Clinical trial NCT02618421: A Cross-sectional Internet Survey to Estimate Prevalence of Lower Urinary Tract Symptoms (LUTS)
Official title: A Cross-sectional Population Representative Internet Survey to Estimate Prevalence of Lower Urinary Tract Symptoms (LUTS) in China, Taiwan and South Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Urinary Tract Symptoms
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2015-12-01
Enrollment: 8284
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Population aged 40 years or over, in China, Taiwan and South Korea

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

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

Primary outcomes:
measure: The prevalence of lower urinary tract symptoms using ICS 2002 symptom definition
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Astellas Pharma Singapore
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.