# Simple Use of the Suppository Type Povidone-Iodine Can Prevent Infectious Complications in Transrectal Ultrasound-Guided Prostate Biopsy

Authors: Dong Soo Park; Jong Jin Oh; Jin Ha Lee; Woong Ki Jang; Young Kwon Hong; Sung Keun Hong
Journal: Advances in Urology
 (2009)

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## Abstract

Purpose. To determine the effect of simple use of suppository povidone-iodine on infectious complications after transrectal ultrasonography-guided biopsy of the prostate. Methods. All 481 patients are included and received antibiotic prophylaxis. Among them, 360 patients received povidone-iodine suppository (Gynobetadine; 200 mg) immediately prior to biopsy and 121 patients did not. Infectious complications were classified. To evaluate bactericidal effects, we counted bacterial colonies in the rectum, harvested from a rectal swab before insertion of the suppository and after biopsy. Aliquots of the suspended bacterial strains were added to Mueller-Hinton agar medium for incubation. Colony counts were determined. Results. Infectious complications developed in 1 case (0.3%) in the rectal preparation group (Group 1) and in 8 cases (6.6%) in the nonrectal preparation group (Group 2). One in Group 1 had a fever without sepsis. Two patients had sepsis and six had fever without sepsis in Group 2. Rectal preparation was a statistically significant risk factor influencing the development of infectious complications. In vitro experiments, the mean number of colony-forming units decreased 99.9% after the rectal povidone-iodine preparation. Conclusions. All through the biopsy, povidone-iodine melted into the rectum and decreased the bacterial colony count. Simple use of povidone-iodine suppository before prostate biopsy minimizes the risk of infectious complications.


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## Body

## 1. Introduction

Since the introduction of PSA as a marker in the diagnosis
of prostate cancer, the rate of biopsies taken from the prostate has increased
dramatically. Although prostate biopsies are generally considered a safe
procedure, complications secondary to biopsy are some of the most common
adverse events encountered in practice. Usually minor and self-limiting, they
are occasionally serious and even fatal. A major problem of the transrectal
approach is the risk of infection, leading to febrile reactions, epididymitis,
prostatitis, sepsis, and even death. Currently, many urologists use
prophylactic antibiotic therapy to minimize the infectious complications after biopsy, but these
therapies do not completely eliminate the incidence of infection [1, 2]. For this reason, a rectal
preparation has been used as a cleansing technique before biopsy to reduce
infectious complications [1–3]. However, the effect of a rectal
preparation applied before biopsy has not yet been validated. We therefore
determined the effect of povidone-iodine suppository (Gynobetadine)
prophylaxis on infectious
complications after transrectal needle biopsy of the prostate.


## 2. Material and Methods

This study was performed on 481 patients in our hospital
from January 2004 to December 2007 who had indications for a prostate biopsy,
including an elevated PSA, hypoechoic lesions on ultrasonography, or abnormal
digital rectal findings.All patients received antibiotic prophylaxis consisting
of a single intravenous
injection of a 3rd generation cephalosporin just before biopsy and oral administration of
cefixime (100 mg twice daily) at morning of
day of biopsy
and then continued for 5 days thereafter. Between April 2005 and December 2007,
360 patients (group 1) received a povidone-iodine suppository (Gynobetadine; 200 mg) just before biopsy, and between January
2004 and March 2005 121 patients (group 2) did not receive Gynobetadine.
All patients were provided with informed consent before the biopsy. Transrectal
ultrasound (TRUS-) guided prostate biopsies were performed without anesthesia in
an outpatient setting by experienced
urology doctors. 12
cores were obtained in the same way between two groups. An
Aloka Prosound SSO-4000 ultrasonography unit and a transrectal 7.5 MHz biplane
probe were used during the procedure. Biopsies were taken with an 18G ASAP
automatic biopsy needle (SACN Biopsy Needle).
At the one week followup visit, any complications after the biopsy were
evaluated and recorded.Infectious complications were classified as sepsis, fever
(temperature higher than38°C) without sepsis, and other clinical infections.
Sepsis was defined as two or more of the following conditions as a result of
infection: body temperature >38C° or <36C°, heart rate >90 beats
per minute, respiration rate >20 breaths per minute or arterial partial
pressure of carbon dioxide <32 mmHg, and white blood cell count >12 000 cells/cm3 or
<4000 cells/cm3, or
>10% immature (band) forms [4]. Noninfectious
complications were evaluated and classified as hematuria, rectal bleeding, and
perineal pain.To evaluate the bactericidal effects of Gynobetadine,
we counted bacterial colonies in the rectum that had been harvested from rectal
swab before the insertion of Gynobetadine and after biopsy. Colony
counts were determined by agar dilution. Bacterial strains of the rectal swab
were suspended and diluted in sterile saline, and aliquots of this suspension
were added to Mueller-Hinton agar medium. After overnight incubation, the
colony counts were determined.


## 3. Results

The mean ages of groups 1 and 2 patients were 64.6 years
(range, 29–88 years) and 65.7 years (range, 31–96 years), respectively. The PSA levels in groups 1 and 2 were  6.45 ng/mL and 7.34 ng/mL, , respectively. The patient demographic data and complications are shown in Table1. There was no statistically significant difference between groups 1 and 2 with respect to demographic data.Table 1
Demographic data of patients.
Group 1Group 2Number of
patients360121Mean age
(years)64.6
(29–88)65.7
(31–96)Average PSA
(ng/mL)6.457.34Prostate
cancer diagnosis104 (29%)30 (25%)Infectivecomplications*18Sepsis02Fever without
sepsis16Noninfectivecomplications†2922Hematuria1713Rectal
bleeding54Perineal
pain75P=.001*;P†=.391.Infectious complications developed in 8 cases (6.6%) in
the nonrectal preparation group (group 2) and in 1 case (0.3%) in the rectal
preparation group (group 1). Among eight infectious complications in the nonrectal
preparation group, two patients had sepsis and six patients had fever without
sepsis. Among the eight patients, four patients developed an acute bacterial
prostatitis and one patient developed an acute epididymitis. One patient from
group I complained of a febrile sensation one day after biopsy, which resolved
spontaneously. A single rectal preparation using Gynobetadine significantly lowered the risk of development
of infectious complications (P=.001). In in
vitro experiments, the mean number of colony-forming units decreased 99.9%
after rectal preparation (Table 2). We found that the bacterial colony count
before rectal preparation ranged from 7.0×103 to 7.0×105,
but decreased to <3.0 ×101 after biopsy. Figure 1 shows the
bactericidal effects of povidone-iodine, and it is clear that the bacterial
count was significantly reduced after the insertion of Gynobetadine.
The Gynobetadine preparation statistically decreased the colony
count (P=.002).Table 2
Colony counts before insertion of povidone-iodine and after biopsy.
Plate no.BeforeAfter11.19×1055.0×10221.93×104<3.0×10131.09×104<3.0×10147.0×1033.6×10157.0×105<3.0×10167.4×1044.0×102P*=.002.In in vitro experiments (a) bacterial colony plate in an agar dilution
before insertion of povidone-iodine. (b)
Bacterial colony plate in an agar dilution after biopsy; the mean number of colony-forming units
decreased 99.9% after rectal preparation.
(a)(b)Noninfectious complications (classified as hematuria,
rectal bleeding, and perineal pain) developed in 22 cases (18.2%) in the
nonrectal preparation group and in 29 cases (8.1%) in the rectal preparation
group. The noninfectious
complications were self-limiting and did not require intervention or transfusion.
No patient developed urinary retention after the procedure. There was no
statistically significant difference in terms of noninfectious complications.


## 4. Discussion

Transrectal prostate biopsy with ultrasonography is the
gold standard in the diagnosis of prostate cancer. Most men undergoing prostate
biopsy are otherwise healthy. The procedure, however, is not harmless.
Transient side events, such as local pain, hematuria, hemospermia, dysuria, and
rectal bleeding have been reported in a large number of patients [5, 6]. Bacteriuria occurs in 20–53% and
bacteremia in as many as 73% of patients following a biopsy of the prostate [7, 8], and rectal bleeding has been reported
in 75% of such patients [2–4].
Fever associated with genitourinary symptoms is described in 3–10% and
septicemia in <5% of patients following a biopsy of the prostate [7–9]. Antimicrobial agents lower
the incidence of postbiopsy infectious complications [1, 9, 10]. Most urologists agree in
the necessity of antibiotic prophylaxis, but the timing, duration of the
regimen, and the route of administration remain controversial [11]. In most studies, an antibiotic regimen
of at least 3 days has been used [12].Despite the use of prophylactic antibiotics, the
development of infectious complications after biopsy remains possible, although
its incidence is low [1, 13, 14]. For
this reason, a cleansing rectal enema has been used by 81% of urologists as a
means to reduce infectious complications
[15].
Most investigators believe that rectal preparation reduces the rate of
bacteremia [16, 17]. In
a prospective randomized study, Lindert et al. [8]
proposed that bacteremia might be minimized by a prebiopsy enema. In their
study, bacteremia following prostate biopsy occurred in 4% (1 of 25) of patients
who had prebiopsy enemas compared with 28% (7 of 25) of those who did not.
This study therefore provided a theoretical basis for using a prebiopsy rectal
preparation for the prevention of infectious complications.Povidone-iodine also may be used to prepare the rectum
for transrectal biopsy of the prostate intraoperatively. The use of povidone-iodine is well
known in clinical medical practice. Its use in dermatology and surgery as a
disinfectant is ubiquitous and is based on the fact that povidone-iodine has
broad-spectrum antimicrobial activity
[18],
including viruses [19],
fungi [20], and
parasites, as well as anti-inflammatory activity [21]. Povidone-iodine is an antiseptic solution extensively
used in different concentrations.Brown et al. [16]
reported that a povidone-iodine enema provided a safe and effective means for
preventing bacteremia and bacteriuria and Melekos [17] showed that parenteral piperacillin in combination with
a povidone-iodine enema significantly reduces the incidence of infectious
complications. Khan et al. [22]
reported that intraoperative preparation of the rectum with a
povidone-iodine-saturated gauze during transrectal biopsy of prostate decreased
the incidence of bacteriuria and bacteremia. Akay et al. [23] reported that lavage with Betadine prior to transrectal prostate biopsy is adequate in the prevention of infectious complications.Huang et al.
[24]
reported that a phosphate-based enema combined with povidone-iodine is
effective in reducing postprostate biopsy infectious complications (9.23 versus
0%).A povidone-iodine suppository (Gynobetadine; 200 mg) is more effective than a
povidone-iodine enema, because the contact surface between the rectal mucosa of
the prostate area is more constant during the biopsy procedure than with the
enema. With the enema technique, the solution of povidone-iodine is retained in
the dependent portion of the rectum and may not effectively bathe the rectal
mucosa of the prostatic area. A povidone-iodine suppository has better patient
acceptance than an enema.There have been some reports that have shown the effects
of povidone-iodine in the treatment of infectious
complications [22].
However, there are no studies that have verified the bactericidal effects of
povidone-iodine in in vitro experiments. For this reason, we counted bacterial colonies in the rectum that
had been harvested from rectal swabs before the insertion of povidone-iodine
and after biopsy to evaluate the bactericidal effects of povidone-iodine. We
found that the bacterial colony counts before the rectal preparation were
decreased dramatically after biopsy. These local antiseptic
precautions seem worthwhile. With the large reduction in microorganisms,
contamination is likely to be considerably reduced.Periprostatic local anesthesia for transrectal
ultrasound-guided prostate biopsy is known to reduce pain but increases the
incidence of bacteriuria and bacteremia
[25].
Using our technique with povidone-iodine, local anesthesia for prostate biopsy
is effective and safe for those in which it is necessary.According to the data obtained in the present study, it
is apparent that a Gynobetadine rectal
preparation is reliable in preventing infection. Other anti-infectious enemas
increase patient cost and discomfort [26]. The
cost of Gynobetadine is very low (approximately US $0.50), and it is
comfortable to patients by reason of quick
and easy delivery. And it is better tolerated to the patients. After our prospective
randomized trial with iodine suppository considered, we
conclude that the povidone-iodine suppository is important to protect against infectious
complications in patients undergoing biopsy of the prostate.


## 5. Conclusions

Simple rectal preparation using a povidone-iodine
suppository was a statistically significant risk factor for infectious
complications after prostate biopsy in our study.Thus, we recommend a povidone-iodine suppository (200 mg)
rectal preparation before prostate biopsy because of its effectiveness in
controlling rectal bacterial colony-forming units and species, its very low
cost, and its availability.



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