NCT07357714

Brief Summary

This study focuses on Beijing community residents aged 60 and above, aiming to understand how urinary function (like bladder or kidney function) and multiple health problems (such as high blood pressure, diabetes) affect each other as people age-since current studies often only look at single diseases and don't cover this group well. To join, participants need to be a 60+ Beijing community resident who can answer simple questions; those with serious mental illnesses or expected lifespan under 1 year can't take part. The study starts with a baseline check (asking about the participants' health, habits, doing blood/urine tests or urinary function assessments, and possibly collecting small blood/urine samples). After that, the investigators will follow up every 6-12 months (via phone or clinic to update health info) and repeat key checks yearly; people with lower cognitive ability will be checked every 3 months. The investigators will also record new illnesses, mobility issues (like falls), or death. The study has passed ethical review-participants will get clear info before joining, can quit anytime, and participants' data will stay private; participants will also get free health check reports and basic advice. For participants, this means regular health monitoring; for everyone, it'll help make tools to spot high-risk groups (like a community app), design better help (e.g., exercise plans), and push for yearly urinary health checks in communities.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Jan 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jan 2026Dec 2028

First Submitted

Initial submission to the registry

December 4, 2025

Completed
28 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

2.7 years

First QC Date

December 4, 2025

Last Update Submit

January 13, 2026

Conditions

Keywords

Beijing community-dwelling elderlyUrinary functionMultimorbidityLongitudinal studyAge-related functional decline

Outcome Measures

Primary Outcomes (5)

  • Annual Incidence of Age-Related Multimorbidity Associated with Urinary Function

    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 (%)".

    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)

  • Annual Progression Rate of Age-Related Multimorbidity Associated with Urinary Function

    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 (%)".

    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)

  • Annual Change in International Prostate Symptom Score (IPSS)

    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)".

    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)

  • Annual Change in Maximum Urinary Flow Rate (Qmax)

    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)".

    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)

  • Annual Change in Post-Void Residual Urine Volume

    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)".

    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)

Study Arms (1)

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.

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population is derived from community-dwelling elderly residents in Beijing. Specifically, it includes individuals aged 60 years and older who live permanently in Beijing's communities (not in hospitals, nursing homes, or other institutional care settings) and are able to participate in routine health assessments and follow-ups. This population covers a broad age spectrum, ranging from young elderly (60-69 years) to super-elderly (90 years and older), and reflects the general health and living characteristics of Beijing's community-residing elderly group.

You may qualify if:

  • Age ≥ 60 years
  • Permanent resident of the participating Beijing community
  • Able to cooperate with and complete study questionnaires and related procedures

You may not qualify if:

  • Severe mental illness that impairs ability to cooperate with the study
  • End-stage disease (confirmed by clinical diagnosis)
  • Clinically assessed life expectancy \< 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

1. Blood samples: Including whole blood, serum, and plasma; retained for subsequent omics detection (genomics, proteomics, metabolomics) and analysis of biochemical/metabolic indicators related to urinary function and multimorbidity. 2. Urine samples: Retained for urinary function assessment (e.g., urine composition analysis, urinary marker detection) and exploration of associations between urinary biomarkers and age-related urinary system diseases (e.g., Overactive Bladder, Benign Prostatic Hyperplasia). 3. Fresh frozen tissue samples: Retained (when clinically available and with informed consent) for in-depth study of pathological mechanisms underlying urinary system diseases and multimorbidity interactions.

MeSH Terms

Conditions

Renal Insufficiency, ChronicUrinary Bladder, OveractiveProstatic HyperplasiaLower Urinary Tract SymptomsMetabolic SyndromeCardiovascular DiseasesDiabetes Mellitus

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsUrinary Bladder DiseasesUrological ManifestationsSigns and SymptomsProstatic DiseasesGenital Diseases, MaleGenital DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Qing Yuan, Doctor of Medicine

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief Physician

Study Record Dates

First Submitted

December 4, 2025

First Posted

January 22, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations