LBA03-03 INFECTIOUS AND NON-INFECTIOUS COMPLICATIONS FOLLOWING PROSTATE BIOPSY: A RANDOMIZED CLINICAL TRIAL

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You have accessJournal of UrologyCME1 Apr 2023LBA03-03 INFECTIOUS AND NON-INFECTIOUS COMPLICATIONS FOLLOWING PROSTATE BIOPSY: A RANDOMIZED CLINICAL TRIAL Badar M. Mian, Paul J. Feustel, Asef Aziz, Ronald Kaufman, Svetlana Avulova, Adrien Bernstein, and Hugh Fisher Badar M. MianBadar M. Mian More articles by this author , Paul J. FeustelPaul J. Feustel More articles by this author , Asef AzizAsef Aziz More articles by this author , Ronald KaufmanRonald Kaufman More articles by this author , Svetlana AvulovaSvetlana Avulova More articles by this author , Adrien BernsteinAdrien Bernstein More articles by this author , and Hugh FisherHugh Fisher More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003426.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Prostate biopsy for cancer detection may be performed either through transrectal (TR-Bx) or transperineal (TP-Bx) approach. Recently, TP-Bx approach is being promoted as the superior alternative to TR-Bx due to potentially lower complication rates. However, there are conflicting clinical guidelines regarding the preferred option, and high level comparative evidence is lacking. We conducted a randomized clinical trial, sufficiently powered to determine if TP-Bx is associated with lower risk of infectious and other complications (ClinicalTrials.gov: NCT04081636). METHODS: 763 men undergoing prostate biopsy were recruited for the randomized study comparing TR-Bx and TP-Bx procedures. All procedures were performed in the office, under local anesthesia. The primary outcome was the 30-day incidence of post-biopsy composite infectious complications (including fever, antibiotic prescriptions, genitourinary infection, sepsis, office or emergency room visits, or hospitalization). Secondary outcome was the 30-day post-biopsy composite non-infectious complication rate (including urinary retention, any hemorrhage requiring intervention, or unplanned heath care utilization). Follow up and data collection included clinic visit at 2 weeks, phone survey at 30 day, and medical record review after 30 days. RESULTS: 718 men completed either the TR-Bx (351) or the TP-Bx (367) procedure and the required follow up. The mean (±SD) age was 64.7 (6.9) years. A composite infectious complication event occurred in 9 patients (2.6%) in the TR-Bx group, and 10 patients (2.7%) in the TP-Bx group (risk ratio 1.06; 95% CI, 0.43 to 2.65; p=0.99). Fever was the most frequent event, reported by 6 patients (1.7%) in each group. Overnight hospitalization required for 2 patients (0.55%) in TR-Bx and 1 patient (0.27%) in TP-Bx group. There were no episodes of sepsis in either group. There were no between-group differences in the occurrence of any of the component outcomes. A composite non-infectious event occurred in 6 (1.7%) and 8 (2.2%) patients in the TR-Bx and TP-Bx groups, respectively (OR 1.28; 95% CI, 0.44 to 3.73; p=0.79). Phone call to the office was the most frequent event that was noted in 3 patients (0.9%) in the TR-Bx and 7 patients (1.9%) in TP-Bx group. Urinary retention occurred in 1 patient in each group, and no patients required hospitalization. CONCLUSIONS: Among men undergoing biopsy for prostate cancer detection, transrectal and transperineal prostate biopsy procedures are associated with a similar risk of infectious and non-infectious complications. Source of Funding: Capital Region Medical Research Institute, SUNY-School of Public Health © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1192 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Badar M. Mian More articles by this author Paul J. Feustel More articles by this author Asef Aziz More articles by this author Ronald Kaufman More articles by this author Svetlana Avulova More articles by this author Adrien Bernstein More articles by this author Hugh Fisher More articles by this author Expand All Advertisement PDF downloadLoading ...