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ORIGINAL CONTRIBUTIONS

Received: January 12^th 2014

Accepted: July 21^st 2015

Intrarectal povidone-iodine to reduce the risk of genitourinary infections after transrectal prostate biopsy

Jorge Moreno-Palacios,^a Alejandro Espinosa-Guerrero,^a Juan Ramón Torres-Anguiano,^a Guillermo Montoya-Martínez,^a Virgilio López-Samano,^a Eduardo Serrano-Brambila^a

^aServicio de Urología, Hospital de Especialidades Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Distrito Federal, México

Communication with: Eduardo Serrano-Brambila

Telephone: (55) 5627 6900, extensión 21516

Email: eserranob@hotmail.com

Background: The aim of this study is to compare two different preparations in patients undergoing transrectal prostate biopsies samples (TPBS) and assess the prevalence of genitourinary infections (GUI).

Methods: A historical cohort of patients undergoing TBPS for suspected prostate cancer. Two groups were compared: one with endorectal lubricant jelly and another with the addition of a povidone-iodine lubricating jelly. Complications were evaluated at three weeks. A bivariate analysis was performed by calculating the OR (95 % CI) to determine if the additional endorectal povidone-iodine pre-TBPS reduced GUI and other complications.

Results: 185 patients (Group I n = 86, Group II n = 96) were evaluated. 45 and 25 % had genitourinary tract infection (OR: 0.4, CI: 0.2-0.9, p = 0.004); fever was presented in 21 and 10 % respectively (OR: 0.42, CI: 0.1-0.9, p = 0.04).

Conclusions: A reduction was observed in the presence of genitourinary infections in patients who had intrarectal povidone-iodine preparation applied.

Keywords: Biopsy, Prostate, Urinary tract, Povidone-Iodine.

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In early 1990, the number of diagnoses of prostate cancer (PC) in the United States increased dramatically, surpassing lung cancer as the most common cancer among men. It is generally accepted that these changes resulted from the evaluation of prostate-specific antigen (PSA), which allowed many cases of PC to be suspected at an early stage. An estimated 233,000 new cases were diagnosed in the US in 2014, representing 27% of new cases of cancer in men in 2014. The mortality rate from PC adjusted for age has declined (-4.1% annually from 1994 to 2001).¹

Transrectal prostate biopsy (TRPB) was proposed in 1937 by Astraldi, and in 1980 it was performed guided by ultrasound to take samples transperineally, transrectally in 1981, and in 1989 Torp-Pedersen reported his results from ultrasound-guided TRPB with an automatic lancing device. Currently, the transrectal route is the most used path to the prostate both for its ease of learning and its high diagnostic performance.²

Current indications for TRPB include an abnormal finding on digital rectal examination (DRE) and elevated serum PSA.³ TRPB guided by ultrasound is considered a simple and accurate method for obtaining prostate tissue and making its histological evaluation. The most common complication is genitourinary infection (GUI) despite antibiotic prophylaxis.^4-7

Various additional methods have been studied to reduce the frequency of infections following ultrasound-guided TRPB, including the use of transrectal enemas before the procedure, without good results.^8,9 There are few available studies on the use of local antiseptic materials.^10-13

The aim of this study is to compare two different rectal preparations in patients undergoing transrectal prostate biopsies (TRPB) and to assess the risk of genitourinary infections (GUI).

Methods

With prior approval of the ethics committee of the institution, a prospective cohort (experimental group) was evaluated from November 2012 to June 2013 and compared with a historical cohort (control group) from March 2012 to November 2012, of male patients presenting with indication for TRPB at the Servicio de Urología of the Hospital de Especialidades of the Centro Médico Nacional Siglo XXI. All male patients were included with clinical indication for biopsy with no history of allergy to iodine and quinolones, who had no GUI at the time of biopsy.

The procedures were performed by doctors of the Servicio de Urología and all patients included in the study underwent preparation with ciprofloxacin 500 mg orally every 12 hours, starting two days before the procedure, applying two evacuant enemas, one the night before the study and another on the morning of the procedure, in addition to a liquid diet the day before. The control group were only administered 20 ml endorectal water-soluble lubricating jelly via syringe prior to the introduction of the ultrasonic transducer, and the experimental group were administered 10 ml water-soluble lubricating jelly plus 10 ml of 8% povidone-iodine. Biopsies were taken using ultrasound equipment BK PRO FOCUS Ultra View2202, with biplane intracavity transducer 6 MHz, after placing the patient in lithotomy position. The measuring transducer was introduced and, visualizing the prostate, periprostatic block was performed with 2% lidocaine, 6 samples were taken from each lobe (12) with Bard® Magnum® biopsy gun using a needle 18G by 20 cm: 2 of the peripheral zone, 2 of the transitional zone, and 2 of the apex. Additional samples were taken of suspicious areas. After the procedure, ciprofloxacin 500 mg was indicated every 12 hours for 7 days, plus diclofenac 100 mg orally every 12 hours for three days. All patients had appointments three weeks after TRPB with general urinalysis and urine culture. There was attempt to locate patients who did not attend the appointment for telephone interview to obtain data related to possible complications. GUI was considered one or more of the following findings: fever, urinary irritation symptoms, systemic inflammatory response (urosepsis), general pathological examination of urine, and positive urine culture. The presence of hematuria and rectal bleeding was secondarily evaluated.

Statistical analysis

The sample size was calculated based on two proportions, considering an alpha of 5% and 80% power, delta of 17%,¹⁰ making for 82 patients per group. For data management, bivariate analysis was performed by calculating the OR (95% CI) to determine if additional povidone-iodine prior to TRPB decreases endorectal GUI and other complications. SPSS version 20 was used.

Results

98 patients were evaluated in the control group and 98 in the experimental group. The overall average age was 65.89 (± 6.6) years, median PSA was 10 ng/ml (range 1-82 ng/ml), normal transrectal prostate digital examination in 91 (49.2%) and abnormal in 94 (50.8%). Significant difference was found only in the value of PSA (Table I). 9 patients in the control group and 2 in the experimental group were excluded for lack of sufficient data for analysis.

45% of the control group had genitourinary tract infection, and 25% of the experimental group (OR: 0.4, CI: 0.2-0.9, p = 0.004). Only fever had significant difference, presented in 21.3 versus 10.5% of patients (p = 0.04); irritation symptoms in 31.5 versus 20%; positive urine culture in 15.7 versus 7.2%; and urosepsis in 5.6 versus 4.2% in the control and experimental groups, respectively (Table II).

Discussion

Transrectal ultrasound-guided prostate biopsies are the gold standard for the diagnosis of prostate cancer in patients with suspicion. Most men undergoing these are healthy, but the procedure is not harmless, and side effects such as pain, hematuria, rectal bleeding, and hemospermia have been reported; the most important is GUI, as this can endanger life, especially urosepsis.^4,7-9
10% povidone-iodine solution was applied for the first time in 1980, with the aim of preventing infectious complications during TRPB without antibiotic prophylaxis, and it was subsequently applied associated with antibiotic prophylaxis.¹⁴ This compound is a good option given its broad antibiotic spectrum and its low rate of resistance.¹⁵

A recent meta-analysis, which evaluated 2049 patients undergoing various modes of povidone-iodine use, showed an advantage in the use of this antiseptic to prevent infectious complications (RR 0.31; 95% CI 0.21-0.45, p < 0.00001).¹⁶

The form of application has varied between studies: Park et al. used a suppository preparation of povidone-iodine (200 mg), reducing severe infectious complications significantly, however we do not have this preparation in our country.¹⁷

Gil Vernent et al. reported the use of 30 grams of intrarectal 10% povidone-iodine gel in 530 patients, documenting only one patient with GUI in follow-up, however the study did not have a control arm.¹¹

Abughosh et al. compared 421 against 444 subjects without and with application of endorectal povidone-iodine (rubbing the prostate laterally five times with a gauze submerged in povidone-iodine), finding GUI and urosepsis in 2.6 and 1% versus 4.5 and 1.6%, respectively. There was 42% decrease in the relative risk of infectious complications, but the difference was not significant.10
Ghafoori et al., in a manner similar to our population, evaluated 280 patients in two groups, the experimental arm having a mixture containing 50 g of 2% lidocaine with 20 ml of povidone-iodine, observing at 30 days that 27 (19.3%) and 51 (36.4%), p = 0.001 patients had infectious complications, respectively.¹²

These studies demonstrate a decrease in the presence of severe complications (sepsis), however it is not a statistically significant decrease, which may be due to the low overall prevalence of septicemia. Our study identified that this complication was similar for both groups, so other factors may be involved in this. 

An increased prevalence in these infection post-TRPB has been demonstrated in recent years.^18-20 This may be due to increased fluoroquinolone resistance in the intestinal flora, which implies a problem with antibiotics being the most used prophylaxis for this procedure.^21-23 Cleaning the rectum with povidone-iodine (local application) is a safe, well-tolerated, and inexpensive method that only takes a few extra seconds during the procedure.

Our study showed results similar to those described in the literature with a significant decrease in the rate of GUI, especially the presence of fever. However, it is a historical cohort that may have assembly biases, so a randomized clinical trial in our population is suggested to confirm these findings.

Conclusions

The application of intrarectal povidone-iodine additional to the usual bowel preparation protocol is easy to perform, low-cost, easy-access, and requires little time to apply. Our study showed a reduction in the rate of GUI after ultrasound-guided TRPB when additional intrarectal povidone-iodine was applied.

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