Lower Urinary Tract SymptomsNCT02618421
A Cross-sectional Internet Survey to Estimate Prevalence of Lower Urinary Tract Symptoms (LUTS)
An observational study of Lower Urinary Tract Symptoms, run by Astellas Pharma Singapore Pte. Ltd..
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Lower Urinary Tract Symptoms
- How many people
- 8,284 participants
- Where
- No sites listed yet
- Study dates
- 2 Jun 2015to 20 Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population aged 40 years or over, in China, Taiwan and South Korea
Who may be able to join
- 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
Who cannot join
- Is pregnant
- Diagnosed as having urinary tract infection by a physician in the past one month which may be cured or persisting
About this study
Official title: 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.
Read the 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
- Conditions
- Lower Urinary Tract Symptoms
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants Aged 40 Years or Over | Cross-section of general population of males and females in China, Taiwan, and South Korea |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study start2 Jun 2015
- Primary completion20 Jul 2015
- Study completion20 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 8,284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Singapore Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618421
- Sponsor's protocol ID
- URO-MA-1006
- Status last verified
- Jan 2019
- First submitted
- 26 Nov 2015
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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/.
Publications
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.
PubMed 36597480Cheng 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.
PubMed 34983125Wang 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.
PubMed 30142751Chow 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.
PubMed 29796775Liu 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.
PubMed 29655606Lee 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.
PubMed 29162085Chapple 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.
PubMed 28687936
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Population Representative Internet Survey to Estimate Prevalence of Lower Urinary Tract Symptoms (LUTS) in China, Taiwan and South Korea
- ClinicalTrials.gov ID
- NCT02618421
- Acronym / sponsor ID
- URO-MA-1006
- Conditions
- Lower Urinary Tract Symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,284 participants (actual)
- Lead sponsor
- Astellas Pharma Singapore Pte. Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2015 (actual)
- Primary completion
- 20 Jul 2015 (actual)
- Study completion
- 20 Jul 2015 (actual)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Aged 40 Years or Over | – | –Cross-section of general population of males and females in China, Taiwan, and South Korea |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population aged 40 years or over, in China, Taiwan and South Korea
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Is pregnant
- Diagnosed as having urinary tract infection by a physician in the past one month which may be cured or persisting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Derived from this study: PubMed 36597480Chow 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.
- Derived from this study: PubMed 34983125Cheng 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.
- Derived from this study: PubMed 30142751Wang 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.
- Derived from this study: PubMed 29796775Chow 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.
- Derived from this study: PubMed 29655606Liu 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.
- Derived from this study: PubMed 29162085Lee 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.
- Derived from this study: PubMed 28687936Chapple 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.
- Individual participant dataSharing planned: No. 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/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Singapore
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Urinary Tract Symptoms, run by Astellas Pharma Singapore Pte. Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of lower urinary tract symptoms using ICS 2002 symptom definition (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02618421, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.