Clinical trial NCT06352736: Status of Disease Burden of Lower Urinary Tract Symptoms in Chinese Male Community
Official title: Status of Disease Burden of Lower Urinary Tract Symptoms in Chinese Male Community
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lower Urinary Tract Symptoms
Keywords: Lower Urinary Tract Symptoms
Chinese community male population
Prevalence rate
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 12567
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: community sample

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Mainland China, aged 40 or older, male, in 31 provincial-level administrative regions.
2. Have resided for a total of 6 months or more in the survey county (district) in the past 12 months.
3. Normal communication, cooperation during physical examination, and good cognitive ability.
4. Willing to participate in and cooperate with this study, and sign the informed consent form.

Exclusion Criteria:

1. Closed communities, such as armed forces and nursing homes.
2. Individuals with mental illnesses or other conditions that prevent cooperation.

Primary outcomes:
measure: International Prostate Symptom Score(IPSS)
timeFrame: DAY 1
measure: Overactive Bladder Syndrome Score(OABSS)
timeFrame: Day 1
measure: International Consultation on Incontinence Questionnaire - Short Form(ICIQ-SF)
timeFrame: Day 1
measure: Quality of Life Score（QOL）
timeFrame: Day 1
Secondary outcomes:
measure: Prostatic volume
timeFrame: Day 1
measure: Maximum urinary flow rate
timeFrame: Day 1
measure: Residual urine
timeFrame: Day 1
measure: free prostatic specific antigen(fPSA)
timeFrame: Day 1
measure: total prostatic specific antigen(tPSA)
timeFrame: Day 1
measure: fPSA/ tPSA
timeFrame: Day 1
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
References:
citation: 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.
citation: Nambiar 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.
citation: Gratzke 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.
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.
citation: Chow 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.
citation: Zhang 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.