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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02618421
Other study ID # URO-MA-1006
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2, 2015
Est. completion date July 20, 2015

Study information

Verified date January 2019
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 8284
Est. completion date July 20, 2015
Est. primary completion date July 20, 2015
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Astellas Pharma Singapore Pte. Ltd.

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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