Urinary Incontinence in Older Hong Kong Women: A Cross-sectional Study

NCT07243223 | Not Yet Recruiting

• 1 other identifier: REC/24-25/0631
• Study Type: observational
• Target: 1,100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, cross-sectional study aim to include 1000 patients with urinary incontinence and 100 healthy controls in Hong Kong. The overall objection is to address the gaps in epidemiological profiles, TCM syndrome differentiation, and biomarkers discovery of urinary incontinence among older women. The specific aims including:

1. 1.To assess the epidemiological characteristics of urinary incontinence among older women, as well as patients' knowledge and healthcare-seeking barriers, and to explore factors influencing the disease subtypes, severity, and healthcare-seeking behaviors;
2. 2.To establish diagnostic criteria for traditional Chinese medicine (TCM) syndrome differentiation of urinary incontinence, and analyze the distribution of TCM syndromes;
3. 3.To explore diagnostic biomarkers and severity evaluation biomarkers for three subtypes of urinary incontinence (SUI, UUI, MUI).

Conditions

Urinary Incontinence in Old Age

Keywords

urinary incontinence; female

Outcome Measures

Primary Outcomes (4)

• Prevalence of each urinary incontinence (UI) subtype (SUI, UUI, MUI) among older women with UI in Hong Kong

  Percentage of participants diagnosed with SUI, UUI, or MUI, determined by standardized clinical assessment (1-hour pad test, bladder diary, ICS/EAU criteria).

  Baseline visit and 1-week diaries

• Distribution of Severity among UI Patients

  Proportion of UI patients classified as mild, moderate, or severe according to the Sandvik Severity Index and results of the 1-hour pad test.

  Baseline visit and 1-week diaries

• Distribution of TCM Syndromes

  Classification of TCM syndromes identified through standardized symptom and sign assessment, using consensus or statistical grouping approaches.

  Baseline visit

• Biomarker Profiles and Their Associations with Clinical Features in UI Patients and Healthy Controls

  Measurement of laboratory and -omics biomarkers in blood, urine, and stool samples of UI patients (by subtype and severity) and healthy controls

  Baseline biosample collection

Secondary Outcomes (4)

• Urinary Incontinence Knowledge Score

  Baseline assessment

• Barriers to Incontinence Care Seeking

  Baseline assessment

• Quality of Life Scores (IIQ-7, ICIQ-UI-SF)

  Baseline assessment

• Hand Grip Strength

  Baseline assessment

Study Arms (4)

Stress Urinary Incontinence (SUI)

Women diagnosed with SUI per EAU and ICS criteria: involuntary leakage during increased intra-abdominal pressure (e.g., exertion, coughing), stopping when the activity ends. Confirmed by positive cough stress or 1-hour pad test (\>1g leakage), and bladder diary showing stress-only leakage. Initial screening uses the Chinese 3IQ, option A ("leakage with physical activity"). Cases with urge or mixed symptoms are excluded. No intervention to be administered.

Urge Urinary Incontinence (UUI)

Women diagnosed with UUI per EAU and ICS criteria: involuntary leakage of urine accompanied by or immediately preceded by urgency. Preliminary screening with Chinese 3IQ, option B ("leakage with urgency"). Final diagnosis confirmed by a bladder diary showing urgency-only leakage. Cases with stress or mixed symptoms are excluded. No intervention to be administered.

Mixed Urinary Incontinence (MUI)

Women diagnosed with MUI per EAU and ICS guidelines: symptoms of both stress and urge urinary incontinence. Confirmed by positive 1-hour pad test (\>1g) and bladder diary showing both stress- and urgency-related leakage. Preliminary screening with Chinese 3IQ, option D ("leakage equally with activity and urgency"). Cases with pure stress or urge incontinence excluded. No intervention to be administered.

Healthy Volunteers (HC)

Female volunteers aged ≥55, living in Hong Kong ≥1 year, no history or symptoms of urinary incontinence, no recent urological consultation, and no major comorbidities (except well-controlled hypertension/hyperlipidemia). Not using drugs affecting urination or the gut microbiota. Able to understand instructions and provide consent. Exclusions: UI diagnosis, involuntary urine leakage, severe illness interfering with assessment. No intervention to be administered.

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Urinary incontinence group: Aged ≥55 years; Has been living in Hong Kong for one year or more; Meet the diagnostic criteria for MUI, UUI, or MUI defined by the International Continence Society (ICS); Able to understand and use Chinese or English; Signed the informed consent form. Healthy group: Aged ≥55 years; Has been living in Hong Kong for one year or more; Never went through urinary incontinence and never consult the doctor for suspect urinary incontinence related symptoms; No chronic comorbidity (expect for well-controlled hypertension and hyperlipidemia); Not taking medications that affect urination or gut microbiota; Able to understand and use Chinese or English; Signed the informed consent form.

You may qualify if:

• Females aged ≥55 years
• Has been living in Hong Kong for one year or more.
• Meet the diagnostic criteria for SUI, UUI, or MUI, and the symptoms of urinary incontinence have persisted for at least 6 months.
• Able to understand and follow written and verbal instructions in Chinese or English.
• Provide informed consent voluntarily after being fully informed

You may not qualify if:

• Diagnosed with types of urinary incontinence other than stress, urge, or mixed urinary incontinence, including those secondary to neurological or systemic diseases (such as post-stroke, post-spinal cord injury, multiple sclerosis, Alzheimer's disease, Parkinson's disease, or uncontrolled diabetic peripheral neuropathy), as well as the overflow incontinence.
• Active or structural urogenital diseases (such as unrepaired vesicoureteral reflux, congenital urethral malformations, urogenital fistula, urethral diverticulum, or active pelvic malignancies).
• Deemed by researchers to be unable to cooperate with assessments due to severe mental or physical illness.
• \. Eligible Urinary Incontinence Patients for Bio-Sample Collection
• The first 300 urinary incontinence patients (100 each with SUI, UUI, and MUI) enrolled in the study.
• No chronic comorbidities (except for well-controlled hypertension, defined as systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg, and hyperlipidemia), including neurological disorders (central nervous system injury, motor neuron diseases, neurodegenerative diseases), diabetes, connective tissue diseases, psychiatric disorders, severe cardiovascular or cerebrovascular diseases, and severe liver or kidney diseases.
• Not using medications that affect urination or gut microbiota (including but not limited to thiazolidinediones, sodium-glucose cotransporter-2 inhibitors, anticholinergics, α- and β-adrenergic blockers, α- and β-adrenergic agonists, diuretic antihypertensives, antihistamines, muscarinic receptor antagonists, calcium channel blockers, angiotensin-converting enzyme inhibitors, hormone medications, neurotransmitter-related drugs, gut microbiota modulators, etc.).
• Female, aged ≥55 years;
• Has been living in Hong Kong for one year or more;
• Able to understand and follow written and verbal instructions in Chinese or English;
• Fully informed and voluntarily signs the informed consent form.
• Meet the diagnostic criteria for urinary incontinence;
• Has a history of involuntary urine leakage, or has sought medical consultation for symptoms related to urinary incontinence;
• Has chronic comorbidities (except for well-controlled hypertension, defined as systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg, and hyperlipidemia).
• Uses medications that affect urination or gut microbiota (including but not limited to thiazolidinediones, sodium-glucose cotransporter-2 inhibitors, anticholinergics, α- and β-adrenergic blockers, α- and β-adrenergic agonists, diuretic antihypertensives, antihistamines, muscarinic receptor antagonists, calcium channel blockers, angiotensin-converting enzyme inhibitors, hormone medications, neurotransmitter-related drugs, and gut microbiota modulators, etc.).

Sponsors & Collaborators

• Hong Kong Baptist University: lead

Biospecimen

Retention: SAMPLES WITH DNA

Urine, blood, and stool samples will be collected. Urine: urinalysis, urinary microbiome (16S sequencing), and metabolomics. Blood: routine tests, metabolic and inflammatory markers, transcriptomics (whole blood), metabolomics and proteomics (serum). Stool: routine tests, metabolomics, gut microbiome (16S sequencing). Analyses will explore associations between biospecimen profiles and urinary incontinence clinical features.

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Qianqian Xu, MS, RCMP

  Vincent V.C. Woo Chinese Medicine Clinical Research Institute, Hong Kong Baptist University

  STUDY DIRECTOR

Central Study Contacts

ZhaoXiang Bian, Prof.

CONTACT

852-34116521; bzxiang@hkbu.edu.hk

Qianqian Xu, MS, RCMP

CONTACT

852-34112096; 24481467@life.hkbu.edu.hk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11