Intrarectal povidone-iodine cleansing plus formalin disinfection of the needle tip decreases infectious complications after transrectal ultrasound (TRUS)-guided prostate biopsy, when used in conjunction with antibiotic prophylaxis, according to results from a recent study.

In a phase 3 trial, investigators randomly 633 men undergoing TRUS-guided prostate biopsy with oral antibiotic prophylaxis to an intervention group and 623 to a control group. Prior to biopsy, the intervention group received rectal mucosa cleansing with gauze soaked in 10% povidone-iodine solution wrapped around the gloved index finger along with needle tip disinfection by immersion in a 10% formalin solution before each puncture The composite primary endpoint was the rate of infectious complications, including fever, urinary tract infection (UTI), or sepsis.

The infectious complication rate was significantly lower in the intervention than control group: 3.9% vs 6.4%, Jose Pontes-Junior, MD, PhD, of the Institute of Cancer of São Paulo at the University of São Paulo in Brazil, and colleagues reported in The Journal of Urology. The positive urine culture rate 72 hours after biopsy also was significantly lower in the intervention than control group: 5.2% vs 9%. Escherichia coli was isolated in 92.8% of cases, and 94% of these were quinolone resistant.

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Individual rates of sepsis, UTI, and fever did not differ between groups, nor did the rate of noninfectious adverse events.

“Because of the simplicity of use and low associated costs, its routine use along with an oral antibiotic is an attractive option to reduce [infectious complication] rates after TRUS-Bx,” Dr Pontes-Junior’s team concluded. They estimated that 40 patients undergoing TRUS-guided prostate biopsy would need to receive the 2 nonantibiotic strategies to avoid 1 infectious complication.

Limitations of the trial include its single-center design. The investigators noted that the 2 nonantibiotic strategies used alone without prophylaxis did not lower infectious complication rates, according to previous research.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.


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 Dec;208(6):1194-1202. doi:10.1097/JU.0000000000002910