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

September 18, 2014 updated by: Seoul National University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

1578

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyunggi-do
      • Seongnam, Gyunggi-do, Korea, Republic of, 463-707
        • Department of Urology, Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: no intervention
Experimental: Povidone-iodine
povidone iodine pill
Drug: Povidone-Iodine
1 pill per biopsy
Other Names:
  • Gynobetadine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with febrile infection
Time Frame: 1 week
consider fever over 38 degree celsius or admission due to fever
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
voiding questionnaire
Time Frame: 1-2 week
check International Prostate Symptom Score (IPSS)
1-2 week
sexual function questionnaire
Time Frame: 1-2 week
International Index of Erectile Function-5 (IIEF-5)
1-2 week
quality of life questionnaire
Time Frame: 1-2 week
European Organization for Research and Treatment fo Cancer (EORTC) Quality of life Questionnaire (QLQ)-C30 questionnaire
1-2 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Sangchul Lee, MD.PhD., Prof

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

September 10, 2014

First Submitted That Met QC Criteria

September 17, 2014

First Posted (Estimate)

September 19, 2014

Study Record Updates

Last Update Posted (Estimate)

September 22, 2014

Last Update Submitted That Met QC Criteria

September 18, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1403/243-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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