimes present as much more serious problems to both patients and urologists. Febrile UTIs or urosepsis frequently require hospital admission for supportive care and antibiotic treatment (8, 9). "
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    ABSTRACT: Although prostate-specific antigen (PSA) is a very useful screening tool, prostate biopsy is still necessary to confirm prostate cancer (PCA). However, it is reported that PSA is associated with a high false-positive rate and prostate biopsy also has various procedure-related complications. Therefore, the authors have devised a nomogram, which can be used to estimate the risk of PCA, using available clinical data for men with a serum PSA less than 10 ng/mL. Prostate biopsies were obtained from 2,139 patients from January 1998 to March 2011. Of them, 1,171 patients with a serum PSA less than 10 ng/mL were only included in this study. Patient age, PSA, free PSA, prostate volume, PSA density and percent free PSA ratio were analyzed. Among 1,171 patients, 255 patients (21.8%) were diagnosed as PCA. Multivariate analyses showed that patient age, prostate volume, PSA and percent free PSA had statistically significant relationships with PCA (P < 0.05) and were used as nomogram predictor variables. The area under the (ROC) curve for all factors in a model predicting PCA was 0.759 (95% CI, 0.716-0.803). Graphical Abstract
    Full-text · Article · Mar 2014 · Journal of Korean medical science
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    • "In the United States, a retrospective analysis of the Surveillance Epidemiology and End Results prostatic biopsies database, consisting of older subjects (median age: 73 yr), documented a 2.65-fold increased risk of hospitalization within 30 d (6.9% vs 2.7% in controls) [3]. There is a recent trend toward an increase of infective biopsy complications due to increased germ resistance to fluoroquinolones [4], and the present consensus is that local anesthetic given as a periprostatic nerve block is more effective than intrarectal instillation in alleviating pain from ultrasound-guided prostatic biopsy [5]. "

    Full-text · Article · Feb 2014 · European Urology
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