A Prospective Trial of Povidone-iodine Suppository Before... | NCT02245334

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

NCT02245334

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Sep 22, 2014Estimated

Enrollment

1,578Estimated

Phase

Phase 4

Conditions

Infection
Prostatic Diseases
Misadventure During Aspirating Needle Biopsy

Interventions

Povidone-Iodine

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Oct 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Sep 10, 2014

First Submission Date that Met QC Criteria

Sep 17, 2014

First Posted Date

Sep 19, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2014

Last Update Posted Date

Sep 22, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,578Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Povidone-iodine	Experimental	povidone iodine pill	Drug: Povidone-Iodine
no intervention	No Intervention	no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Povidone-Iodine	Drug	1 pill per biopsy	Povidone-iodine	Gynobetadine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
voiding questionnaire	check International Prostate Symptom Score (IPSS)	1-2 week
sexual function questionnaire	International Index of Erectile Function-5 (IIEF-5)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sangchul Lee	Contact	+82-31-787-7345		uromedi@naver.com

Overall Officials

Name	Affiliation	Role
Sangchul Lee, MD.PhD.	Prof	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Urology, Seoul National University Bundang Hospital		Seongnam	Gyunggi-do	463-707	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections
D011469	Prostatic Diseases

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011206	Povidone-Iodine

Ancestor Terms

ID	Term
D007466	Iodophors
D017613	Iodine Compounds
D007287	Inorganic Chemicals
D011145	Polyvinyls

Browse Leaves

Not provided

Browse Branches

Not provided