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JU INSIGHT: Effectiveness of Intrarectal Povidone-iodine Cleansing Plus Formalin Disinfection of the Needle Tip in Decreasing Infectious Complications After Transrectal Prostate Biopsy: A Randomized Controlled Trial

By: Jose Pontes-Junior, MD, PhD; Tiago Magalhaes Freire, MD; Felipe Guimaraes Pugliesi, MD; Felipe Machado de Moura Costa, MD; Vinicius Meneguette Gomes de Souza, MD; Fabio Pescarmona Galucci, MD; Aline Albertini, MD; Adriano Borba Couto, MD; Claudio Bovolenta Murta, MD, PhD; Giuliano Betoni Guglielmetti, MD, PhD; William C. Nahas, MD, PhD; Adalberto Andriolo Junior, MD; Alcides Mosconi Neto, MD; Joaquim Francisco de Almeida Claro, MD, PhD | Posted on: 01 Dec 2022

Pontes-Junior J, Freire TM, Pugliesi FG, et al. Effectiveness of intrarectal povidone-iodine cleansing plus formalin disinfection of the needle tip in decreasing infectious complications after transrectal prostate biopsy: a randomized controlled trial. J Urol. 2022;208(6):1194-1202.

Study Need and Importance

Prostate biopsy is frequently performed through the transrectal route worldwide and infectious complications (ICs) rates are on a rise due to increasing enterobacteria resistance to quinolones and cephalosporins. Therefore, alternative strategies to decrease ICs are welcome. Our aim was to evaluate the effectiveness of intrarectal povidone-iodine cleansing plus formalin disinfection of the needle tip in decreasing ICs after transrectal ultrasound guided prostate biopsy (TRUS-Bx). The primary end point was the IC rate described as 1 or more of the following events: fever, urinary tract infection, or sepsis.

What We Found

We randomized 1,234 patients undergoing TRUS-Bx 1:1 to rectal cleansing with gauze soaked in 10% povidone-iodine solution wrapped around the gloved index finger and needle tip disinfection by immersion in a formalin solution before each puncture versus control. All patients received ciprofloxacin for 3 days starting the night before the biopsy. We observed that IC rate was 39% lower in the intervention group (3.9% vs 6.4%, RR 0.61; 95% CI 0.36-0.99; P = .049; see Table). This 2.5% absolute difference indicates that 40 patients undergoing TRUS-Bx should receive the intervention in order to avoid an IC event. The occurrence of sepsis, urinary tract infection, and fever are displayed in the Table. The rate of positive urine culture obtained 72 hours after biopsy was lower with the intervention (5.2% vs 9%, RR 0.57; P = .015).

Limitations

Conducting this high level of evidence phase III trial at a single center is the main limitation of our study; even so, we believe that this nonantibiotic adjuvant method is simple and easy to be reproduced.

Interpretation for Patient Care

The adoption of prostate biopsy through the transperineal route is the best option for reducing post-biopsy IC. However, when this option is unavailable we propose a simple, low-cost and effective nonantibiotic strategy that significantly decreases IC following TRUS-Bx.

Table. ICs in the Intervention and Control Groups

Outcomes Intervention group, No./total No. (%)
(n = 621)		 Control group, No./total No. (%)
(n = 613)		 Effect estimate, RR P valuea
IC 24/621 (3.9) 39/613 (6.4) 0.61 (0.37, 0.99) .049
Fever 8/605 (1.3) 11/585 (1.9) 0.70 (0.27, 1.73) .445
UTI 14/619 (2.3) 25/610 (4.1) 0.55 (0.28, 1.04) .071
Sepsis 2/621 (0.3) 3/613 (0.5) 0.66 (0.09, 3.96) .646
Abbreviations: IC, infection complication; RR, relative risk; UTI, urinary tract infection.
aP value obtained by Wald test in log binomial model.

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