A Prospective Trial of Povidone-iodine Suppository Before Transrectal Ultrasound Guided Prostate Biopsy
Phase 4
- Conditions
- InfectionProstatic DiseasesMisadventure During Aspirating Needle Biopsy
- Interventions
- Registration Number
- NCT02245334
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
To assess the effect of povidone-iodine on infectious complication rate caused by transrectal prostate biopsy
- Detailed Description
the effect of povidone-iodine on infectious complication rate caused by transrectal prostate biopsy
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 1578
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Povidone-iodine Povidone-Iodine povidone iodine pill
- Primary Outcome Measures
Name Time Method Number of participants with febrile infection 1 week consider fever over 38 degree celsius or admission due to fever
- Secondary Outcome Measures
Name Time Method voiding questionnaire 1-2 week check International Prostate Symptom Score (IPSS)
sexual function questionnaire 1-2 week International Index of Erectile Function-5 (IIEF-5)
quality of life questionnaire 1-2 week European Organization for Research and Treatment fo Cancer (EORTC) Quality of life Questionnaire (QLQ)-C30 questionnaire
Trial Locations
- Locations (1)
Department of Urology, Seoul National University Bundang Hospital
🇰🇷Seongnam, Gyunggi-do, Korea, Republic of