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

Not Applicable

Completed

• Conditions: Prostate Biopsy; Prostatitis; Prostatic Neoplasms; Prostate Cancer
• Interventions: Other: Intrarectal povidone-iodine cleansing plus formalin disinfection of needle tip during transrectal ultrasound guided prostate biopsy

• Registration Number: NCT03879486
• Lead Sponsor: Hospital de Transplante Doutor Euryclides de Jesus Zerbini

Brief 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

Study Timeline

• Study Start: 2017-05-31
• Study First Submitted: 2018-11-01
• Study First Submitted QC: 2019-03-15
• Study First Posted: 2019-03-18
• Primary Completion: 2019-07-24
• Study Completion: 2019-07-24
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1257

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PVPI intervention	Intrarectal povidone-iodine cleansing plus formalin disinfection of needle tip during transrectal ultrasound guided prostate biopsy	rectal cleansing and disinfection of the needle tip at transrectal ultrasound guided prostate biopsy

Primary Outcome Measures

Name	Time	Method
Infectious complications	1 week	compare the infectious outcomes of intrarectal povidone-iodine cleansing plus formalin disinfection of needle tip during transrectal ultrasound guided prostate biopsy

Secondary Outcome Measures

Name	Time	Method
evaluate predictive factors of infectious complications after prostate biopsy.	1 week	evaluate predictive factors of infectious complications after prostate biopsy.

Trial Locations

Locations (1)

Hospital de Transplantes Euryclides de Jesus Zerbini; 🇧🇷 Sao Paulo, Brazil