Status of Disease Burden of Lower Urinary Tract Symptoms in Chinese Male Community

Lower Urinary Tract Symptoms Clinical Trial

Official title:

Status of Disease Burden of Lower Urinary Tract Symptoms in Chinese Male Community

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06352736
• Other study ID #: LUTS2023
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Chinese PLA General Hospital
• Contact: Qing Yuan, Doctor's degree
• Phone: 18910980422
• Email: qyuanmd[@]outlook.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12567
• Est. completion date: December 31, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View 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. — View 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. — View 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. Erratum In: J Urol. 2021 Nov;206(5):1339. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	DAY 1
Primary	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.	Day 1
Primary	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	Day 1
Primary	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.	Day 1
Secondary	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	Day 1
Secondary	Maximum urinary flow rate	Detection through urinary flow rate meter (ml/min)	Day 1
Secondary	Residual urine	By transabdominal ultrasound (ml)	Day 1
Secondary	free prostatic specific antigen(fPSA)	ng/ml	Day 1
Secondary	total prostatic specific antigen(tPSA)	ng/ml	Day 1
Secondary	fPSA/ tPSA	fPSA/ tPSA, Ratio of the two	Day 1