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 range
55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. 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;