Urinary Incontinence in Older Hong Kong Women: A Cross-sectional Study (NCT07243223) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Urinary Incontinence in Older Hong Kong Women: A Cross-sectional Study
1,100 participantsStarted 2025-11-30
Plain-language 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. 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. To establish diagnostic criteria for traditional Chinese medicine (TCM) syndrome differentiation of urinary incontinence, and analyze the distribution of TCM syndromes;
3. To explore diagnostic biomarkers and severity evaluation biomarkers for three subtypes of urinary incontinence (SUI, UUI, MUI).
Who can participate
Age range55 Years
SexFEMALE
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.
What they're measuring
1
Prevalence of each urinary incontinence (UI) subtype (SUI, UUI, MUI) among older women with UI in Hong Kong
Timeframe: Baseline visit and 1-week diaries
2
Distribution of Severity among UI Patients
Timeframe: Baseline visit and 1-week diaries
3
Distribution of TCM Syndromes
Timeframe: Baseline visit
4
Biomarker Profiles and Their Associations with Clinical Features in UI Patients and Healthy Controls
✕. 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;