A Cross-sectional Internet Survey to Estimate Prevalence of Lower Urinary Tract Symptoms (LUTS)
October 19, 2024 updated by: Astellas Pharma Singapore Pte. Ltd.
A Cross-sectional Population Representative Internet Survey to Estimate Prevalence of Lower Urinary Tract Symptoms (LUTS) in China, Taiwan and South Korea
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.
Study Overview
Status
Completed
Conditions
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
Study Type
Observational
Enrollment (Actual)
8284
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Population aged 40 years or over, in China, Taiwan and South Korea
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Participants Aged 40 Years or Over
Cross-section of general population of males and females in China, Taiwan, and South Korea
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The prevalence of lower urinary tract symptoms using ICS 2002 symptom definition
Time Frame: At enrollment
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Medical Director, Astellas Pharma Singapore
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cheng MC, Liu SP, Chuang YC, Hsu KCP, Chow PM. Prevalence and impacts of male urinary incontinence on quality of life, mental health, work limitation, and health care seeking in China, Taiwan, and South Korea (LUTS Asia): Results from a cross-sectional, population-based study. Investig Clin Urol. 2022 Jan;63(1):71-82. doi: 10.4111/icu.20210259.
- Wang JY, Liao L, Liu M, Sumarsono B, Cong M. Epidemiology of lower urinary tract symptoms in a cross-sectional, population-based study: The status in China. Medicine (Baltimore). 2018 Aug;97(34):e11554. doi: 10.1097/MD.0000000000011554.
- Chow PM, Liu SP, Chuang YC, Lee KS, Yoo TK, Liao L, Wang JY, Liu M, Sumarsono B, Jong JJ. The prevalence and risk factors of nocturia in China, South Korea, and Taiwan: results from a cross-sectional, population-based study. World J Urol. 2018 Nov;36(11):1853-1862. doi: 10.1007/s00345-018-2329-0. Epub 2018 May 23.
- Liu SP, Chuang YC, Sumarsono B, Chang HC. The prevalence and bother of lower urinary tract symptoms in men and women aged 40 years or over in Taiwan. J Formos Med Assoc. 2019 Jan;118(1 Pt 1):170-178. doi: 10.1016/j.jfma.2018.03.006. Epub 2018 Apr 11.
- Lee KS, Yoo TK, Liao L, Wang J, Chuang YC, Liu SP, Chu R, Sumarsono B. Association of lower urinary tract symptoms and OAB severity with quality of life and mental health in China, Taiwan and South Korea: results from a cross-sectional, population-based study. BMC Urol. 2017 Nov 21;17(1):108. doi: 10.1186/s12894-017-0294-3.
- Chapple C, Castro-Diaz D, Chuang YC, Lee KS, Liao L, Liu SP, Wang J, Yoo TK, Chu R, Sumarsono B. Prevalence of Lower Urinary Tract Symptoms in China, Taiwan, and South Korea: Results from a Cross-Sectional, Population-Based Study. Adv Ther. 2017 Aug;34(8):1953-1965. doi: 10.1007/s12325-017-0577-9. Epub 2017 Jul 7.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 2, 2015
Primary Completion (Actual)
July 20, 2015
Study Completion (Actual)
July 20, 2015
Study Registration Dates
First Submitted
November 26, 2015
First Submitted That Met QC Criteria
November 30, 2015
First Posted (Estimated)
December 1, 2015
Study Record Updates
Last Update Posted (Actual)
October 22, 2024
Last Update Submitted That Met QC Criteria
October 19, 2024
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- URO-MA-1006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Access to anonymized individual participant level data will not be provided for this trial.
Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.