Back to resultsA Prospective Trial of Povidone-iodine Suppository Before Transrectal Ultrasound Guided Prostate Biopsy
Primary Purpose
Infection, Prostatic Diseases, Misadventure During Aspirating Needle Biopsy
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Povidone-Iodine
Sponsored by
About this trial
This is an interventional prevention trial for Infection
Eligibility Criteria
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
Sites / Locations
- Department of Urology, Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Povidone-iodine
no intervention
Arm Description
povidone iodine pill
no intervention
Outcomes
Primary Outcome Measures
Number of participants with febrile infection
consider fever over 38 degree celsius or admission due to fever
Secondary Outcome Measures
voiding questionnaire
check International Prostate Symptom Score (IPSS)
sexual function questionnaire
International Index of Erectile Function-5 (IIEF-5)
quality of life questionnaire
European Organization for Research and Treatment fo Cancer (EORTC) Quality of life Questionnaire (QLQ)-C30 questionnaire
Full Information
NCT ID
NCT02245334
First Posted
September 10, 2014
Last Updated
September 18, 2014
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02245334
Brief Title
A Prospective Trial of Povidone-iodine Suppository Before Transrectal Ultrasound Guided Prostate Biopsy
Official Title
A Prospective Randomized Trial of Povidone-iodine Suppository Before Transrectal Ultrasound Guided Prostate Biopsy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Prostatic Diseases, Misadventure During Aspirating Needle Biopsy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1578 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Povidone-iodine
Arm Type
Experimental
Arm Description
povidone iodine pill
Arm Title
no intervention
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Drug
Intervention Name(s)
Povidone-Iodine
Other Intervention Name(s)
Gynobetadine
Intervention Description
1 pill per biopsy
Primary Outcome Measure Information:
Title
Number of participants with febrile infection
Description
consider fever over 38 degree celsius or admission due to fever
Time Frame
1 week
Secondary Outcome Measure Information:
Title
voiding questionnaire
Description
check International Prostate Symptom Score (IPSS)
Time Frame
1-2 week
Title
sexual function questionnaire
Description
International Index of Erectile Function-5 (IIEF-5)
Time Frame
1-2 week
Title
quality of life questionnaire
Description
European Organization for Research and Treatment fo Cancer (EORTC) Quality of life Questionnaire (QLQ)-C30 questionnaire
Time Frame
1-2 week
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sangchul Lee
Phone
+82-31-787-7345
Email
uromedi@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sangchul Lee, MD.PhD.
Organizational Affiliation
Prof
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Urology, Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyunggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sangchul Lee, MD, PhD
Phone
+82-31-787-7345
Email
uromedi@naver.com
First Name & Middle Initial & Last Name & Degree
Sangchul Lee, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
A Prospective Trial of Povidone-iodine Suppository Before Transrectal Ultrasound Guided Prostate Biopsy
We'll reach out to this number within 24 hrs