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NCT02245334 Clinical Trial

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

Infection Clinical Trial

Official title:
A Prospective Randomized Trial of Povidone-iodine Suppository Before Transrectal Ultrasound Guided Prostate Biopsy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02245334
Other study ID # B-1403/243-004
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received September 10, 2014
Last updated September 18, 2014
Start date October 2014
Est. completion date December 2015

Study information
Verified date September 2014
Source Seoul National University Hospital
Contact Sangchul Lee
Phone +82-31-787-7345
Email uromedi@naver.com
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1578
Est. completion date December 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Povidone-Iodine
1 pill per biopsy

Locations
Country Name City State
Korea, Republic of Department of Urology, Seoul National University Bundang Hospital Seongnam Gyunggi-do

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with febrile infection consider fever over 38 degree celsius or admission due to fever 1 week No
Secondary voiding questionnaire check International Prostate Symptom Score (IPSS) 1-2 week No
Secondary sexual function questionnaire International Index of Erectile Function-5 (IIEF-5) 1-2 week No
Secondary quality of life questionnaire European Organization for Research and Treatment fo Cancer (EORTC) Quality of life Questionnaire (QLQ)-C30 questionnaire 1-2 week No
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