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

Abstract

Purpose:Prostate biopsy is mostly performed through the transrectal route worldwide and infectious complications may occur in up to 7% of cases. Therefore, alternative strategies to decrease infectious complications are needed. Our aim was to evaluate the effectiveness of intrarectal povidone-iodine cleansing plus formalin disinfection of the needle tip in decreasing infectious complications after transrectal ultrasound guided prostate biopsy.Materials and Methods:We conducted a prospective, single-center, phase III trial in patients undergoing transrectal ultrasound guided prostate biopsy randomized 1:1 to rectal mucosa cleansing with gauze soaked in 10% povidone-iodine solution wrapped around the gloved index finger and needle tip disinfection by immersion in a 10% formalin solution before each puncture vs control group. The primary end point was the rate of infectious complications defined as 1 or more of the following events: fever, urinary tract infection, or sepsis.Results:Overall, 633 patients were randomized to the intervention group and 623 to the control group. The infectious complication rate was 3.9% in the intervention group and 6.4% in the control group (RR 0.61; 95% CI 0.36-0.99; P = .049). The rates of sepsis, urinary tract infection, and fever were 0.3% vs 0.5% (P = .646), 2.3% vs 4.1% (P = .071), and 1.3% vs 1.9% (P = .443), respectively. The positive urine culture rate was 5.2% in the intervention group and 9% in the control group (RR 0.57; P = .015). There was no statistically significant difference between the groups regarding the occurrence of noninfectious adverse events.Conclusions:Intrarectal povidone-iodine cleansing plus formalin disinfection of the biopsy needle tip was associated with a reduction in infectious complications after transrectal prostate biopsy.

Infection risk reduction with povidone-iodine rectal disinfection prior to transrectal prostate biopsy: an updated systematic review and meta-analysis

“…However, TRUS-Bx leads to higher incidence of infectious complications based on the translocation of rectal bacteria during the procedure. The estimated incidence rate of infectious complications by TRUS-PB, such as acute bacterial prostatitis, fever, and sepsis, is reported to be as high as 6.3% [ 2 , 3 ].…”

“…Several studies, including randomized controlled trials (RCT), have been conducted to assess the efficacy of PI disinfection of the rectum in reducing infectious complications after TRUS-PB [ 2 , 4 – 9 ]. These studies have indicated that PI disinfection can reduce infectious complications, leading to the EAU guidelines to recommend rectal disinfection with PI prior to TRUS-PB [ 10 ].…”

Round up

“…This single-center RCT randomized 1234 patients undergoing TRUS-Bx to receive preprocedure rectal cleansing with 10% povidone-iodine and used a formalin-dipped needle in the intervention arm. [ 23 ] Both the treatment groups received 3 days of ciprofloxacin starting one night before. Infectious complications in terms of fever, UTI, or sepsis were significantly decreased in the intervention arm (3.9% vs. 6.4%, P = 0.49).…”

This Month in Adult Urology

“…Pontes Junior et al (page 1194) from Brazil report a randomized single center study looking at rectal cleaning with a gauze soaked in 10% povidone-iodine while the patient is positioned, and cleaning the needle tip with formalin before each puncture. 3 The authors are to be commended in randomizing 1,256 patients. They found a decrease in positive urine cultures and a difference in overall infectious complications: 3.9% in the intervention group and 6.4% in controls.…”