Antibiotic Prophylaxis in Urologic Procedures: A

european urology 54 (2008) 1270–1286

available at www.sciencedirect.com journal homepage: www.europeanurology.com

Review – Infections

Antibiotic Prophylaxis in Urologic Procedures: A Systematic Review A.M. Jikke Bootsma a, M. Pilar Laguna Pes a, Suzanne E. Geerlings b, Astrid Goossens c,* a

Department of Urology, Academic Medical Center, University of Amsterdam, The Netherlands Department of Infectious Diseases, Tropical Medicine and AIDS, Center for Infection and Immunity Amsterdam, Academic Medical Center, University of Amsterdam, The Netherlands c Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, University of Amsterdam, The Netherlands b

Article info

Abstract

Article history: Accepted March 11, 2008 Published online ahead of print on March 24, 2008

Objective: Antibiotic prophylaxis is used to minimize infectious complications resulting from interventions. Side-effects and development of microbial resistance patterns are risks of the use of antibiotics. Therefore, the use should be well considered and based on high levels of evidence. In this review, all available evidence on the use of antibiotic prophylaxis in urology is gathered, assessed, and presented in order to make choices in the use of antibiotic prophylaxis on the best evidence currently available. Methods: A systematic literature review was conducted, searching Medline, Embase (1980–2006), the Cochrane Library, and reference lists for relevant studies. All selected articles were reviewed independently by two, and, in case of discordance, three, reviewers. Results: Only the transurethral resection of prostate (TURP) and prostate biopsy are well studied and have a high and moderate to high level of evidence in favour of using antibiotic prophylaxis. Other urologic interventions are not well studied. The moderate to low evidence suggests no need for antibiotic prophylaxis in cystoscopy, urodynamic investigation, transurethral resection of bladder tumor, and extracorporeal shock-wave lithotripsy, whereas for therapeutic ureterorenoscopy and percutaneous nephrolithotomy, the low evidence favours the use of antibiotic prophylaxis. Urologic open and laparoscopic interventions were classified according to surgical wound classification, since no studies were identified. Antibiotic prophylaxis is not advised in clean surgery, but is advised in cleancontaminated and prosthetic surgery. Conclusions: Except for the TURP and prostate biopsy, there is a lack of wellperformed studies investigating the need for antibiotic prophylaxis in urologic interventions.

Keywords: Antibiotic prophylaxis Bacteriuria Infection Postoperative complications Urologic interventions

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# 2008 European Association of Urology. Published by Elsevier B.V. All rights reserved.

* Corresponding author. Department of Clinical Epidemiology, Biostatistics & Bioinformatics, AMC, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands. Tel. +31 20 65283; Fax: +31 20 6912683. E-mail address: [email protected] (A. Goossens). 0302-2838/$ – see back matter # 2008 European Association of Urology. Published by Elsevier B.V. All rights reserved.

doi:10.1016/j.eururo.2008.03.033

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1.

Introduction

Antibiotic prophylaxis is a brief course of antibiotics administered before or at the start of an intervention and used to minimize the infectious complications resulting from diagnostic and therapeutic interventions. While the rationale for the use of antibiotics is well accepted, possible side-effects and development of microbial resistance patterns are potential risks. Therefore, an antibiotic prophylaxis policy should be well considered and, ideally, based on high levels of evidence. Urology is a surgical speciality which has undergone many changes in the last decade. Surgical procedures have mainly shifted from open to endoscopic and laparoscopic procedures, and nowadays, a greater number of elderly patients or carriers of temporary urinary derivations are being operated on. These developments can influence the choice of antibiotic prophylaxis policy. Although it is common practice to administer antibiotic prophylaxis in many urologic procedures, there is still little evidence for the use of antibiotic prophylaxis in most of these procedures. This is mainly due to the lack of well-designed studies as well as the lack of clear definitions of favourable outcome parameters. The question remains to what extent antibiotic prophylaxis is beneficial in the different urologic procedures. Various authors have addressed this issue in reviews in recent years [1–4]. Also, the European Association of Urology (EAU) has recently updated the guideline ‘‘Management of urinary and male genital tract infections,’’ including a chapter on perioperative antibacterial prophylaxis in urology [5]. However, with the exception of the transurethral resection of the prostate [6,7], few of the recommendations in these reviews and guidelines are supported by evidence gathered in a structured

systematic review. The aim of this paper is to provide a systematic review on the value of antibiotic prophylaxis during different urologic procedures in order to make choices in the use of antibiotic prophylaxis on the best evidence currently available. 2.

Methods

Between June 2006 and March 2007, the electronic databases Medline, Embase (1980–2006), and the Cochrane Library were searched using the terms postoperative complications, infection, bacteriuria, antibiotic prophylaxis, chemoprophylaxis, antibiotics, and premedication plus randomized controlled trial (RCT). Additional search terms were added for the different urologic interventions investigated (Table 1). Reference lists were screened for relevant trials. RCTs comparing antibiotic prophylaxis during urologic procedures with a placebo or no antibiotic prophylaxis in patients with preoperative sterile urine were selected with language restriction (English, French, Spanish, German). Studies included in a pre-existent systematic review of good quality were not separately included. In the absence of a relevant RCT on the subject, case series and expert opinions were selected. Inclusion criteria were RCT, and, if absent, observational study, of good quality, clear definitions of outcome parameters, and minimal post-intervention followup of 30 d. All selected articles were reviewed independently on inclusion criteria and study design by two reviewers (AB, MPL). In case of discordance, a third reviewer was consulted (AG). Each included article was graded on level of evidence according to the level-of-evidence list of the Oxford Centre for Evidence-Based Medicine [8]. The primary outcome parameter was postoperative bacteriuria, in which postoperative was defined as the period of 30 d after the procedure, and bacteriuria as 103 colony forming units (CFU)/ml in symptomatic urinary tract infection and 105 CFU/ml in asymptomatic bacteriuria [5]. The secondary outcome parameters were postoperative symptomatic urinary tract infection, fever, sepsis, and bacteraemia. Antibiotic prophylaxis was defined as use of antibiotics around an

Table 1 – Search terms per urologic intervention Intervention Cystoscopy Prostate biopsy Urodynamic investigation Transurethral resection of prostate Transurethral resection of bladder tumor Extracorporeal shock wave lithotripsy Ureterorenoscopy Percutaneous nephrolithotomy

Search terms Cystoscopy Prostate biopsy Urodynamics, urodynamic investigation, urodynamic examination, urodynamic study Transurethral resection, prostatic transurethral resection, prostatectomy, TURP TURT, TURB, transurethral resection bladder tumor, bladder tumor resection Lithotripsy, ESWL, shock wave therapy, shock wave lithotripsy, extracorporeal lithotripsy Ureteroscopy, ureterorenoscopy Kidney stone surgery, percutaneous nephrolithotomy, percutaneous nephrostomy lithotripsy

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intervention, preferably for a duration of less than 24 hr, with the first dose given before or at the start of the intervention.

3.

prophylaxis. These results suggest that antibiotic prophylaxis is not needed for cystoscopy in the absence of risk factors for developing UTI.

Results 3.2.

The included RCTs are presented in Tables 2–8, along with their level of evidence. When no RCT was included, the results and level of evidence of the non-RCTs are described in the corresponding paragraph below, along with the reasons for exclusion of the corresponding RCTs. For uniformity of outcomes, asymptomatic bacteriuria and asymptomatic urinary tract infection are both referred to as bacteriuria and symptomatic urinary tract infection (UTI) and symptomatic bacteriuria is referred to as symptomatic UTI. 3.1.

Cystoscopy

A total of nine RCTs was found, of which four were included in this review (Table 2) [9–12]. The other studies were excluded because of lack of description of randomization method and group composition [13,14], investigating the effect of antibiotic treatment instead of prophylaxis [15], and studying more interventions than cystoscopy alone, without possibility of a separate analysis [16,17]. Of the included studies, Wilson et al [12] and Tsugawa et al [11] did not find a decrease in either bacteriuria or in symptomatic UTIs after use of antibiotic prophylaxis. Two studies, Jimenez Cruz et al [9] and MacDermott et al [10], found a significant decrease of symptomatic UTIs and bacteriuria, respectively. Additionally, two useful case series were identified describing the post-cystoscopy infection incidence without use of antibiotic prophylaxis [18,19] (level of evidence (LOE) 4). Almallah et al [18] found a bacteriuria incidence of 4.9% (n = 103) within 48 hr post-cystoscopy. Although 14% of all patients reported irritative symptoms within 48 hr, only a small portion developed bacteriuria as well, resulting in a symptomatic UTI incidence of 1.9%. Clark et al [19] described a 7.5% incidence of postcystoscopy bacteriuria. After identifying and excluding patients with risk factors, the incidence dropped to 0.8%. A history of symptomatic UTI and additional procedures performed during cystoscopy were identified as risk factors for developing post-cystoscopy bacteriuria. In summary, it can be concluded that there is low to moderate evidence for the use of antibiotic prophylaxis in cystoscopy. A low incidence of bacteriuria and symptomatic UTIs is seen after cystoscopy, irrespective of the use of antibiotic

Prostate biopsy

Thirteen RCTs were identified concerning prostate biopsy. Seven were excluded because they investigated prophylaxis methods other than antibiotic prophylaxis [20,21], used inadequate randomization methods [22–25], or investigated the effect of antibiotic treatment instead of prophylaxis [26]. Six RCTs comparing antibiotic prophylaxis with the use of a placebo or no antibiotic prophylaxis were included [27–32] (Table 3). They show a significant decrease of bacteriuria after prostate biopsy with the use of antibiotic prophylaxis compared with no use of antibiotics. Several RCTs also reported secondary outcome parameters. Fever was not significantly reduced after use of antibiotic prophylaxis in four RCTs [27,28,31,32], but was significantly reduced in another RCT of lower quality [29]. No significant difference in bacteraemia was found between placebo or control and antibiotic prophylaxis in four RCTs [27–29,32]. Two studies with high level of evidence showed opposite results regarding the incidence of post-procedural symptomatic UTI [27,31]. Consequently, there is moderate to high evidence that the use of antibiotic prophylaxis in prostate biopsy reduces the incidence of postprostate biopsy bacteriuria, although no conclusive evidence was found on the effect of antibiotic prophylaxis on symptomatic UTIs and other infectious complications. These results indicate a need for antibiotic prophylaxis in prostate biopsy. 3.3.

Urodynamic investigation

A total of five RCTs evaluated the effect of antibiotic prophylaxis on bacteriuria after urodynamic investigation. However, none were included in this review because no ‘‘true’’ antibiotic prophylaxis was used, but rather administration of antibiotics after the intervention, use of incorrect randomisation methods, or use of outdated investigation techniques [33– 37]. Cundiff et al investigated the effect of prophylaxis on combined cystoscopy and urodynamics in a well-designed study in women with stress incontinence (LOE 1B) [16]. No significant differences were found between the frequency of bacteriuria after use of prophylaxis (7.1%) and placebo (4.7%) at 1 wk follow up. However, since no separate analyses of both interventions were given, the study was excluded.

Table 2 – Included studies on cystoscopy Author

Wilson et al, 2005 [12]

Level of evidence

Study typea

Population control/ intervention

1B

RCT, double blind

N = 234 (122/112)

2B

RCT

N = 45 (24/21)

Jimenez Cruz et al, 1993 [9]

2B

RCT

N = 2172 (1057/1115)

MacDermott et al, 1988 [10]

2B

RCT

N = 98 (51/47)

- No AB prior

- No need therapeutic intervention - No bacteriuria (> 104, no pyuria (> 5 white blood cells/HPF) - Pre-cystoscopy sterile urine

- Pre-cystoscopy sterile urine

- No AB < 7 d prior

Intervention/ Control

Outcome parameter

Outcome

Remarks

- Single dose norfloxacin 400 mg p.o. - Placebo

- Symptomatic UTI: bacteriuria > 102 CFU/ml + symptoms 7 d postcystoscopy - Pyuria, bacteriuria, fever 1 mo post-cystoscopy

- Post-cystoscopy incidence symptomatic UTI: placebo 0.82%, ABP 0.89%

- Trial discontinued at interim analysis (low infection rate + no differences between 2 groups)

- Single dose sparfloxacin 200 mg p.o. - No AB - Single dose ceftriaxon 1 gram i.m. - No AB

- 3 doses cephradine 1 g <24 h around cystoscopy - No AB

- ASB, symptomatic UTI 2–3 d + 1 mo post-cystoscopy

- Bacteriuria > 105 CFU/ml 5 d postcystoscopy

- None of patients in control or intervention group developed pyuria, bacteriuria, or fever - Incidence control/intervention group: - ASB: 3.02%/1.52% (not significant) - Symptomatic UTI: 10.2%/2.5% (significant) - Post-cystoscopy incidence bacteriuria no ABP 15.7% ! ABP 2% (significant)

- No definition of bacteriuria (count) - Most cultured organism: E. coli


Tsugawa et al, 1998 [11]

Inclusion criteria

RCT = Randomized Controlled Trial, AB = antibiotics, p.o. = per os (orally), UTI = urinary tract infection, CFU = colony forming units, ABP = antibiotic prophylaxis, HPF = high power field, ASB = asymptomatic bacteriuria, i.m. = intramuscular. a It is mentioned if the study was performed in a double-blind, investigator-blinded, or patient-blinded manner. When no blinding took place, nothing is mentioned.

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Table 3 – Included studies on prostate biopsy Author

Level of evidence

Study typea


Inclusion criteria


Outcome

- Incidence postprostate biopsy bacteriuria placebo 8% ! ABP 3% (significant difference) - Incidence postprostate biopsy symptomatic UTI placebo 5% ! ABP 3% (not significant) - Incidence postprostate biopsy bacteriuria placebo 18.6% ! ABP 5%–7.8% (significant difference) - Incidence postprostate biopsy fever placebo 6.7% ! ABP 2.5%–2.6% - Incidence postprostate biopsy bacteraemia placebo 2.7% ! ABP 0%–1.3% - Incidence postprostate biopsy overall infective complications placebo 25.3% ! ABP 7.6%–10.4% (significant difference) - Incidence postprostate biopsy bacteriuria day 2 placebo 36% ! ABP 8.6%, day 14 placebo 20% ! ABP 8.6% - Incidence postprostate biopsy bacteraemia placebo 16% ! ABP 22% - Incidence postprostate biopsy fever placebo 48% ! ABP 17%

Kapoor et al, 1998 [31]

1B

RCT, double blind

N = 457 (230/227)

- No bacteriuria - No AB or endoscopic manipulation 1 wk prior - No indwelling catheter

- Single dose ciprofloxacin 500 mg p.o. - Placebo

- Bacteriuria > 104 CFU/ml 15 d postprostate biopsy - Symptomatic UTI

Aron et al, 2000 [27]

1B

RCT, patient blinded

N = 231 (75/79/77)

- No UTI - No indwelling catheter

- Single dose ciprofloxacin 500 mg + tinidazole 600 mg p.o. + placebo until 3 d - Ciprofloxacin 500 mg + tinidazole 600 mg p.o. twice daily for 3 d - Placebo 3 d

- Bacteriuria (48 h post-biopsy) - Fever (> 38 8C) - Bacteraemia

Crawford et al, 1982 [29]

2B


N = 48 (25/23)

- No UTI - No AB 2 wk prior - No VHD or prothesis

- Carbenicillin 1 d prior + 1 d post biopsy - Placebo

- Bacteriuria (> 105 CFU/ml) 2 + 14 d post biopsy - Bacteraemia - Fever (> 38.5 8C)

Remarks

- No significant differences between single dose and 3 d of antibiotics.


Outcome parameter

1B

RCT

N = 110 (23/42/45)

- No AB 3 d prior - No VHD, indwelling catheter, DM, steroid use, prostatitis

Melekos et al, 1990 [32]

2B

RCT

N = 38 (16/22)

- Negative urine and blood cultures prior - No AB or endoscopic manipulation 24 h prior - No VHD

Brown et al, 1981 [28]

2B

RCT

N = 19 (9/10)

- Negative urine and blood cultures prior - No AB or endoscopic manipulation 24 h prior - No VHD

- Single dose ofloxacin 400 mg p.o. - Single dose TMP/SMX 160/800 mg p.o. - No AB - Piperacillin 2 g i.v. 2 h prior + 2 h post biopsy - No AB

- Bacteriuria 7–10 d post biopsy

- Incidence postprostate biopsy bacteriuria no AB 26.1% ! ABP ofloxacin 4.8%, ABP TMP/SMX 6.7%

- Difference significant between no-AB group and ABP-group. No significant difference between 2 antibiotic schemes.

- Bacteriuria 1 d post biopsy - Bacteraemia 1 d post biopsy

- Incidence postprostate biopsy bacteriuria no AB 31% ! ABP 9% - Incidence postprostate biopsy bacteraemia no AB 37.5% ! ABP 14%

- Gentamicin 80 mg i.v. 30 min before biopsy - No AB

- Bacteriuria (> 105 CFU/ml) 1 d post biopsy - Bacteraemia - Fever (> 101 8F)

- Incidence postprostate biopsy bacteriuria no AB 44% ! ABP 20% - Incidence postprostate biopsy bacteraemia no AB 33% ! ABP 40% - Incidence postprostate biopsy fever no AB 22% ! ABP 50%

- No significant differences. - In the same study, effect of povidoneiodine enema on post- biopsy infectious complications was studied. - No significant differences. - In the same study, effect of povidoneiodine enema on post biopsy infectious complications was studied.

RCT = Randomized controlled trial, AB = antibiotics, p.o. = per os (orally), UTI = urinary tract infection, CFU = colony forming units, ABP = antibiotic prophylaxis TMP/SMX = trimethoprim/ sulfamethoxazole, i.v. = intravenously, DM = diabetes mellitus, VHD = valvular heart disease. a It is mentioned if the study was performed in a double-blind, investigator-blinded, or patient-blinded manner. When no blinding took place, nothing is mentioned.


Isen et al, 1999 [30]

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Table 4 – Included studies on TURP Author

Level of Study typea evidence


Inclusion criteria


Outcome

Remarks

ABP gives: - Postoperative bacteriuria significant decrease 26% ! 9.1% - Postoperative sepsis significant decrease 4.4% ! 0.7% - All treatment duration protocols significant decrease bacteriuria: - Single dose: 57% decrease, short course (< 72 h) 68% decrease, extended course (> 72 h) 72% decrease ABP gives significant reduction in postoperative complications: - Postoperative bacteriuria incidence decrease 26% ! 9%; - Postoperative fever RD 0.11; - bacteraemia RD 0.02; - use additional antibiotics RD 0.20; - No significant reduction in post-TURP catheterization or hospitalization

- Significant decrease by different AB: aminoglycosides, TMP/SMX, 1st/2nd/3rd generation cephalosporin, quinolone - No significant decrease: nitrofurantoin, penicillin, b-penicillin

Berry et al, 2002 [6]

1A

Meta-analysis

- Bacteriuria: 32 RCTs N = 4260 (1914/2346) - Sepsis: 8 RCTs N = 1979

- Pre-TURP sterile urine - RCT

- Different ABP schemes

- Postoperative bacteriuria (104–107 CFU/ml) 2–5 d after surgery - Postoperative sepsis (> 38.5 8C, rigors, elevated CRP)

Qiang et al, 2005 [7]

1A

Systematic review

- 28 RCTs N = 4694

- Pre-TURP sterile urine (< 104 CFU/ml) - RCT

- Different ABP schemes

- Postoperative bacteriuria 1 wk post-TURP - Postoperative fever, bacteraemia, sepsis, additional antibiotic treatment needed, urethral stricture, catheterization, hospital duration

- Different AB and schemes effective - Most common organisms cultured: E. coli, Staphylococcus, enterococcus, Streptococcus. - Single dose seems less effective than short-term dose prophylaxis


Outcome parameters

Wagenlehner et al, 2005 [49]

1B

RCT

N = 376

- Pre-TURP sterile urine (< 104 CFU/ml) - No AB < 4 d prior

- Single dose levofloxacin 500 mg p.o. (A) - Single dose 320/1600 mg TMP/SMX p.o. (B) - No AB (C)

- Postoperative bacteriuria (> 104 CFU/ml) 3–5 d and 3–5 wk post-TURP - Postoperative complications

- Incidence bacteriuria 3–5 d post-TURP decrease 29.7% (C) ! 21.2% (A)/19.9% (B) - Incidence bacteriuria 3–5 wk post-TURP decrease 36.3% (C) ! 25.9% (A)/26.1% (B) - Higher additional AB consumption no-ABP group, significance 5.0 (A+B) ! 6.9 doses/ patient (C)

- Not all patients with bacteriuria postoperative complication, but correlation present

Table 5 – Included studies on TURT Author

Level of evidence

Study typea

Population control/intervention

Inclusion criteria

Intervention/Control

Outcome parameter

Outcome - Post-TURT incidence bacteriuria placebo 24.1% ! ABP 9.4% (not significant) - Symptomatic UTI 0% in both groups - Post-TURT incidence bacteriuria no ABP 17% ! ABP 4.5% (not significant)

Delavierre et al, 1993 [53]

2B

RCT, double blind

N = 61 (29/32)

- Pre-TURT sterile urine - No AB < 14 d prior

- Single dose pefloxacine 800 mg i.v. - Placebo

- Bacteriuria > 104 CFU/ml 2 wk post-TURT - Symptomatic UTI

MacDermott et al, 1988 [10]

2B

RCT

N = 91 (47/44)

- Pre-TURT sterile urine - No AB < 7 d prior

- 3 doses cephradine 1 g < 24 h around TURT - No AB

- Bacteriuria > 105 CFU/ml 5 d post-TURT

Remarks


TURP = Transurethral resection of the prostate, RCT = Randomized controlled trial, ABP = antibiotic prophylaxis, CFU = colony forming units, CRP = C reactive protein, AB = antibiotics, TMP/ SMX = trimethoprim/sulfamethoxazole, RD = risk difference, p.o. = per os (orally). a It is mentioned if the study was performed in a double-blind, investigator-blinded, or patient-blinded manner. When no blinding took place, nothing is mentioned.

TURT = Transurethral resection of bladder tumor, RCT = Randomized controlled trial, AB = antibiotics, CFU = colony forming units, i.v. = intravenously, UTI = urinary tract infection, ABP = antibiotic prophylaxis. a It is mentioned if the study was performed in a double-blind, investigator-blinded, or patient-blinded manner. When no blinding took place, nothing is mentioned.

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Table 6 – Included studies on ESWL Author

Population Level of Study typea control/intervention evidence

Inclusion criteria


Outcome Incidence 2 wk post-ESWL: - Bacteriuria overall 20% - Symptomatic UTI placebo 3% ! ABP 2% Incidence 6 wk post-ESWL: - Bacteriuria placebo 18.9% ! ABP 24.3% - Symptomatic UTI placebo 2.7% ! ABP 1.4% - Presence of indwelling catheter no different outcome Incidence bacteriuria: - Control 0.68% ! ABP 1.2% 7 d post-ESWL - 0% bacteriuria 1 d + 4 wk follow-up - No symptomatic UTI in both groups - 0% bacteriuria, bacteremia and fever in both groups

Bierkens et al, 1997 [57]

1B


N = 177 (30/41/ 39/29/38)

- Pre-ESWL sterile urine (< 104 CFU/ml)

- Single dose ciprofloxacin 200 mg iv (A) - Single dose cefuroxime 750 mg iv (B) - Ciprofloxacin 200 mg once daily 7 d (C) - Cefuroxime 750 mg day 1 + 250 mg day 2–7 (D) - Placebo

- Bacteriuria (> 104 CFU/ml) - Symptomatic UTI (bacteriuria + pyuria + symptoms) - Symptomatic UTI in presence of risk factor (indwelling catheter) 2+ 6 wk post- ESWL

Ilker et al, 1995 [60]

1B

RCT

N = 311 (148/163)

- Pre-ESWL sterile urine - No risk factors (manipulation pre-ESWL, staghorn stone)

- Single dose ofloxacin 200 mg p.o. - No AB

- Bacteriuria (> 105 CFU/ml) - Symptomatic UTI 1 d, 7 d, 4 wk post-ESWL

Gattegno et al, 1988 [59]

2B


N = 50 (25/25)

- Pre-ESWL sterile urine - No AB 7 d prior

- Single dose ceftriaxon 1 g iv - Placebo

Claes et al, 1989 [58]

2B

RCT

N = 181 (92/89)

- Pre-ESWL sterile urine - No risk factors (staghorn stone, JJ, UTI)

- Single dose amoxycillin/ clavulanate 2 g/0,2 g iv - No AB

- Bacteriuria (> 105 CFU/ml) 1 + 7 d post-ESWL - Bacteremia 1 + 5h post-ESWL - Fever 1 + 5 + 24h post-ESWL - Bacteriuria - Symptomatic UTI (bacteriuria + fever) 1 d post-ESWL

Remarks Study ended after interim analysis because of no differences between placebo-ABP groups

- Incidence symptomatic UTI 7.6% in no AB-group, 0% in ABP group 1 d post-ESWL (significant)

ESWL = Extracorporeal shock-wave lithotripsy, RCT = Randomized controlled trial, CFU = colony forming units, iv = intravenously, UTI = urinary tract infection, ABP = antibiotic prophylaxis, p.o. = per os (orally), AB = antibiotic. a It is mentioned if the study was performed in a double-blind, investigator-blinded, or patient-blinded manner. When no blinding took place, nothing is mentioned.


Outcome parameter

Table 7 – Included studies on therapeutic URS Author

Level of evidence

Study typea


Inclusion criteria


Outcome - Bacteriuria: control 12.5% ! ABP 1.8% (significant difference) - Symptomatic UTI 0% both groups - Bacteriuria: placebo 13% ! ABP 3.5% 3 d post-URS (not significant) - Fever not separately reported

Knopf et al, 2003 [69]

2B

RCT

N = 113 (56/57)

- No clinical/laboratory signs of infection - No AB for 1 wk prior

- Single dose levofloxacin 250 mg p.o. - No AB

- Bacteriuria (> 105 CFU/ml) - Symptomatic UTI 1 wk post-URS

Fourcade et al, 1990 [68]

2B

RCT, double blind

N = 71 (38/33)

- Pre-intervention sterile urine - No AB 1 mo prior

- Single dose cefotaxim 1 gram iv - Placebo

- Bacteriuria (> 105 CFU/ml) - Fever (> 38 8C) 3 + 30 d post-URS

Remarks

Study reports on both URS and PNL. Group numbers of interventions separate too small for significance.

URS = Ureterorenoscopy, RCT = Randomized controlled trial, AB = antibiotics, p.o. = per os (orally), CFU = colony forming units, UTI = urinary tract infection, ABP = antibiotic prophylaxis, iv = intravenously, PNL = Percutaneous nephrolithotomy. a It is mentioned if the study was performed in a double-blind, investigator-blinded, or patient-blinded manner. When no blinding took place, nothing is mentioned.

Table 8 – Included studies on PNL Author Fourcade et al, 1990 [68]

Level of evidence

Study typea


Inclusion criteria


Outcome parameter

Outcome

2B

RCT, double blind

N = 49 (22/27)

- Pre-intervention sterile urine - No AB 1 mo prior

- Single dose cefotaxim 1 gram iv - Placebo

- Bacteriuria (> 105 CFU/ml) - Fever (> 38 8C) 3 + 30 d post-PNL

- Bacteriuria: placebo 12% ! ABP 5% 3 d post-URS (not significant) - Fever not separately reported

Remarks


Outcome parameter

Study reports on both URS and PNL. Group numbers of interventions separate too small for significance.

PNL = Percutaneous nephrolithotomy, RCT = Randomized controlled trial, AB = antibiotics, iv = intravenously, CFU = colony forming units, ABP = antibiotic prophylaxis, URS = Ureterorenoscopy. It is mentioned if the study was performed in a double-blind, investigator-blinded, or patient-blinded manner. When no blinding took place, nothing is mentioned.

a

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Case series (LOE 4) report a pre-urodynamics bacteriuria incidence of 1.9%–10.3% [38–41]. Without use of antibiotic prophylaxis, the post-urodynamics bacteriuria frequency was 1.1%–19.6% after 2–3 d follow-up and 4.1%–13.9% after 1 wk followup [38,39,41–46], whereas with use of antibiotics, the reported incidence was 1.8%–4.0% for women and 3.6%–6.2% for men [47,48]. Additionally, increasing age was identified as a risk factor for developing posturodynamics bacteriuria [41,43,45]. Consequently, the evidence for use of antibiotic prophylaxis in urodynamic investigation is low and can only be gained from case series. Furthermore, a relatively low incidence of posturodynamics bacteriuria is seen, with a small increase in bacteriuria when no antibiotic prophylaxis is given, whereas no information on posturodynamics symptomatic UTI is available. These results suggest there is no need for antibiotic prophylaxis in urodynamic investigations. However, the same low level of evidence may support the use of antibiotic prophylaxis in those patients with known increased risk for infections (eg, neurogenic bladder, transplant patients, immunodepressed patients, or carriers of vesicoureteral reflux).

ner et al [49] are comparable, although the findings did not reach statistical significance. In summary, it can be concluded that there is high evidence that the use of prophylactic antibiotics in TURP decreases bacteriuria and clinical infectious complications. 3.5.

Four studies of transurethral resection of bladder tumor (TURT) met the inclusion criteria. Two were excluded from the present review due to a lack of proper randomisation [51] and questionable statistical analysis [52]. The two included studies of Delavierre et al [53] and MacDermott et al [10] are relatively outdated and included small numbers of subjects (Table 5). Both studies found a nonsignificant decrease in incidence of post-TURT bacteriuria with the use of antibiotic prophylaxis, and the 0% incidence of symptomatic UTIs in both groups precludes any conclusion in the study of Delavierre et al [53]. In conclusion, there is moderate to low-grade evidence suggesting that antibiotic prophylaxis is not necessary in TURT. 3.6.

3.4.

Transurethral resection of bladder tumor

Extracorporeal shock-wave lithotripsy

Transurethral resection of the prostate

Transurethral resection of the prostate (TURP) is the most extensively studied subject in urology regarding the use of antibiotic prophylaxis. A good number of RCTs published before 2005 was identified, but since those RCTs were already included in the highquality systematic reviews of Berry and Qiang, they were not included separately in this review. Next to the systematic reviews of Berry [6] and Qiang [7], one study was included [49]; and another was excluded [50] because no univocal antibiotics regimen was followed. The systematic reviews by Berry et al [6] and Qiang et al [7] included 32 and 28 RCTs, respectively, with 21 RCTs reviewed in both studies. The average enrollment was 4474 patients (Table 4). Both reviews used postoperative bacteriuria as their main outcome parameter, complemented by several additional outcome parameters. Their conclusions were similar, favouring the use of antibiotic prophylaxis in TURP. They concluded that antibiotic prophylaxis gives a significant decrease in post-TURP bacteriuria, post-TURP fever, sepsis, and the need for additional antibiotics post-TURP. There was a trend suggesting higher efficacy for a short course (< 72 hours) of antibiotic prophylaxis than for a single-dose regimen [6]. The findings of Wagenleh-

Extracorporeal shock-wave lithotripsy (ESWL) originated in the 1980s as a treatment for renal and ureter stones. Since then, several studies have been performed questioning the need for antibiotic prophylaxis in this intervention. Pearle et al [54] concluded in a meta-analysis of eight RCTs that the use of antibiotic prophylaxis in patients with preESWL sterile urine is beneficial and reduces the post-ESWL complication rate. However, since several of the evaluated studies in their review did not meet the selected inclusion criteria of the present systematic review; ie, evaluation of the effect of antibiotic prophylaxis instead of treatment [55,56], this review was excluded. Reference lists were screened and RCTs meeting our inclusion criteria were added to the already identified ones and assessed. Four RCTs met the inclusion criteria and were included in this review [57–60] (Table 6). Two RCTs were excluded because of incomplete description of methodology and results [61] and inconsistency between results and conclusions [62]. Only one of the included studies showed a significant decrease in the incidence of postESWL symptomatic UTIs after use of antibiotic prophylaxis [58]. None of the other included RCTs with a higher level of evidence reproduced those data. The overall incidence of post-ESWL


symptomatic UTIs was low both with and without use of antibiotics. In a number of case series, the reported incidence of post-ESWL bacteriuria is 0%–5.1% in patients with pre-ESWL sterile urine (LOE 4) [63–67]. This finding is consistent with the results from the RCTs. Presence of a struvite stone was identified as a risk factor for developing post-ESWL bacteriuria [65]. Altogether, there is a fair amount of evidence available for this intervention showing that the post-ESWL rate of bacteriuria and symptomatic UTIs is low and use of antibiotic prophylaxis does not decrease this incidence. This implies there is no need for antibiotic prophylaxis in uncomplicated patients undergoing ESWL when preoperative cultures are negative. 3.7.

Ureterorenoscopy

Ureterorenoscopy (URS) can be used for diagnostic and therapeutic measures. No studies were found examining the diagnostic option. Two small RCTs concerning the use of antibiotic prophylaxis in endoscopic stone removal were identified and included [68,69] (Table 7). They both describe a positive effect of antibiotic prophylaxis on post-URS bacteriuria. Post-URS symptomatic UTI was 0% in both groups in a study by Knopf et al [69]. Only moderate to low-level evidence advocates the use of antibiotic prophylaxis in therapeutic URS with respect to postoperative bacteriuria. Low evidence supports the nonbeneficial effect of prophylactic antibiotics regarding post-URS symptomatic UTI. For diagnostic URS, no studies were found and reference to expert opinion may be advocated, with consequent low evidence (LOE 5). The results suggest no need for prophylaxis in diagnostic URS in uncomplicated patients and moderate to low evidence for prophylaxis in therapeutic URS [2,5]. 3.8.

Percutaneous nephrolithotomy

Only one RCT was found comparing placebo with antibiotic prophylaxis in both percutaneous nephrolithotomy (PNL) and URS, with separate analyses possible for both interventions [68] (Table 8). Unfortunately, the individual group size was too small to reach statistically significant differences in both PNL and therapeutic URS. Several case studies were identified [70,71]. Following 107 patients with preoperative sterile urine, Charton et al found a postPNL bacteriuria of 35% while using no antibiotic prophylaxis and 10% of patients presenting with post-PNL fever without sepsis or bacteraemia [70] (LOE 4). Whereas Osman et al describe a post-PNL

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transient fever and symptomatic UTI in 32.1% and 3.5% of 315 patients, needing treatment with antibiotics [71] (LOE 4). When comparing different antibiotic prophylaxis regimens in a RCT, it showed that a single dose was as effective in preventing postoperative infections as multiple doses when using ofloxacin or cefuroxim in combination with norfloxacin [72,73]. Therefore, when the preoperative urine culture is negative, there is low evidence suggesting a more favourable outcome after PNL when using prophylactic antibiotics, without an evident advantage for any specific antimicrobial regimen. 3.9.

Open/laparoscopic urologic interventions

An extensive search was performed addressing urologic open and laparoscopic interventions, but no relevant urologic studies could be identified. Subsequently, the relevant surgical literature was screened. Surgical wound classification in the categories clean, clean-contaminated, contaminated, and dirty seems just as relevant for urologic surgery as for general surgery [74]. In this way, by assessing the pre-intervention surgical wound class, an estimate can be made of the need for antibiotic prophylaxis during surgery. Clean surgery involves uninfected tissues without opening of the urinary tract and with primary closure of the wound. In clean-contaminated surgery, the urinary tract is entered under controlled conditions, without the presence of infected tissues or bacteriuria. Surgery with use of bowel tissue is also classified as clean-contaminated. The presence of a nontreated infection, including UTI, should be considered as contaminated urologic surgery. When pus is present, the surgery is labelled dirty [74]. Implantation of prosthesis material is not classified as above. Since infectious complications are potentially serious when involving prosthesis material, antibiotic coverage is advocated irrespective of surgical class [74]. Derived from the surgical literature and not supported by urologic evidence, there is no indication for antibiotic prophylaxis in clean surgery, whereas there is an indication in clean-contaminated and prosthetic surgery. Contaminated and dirty surgery should be covered by therapeutic antibiotics instead of prophylactic dosages.

4.

Discussion

In this systematic review, all currently available RCTs addressing the use of antibiotic prophylaxis in

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urologic interventions were identified and assessed and the results grouped and presented. For most urologic interventions, there is only moderate to low evidence for the use of antibiotic prophylaxis, with the exception of TURP and prostate biopsy. Strong evidence supports the use of short-term prophylaxis for TURP, and this evidence is moderate to high for prostate biopsy. The main point of consideration when assessing the benefit of antibiotic prophylaxis is what to consider as a favourable outcome. Is it decrease of postintervention bacteriuria, or the decrease of symptomatic UTIs or other infectious complications? While the aim of preventing symptomatic UTIs and other serious infectious complications seems evident, the need to prevent asymptomatic bacteriuria remains questionable. Asymptomatic bacteriuria is often of no clinical importance and resolves spontaneously in many cases. While all the studies included in our review had bacteriuria as primary parameters, few of them [6,7,9,11,12,27,31,53,57,58,60,69] contemplated UTI, fever, or symptoms as an outcome. Since ‘‘postoperative bacteriuria’’ is the best-assessed outcome parameter, we chose it as the primary outcome parameter for our review purposes. Because we were aware of the possible lack of clinical significance of bacteriuria, our secondary outcome parameters were symptomatic UTI, fever, sepsis, and bacteraemia. In our review, we could not find high evidence supporting the use of antibiotic prophylaxis in urologic interventions to prevent UTI except for TURP [6]. The evidence was moderate to high for prostate biopsy [27,31], and low to moderate for cystoscopy [9,11,12]. Currently, not enough evidence supports the systematic use of antibiotic prophylaxis to prevent UTIs in the rest of the procedures. However, when performing the present systematic review, we realized not only that variations in duration, antibiotic agent, or dose of what was considered ‘‘antibiotic prophylaxis’’ existed, but also that variables of importance in some complicated conditions as can be the presence of indwelling upper urinary tract drainages (eg, lithiasic obstruction, simple interventions in immunodepresed patients) were insufficiently explored. In fact, the presence of risk factors for infection was an exclusion criterion in all the RCTs analyzed. The presence of general risk factors (eg, comorbidity), risk factors related to the type of intervention (eg, oncologic) or urologic risk factors (eg, high irrigation pressure during endoscopy or infected stone) [5,74] increases the risk of a postoperative infectious complication and, therefore, the need for an adequate antibiotic prophylaxis even in cases of low evidence for benefit. Still, good

clinical practice should drive the decision in those circumstances. The inclusion of laparoscopic intervention under the same classification as for open surgery is justified by the lack of RCTs examining antibiotic prophylaxis. Some observational series illustrate the direct correlation between complication rate and complexity of the laparoscopic surgery. It is possible that infective outcomes increase with laparoscopic complexity, but the urologic case series report an extremely low rate, between 0.1% and 0.8% of infective complications. However, neither UTI as such nor the relation between infection rate and type of laparoscopic procedure were described in any of those series [75–77]. Finally, the reader should keep in mind that antibiotic prophylaxis is only one of the various measures to prevent post-intervention infectious complications. Antibiotic prophylaxis cannot compensate for inadequate operative care, and, therefore, general recommendations for prevention of surgical site infections should be followed [74]. Altogether, the evidence presented in this review can be used to establish local antibiotic prophylaxis guidelines. Such guidelines will increase the quality of care and at the same time reduce both costs and the development of microbial resistance [78,79].

5.

Conclusions

Ideally, antibiotic prophylaxis in urologic procedures should only be administered when wellperformed studies demonstrate its beneficial effect on post-intervention infectious complications. Because of the current lack of evidence, those patients with increased risk for infectious complications should receive antibiotic prophylaxis. Further research is needed because, except for TURP and prostate biopsy, there is a lack of well-performed studies. Author contributions: Astrid Goossens had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Goossens, Laguna. Acquisition of data: Bootsma, Laguna, Goossens. Analysis and interpretation of data: Laguna, Geerlings. Drafting of the manuscript: Bootsma. Critical revision of the manuscript for important intellectual content: Laguna, Geerlings, Goossens. Statistical analysis: Goossens, Bootsma, Laguna. Obtaining funding: None. Administrative, technical, or material support: Bootsma, Laguna, Goossens, Geerlings.


Supervision: Goossens, Geerlings. Other (specify): None. Financial disclosures: I certify that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: None. Funding/Support and the role of the sponsor: This work was supported by a grant of the AMC, University of Amsterdam.

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[48] Porru D, Madeddu G, Campus G, Montisci I, Scarpa RM, Usai E. Evaluation of morbidity of multi-channel pressure-flow studies. Neurourol Urodyn 1999;18:647–52. [49] Wagenlehner FME, Wagenlehner C, Schinzel S, Naber KG. Prospective, randomized, multicentric, open, comparative study on the efficacy of a prophylactic single dose of 500 mg levofloxacin versus 1920 mg trimethoprim/sulfamethoxazole versus a control group in patients undergoing TUR of the prostate. Eur Urol 2005;47:549–56. [50] Rodrigues P, Hering F, Meller A, Campagnari JC, D’Imperio M. A randomized and prospective study on the value of antibiotic prophylaxis administration in transurethral resection of the prostate. Sao Paulo Med J 2004; 122:4–7. [51] Upton JD, Das S. Prophylactic antibiotics in transurethral resection of bladder tumors: are they necessary? Urology 1986;27:421–3. [52] Klimberg IW, Malek GH, Cox CE, Patterson AL, Whalen E, Kowalsky SF, et al. Single-dose oral ciprofloxacin compared with cefotaxime and placebo for prophylaxis during transurethral surgery. J Antimicrob Chemother 1999; 43(suppl A):77–84. [53] Delavierre D, Huiban B, Fournier G, Le GG, Tande D, Mangin P. The value of antibiotic prophylaxis in transurethral resection of bladder tumors. Apropos of 61 cases. Prog Urol 1993;3:577–82. [54] Pearle MS, Roehrborn CG. Antimicrobial prophylaxis prior to shock wave lithotripsy in patients with sterile urine before treatment: a meta-analysis and cost-effectiveness analysis. Urology 1997;49:679–86. [55] Pettersson B, Tiselius HG. Are prophylactic antibiotics necessary during extracorporeal shockwave lithotripsy? Br J Urol 1989;63:449–52. [56] Tominaga T, Tomita K, Shibamoto K, et al. Clinical study of urinary tract infection after treatment with extracorporeal shock-wave lithotriptor. Extracorporeal shock-wave lithotriptor. Nippon Hinyokika Gakkai Zasshi 1987;78:1240–5. [57] Bierkens AF, Hendrikx AJ, Ezz el Din KE, et al. The value of antibiotic prophylaxis during extracorporeal shock wave lithotripsy in the prevention of urinary tract infections in patients with urine proven sterile prior to treatment. Eur Urol 1997;31:30–5. [58] Claes H, Vandeursen R, Baert L. Amoxycillin/clavulanate prophylaxis for extracorporeal shock wave lithotripsy—a comparative study. J Antimicrob Chemother 1989; 24(suppl B):217–20. [59] Gattegno B, Sicard F, Alcaidinho D, Arnaud E, Thibault P. Extracorporeal lithotripsy and prophylactic antibiotic therapy. Ann Urol (Paris) 1988;22:101–2. [60] Ilker Y, Tarcan T, Akdas A. When should one perform shockwave lithotripsy for lower caliceal stones? J Endourol 1995;9:439–41. [61] Herrlinger A, Bornhof C, Kuehn R. Antibiotic prophylaxis before extracorporeal shock wave lithotripsy by singleshot application of azlocillin. Chemioterapia 1987;6:607–9. [62] Knipper A, Bohle A, Pensel J, Hofstetter AG. Antibiotic prophylaxis with enoxacin in extracorporeal shockwave lithotripsy. Infection 1989;17(suppl 1):S37–8.


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Editorial Comment on: Antibiotic Prophylaxis in Urologic Procedures: A Systematic Review Luigi Cormio Department of Urology and Renal Transplantation, University of Foggia, Foggia, Italy [email protected] Antimicrobial prophylaxis for urologic procedures is a major issue, as potential advantages of antibiotic administration should be carefully weighed against potential side effects, microbial resistance, and health care costs. The present systematic literature review [1] adds further information to available European Association of Eurology (EAU) recommendations for antibiotic prophylaxis in urologic surgery, which currently exist in the form of a nonstructured review [2]. Both reviews recommend no prophylaxis for cystoscopy, transurethral resection of bladder tumours, urodynamics, simple ureteroscopy (diagnostic or for distal uncomplicated stones), extracorporeal shock wave lithotripsy

[72]

[73] [74]

[75]

[76]

[77]

[78]

[79]

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graphy-guided renal access: experience from over 300 cases. BJU Int 2005;96:875–8. Dogan HS, Sahin A, Cetinkaya Y, Akdogan B, Ozden E, Kendi S. Antibiotic prophylaxis in percutaneous nephrolithotomy: prospective study in 81 patients. J Endourol 2002;16:649–53. Cutajar CL. Norfloxacin prophylaxis for endoscopic urological surgery. Br J Urol 1992;69:421–4. Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control 1999;27:97–132. Rassweiler J, Fornara P, Weber M, et al. Laparoscopic nephrectomy: the experience of the laparoscopy working group of the German Urologic Association. J Urol 1998; 160:18–21. Fahlenkamp D, Rassweiler J, Fornara P, Frede T, Loening SA. Complication of laparoscopic procedures in urology: experience with 2,407 procedures at 4 German centers. J Urol 1999;162:765–70. Colombo Jr JR, Haber GP, Jelovsek JE, et al. Complications of laparoscopic surgery for urological cancer: a single institution analysis. J Urol 2007;178:786–91. Frei CR, Restrepo MI, Mortensen EM, Burgess DS. Impact of guideline-concordant empiric antibiotic therapy in community-acquired pneumonia. Am J Med 2006;119: 865–71. Menendez R, Torres A, Zalacain R, et al. Guidelines for the treatment of community-acquired pneumonia: predictors of adherence and outcome. Am J Respir Crit Care Med 2005;172:757–62.

(ESWL), and clean (urinary tract not opened) open or laparoscopic surgery, providing absence of risk factors. Both recommend prophylaxis for transurethral resection of the prostate (TURP); but while EAU guidelines suggest it can be omitted for lowrisk patients with small prostates, the present review outlines the higher efficacy of short-course (<72 h) over single-shot prophylaxis found in randomised controlled trials (RCTs). Both reviews recommend prophylaxis for prostate biopsy, complicated (proximal or impacted stone) ureteroscopy, percutaneous nephrolithotomy, and clean/ contaminated (urinary tract opened) surgery (either open or laparoscopic), but EAU guidelines favour short-course prophylaxis over single-shot prophylaxis. Again, the present review outlines no advantage of short-course over single-shot prophylaxis for prostate biopsy in RCTs, and that issue is far from having been solved or even adequately addressed for the other procedures. While for endourologic procedures such lack of information may be justified by the great number of clinical

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variables (infection, obstruction, surgical technique, patient conditions, and comorbidities) to be taken into account, quite impressive is the absence of RCTs testing antibiotic prophylaxis in open and laparoscopic urological procedures. It is noteworthy that EAU recommendations on open procedures are based on general surgery, whereas laparoscopic procedures are just assumed to require the same prophylactic regimen used for the corresponding open procedures. Well-designed RCTs are therefore eagerly awaited, as in the era of evidence-based medicine rational use of antibiotics should be a marker of quality in a urologic centre.

References [1] Bootsma AMJ, Laguna Pes MP, Geerlings SE, Goossens A. Antibiotic prophylaxis in urological procedures: a systematic review. Eur Urol 2008;54:1270–86. [2] Naber KG, Bishop MC, Bjerklund-Johansen TE, et al. Guidelines on the management of urinary and male genital tract infections. http://www.uroweb.org/nc/ professional-resources/guidelines/online/?no_cache= 1&view=archive.

DOI: 10.1016/j.eururo.2008.03.034 DOI of original article: 10.1016/j.eururo.2008.03.033

Antibiotic Prophylaxis in Urologic Procedures: A

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