A Cross-sectional Internet Survey to Estimate Prevalence... | NCT02618421

Studies
A Cross-sectional Internet Survey to Estimate Prevalence of Lower Urinary Tract Symptoms (LUTS)

NCT02618421

Sponsor

Astellas Pharma Singapore Pte. Ltd.

Status

Completed

Last Update Posted

Oct 22, 2024Actual

Enrollment

8,284Actual

Phase

Not provided

Conditions

Lower Urinary Tract Symptoms

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

Jan 2019

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 2, 2015Actual

Primary Completion Date

Jul 20, 2015Actual

Completion Date

Jul 20, 2015Actual

First Submitted Date

Nov 26, 2015

First Submission Date that Met QC Criteria

Nov 30, 2015

First Posted Date

Dec 1, 2015Estimated

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

Oct 19, 2024

Last Update Posted Date

Oct 22, 2024Actual

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

The purpose of the study is to determine prevalence of lower urinary tract symptoms in population aged 40 years or over, in China, Taiwan and South Korea using latest ICS definition.

Detailed Description

The research question for this study pertains to assessing prevalence and symptom specific bother of LUTS and its impact on HRQL, work productivity, mental and sexual health across China, Taiwan and South Korea, using latest ICS definition.

The research is a cross sectional population-representative internet survey among general population of males and females aged 40 years or older. The research would be an internet-based self-administration survey across China, Taiwan and South Korea.

The primary objective of the study is to determine the prevalence of lower urinary tract symptoms in population aged 40 years or over, in China, Taiwan and South Korea using latest ICS definition.

Secondary objectives of the study are:

To examine the symptom-specific bother of LUTS
To evaluate impact of these symptoms on health-related quality of life, work productivity, mental and sexual health using standard survey instruments
To explore the differences in prevalence of LUTS across males and females, across age groups, across different socioeconomic strata and across China, Taiwan and South Korea
To examine the extent of overlap of voiding and storage symptoms among the study participants
To explore treatment seeking behavior and determine treatment rate and satisfaction with current treatment

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8,284Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants Aged 40 Years or Over		Cross-section of general population of males and females in China, Taiwan, and South Korea

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The prevalence of lower urinary tract symptoms using ICS 2002 symptom definition	Prevalence of lower urinary tract symptoms in population aged 40 years or over, in China, Taiwan and South Korea using ICS 2002 symptom definition. Measured at enrollment.	At enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 40 years or older on the date of survey
Able to read local language
Able to access the internet and use a computer (with or without the help of an assisting person who may or may not be a family member)
Provides of informed consent

Exclusion Criteria:

Is pregnant
Diagnosed as having urinary tract infection by a physician in the past one month which may be cured or persisting

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Population aged 40 years or over, in China, Taiwan and South Korea

Sampling Method

Probability Sample

Name	Affiliation	Role
Medical Director	Astellas Pharma Singapore	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36597480	Derived	Chow PM, Chuang YC, Hsu KCP, Shen YC, Liu SP. Impact of Female Stress Urinary Incontinence on Quality of Life, Mental Health, Work Limitation, and Healthcare Seeking in China, Taiwan, and South Korea (LUTS Asia): Results from a Cross-Sectional, Population-Based Study. Int J Womens Health. 2022 Dec 28;14:1871-1880. doi: 10.2147/IJWH.S383651. eCollection 2022.
34983125

ID	Term
D020924	Urological Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms