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

No AccessJournal of UrologyAdult Urology1 Dec 2022Effectiveness of Intrarectal Povidone-iodine Cleansing Plus Formalin Disinfection of the Needle Tip in Decreasing Infectious Complications After Transrectal Prostate Biopsy: A Randomized Controlled Trial Jose Pontes-Junior, Tiago Magalhães Freire, Felipe Guimarães Pugliesi, Felipe Machado de Moura Costa, Vinicius Meneguette Gomes de Souza, Fabio Pescarmona Galucci, Aline Albertini, Adriano Borba Couto, Claudio Bovolenta Murta, Giuliano Betoni Guglielmetti, William C. Nahas, Adalberto Andriolo Junior, Alcides Mosconi Neto, and Joaquim Francisco de Almeida Claro Jose Pontes-JuniorJose Pontes-Junior Department of Urology, Men's Health Centre, Hospital Brigadeiro, São Paulo, Brazil Department of Urology, Institute of Cancer of São Paulo, University of São Paulo, São Paulo, Brazil , Tiago Magalhães FreireTiago Magalhães Freire *Correspondence: Department of Urology, Men's Health Centre, Hospital Brigadeiro, 2651, Av. Brigadeiro Luís Antônio, São Paulo, SP, 01401000, Brazil (email: E-mail Address: [email protected] https://orcid.org/0000-0002-9720-9016 Department of Urology, Men's Health Centre, Hospital Brigadeiro, São Paulo, Brazil , Felipe Guimarães PugliesiFelipe Guimarães Pugliesi Department of Urology, Men's Health Centre, Hospital Brigadeiro, São Paulo, Brazil , Felipe Machado de Moura CostaFelipe Machado de Moura Costa Department of Urology, Men's Health Centre, Hospital Brigadeiro, São Paulo, Brazil , Vinicius Meneguette Gomes de SouzaVinicius Meneguette Gomes de Souza Department of Urology, Men's Health Centre, Hospital Brigadeiro, São Paulo, Brazil , Fabio Pescarmona GalucciFabio Pescarmona Galucci Department of Urology, Men's Health Centre, Hospital Brigadeiro, São Paulo, Brazil Department of Urology, Institute of Cancer of São Paulo, University of São Paulo, São Paulo, Brazil , Aline AlbertiniAline Albertini Department of Urology, Men's Health Centre, Hospital Brigadeiro, São Paulo, Brazil , Adriano Borba CoutoAdriano Borba Couto Department of Urology, Men's Health Centre, Hospital Brigadeiro, São Paulo, Brazil , Claudio Bovolenta MurtaClaudio Bovolenta Murta Department of Urology, Men's Health Centre, Hospital Brigadeiro, São Paulo, Brazil Department of Urology, Institute of Cancer of São Paulo, University of São Paulo, São Paulo, Brazil , Giuliano Betoni GuglielmettiGiuliano Betoni Guglielmetti Department of Urology, Institute of Cancer of São Paulo, University of São Paulo, São Paulo, Brazil , William C. NahasWilliam C. Nahas Department of Urology, Institute of Cancer of São Paulo, University of São Paulo, São Paulo, Brazil , Adalberto Andriolo JuniorAdalberto Andriolo Junior Department of Urology, Men's Health Centre, Hospital Brigadeiro, São Paulo, Brazil , Alcides Mosconi NetoAlcides Mosconi Neto Department of Urology, Men's Health Centre, Hospital Brigadeiro, São Paulo, Brazil , and Joaquim Francisco de Almeida ClaroJoaquim Francisco de Almeida Claro Department of Urology, Men's Health Centre, Hospital Brigadeiro, São Paulo, Brazil View All Author Informationhttps://doi.org/10.1097/JU.0000000000002910AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail 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. References 1. . Increasing hospital admission rates for urological complications after transrectal ultrasound guided prostate biopsy. J Urol. 2013; 189(1 suppl):S12-S17. Abstract, Google Scholar 2. AUA/SUNA White Paper on the Incidence, Prevention and Treatment of Complications Related to Prostate Needle Biopsy. Accessed March 2021. https://www.suna.org/resource/white-paper-incidenceprevention-and-treatment-complications-related-prostate-needle-biopsy. Google Scholar 3. . Systematic review of complications of prostate biopsy. Eur Urol. 2013; 64(6):876-892. Google Scholar 4. . Antibiotic prophylaxis for the prevention of infectious complications following prostate biopsy: a systematic review and meta-analysis. J Urol. 2020; 204(2):224-230. Link, Google Scholar 5. . Prostate biopsy-related infection: a systematic review of risk factors, prevention strategies, and management approaches. Urology. 2017; 104:11-21. Google Scholar 6. . Complications after prostate biopsy: data from SEER-Medicare. J Urol. 2011; 186(5):1830-1834. Link, Google Scholar 7. . Rapid increase in multidrug-resistant enteric bacilli blood stream infection after prostate biopsy—a 10-year population-based cohort study. Prostate. 2015; 75(9):947-956. Google Scholar 8. . Potential burden of antibiotic resistance on surgery and cancer chemotherapy antibiotic prophylaxis in the USA: a literature review and modelling study. Lancet Infect Dis. 2015; 15(12):1429-1437. Google Scholar 9. . Complications after systematic, random, and image-guided prostate biopsy. Eur Urol. 2017; 71(3):353-365. Google Scholar 10. . Fluoroquinolone resistant rectal colonization predicts risk of infectious complications after transrectal prostate biopsy. J Urol. 2014; 192(6):1673-1678. Link, Google Scholar 11. . A prospective randomized trial of povidone-iodine prophylactic cleansing of the rectum before transrectal ultrasound guided prostate biopsy. J Urol. 2013; 189(4):1326-1331. Link, Google Scholar 12. MP38-01 A prospective randomized controlled trial to compare the outcomes of 12 versus 20 core ultrasound guided transrectal prostate biopsy. J Urol. 2017; 197(4S):e484. Link, Google Scholar 13. . The Third international Consensus Definitions for sepsis and septic Shock (Sepsis-3). JAMA. 2016; 315(8):801-810. Google Scholar 14. . Infectious complications of prostate biopsy: winning battles but not war. World J Urol. 2020; 38(11):2743-2753. Google Scholar 15. . Sample Size Calculations in Clinical Research, 2nd ed. Chapman & Hall/CRC Biostatistics Series, Vol. 465. CRC Press; 2007. Google Scholar 16. . Antibiotic resistance, hospitalizations, and mortality related to prostate biopsy: first report from the Norwegian Patient Registry. World J Urol. 2020; 38(1):17-26. Google Scholar 17. . Update on strategies to reduce infectious complications after prostate biopsy. Eur Urol Focus. 2019; 5(1):20-28. Google Scholar 18. . A systematic review and meta-analysis of methods used to reduce infectious complications following transrectal prostate biopsy. Urology. 2020; 144:21-27. Google Scholar 19. . The effectiveness of targeted relative to empiric prophylaxis on infectious complications after transrectal ultrasound-guided prostate biopsy: a meta-analysis. World J Urol. 2018; 36(7):1007-1017. Google Scholar 20. EAU guidelines. 3. Urological Infections 3.15; Peri-Procedural Antibiotic Prophylaxis; 3.15.2.8. Prostate biopsy. Paper presented at: EAU Annual Congress Amsterdam 2022. Google Scholar 21. . Transperineal versus transrectal prostate biopsy in the diagnosis of prostate cancer: a systematic review and meta-analysis. World J Surg Oncol. 2019; 17(1):31. Google Scholar 22. . European Association of Urology position paper on the prevention of infectious complications following prostate biopsy. Eur Urol. 2021; 79(1):11-15. Google Scholar 23. . Morbidity of prostate biopsy after simplified versus complex preparation protocols: assessment of risk factors. Urology. 2011; 77(4):910-914. Google Scholar 24. . Antibiotic prophylaxis for transrectal prostate biopsy. Cochrane Database Syst Rev. 2011;(5):CD006576. Google Scholar 25. . Nonantibiotic strategies for the prevention of infectious complications following prostate biopsy: a systematic review and meta-analysis. J Urol. 2021; 205(3):653-663. Link, Google Scholar 26. EAU guidelines urologic infections. Paper presented at: the EAU Annual Congress Amsterdam the Netherlands. Google Scholar 27. . Formalin disinfection of prostate biopsy needles may reduce post-biopsy infectious complications. Prostate Cancer Prostatic Dis. 2017; 20(2):216-220. Google Scholar 28. . Formalin disinfection of biopsy needle minimizes the risk of sepsis following prostate biopsy. J Urol. 2013; 190(5):1769-1775. Link, Google Scholar 29. . Evaluation of a needle disinfectant technique to reduce infection-related hospitalisation after transrectal prostate biopsy. BJU Int. 2018; 121(2):232-238. Google Scholar 30. . Bacterial sepsis after prostate biopsy—a new perspective. Urology. 2009; 74(6):1200-1205. Google Scholar Submitted February 23, 2022; accepted August 1, 2022; published August 25, 2022. Conflict of Interest: Vinicius Meneguette Gomes de Souza: Janssen Pharmaceuticals, Apsen Farmacêutica, Astellas Pharma Inc., AstraZeneca PLC; Claudio Bovolenta Murta: Janssen Farmacêutica, Astellas, Zodiac. Ethics Statement: This study received Institutional Review Board approval (IRB No. 78099417.2.0000.0091). Author contributions: Jose Pontes-Junior: Principal investigator, Conceptualization, Methodology, Submission to the ethical committee, Execution of study biopsies, Paper writing—original draft, review and editing. Tiago Magalhães Freire: Data curation, Paper writing—original draft, review and editing. Giuliano Betoni Guglielmetti, William C. Nahas: Paper writing—review and editing. Adriano Borba Couto: Data curation. Aline Albertini, Felipe Machado de Moura Costa: Conceptualization, Methodology, Submission to the ethical committee, Execution of study biopsies. Felipe Guimarães Pugliesi, Vinicius Meneguette Gomes de Souza, Claudio Bovolenta Murta, Adalberto Andriolo Junior, Fabio Pescarmona Galucci, Alcides Mosconi Neto, Joaquim Francisco de Almeida Claro: Execution of study biopsies and Paper writing—review Editor's Note: This article is the first of 5 published in this issue for which Category 1 CME credits can be earned. Instructions for obtaining credits are given with the questions on pages 1362 and 1363. © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byTan W and Tan W (2022) 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. Letter.Journal of Urology, VOL. 209, NO. 1, (73-74), Online publication date: 1-Jan-2023. Volume 208Issue 6December 2022Page: 1194-1202Supplementary Materials PEER REVIEW REPORTS Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.Keywordsbiopsysepsiscomplicationsurinary tract infectionsACKNOWLEDGMENTSWe thank Bruna Bronhara Damiani, who was responsible for statistical analysis.MetricsAuthor Information Jose Pontes-Junior Department of Urology, Men's Health Centre, Hospital Brigadeiro, São Paulo, Brazil Department of Urology, Institute of Cancer of São Paulo, University of São Paulo, São Paulo, Brazil More articles by this author Tiago Magalhães Freire Department of Urology, Men's Health Centre, Hospital Brigadeiro, São Paulo, Brazil *Correspondence: Department of Urology, Men's Health Centre, Hospital Brigadeiro, 2651, Av. Brigadeiro Luís Antônio, São Paulo, SP, 01401000, Brazil (email: E-mail Address: [email protected] More articles by this author Felipe Guimarães Pugliesi Department of Urology, Men's Health Centre, Hospital Brigadeiro, São Paulo, Brazil More articles by this author Felipe Machado de Moura Costa Department of Urology, Men's Health Centre, Hospital Brigadeiro, São Paulo, Brazil More articles by this author Vinicius Meneguette Gomes de Souza Department of Urology, Men's Health Centre, Hospital Brigadeiro, São Paulo, Brazil More articles by this author Fabio Pescarmona Galucci Department of Urology, Men's Health Centre, Hospital Brigadeiro, São Paulo, Brazil Department of Urology, Institute of Cancer of São Paulo, University of São Paulo, São Paulo, Brazil More articles by this author Aline Albertini Department of Urology, Men's Health Centre, Hospital Brigadeiro, São Paulo, Brazil More articles by this author Adriano Borba Couto Department of Urology, Men's Health Centre, Hospital Brigadeiro, São Paulo, Brazil More articles by this author Claudio Bovolenta Murta Department of Urology, Men's Health Centre, Hospital Brigadeiro, São Paulo, Brazil Department of Urology, Institute of Cancer of São Paulo, University of São Paulo, São Paulo, Brazil More articles by this author Giuliano Betoni Guglielmetti Department of Urology, Institute of Cancer of São Paulo, University of São Paulo, São Paulo, Brazil More articles by this author William C. Nahas Department of Urology, Institute of Cancer of São Paulo, University of São Paulo, São Paulo, Brazil More articles by this author Adalberto Andriolo Junior Department of Urology, Men's Health Centre, Hospital Brigadeiro, São Paulo, Brazil More articles by this author Alcides Mosconi Neto Department of Urology, Men's Health Centre, Hospital Brigadeiro, São Paulo, Brazil More articles by this author Joaquim Francisco de Almeida Claro Department of Urology, Men's Health Centre, Hospital Brigadeiro, São Paulo, Brazil More articles by this author Expand All Submitted February 23, 2022; accepted August 1, 2022; published August 25, 2022. Conflict of Interest: Vinicius Meneguette Gomes de Souza: Janssen Pharmaceuticals, Apsen Farmacêutica, Astellas Pharma Inc., AstraZeneca PLC; Claudio Bovolenta Murta: Janssen Farmacêutica, Astellas, Zodiac. Ethics Statement: This study received Institutional Review Board approval (IRB No. 78099417.2.0000.0091). Author contributions: Jose Pontes-Junior: Principal investigator, Conceptualization, Methodology, Submission to the ethical committee, Execution of study biopsies, Paper writing—original draft, review and editing. Tiago Magalhães Freire: Data curation, Paper writing—original draft, review and editing. Giuliano Betoni Guglielmetti, William C. Nahas: Paper writing—review and editing. Adriano Borba Couto: Data curation. Aline Albertini, Felipe Machado de Moura Costa: Conceptualization, Methodology, Submission to the ethical committee, Execution of study biopsies. Felipe Guimarães Pugliesi, Vinicius Meneguette Gomes de Souza, Claudio Bovolenta Murta, Adalberto Andriolo Junior, Fabio Pescarmona Galucci, Alcides Mosconi Neto, Joaquim Francisco de Almeida Claro: Execution of study biopsies and Paper writing—review Editor's Note: This article is the first of 5 published in this issue for which Category 1 CME credits can be earned. Instructions for obtaining credits are given with the questions on pages 1362 and 1363. Advertisement PDF downloadLoading ...