Infectious Outcomes of Povidone-iodine Rectal Cleansing Plus Formalin Disinfection of Needle During Prostate Biopsy
Condition: Prostate Cancer; Prostatic Neoplasms; Prostate Biopsy; Prostatitis
MeSH terms: Prostatic Neoplasms; Prostatitis
Study type: Interventional

Summary: 
      The main purpose of this study is to compare the infectious outcomes of intrarectal
      povidone-iodine cleansing plus formalin disinfection of needle tip during transrectal
      ultrasound guided prostate biopsy. The secondary objective is to evaluate predictive factors
      of infectious complications after prostate biopsy. Data will be prospectively collected from
      patients who will undergo prostate biopsy in a single high volume urology center. The
      patients will be randomized to two different groups: group A - rectal cleansing and
      disinfection of the needle tip vs group B - controls.
    

Detailed description: 
      Prostate cancer is the most common neoplasm of solid organs in Brazil. Definitive diagnosis
      of the tumor is established through prostate biopsy, indicated in patients with elevated
      levels of PSA or suspicious rectal examination. The ultrasound or MRI-guided prostate biopsy
      is mostly performed through the transrectal route worldwide. Although it is a relatively safe
      procedure, transrectal prostate biopsy (TRUSB) can present several complications, such
      bleeding, acute urinary retention or infection. Infectious complications are an important
      concern for the urologist and have different presentation, ranging from isolated fever to
      severe sepsis. Antibiotic prophylaxis is an effective widely used practice, however, due to
      increasing rates of bacterial resistance, there is a growing trend in the incidence of
      infectious complications after TRUSB. Therefore, alternative strategies to decrease
      infections rates following biopsies are welcome. Our aim was to compare the infectious
      complications of intrarectal povidone-iodine cleansing associated to formalin disinfection of
      biopsy needle tip at prostate biopsy.

      A prospective controlled study will be conducted enrolling 1152 consecutive prostate biopsies
      in a single center high volume urology Brazilian Public Hospital. The patients will be
      randomized at a 1: 1 ratio for two different groups: group A - rectal cleansing and
      disinfection of the needle tip vs. Group B - controls at transrectal ultrasound guided
      prostate biopsy. Patients will obtain a urine culture 48 hours after biopsy and complete a
      telephone interview 7 days after undergoing the procedure. The primary endpoint will be the
      rate of infectious complications, defined as 1 or more of the following events: fever ≥37.8
      ºC; urinary tract infection (UTI) or sepsis (standardized definition). We will also evaluate
      the predictive factors of infectious complications
    

Intervention name(s): Intrarectal povidone-iodine cleansing plus formalin disinfection of needle tip during transrectal ultrasound guided prostate biopsy
Intervention type(s): Other
Intervention description(s): The examiner will use a gauze soaked and saturated with iodopovidone and perform a mechanical friction motion on the anterior wall of the rectum, at least 5 times from one margin to another of the prostate laterally-laterally. A period of two (2) minutes shall be waited from the prophylactic cleaning of the rectum to the beginning of the biopsy. The examiner will use a technique of disinfecting the 10% formaldehyde biopsy needle without manual contact by soaking the distal 3 cm of the needle directly into a vial containing the bactericidal solution between obtaining the different fragments. An individual bottle will be used for each patient
Intervention MeSH terms: Povidone-Iodine; Formaldehyde; Povidone
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Prospective controlled study
Masking: None (Open Label)
Primary purpose: Prevention