Between January/2014 and September/2016, 94 men in private office were prospectively randomized to rectal cleansing (an original transrectal prostate massage for about half a minute with 2.5ml of betadine 100 mg/ml) (47) or no cleansing (47) before TRUS guided prostate biopsy with periprostatic local injection of lidocaine. All of the patients received prophylactic antibiotics: levofloxacine 500mg PO for 7 days, beginning the day before procedure. Patients completed a telephone interview 4 days after undergoing the biopsy and went to doctor office 2 weeks after biopsy. The primary end point was the rate of infectious complications, a composite end point of 1 or more of 1) fever greater than 38.0C, 2) urinary tract infection or 3) sepsis (standardized definition).
Infectious complications developed in 6 cases (11%) in the non-rectal preparation group: one patient had sepsis (2%) and five had fever without sepsis. In the povidone-iodine rectal preparation group we had no infectious complication (0.0%).
Of the 94 men who underwent TRUS guided biopsy, 45 (47.9%) were diagnosed with prostate cancer and 3 (3.2%) had Atypical Small Acinar Proliferation (ASAP) in the result. The hospital admission rate for urological complications within 30 days of the procedure was 1%, and only for infection related reasons (sepsis).
Given the recent rise in infection rates resulting from transrectal ultrasound (TRUS) biopsies and other transrectal procedures, the administration of quinolone-based prophylactic antibiotics and the simple use of 2.5 ml of povidone-iodine solution in a transrectal prostate massage for about half a minute provided an excellent protocol for reducing infective complications of TRUS-guided prostate biopsy. The simplicity of this method and cost effectiveness of betadine100 mg/ml is noteworthy, with statistically significant relative risk reduction of infectious complications in this study. While a member of the panel pointed out that use of 2.5 ml of povidone-iodine solution in a transrectal prostate massage for about half minute is not new, the author pointed out that this step, along with quinolone-based prophylactic antibiotics, is not typically used but could easily be added to a the pre-biopsy protocol to help lower infection rates. While the study shows promising results, randomized study on a much larger population base would be warranted to show conclusive results.
Presented By: Dr. Jose Cdilhe, Universidade do Minho
Authors: José Cadilhe*, Viana do Castelo, Portugal
Written By: Henry Oat, Clinical Trial - Patient Coordinator at Desert Medical Imaging, Prostate Cancer Support Group Leader, Patient-Advocate and John Fortin, Retired Healthcare Actuary, Fellow in the Society of Actuaries, and Patient-Advocate. Both John and Henry are prostate cancer survivors.
at the 2017 AUA Annual Meeting - May 12 - 16, 2017 – Boston, Massachusetts, USA