Validation of Korean Version of ICIQ-SF | NCT02145806

Studies
Validation of Korean Version of ICIQ-SF

NCT02145806

Sponsor

The Catholic University of Korea

Status

Completed

Last Update Posted

Feb 13, 2015Estimated

Enrollment

134Actual

Phase

Not provided

Conditions

Urinary Incontinence

Interventions

Not provided

Countries

Not provided

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

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

May 21, 2014

First Submission Date that Met QC Criteria

May 21, 2014

First Posted Date

May 23, 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

Feb 12, 2015

Last Update Posted Date

Feb 13, 2015Estimated

Name	Class
National Cancer Center, Korea	OTHER_GOV

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

Validation of the Korean version of the ICIQ-UI SF for pregnant and postpartum women
Evaluation the effect of urinary incontinence in pregnant and postpartum women.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Week

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

134Actual

Measure	Description	Time Frame
Urinary incontinence		1-2 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Being pregnant or postpartum ≤ 3 weeks
Able to read and understand Korean
At least 18 years of age

Exclusion Criteria:

Refuse to participate in the study
Pelvic inflammatory disease
Psychiatric disease
Needed to be treated in the 7 days

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

130

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D014549	Urinary Incontinence

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided