A Prospective Trial of Povidone-iodine Suppository Before Transrectal Ultrasound Guided Prostate Biopsy

Phase 4UnknownNCT02245334

Seoul National University Hospital1,578 enrolled

Overview

To assess the effect of povidone-iodine on infectious complication rate caused by transrectal prostate biopsy

the effect of povidone-iodine on infectious complication rate caused by transrectal prostate biopsy

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,578

Conditions

Infection Prostatic Diseases Misadventure During Aspirating Needle Biopsy

Interventions

Povidone-IodineDRUG

1 pill per biopsy

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * who undergo transrectal prostate biopsy Exclusion Criteria: * patients who refuse to be included, patients who have hypersensitivity to iodine, patients who have abnormal thyroid function, patients who do not visit follow-up, patients who have received prior radioactive-iodine therapy

Locations (1)

Department of Urology, Seoul National University Bundang Hospital

Seongnam, Gyunggi-do, South Korea

Outcomes

Primary Outcomes

Number of participants with febrile infection

consider fever over 38 degree celsius or admission due to fever

Time frame: 1 week

Secondary Outcomes

voiding questionnaire

check International Prostate Symptom Score (IPSS)

Time frame: 1-2 week

sexual function questionnaire

International Index of Erectile Function-5 (IIEF-5)

Time frame: 1-2 week

quality of life questionnaire

European Organization for Research and Treatment fo Cancer (EORTC) Quality of life Questionnaire (QLQ)-C30 questionnaire

Time frame: 1-2 week

Central Contacts

Sangchul Lee

CONTACT

+82-31-787-7345 uromedi@naver.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.