NCT02245334

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,578

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 22, 2014

Status Verified

September 1, 2014

Enrollment Period

1 year

First QC Date

September 10, 2014

Last Update Submit

September 18, 2014

Conditions

InfectionProstatic DiseasesMisadventure During Aspirating Needle Biopsy

Outcome Measures

Primary Outcomes (1)

  • Number of participants with febrile infection

    consider fever over 38 degree celsius or admission due to fever

    1 week

Secondary Outcomes (3)

  • voiding questionnaire

    1-2 week

  • sexual function questionnaire

    1-2 week

  • quality of life questionnaire

    1-2 week

Study Arms (2)

Povidone-iodine

EXPERIMENTAL

povidone iodine pill

Drug: Povidone-Iodine

no intervention

NO INTERVENTION

no intervention

Interventions

Povidone-IodineDRUG

1 pill per biopsy

Also known as: Gynobetadine
Povidone-iodine

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • who undergo transrectal prostate biopsy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, Seoul National University Bundang Hospital

Seongnam, Gyunggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

InfectionsProstatic Diseases

Interventions

Povidone-Iodine

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

IodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Sangchul Lee, MD.PhD.

    Prof

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sangchul Lee

CONTACT

+82-31-787-7345uromedi@naver.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2014

First Posted

September 19, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

September 22, 2014

Record last verified: 2014-09

Locations

KR(1)