International Journal of Urology (2020) 27, 244--248 doi: 10.1111/iju.

14181

Original Article: Clinical Investigation

Comparison of single- and multiple-dose cefazolin as prophylaxis for

transurethral enucleation of prostate: A multicenter, prospective,
randomized controlled trial by the Japanese Research Group for
Urinary Tract Infection
Yoshikazu Togo,1 Koji Fukui,2 Yasuo Ueda,3 Sojun Kanamaru,4 Yosuke Shimizu,4 Koichiro Wada,5
Takuya Sadahira,5 Yusuke Yamada,1 Masahiro Matsumoto,6 Ryoichi Hamasuna,7 Kiyohito Ishikawa,8
Manabu Takai,9 Yuka Maekawa,10 Mitsuru Yasuda,11 Koji Kokura,2 Nobuyuki Kondoh,12
Hidekazu Takiuchi3 and Shingo Yamamoto1
1
Department of Urology, Hyogo College of Medicine, Nishinomiya, 2Department of Urology, Takarazuka City Hospital, Takarazuka,
3
Department of Urology, Nishinomiya Municipal Central Hospital, Nishinomiya, 4Department of Urology, Kobe City Nishi-Kobe
Medical Center, Kobe, Hyogo, 5Department of Urology, Okayama University Graduate School of Medicine, Dentistry and
Pharmaceutical Sciences, Okayama, Okayama, 6Department of Urology, University of Occupational and Environmental Health Japan,
Kitakyushu, 7Department of Urology, Federation of National Public Services Affiliated Personal Mutual Aid Associations, Shin-
Kokura Hospital, Kitakyushu, Fukuoka, 8Department of Urology, Fujita Health University School of Medicine, Toyoake, Aichi,
9
Department of Urology, Kizawa Memorial Hospital, Minokamo, 10Department of Urology, Gifu University Hospital, 11Center for
Nutrition Support and Infection Control, Gifu University Hospital, Gifu, Gifu, and 12Department of Urology, Kyowakai Kyoritsu
Hospital, Kawanishi, Hyogo, Japan

Abbreviations & Acronyms
AE = adverse event
AMP = antimicrobial
prophylaxis
BPH = benign prostatic
hyperplasia
HoLEP = holmium laser
enucleation of the prostate
JRGU = Japanese Research
Group for Urinary Tract
Infection
RCT = randomized
controlled trial
TUEB = transurethral
enucleation with bipolar
TURP = transurethral
prostatic resection
UMIN = University Hospital
Medical Information
Network
UTI = urinary tract infection
Correspondence: Yoshikazu
Togo M.D., Ph.D., Department
of Urology, Hyogo College of
Medicine, 1-1 Mukogawacho,
Nishinomiya, Hyogo 663-8501,
Japan. Email:
ytogohg@gmail.com
Received 27 August 2019;
accepted 16 December 2019.
Online publication 21 January
2020
Objectives: To compare the optimal administration period of antimicrobial prophylaxis
in patients undergoing transurethral enucleation of the prostate for benign prostatic
hyperplasia.
Methods: We carried out a randomized controlled trial to compare the differences in
incidence of perioperative genitourinary tract infection between single and multiple
(3 days) administrations of cefazolin for transurethral enucleation of the prostate in
benign prostatic hyperplasia patients without pyuria or bacteriuria between January 2015
and December 2018.
Results: This multicenter randomized controlled trial included 203 patients who
underwent a transurethral enucleation of the prostate procedure. All received
antimicrobial prophylaxis, and were randomized into those who received single-dose
(n = 101) or multiple-dose (n = 102) therapy. The rate of genitourinary tract infection
after transurethral enucleation of the prostate for all patients was 1.5%, whereas that in
the single-dose group was 1.0% and in the multiple-dose group was 2.0%, which were
not significantly different (P = 1.00).
Conclusions: A single dose of antimicrobial prophylaxis as a prophylactic antibacterial
drug is sufficient for patients undergoing transurethral enucleation of the prostate who
do not have presurgical pyuria or bacteriuria.
Key words: antimicrobial prophylaxis, benign prostatic hyperplasia, optimal
administration period, randomized controlled trial, transurethral enucleation of the
prostate.
Introduction
A TURP procedure was considered the gold standard for surgical treatment of BPH for sev-
eral years, although other methods for transurethral enucleation of the prostate, such as
HoLEP and TUEB, have recently been frequently used. Although both HoLEP and TUEB are
highly recommended in Japanese guidelines,1 HoLEP have become established as the first
choice in patients with an enlarged prostate in the guidelines of the American Urological

244 © 2020 The Japanese Urological Association


Association.2 Similarly, the guidelines of the European Asso-
ciation of Urology state that HoLEP is the first choice for
BPH of ≥80 mL, as well as for an open prostatectomy.3
Several reports have compared surgical results for transure-
thral enucleation of the prostate; however, few have investi-
gated the optimal use of AMP. Substantial evidence has been
presented showing that prophylactic antibiotics are required for
TURP,4–7 but no study has examined the optimal regimens of
prophylactic antibiotics for transurethral enucleation of the
prostate, thus no such recommendations are indicated in guide-
lines used in the USA or Europe.8,9 In Japanese guidelines, evi-
dence showing the necessity of AMP for TURP is only
mentioned.10 With increasing numbers of resistant bacteria,
proper use of antimicrobials is important and the need for pre-
ventive antimicrobials must be verified for each procedure.
Furthermore, it has been reported that adherence to such guide-
lines reduces the use of unnecessary antibiotics without
increasing the risk of postoperative infections of resistant bac-
teria, supporting the important role of guidelines.11
To determine the optimal period of antibiotics administra-
tion for patients undergoing transurethral enucleation of the
prostate, the present multicenter prospective RCT was carried
out by the JRGU.
Methods
Patients scheduled for a transurethral enucleation of the pros-
tate procedure from January 2015 to December 2018 were ran-
domly allocated to either the single-dose group (cefazolin 1 g,
within 30 min before surgery) or multiple-dose group (cefa-
zolin 1 g, 3 days, twice a day from just before surgery until
postoperative day 2) at a 1:1 ratio by a random number table at
the central registered facility (Fig. 1). We investigated the
occurrence of perioperative genitourinary infection until
30 days after the procedure and compared between the groups.
The inclusion criteria were men aged ≥50 years, and no
findings of pyuria (<5 WBCs/hpf or <10 WBCs/lL) or bac-
teriuria (bacterial count <104 CFU/mL), whereas the exclu-
sion criteria included the presence of an indwelling urethral
Enrollment
Single-dose AMP (102)
Excluded (1)
• Change of procedure
Analyzed (101)
Fig. 1 Study flow diagram.
© 2020 The Japanese Urological Association
Comparison of AMP dose for HoLEP/TUEB
catheter, concurrent bladder stone surgery or prostate biopsy
procedure and lack of signed informed consent.
The present study was approved by the ethics committee
of each participating institution, including Hyogo College of
Medicine (approval #1837), and has been registered in the
UMIN Clinical Trials Registry (UMIN ID: UMIN000
016030).
The primary end-point was the comparison of rates of peri-
operative genitourinary infection between the single- and
multiple-dose groups. Secondary end-points examined were
occurrence rates of AMP-related AEs.
Differences between the groups were analyzed using a v2-
test, Fisher’s exact test and a Mann–Whitney U-test. A
P-value <0.05 was considered to show significance.
Results
Of the 219 patients recruited, 14 were excluded (two with
indwelling urethral catheter, 10 declined to participate, two
had surgery canceled), thus 205 were originally enrolled in
this study. Later, two did not undergo the originally allocated
intervention (one changed to TURP, one discontinued pro-
phylaxis due to cefazolin allergy), thus 203 patients were ran-
domized to either the single-dose AMP (n = 101) or
multiple-dose AMP (n = 102) group (Fig. 1). Preoperative
and perioperative patient characteristics are presented in
Tables 1 and 2. The postoperative urethral catheter duration
was significantly longer for patients who received HoLEP as
compared with TUEB (P = 0.001). There were no significant
differences for patient characteristics between the single- and
multiple-dose groups.
Of the 203 investigated patients, three (1.5%) developed a
febrile genito-UTI after the procedure, including one (1%) in
the single-dose and two (2%) in the multiple-dose group,
which was not a significant difference (P = 1.00). The post-
operatively infected patients were two (1.6%) with HoLEP
and one (1.3%) with TUEB, also showing no significant dif-
ference between those surgical procedures (P = 1.00;
Table 3). In each procedure, the postoperatively infected
Assessed for eligibility (219)
Excluded (14)
• Inclusion criteria not met,
indwelling urethral catheter (2)
• Declined to participate (10)
• Surgery canceled (2)
Randomized (205)
Multiple-dose AMP (103)
Excluded (1)
• Prophylaxis discontinued,
cefazolin allergy
Analyzed (102)
245
Y TOGO ET AL.

Table 1 Preoperative characteristics

P-value Single-dose (c) Multiple-dose (d) P-value

Characteristics, median (range) Total (n = 203) HoLEP (a) (n = 125) TUEB (b) (n = 78) (a vs b) (n = 101) (n = 102) (c vs d)
Age (years) 73 (56–88) 72 (56–87) 74 (56–88) 0.06 72 (56–87) 73 (57–86) 0.22
Prostate volume (mL) 56 (20–209) 52 (23–209) 58 (20–150) 0.77 56 (12–150) 55 (20–209) 0.87
International Prostate Symptom Score 20 (1–35) 19 (4–35) 20 (1–31) 0.10 20 (4–34) 19 (1–35) 0.37
Qmax (mL/s) 7.9 (1.0–30.1) 8.0 (1.0–28.0) 7.8 (1.5–30.1) 0.48 7.8 (1.5–28.0) 8.0 (1.0–30.1) 0.49
Post-void residual urine volume (mL) 75 (0–700) 72 (0–500) 76 (0–700) 0.10 73 (0–700) 79 (0–700) 0.88
Prostate-specific antigen (ng/mL) 4.5 (0.4–30.0) 4.5 (0.5–27.5) 4.8 (0.4–30.0) 0.48 4.6 (0.6–29.4) 4.3 (0.4–30.0) 0.55
Body mass index 23.5 (16.4–34.3) 23.5 (16.7–32.0) 23.7 (16.4–34.3) 0.84 23.6 (16.4–34.3) 23.5 (17.1–30.5) 0.43
American Society of Anesthesiologists physical status, n (%)
1 108 (53) 69 (55) 39 (50) 51 (50) 57 (56)
2 86 (42) 54 (43) 32 (41) 47 (47) 39 (38)
3 9 (4) 2 (2) 7 (9) 0.05 3 (3) 6 (6) 0.36
Comorbidities, n (%)
Ischemic heart disease 7 (3) 2 (2) 5 (6) 0.11 3 (3) 4 (4) 1.00
Hypertension 36 (18) 19 (15) 17 (22) 1.00 19 (19) 17 (17) 0.72
Chronic pulmonary disease 5 (2) 1 (1) 4 (5) 0.07 3 (3) 2 (2) 0.68
Diabetes 24 (12) 13 (10) 11 (14) 1.00 13 (13) 11 (11) 0.67
Cerebrovascular disease 3 (1) 1 (1) 2 (3) 0.56 1 (1) 2 (2) 1.00

Table 2 Perioperative characteristics of patients

Characteristics, P-value Single-dose (c) Multiple-dose (d)

median (range) Total (n = 203) HoLEP (a) (n = 125) TUEB (b) (n = 78) (a vs b) (n = 101) (n = 102) P-value (c vs d)
Operative time (min) 115 (38–366) 120 (43–366) 100 (38–273) 0.06 115 (50–273) 107 (38–366) 0.65
Resected weight (g) 32 (4–152) 32 (4–152) 33 (4–145) 0.78 33 (4–140) 30 (4–152) 0.84
Catheter duration (days) 3 (2–14) 4 (1–14) 3 (2–12) 0.001 3 (2–14) 3 (2–6) 0.08

patients were zero out of 62 (0%) in the single-dose and two
out of 63 (3.2%) in the multiple-dose group with HoLEP,
and one out of 39 (2.6%) and zero out of 39 (0%) with
TUEB. There was no significant difference between the two
groups in both procedures (P = 0.49 and 0.50, respectively).
All three patients were successfully treated with oral or
parenteral administration of levofloxacin. None of the patients
developed sepsis. One patient in the multiple-dose group had
prophylaxis discontinued due to an allergic reaction after the
first administration of cefazolin, and the symptom immedi-
ately disappeared after drug discontinuation.
Discussion
Patients undergoing conventional TURP have shown a recent
decreasing trend, as the efficacy of nucleation has been
shown to be equal to or better than that method in several
meta-analyses,12–14 with treatment results reported to be
equivalent as compared with open surgery for an enlarged
prostate.15 Additionally, several reports have shown the effec-
tiveness of minimally invasive surgery techniques, such as
enucleation and vaporization, which are becoming main-
stream surgical methods for treatment of BPH. In Japan, the
popularity of transurethral enucleation surgery with HoLEP
or TUEB is surpassing that of TURP, with those newer tech-
niques now used for most cases of prostatic enucleation.16
Historically, the need for preventive antibiotics in patients
undergoing TURP has been widely recognized, with ample
evidence reported in that regard.4–7 In a study of TURP
cases, Qiang et al. reported that the incidence of bacteremia
in the prophylaxis group was lower than that in patients who
received a placebo,4 whereas Berry and Barratt noted that the
frequency of postoperative bacteriuria was reduced from 26%
to 9.1%, and that of sepsis from 4.4% to 0.7% with prophy-
lactic antimicrobial administration.5 In their subgroup analysis
of use of cephalosporin as a preventive antimicrobial agent, a
significant difference in relative risk reduction was found in a
comparison of short-term (within 72 h) and single administra-
tions, with the short-term course showing better results (72%
vs 52%). Furthermore, in guidelines presented in Europe and
the USA, administration of a perioperative prevention
antibacterial agent for TURP is considered to be essential,
with administration within 72 h also recommended in Japa-
nese guidelines. In contrast, Wagenlehner et al. reported that
prophylaxis with levofloxacin or trimethoprim/sulfamethoxa-
zole for TURP is sufficient, even in cases with a single
dose.17 Therefore, it is considered that the optimal dosing
period for individual antibiotic agents requires assessment.
With minimally invasive surgical procedures, such as
HoLEP, becoming mainstream, there have been few studies
that examined the optical regimens for preventive antimicro-
bial agents given to patients undergoing enucleation surgery.
In a report that summarized the results of 23 different RCTs,
the incidence rate of UTI after TURP was higher (4.1%; 0–
22%) than that of HoLEP (0.9%; 0.0–4.9%).12 However, no
description regarding regimens for preventive antimicrobial

246 © 2020 The Japanese Urological Association


Table 3 Outcome of patients with perioperative genitourinary infection
Type of
Type of perioperative
surgical AMP genitourinary
No. procedure regimen infection Date of onset (POD)
1 HoLEP Multiple Prostatitis 11
2 HoLEP Multiple Epididymitis 13
3 TUEB Single Prostatitis 1 No growth
agents in cases that underwent HoLEP was provided, nor was
statistical analysis carried out regarding rates of infection rate
because of the heterogeneity of the patient populations. In
our previous multicenter prospective study, the incidence rate
of postoperative UTI was 8% after TURP, whereas the infec-
tion rate after HoLEP or TUEB was as low as 5%.18 In
recent years, the postoperative infection rate after HoLEP or
TUEB in Japan has been reported to range from 0.3% to
2.3%,19–21 comparable to findings reported by Ahyai et al.12
When carrying out a TUEB or HoLEP surgical procedure,
the perfusate flows from the cut surface into the vein at high
pressure, thus indigenous bacteria present in the urethra or
prostate can be a source of infection.22 The techniques used
might require lower pressure due to lower levels of bleeding
and bacterial spreading inside the prostate caused by its enu-
cleation, which can decrease the incidence of infection after
surgery, as compared with TURP. In view of findings show-
ing that long-term preventive antibacterial drug administration
leads to an increase in resistant bacteria, the duration of AMP
should be shorter for procedures with a low frequency of
infection complications.23
The present study assessed differences in the frequency of
infection between single- and multiple-dose cefazolin admin-
istration given to patients who underwent HoLEP or TUEB
as a multicenter prospective RCT. Of the 203 patients, three
(1.5%) developed a febrile genitourinary tract infection after
the transurethral enucleation procedure – one (1%) in the sin-
gle-dose group and two (2%) in the multiple-dose group –
which was not a significant difference. This result indicates
that a single administration of prophylaxis is sufficient for
prevention of a perioperative genitourinary infection after
enucleation of the prostate. As for the procedures utilized, the
postoperative infection rate was 1.6% (2 of 125) with HoLEP
and 1.3% (1 of 78) with TUEB, also showing no significant
difference between those surgical procedures, though the total
number in our cohort was small.
When determining perioperative infection prevention, the
choice of prophylactic antibiotics is an important issue.
Nearly all bacteria known to cause a UTI are Gram-negative,
such as Escherichia coli. In the present patients, cefazolin
was selected as the preventive antibacterial agent based on
the Japanese guidelines and the recommendation that a nar-
row-spectrum antibacterial agent be selected for preventive
antibacterial treatment. Furthermore, there was only a single
case (0.5%) of drug-related AE, which occurred in the multi-
ple-dose group, indicating the relative safety of cefazolin.
© 2020 The Japanese Urological Association
Comparison of AMP dose for HoLEP/TUEB
Culture at onset
Antimicrobial therapy for Outcome of
Urine Blood infectious diseases treatment
NA NA Levofloxacin (p.o.) Cured
NA NA Levofloxacin (p.o.) Cured
No growth Levofloxacin (i.v.) Cured
The present study had some limitations, including the rela-
tively low number of patients enrolled. Furthermore, only
low-risk patients without pyuria or bacteriuria were enrolled,
thus the overall rate of infection was low. A greater number
of patients is required to examine statistical differences
between prophylaxis regimens. However, to the best of our
knowledge, no RCTs have been carried out for comparing
AMP regimens for transurethral enucleation of the prostate.
Additional studies that include a greater number of patients
are required to confirm the present findings.
In conclusion, this is the first known RCT carried out
to examine the optimal administration period of AMP in
patients undergoing a procedure for transurethral enucle-
ation of the prostate. The rate of genito-UTI after the
procedure was not significantly different between patients
who received single dose of cefazolin and those who
received a 3-day administration, showing that a single-
dose regimen is sufficient for prophylaxis to prevent geni-
tourinary infection in patients without presurgical pyuria
or bacteriuria.
Acknowledgments
The authors express their sincere appreciation to the urolo-
gists and their colleagues at the participating institutions for
cooperation with this study.
Conflict of interest
None declared.
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Editorial Comment
Editorial Comment to Comparison of single- and multiple-dose cefazolin as prophylaxis
for transurethral enucleation of prostate: A multicenter, prospective, randomized
controlled trial by the Japanese Research Group for Urinary Tract Infection
The article by Togo et al. sought to compare the optimal
administration periods of cefazolin, antimicrobial prophylaxis,
in patients undergoing transurethral enucleation of the pros-
tate for benign prostatic hyperplasia.1 No previous study has
carried out the optimal regimens of prophylactic antibiotics
for transurethral enucleation of the prostate. Therefore, this
article is significant, although a relatively small number of
cases were registered.
Cefazolin is a first-generation cephalosporin, and works by
interfering with the bacteria’s cell wall synthesis. It is listed in
the World Health Organization’s List of Essential Medicines,
which shows the most effective and safe medicines for health
systems. Cefazolin is used most often for surgical prophylaxis
in patients without any history of beta-lactam allergy, and
methicillin-resistant Staphylococcus aureus infection.2–5
Antimicrobial resistance is widespread not only in develop-
ing countries, but also in developed countries. It is due to the
lack of routine checks on antibiotic use, over-the-counter
availability of many broad-spectrum antimicrobial agents and
inappropriate perioperative antimicrobial prescription for sur-
gical prophylaxis.6 Long-duration prophylactic antimicrobial
agent administration leads to the emergence of antimicrobial
resistance. Therefore, the duration of antimicrobial
248
16 Takamori H, Masumori N, Kamoto T. Surgical procedures for benign pro-
static hyperplasia: a nationwide survey in Japan, 2014 update. Int. J. Urol.
2017; 24: 476–7.
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"Urological Infections" of German Society of Urology. Prospective, random-
ized, multicentric, open, comparative study on the efficacy of a prophylactic
single dose of 500 mg levofloxacin versus 1920 mg trimethoprim/ sul-
famethoxazole versus a control group in patients undergoing TUR of the
prostate. Eur. Urol. 2005; 47: 549–56.
18 Togo Y, Tanaka S, Kanematsu A et al. Antimicrobial prophylaxis to prevent
perioperative infection in urological surgery: a multicenter study. J. Infect.
Chemother. 2013; 19: 1093–101.
19 Shigemura K, Yamamichi F, Kitagawa K et al. Does surgeon experience
affect operative time, adverse events and continence outcomes in holmium
laser enucleation of the prostate? A review of more than 1,000 cases. J. Urol.
2017; 198: 663–70.
20 Kikuchi M, Kameyama K, Yasuda M, Yokoi S, Deguchi T, Miwa K. Post-
operative infectious complications in patients undergoing holmium laser enu-
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Urol. 2016; 23: 791–6.
21 Hirasawa Y, Kato Y, Fujita K. Transurethral enucleation with bipolar for
benign prostatic hyperplasia: 2-year outcomes and the learning curve of a
single surgeon's experience of 603 consecutive patients. J. Endourol. 2017;
31: 679–85.
22 Ishikawa K, Maruyama T, Kusaka M, Shiroki R, Hoshinaga K. The state of
antimicrobial prophylaxis for holmium laser enucleation of the prostate:
HoLEP and the results of a questionnaire survey. Acta. Urol. Jpn. 2011; 57:
539–43.
23 Harbarth S, Samore MH, Lichtenberg D, Carmeli Y. Prolonged antibiotic
prophylaxis after cardiovascular surgery and its effect on surgical site infec-
tions and antimicrobial resistance. Circulation 2000; 101: 2916–21.
prophylaxis should be the shortest for each procedure, mini-
mizing the frequency of infection complications. In contrast,
antimicrobial stewardship is the systematic effort to recom-
mend medical professionals to comply with evidence-based
prescription, which results in the prevention of antibiotic
overuse and a decrease of antimicrobial resistance. This arti-
cle by Togo et al. provides useful data to support the antimi-
crobial stewardship team members to implement their action
in this area.
The study by Togo et al. has some limitations, including
the relatively small number of cases registered. Further
studies that include a larger number of cases are required to
confirm the present findings.
Satoshi Yazawa M.D.,1,2 Naoki Hasegawa M.D., Ph.D.3 and
Mototsugu Oya M.D., Ph.D.2
1 2
Yazawa Clinic, Department of Urology, Keio University
School of Medicine, and 3Department of Infectious Diseases
and Infection Control, Keio University Hospital, Tokyo,
Japan
syazawa@keio.jp
DOI: 10.1111/iju.14199
© 2020 The Japanese Urological Association