- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07357714
Urinary Function and Multimorbidity Risks: A Longitudinal Study in Beijing Community-Dwelling Elderly (UFMR-BE)
Longitudinal Study on Urinary Function and Multimorbidity Risks Among Beijing Community-dwelling Elderly UFMR-BCE Longitudinal Study
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Qing Yuan, Doctor of Medicine
- Phone Number: 8618910980422
- Email: qyuanmd@outlook.com
Study Locations
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100853
- Chinese PLA General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 60 years
- Permanent resident of the participating Beijing community
- Able to cooperate with and complete study questionnaires and related procedures
Exclusion Criteria:
- Severe mental illness that impairs ability to cooperate with the study
- End-stage disease (confirmed by clinical diagnosis)
- Clinically assessed life expectancy < 1 year
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Beijing Community Elderly
This is a single observational cohort (no intervention applied) consisting of Beijing community-dwelling residents aged ≥60 years who meet the study's eligibility criteria (inclusion: able to cooperate with questionnaires; exclusion: severe mental illness, end-stage disease, or expected lifespan <1 year).
The cohort is established to prospectively track changes in urinary function (e.g., indicators of chronic kidney disease, overactive bladder, benign prostatic hyperplasia) and the occurrence/progression of multimorbidity (e.g., metabolic syndrome, cardiovascular diseases, diabetes) over time.
It serves to analyze the dynamic association between age-related urinary function decline and multimorbidity, without implementing any experimental treatments or interventions-only collecting natural health data, biological samples, and follow-up outcomes (e.g., functional decline, disease diagnosis, death) as part of routine observation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Annual Incidence of Age-Related Multimorbidity Associated with Urinary Function
Time Frame: Baseline (at enrollment), 12 months after enrollment (1st annual assessment), 24 months after enrollment (2nd annual assessment), through study completion (average follow-up duration: 3 years)
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This outcome measures the incidence of newly developed chronic multimorbidities closely linked to age-related urinary function changes, including metabolic syndrome, cardiovascular diseases, diabetes mellitus, and Alzheimer's disease.
Diagnosis is confirmed by clinical diagnostic criteria (e.g., diabetes mellitus defined as fasting blood glucose ≥7.0 mmol/L; hypertension, a subtype of cardiovascular disease, defined as blood pressure ≥140/90 mmHg) combined with medical record review.
It reflects the initial association between urinary function and systemic multimorbidity during the aging process.
The unit of measurement is "incidence rate (%)".
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Baseline (at enrollment), 12 months after enrollment (1st annual assessment), 24 months after enrollment (2nd annual assessment), through study completion (average follow-up duration: 3 years)
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Annual Progression Rate of Age-Related Multimorbidity Associated with Urinary Function
Time Frame: Baseline (at enrollment), 12 months after enrollment (1st annual assessment), 24 months after enrollment (2nd annual assessment), through study completion (average follow-up duration: 3 years)
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This outcome measures the proportion of participants with pre-existing multimorbidities (as specified above) who experience disease deterioration during follow-up.
Progression is confirmed by clinical examinations and medical record review, including escalation of disease severity (e.g., progression from grade 1 to grade 2 hypertension) or occurrence of complications (e.g., diabetic nephropathy).
It reflects the interactive worsening trend between urinary function and multimorbidity with aging.
The unit of measurement is "progression rate (%)".
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Baseline (at enrollment), 12 months after enrollment (1st annual assessment), 24 months after enrollment (2nd annual assessment), through study completion (average follow-up duration: 3 years)
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Annual Change in International Prostate Symptom Score (IPSS)
Time Frame: Baseline (at enrollment), 12 months after enrollment (1st annual follow-up), 24 months after enrollment (2nd annual follow-up), through study completion (average follow-up duration: 3 years)
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This outcome assesses the annual change in the severity of lower urinary tract symptoms (LUTS) using the standardized IPSS scale (range: 0-35 points).
A higher score indicates more severe symptoms such as frequent urination, urgent urination, and dysuria.
Participants complete the questionnaire under the guidance of trained healthcare professionals, and data are directly extracted from the scale results.
It is a key indicator reflecting core urinary function symptoms.
The unit of measurement is "change in score (points)".
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Baseline (at enrollment), 12 months after enrollment (1st annual follow-up), 24 months after enrollment (2nd annual follow-up), through study completion (average follow-up duration: 3 years)
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Annual Change in Maximum Urinary Flow Rate (Qmax)
Time Frame: Baseline (at enrollment), 12 months after enrollment (1st annual follow-up), 24 months after enrollment (2nd annual follow-up), through study completion (average follow-up duration: 3 years)
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This outcome measures the annual change in the maximum speed of urination, which directly reflects bladder contractile function and urinary tract patency.
Qmax is measured using a uroflowmeter, with participants required to empty their bladders completely during the test; the device automatically records the maximum flow rate.
The unit of measurement is "change in value (mL/s)".
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Baseline (at enrollment), 12 months after enrollment (1st annual follow-up), 24 months after enrollment (2nd annual follow-up), through study completion (average follow-up duration: 3 years)
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Annual Change in Post-Void Residual Urine Volume
Time Frame: Baseline (at enrollment), 12 months after enrollment (1st annual follow-up), 24 months after enrollment (2nd annual follow-up), through study completion (average follow-up duration: 3 years)
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This outcome assesses the annual change in the volume of urine remaining in the bladder after voiding, which reflects bladder emptying function.
The measurement is performed by professional physicians using ultrasound, and results are reported in milliliters (mL).
A volume >50 mL indicates bladder emptying dysfunction.
The unit of measurement is "change in volume (mL)".
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Baseline (at enrollment), 12 months after enrollment (1st annual follow-up), 24 months after enrollment (2nd annual follow-up), through study completion (average follow-up duration: 3 years)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Pathologic Processes
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Metabolic Diseases
- Urological Manifestations
- Glucose Metabolism Disorders
- Renal Insufficiency
- Insulin Resistance
- Hyperinsulinism
- Urinary Bladder Diseases
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Cardiovascular Diseases
- Metabolic Syndrome
- Prostatic Hyperplasia
- Diabetes Mellitus
- Renal Insufficiency, Chronic
- Lower Urinary Tract Symptoms
- Urinary Bladder, Overactive
Other Study ID Numbers
- UFMR-BE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This study implements a data management plan centered on privacy protection and regulatory compliance. Individual Participant Data (IPD), including participants' demographic details, health indicators, and biological sample data, is collected via standardized forms and stored in encrypted databases with access controls (e.g., role-based permission management).
IPD might not be shared primarily due to privacy protection requirements. IPD contains sensitive personal health information, which is strictly regulated by laws such as the Personal Information Protection Law and ethical review commitments. Sharing IPD would require explicit informed consent from each participant, and unauthorized sharing risks privacy leakage (e.g., medical history exposure leading to discrimination). Given the sensitivity of elderly participants' health data, non-sharing is adopted to avoid potential harms and ensure compliance.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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