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

NCT ID: NCT02245334

Last Updated: 2014-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1578 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Infection Prostatic Diseases Misadventure During Aspirating Needle Biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Povidone-iodine

povidone iodine pill

Group Type EXPERIMENTAL

Povidone-Iodine

Intervention Type DRUG

1 pill per biopsy

no intervention

no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Povidone-Iodine

1 pill per biopsy

Intervention Type DRUG

Other Intervention Names

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Gynobetadine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sangchul Lee, MD.PhD.

Role: PRINCIPAL_INVESTIGATOR

Prof

Locations

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Department of Urology, Seoul National University Bundang Hospital

Seongnam, Gyunggi-do, South Korea

Site Status

Countries

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South Korea

Central Contacts

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Sangchul Lee

Role: CONTACT

+82-31-787-7345

Facility Contacts

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Sangchul Lee, MD, PhD

Role: primary

+82-31-787-7345

Other Identifiers

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B-1403/243-004

Identifier Type: -

Identifier Source: org_study_id

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