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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02245334
Recruitment Status : Unknown
Verified September 2014 by Seoul National University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 19, 2014
Last Update Posted : September 22, 2014
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Infection Prostatic Diseases Misadventure During Aspirating Needle Biopsy Drug: Povidone-Iodine Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1578 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective Randomized Trial of Povidone-iodine Suppository Before Transrectal Ultrasound Guided Prostate Biopsy
Study Start Date : October 2014
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: Povidone-iodine
povidone iodine pill
Drug: Povidone-Iodine
1 pill per biopsy
Other Name: Gynobetadine

No Intervention: no intervention
no intervention



Primary Outcome Measures :
  1. Number of participants with febrile infection [ Time Frame: 1 week ]
    consider fever over 38 degree celsius or admission due to fever


Secondary Outcome Measures :
  1. voiding questionnaire [ Time Frame: 1-2 week ]
    check International Prostate Symptom Score (IPSS)

  2. sexual function questionnaire [ Time Frame: 1-2 week ]
    International Index of Erectile Function-5 (IIEF-5)

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02245334


Contacts
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Contact: Sangchul Lee +82-31-787-7345 uromedi@naver.com

Locations
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Korea, Republic of
Department of Urology, Seoul National University Bundang Hospital
Seongnam, Gyunggi-do, Korea, Republic of, 463-707
Contact: Sangchul Lee, MD, PhD    +82-31-787-7345    uromedi@naver.com   
Principal Investigator: Sangchul Lee, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Sangchul Lee, MD.PhD. Prof

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02245334    
Other Study ID Numbers: B-1403/243-004
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: September 22, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Prostatic Diseases
Genital Diseases, Male
Iodine
Cadexomer iodine
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes