Chronic Kidney DiseaseUFMR-BENCT07357714
Urinary Function and Multimorbidity Risks: A Longitudinal Study in Beijing Community-Dwelling Elderly
An observational study of Chronic Kidney Disease and Overactive Bladder, run by Chinese PLA General Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, Overactive Bladder, Benign Prostatic Hyperplasia
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2028
- How long will I take part?
- 3 Years
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 60 years
- Permanent resident of the participating Beijing community
- Able to cooperate with and complete study questionnaires and related procedures
Who cannot join
- Severe mental illness that impairs ability to cooperate with the study
- End-stage disease (confirmed by clinical diagnosis)
- Clinically assessed life expectancy < 1 year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Longitudinal Study on Urinary Function and Multimorbidity Risks Among Beijing Community-dwelling Elderly UFMR-BCE Longitudinal Study
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.
- Conditions
- Chronic Kidney Disease, Overactive Bladder, Benign Prostatic Hyperplasia, Female Pelvic Floor Dysfunction, Lower Urinary Tract Symptoms, Metabolic Syndrome
- Keywords
- Beijing community-dwelling elderly, Urinary function, Multimorbidity, Longitudinal study, Age-related functional decline
- Medical subject headings
- Renal Insufficiency, Chronic, Urinary Bladder, Overactive, Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Metabolic Syndrome, Cardiovascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%)".
Measured: 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 (%)".
Measured: 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)".
Measured: 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)".
Measured: 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)".
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Years
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
- NCT07357714
- Sponsor's protocol ID
- UFMR-BE
- Acronym
- UFMR-BE
- Status last verified
- Jan 2026
- First submitted
- 4 Dec 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study on Urinary Function and Multimorbidity Risks Among Beijing Community-dwelling Elderly UFMR-BCE Longitudinal Study
- ClinicalTrials.gov ID
- NCT07357714
- Acronym / sponsor ID
- UFMR-BE / UFMR-BE
- Conditions
- Chronic Kidney Disease, Overactive Bladder, Benign Prostatic Hyperplasia, Female Pelvic Floor Dysfunction, Lower Urinary Tract Symptoms, Metabolic Syndrome
- Keywords
- Beijing community-dwelling elderly, Urinary function, Multimorbidity, Longitudinal study, Age-related functional decline
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Jan 2026 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥ 60 years
- Permanent resident of the participating Beijing community
- Able to cooperate with and complete study questionnaires and related procedures
Key exclusion criteria (3 listed)
- Severe mental illness that impairs ability to cooperate with the study
- End-stage disease (confirmed by clinical diagnosis)
- Clinically assessed life expectancy < 1 year
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
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)
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 (%)".
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)
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 (%)".
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)
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)".
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)
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)".
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)
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)".
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 22 Jan 2026.
- Individual participant dataSharing planned: No. 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.
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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 Chronic Kidney Disease and Overactive Bladder, 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 22 Jan 2026. 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 of Medicine (8618910980422, qyuanmd@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2026.