Infectious Outcomes of Povidone-iodine Rectal Cleansing Plus Formalin Disinfection of Needle During Prostate Biopsy

Study Overview
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Brief Summary
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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
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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

Official Title
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A Randomized Controlled Trial to Investigate the Infectious Outcomes of Intrarectal Povidone-iodine Cleansing Plus Formalin Disinfection of Needle Tip During Transrectal Ultrasound Guided Prostate Biopsy

Conditions
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Prostate Cancer, Prostatic Neoplasms, Prostate Biopsy, Prostatitis

Intervention / Treatment
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* Other: Intrarectal povidone-iodine cleansing plus formalin disinfection of needle tip during transrectal ultrasound guided prostate biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signature of the consent term; Agreement with the study follow-up protocol; Indication of biopsy due to increased PSA (> 2.5), abnormal rectal touch or patients under active surveillance protocol Exclusion Criteria: Existence of cognitive deficit that impedes the reading and comprehension of the EHIC; Allergy to ciprofloxacin or iodine

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective controlled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PVPI intervention<br>rectal cleansing and disinfection of the needle tip at transrectal ultrasound guided prostate biopsy | Other: Intrarectal povidone-iodine cleansing plus formalin disinfection of needle tip during transrectal ultrasound guided prostate biopsy<br>* 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<br>|
| No Intervention: Control arm<br>controls at transrectal ultrasound guided prostate biopsy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infectious complications | compare the infectious outcomes of intrarectal povidone-iodine cleansing plus formalin disinfection of needle tip during transrectal ultrasound guided prostate biopsy | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate predictive factors of infectious complications after prostate biopsy. | evaluate predictive factors of infectious complications after prostate biopsy. | 1 week |