Lower Urinary Tract SymptomsNCT06352736
Status of Disease Burden of Lower Urinary Tract Symptoms in Chinese Male Community
An observational study of Lower Urinary Tract Symptoms, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This study, set up as a cross-sectional survey, seeks to delve into the disease burden and the demographic specifics of lower urinary tract symptoms (LUTS) among the male community in China. Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Lower Urinary Tract Symptoms
- How many people
- 12,567 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: community sample
Who may be able to join
- Mainland China, aged 40 or older, male, in 31 provincial-level administrative regions.
- Have resided for a total of 6 months or more in the survey county (district) in the past 12 months.
- Normal communication, cooperation during physical examination, and good cognitive ability.
- Willing to participate in and cooperate with this study, and sign the informed consent form.
Who cannot join
- Closed communities, such as armed forces and nursing homes.
- Individuals with mental illnesses or other conditions that prevent cooperation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, 100853
Qing Yuan, Doctor's degree, 18910980422, qyuanmd@outlook.com
About this study
This study, set up as a cross-sectional survey, seeks to delve into the disease burden and the demographic specifics of lower urinary tract symptoms (LUTS) among the male community in China. The investigators's main aim is to map out the overall and age-specific prevalence rates of LUTS within the Chinese male population. These insights are critical for understanding the public health dimensions of this condition. Moreover, the investigators plan to investigate several secondary aspects: the correlation of LUTS prevalence with factors like urbanization levels (rural vs. urban), geographical distribution, and lifestyle choices. Another significant focus will involve examining the treatment landscape for LUTS, looking at the portion of sufferers receiving treatment, the diversity in treatment durations, and the types of treatments employed (medication vs. surgery). This comprehensive analysis is intended to shed light on the prevailing management strategies for LUTS in China. The study is scheduled to unfold over 36 months and will comprise three pivotal phases: initial preparations, recruitment of subjects and collection of data, followed by the analysis of data and compilation of reports. The investigators will employ a range of methods such as questionnaires, physical exams, laboratory tests, imaging, and other medical evaluations to amass extensive data. This will allow the investigators to evaluate the prevalence of LUTS across various age groups among men and address the current gaps in epidemiological understanding.
Read the detailed description
Divide the country into 7 geographical regions and stratify them according to urban and rural areas. Based on the size of the male population over 40 years old in the seventh National Census, employ a multi-stage proportional-to-size (PPS) sampling method. The sampling process is divided into six stages. In the first stage, use provincial-level administrative units as sampling units. Based on population size, use the PPS method to select 2 provincial-level administrative units from each region, totaling 14. In the second stage of sampling, use prefecture-level cities in each province as sampling units. The capital cities are directly sampled; based on population size, use the PPS method to select 1 other prefecture-level city from each province. In the third stage of sampling, use urban districts and counties (including county-level cities) in prefecture-level cities/direct-controlled municipalities as sampling units. Use the PPS method to select 2 urban districts and 2 counties in each prefecture-level city, and 4 urban districts and 4 counties in each direct-controlled municipality. In the fourth stage of sampling, use streets in urban districts and towns/townships in counties as sampling units. Use simple random sampling to select 1 street from each urban district and 1 town/township from each county. In the fifth stage of sampling, use communities in streets and villages in towns/townships as sampling units. Use simple random sampling to select 2 communities from each street and 2 villages from each town/township. In the sixth stage of sampling, stratify males over 40 years old in each community/village by age groups (40-49 years,50-59 years,60-69 years,70 years and above). Number individuals of each age group and randomly sample individuals. This survey includes four parts: questionnaire survey, physical examination, laboratory tests, imaging and other examinations. The questionnaire is conducted face-to-face by trained interviewers.
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Lower Urinary Tract Symptoms, Chinese community male population, Prevalence rate
- Medical subject headings
- Lower Urinary Tract Symptoms
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score(IPSS)
A questionnaire to assess the condition of the prostate, report by score.The minimum value is 0, the maximum is 35, and the larger the score, the more severe the symptoms.
Measured: DAY 1
Overactive Bladder Syndrome Score(OABSS)
A questionnaire to assess the condition of overactive bladder, report by score.The minimum value is 0, the maximum is 15, and the larger the score, the more severe the symptoms.The minimum value is 0, the maximum is 15, and the larger the score, the more severe the symptoms.
Measured: Day 1
International Consultation on Incontinence Questionnaire - Short Form(ICIQ-SF)
Detection through urinary flow rate meter, report by score.The minimum value is 0, the maximum is 11, and the larger the score, the more severe the symptoms
Measured: Day 1
Quality of Life Score（QOL）
t was used to assess the impact of lower urinary tract symptoms on quality of life, with a minimum score of 0 and a maximum score of 6. The smaller the score, the higher the quality of life.
Measured: Day 1
Secondary outcomes (6)
Prostatic volume
By transabdominal ultrasound, Prostatic volume (ml)= Lateral diameter of prostate(cm)* Anterior and posterior prostatic diameter(cm) * Diameter superior and inferior prostatic (cm) *0.52
Measured: Day 1
Maximum urinary flow rate
Detection through urinary flow rate meter （ml/min)
Measured: Day 1
Residual urine
By transabdominal ultrasound (ml)
Measured: Day 1
free prostatic specific antigen(fPSA)
ng/ml
Measured: Day 1
total prostatic specific antigen(tPSA)
ng/ml
Measured: Day 1
fPSA/ tPSA
fPSA/ tPSA, Ratio of the two
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 Jun 2023
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 12,567 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing Yuan, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352736
- Sponsor's protocol ID
- LUTS2023
- Status last verified
- Sep 2025
- First submitted
- 25 Mar 2024
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data involves a large amount of personal information and privacy of the population, and the informed consent promises the confidentiality of personal data.
Publications
Lerner LB, McVary KT, Barry MJ, Bixler BR, Dahm P, Das AK, Gandhi MC, Kaplan SA, Kohler TS, Martin L, Parsons JK, Roehrborn CG, Stoffel JT, Welliver C, Wilt TJ. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART I-Initial Work-up and Medical Management. J Urol. 2021 Oct;206(4):806-817. doi: 10.1097/JU.0000000000002183. Epub 2021 Aug 13.
PubMed 34384237Nambiar AK, Arlandis S, Bo K, Cobussen-Boekhorst H, Costantini E, de Heide M, Farag F, Groen J, Karavitakis M, Lapitan MC, Manso M, Arteaga SM, Riogh ANA, O'Connor E, Omar MI, Peyronnet B, Phe V, Sakalis VI, Sihra N, Tzelves L, van Poelgeest-Pomfret ML, van den Bos TWL, van der Vaart H, Harding CK. European Association of Urology Guidelines on the Diagnosis and Management of Female Non-neurogenic Lower Urinary Tract Symptoms. Part 1: Diagnostics, Overactive Bladder, Stress Urinary Incontinence, and Mixed Urinary Incontinence. Eur Urol. 2022 Jul;82(1):49-59. doi: 10.1016/j.eururo.2022.01.045. Epub 2022 Feb 23.
PubMed 35216856Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19.
PubMed 25613154Chapple 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 28687936Chow PM, Chuang YC, Hsu KCP, Shen YC, Hsieh AW, Liu SP. Impacts of nocturia 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. J Formos Med Assoc. 2022 Jan;121(1 Pt 2):285-293. doi: 10.1016/j.jfma.2021.04.005. Epub 2021 May 4.
PubMed 33958270Zhang W, Cao G, Sun Y, Wu F, Wang Q, Xu T, Hu H, Xu K. Depressive symptoms in individuals diagnosed with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) in middle-aged and older Chinese individuals: Results from the China Health and Retirement Longitudinal Study. J Affect Disord. 2022 Jan 1;296:660-666. doi: 10.1016/j.jad.2021.09.045. Epub 2021 Sep 20.
PubMed 34565588
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Status of Disease Burden of Lower Urinary Tract Symptoms in Chinese Male Community
- ClinicalTrials.gov ID
- NCT06352736
- Acronym / sponsor ID
- LUTS2023
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Lower Urinary Tract Symptoms, Chinese community male population, Prevalence rate
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12,567 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Apr 2024 (actual)
- 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.
This study, set up as a cross-sectional survey, seeks to delve into the disease burden and the demographic specifics of lower urinary tract symptoms (LUTS) among the male community in China. The investigators's main aim is to map out the overall and age-specific prevalence rates of LUTS within the Chinese male population. These insights are critical for understanding the public health dimensions of this condition. Moreover, the investigators plan to investigate several secondary aspects: the correlation of LUTS prevalence with factors like urbanization levels (rural vs. urban), geographical distribution, and lifestyle choices. Another significant focus will involve examining the treatment landscape for LUTS, looking at the portion of sufferers receiving treatment, the diversity in treatment durations, and the types of treatments employed (medication vs. surgery). This comprehensive analysis is intended to shed light on the prevailing management strategies for LUTS in China. The study is scheduled to unfold over 36 months and will comprise three pivotal phases: initial preparations, recruitment of subjects and collection of data, followed by the analysis of data and compilation of reports. The investigators will employ a range of methods such as questionnaires, physical exams, laboratory tests, imaging, and other medical evaluations to amass extensive data. This will allow the investigators to evaluate the prevalence of LUTS across various age groups among men and address the current gaps in epidemiological understanding.
Detailed description
Divide the country into 7 geographical regions and stratify them according to urban and rural areas. Based on the size of the male population over 40 years old in the seventh National Census, employ a multi-stage proportional-to-size (PPS) sampling method. The sampling process is divided into six stages. In the first stage, use provincial-level administrative units as sampling units. Based on population size, use the PPS method to select 2 provincial-level administrative units from each region, totaling 14. In the second stage of sampling, use prefecture-level cities in each province as sampling units. The capital cities are directly sampled; based on population size, use the PPS method to select 1 other prefecture-level city from each province. In the third stage of sampling, use urban districts and counties (including county-level cities) in prefecture-level cities/direct-controlled municipalities as sampling units. Use the PPS method to select 2 urban districts and 2 counties in each prefecture-level city, and 4 urban districts and 4 counties in each direct-controlled municipality. In the fourth stage of sampling, use streets in urban districts and towns/townships in counties as sampling units. Use simple random sampling to select 1 street from each urban district and 1 town/township from each county. In the fifth stage of sampling, use communities in streets and villages in towns/townships as sampling units. Use simple random sampling to select 2 communities from each street and 2 villages from each town/township. In the sixth stage of sampling, stratify males over 40 years old in each community/village by age groups (40-49 years,50-59 years,60-69 years,70 years and above). Number individuals of each age group and randomly sample individuals. This survey includes four parts: questionnaire survey, physical examination, laboratory tests, imaging and other examinations. The questionnaire is conducted face-to-face by trained interviewers.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
Key inclusion criteria (4 listed)
- Mainland China, aged 40 or older, male, in 31 provincial-level administrative regions.
- Have resided for a total of 6 months or more in the survey county (district) in the past 12 months.
- Normal communication, cooperation during physical examination, and good cognitive ability.
- Willing to participate in and cooperate with this study, and sign the informed consent form.
Key exclusion criteria (2 listed)
- Closed communities, such as armed forces and nursing homes.
- Individuals with mental illnesses or other conditions that prevent cooperation.
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
International Prostate Symptom Score(IPSS)
Time frame: DAY 1
A questionnaire to assess the condition of the prostate, report by score.The minimum value is 0, the maximum is 35, and the larger the score, the more severe the symptoms.
Overactive Bladder Syndrome Score(OABSS)
Time frame: Day 1
A questionnaire to assess the condition of overactive bladder, report by score.The minimum value is 0, the maximum is 15, and the larger the score, the more severe the symptoms.The minimum value is 0, the maximum is 15, and the larger the score, the more severe the symptoms.
International Consultation on Incontinence Questionnaire - Short Form(ICIQ-SF)
Time frame: Day 1
Detection through urinary flow rate meter, report by score.The minimum value is 0, the maximum is 11, and the larger the score, the more severe the symptoms
Quality of Life Score（QOL）
Time frame: Day 1
t was used to assess the impact of lower urinary tract symptoms on quality of life, with a minimum score of 0 and a maximum score of 6. The smaller the score, the higher the quality of life.
6 secondary outcomes
Prostatic volume
Time frame: Day 1
Maximum urinary flow rate
Time frame: Day 1
Residual urine
Time frame: Day 1
free prostatic specific antigen(fPSA)
Time frame: Day 1
total prostatic specific antigen(tPSA)
Time frame: Day 1
fPSA/ tPSA
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Background: PubMed 34384237Lerner LB, McVary KT, Barry MJ, Bixler BR, Dahm P, Das AK, Gandhi MC, Kaplan SA, Kohler TS, Martin L, Parsons JK, Roehrborn CG, Stoffel JT, Welliver C, Wilt TJ. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART I-Initial Work-up and Medical Management. J Urol. 2021 Oct;206(4):806-817. doi: 10.1097/JU.0000000000002183. Epub 2021 Aug 13.
- Background: PubMed 35216856Nambiar AK, Arlandis S, Bo K, Cobussen-Boekhorst H, Costantini E, de Heide M, Farag F, Groen J, Karavitakis M, Lapitan MC, Manso M, Arteaga SM, Riogh ANA, O'Connor E, Omar MI, Peyronnet B, Phe V, Sakalis VI, Sihra N, Tzelves L, van Poelgeest-Pomfret ML, van den Bos TWL, van der Vaart H, Harding CK. European Association of Urology Guidelines on the Diagnosis and Management of Female Non-neurogenic Lower Urinary Tract Symptoms. Part 1: Diagnostics, Overactive Bladder, Stress Urinary Incontinence, and Mixed Urinary Incontinence. Eur Urol. 2022 Jul;82(1):49-59. doi: 10.1016/j.eururo.2022.01.045. Epub 2022 Feb 23.
- Background: PubMed 25613154Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19.
- Background: 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.
- Background: PubMed 33958270Chow PM, Chuang YC, Hsu KCP, Shen YC, Hsieh AW, Liu SP. Impacts of nocturia 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. J Formos Med Assoc. 2022 Jan;121(1 Pt 2):285-293. doi: 10.1016/j.jfma.2021.04.005. Epub 2021 May 4.
- Background: PubMed 34565588Zhang W, Cao G, Sun Y, Wu F, Wang Q, Xu T, Hu H, Xu K. Depressive symptoms in individuals diagnosed with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) in middle-aged and older Chinese individuals: Results from the China Health and Retirement Longitudinal Study. J Affect Disord. 2022 Jan 1;296:660-666. doi: 10.1016/j.jad.2021.09.045. Epub 2021 Sep 20.
- Individual participant dataSharing planned: No. The data involves a large amount of personal information and privacy of the population, and the informed consent promises the confidentiality of personal data.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Urinary Tract Symptoms, run by Chinese PLA General Hospital at 1 site in China.
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: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qing Yuan, Doctor's degree (18910980422, qyuanmd@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Prostate Symptom Score(IPSS) (time frame: DAY 1). The study lists 4 primary outcomes in all. 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 NCT06352736, which also lists 6 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 25 Sep 2025.