Urinary Incontinence in Older Hong Kong Women: A Cross-sectional Study
- Conditions
- Urinary Incontinence in Old Age
- Registration Number
- NCT07243223
- Lead Sponsor
- Hong Kong Baptist University
- 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. 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).
- Detailed Description
This study is a cross-sectional observational study designed in accordance with the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines. A total of 1,000 female patients with urinary incontinence and 100 healthy controls will be enrolled.
Both urinary incontinence group and healthy group will be recruited through a combination of online publicity (via social media platforms) and offline community outreach. Each participant will be scheduled for a visit, during which the research staff will introduce the study's objectives, procedures, nature, and data privacy policy. Informed consent will be obtained. Socio-epi-demographic information (including age, educational level, marital status, occupation, income, reproductive history, medical history, comorbidities, medication history, diagnosis and treatment for urinary incontinence) and the type, frequency and severity of lower urinary tract symptoms will be collected.
Then, eligible participants with symptoms of urinary incontinence will undergo a 1-hour pad test, bladder capacity and post-void residual volume measurements, and a 1-week bladder diary to confirm the subtype of urinary incontinence (SUI, MUI, UUI) and its severity (mild, moderate, severe). Standardized questionnaires will be administered to assess the cognitive level regarding urinary incontinence (UIQ), quality of life (IIQ-7 and ICIQ-UI-SF), and barriers to care seeking (Barriers to Incontinence Care Seeking Questionnaire). Hand grip strength test will be conducted to evaluate the muscle strength. The first 300 urinary incontinence patients (100 with SUI, 100 with UUI, and 100 with MUI) enrolled in the study, who do not have chronic comorbidities (except for well-controlled hypertension or hyperlipidemia) and are not taking medications that affect urination or gut microbiota, will proceed to TCM syndrome differentiation and bio-sample collection. TCM syndrome differentiation related symptoms and signs will be collected for Delphi consensus research and cluster analysis. Blood, urine, stool routine lab tests (including metabolic and inflammatory markers such as fasting blood glucose, fasting triglycerides, albumin, creatinine, glucose, C-reactive protein, white blood cell count, etc.) and biological sample collection will also be performed for these patients.
Eligible participants who have never experienced symptoms of urinary incontinence and have no chronic comorbidity (expect for well-controlled hypertension and hyperlipidemia) and are not taking medications that affect urination or gut microbiota will serve as healthy controls. For healthy group, only blood, urine, stool routine lab tests and bio-sample will be conducted.
All data will be independently collected and cross-verified by two researchers, and entered into the electronic data management system (REDCap).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 1100
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of each urinary incontinence (UI) subtype (SUI, UUI, MUI) among older women with UI in Hong Kong Baseline visit and 1-week diaries Percentage of participants diagnosed with SUI, UUI, or MUI, determined by standardized clinical assessment (1-hour pad test, bladder diary, ICS/EAU criteria).
Distribution of Severity among UI Patients Baseline visit and 1-week diaries Proportion of UI patients classified as mild, moderate, or severe according to the Sandvik Severity Index and results of the 1-hour pad test.
Biomarker Profiles and Their Associations with Clinical Features in UI Patients and Healthy Controls Baseline biosample collection Measurement of laboratory and -omics biomarkers in blood, urine, and stool samples of UI patients (by subtype and severity) and healthy controls
Distribution of TCM Syndromes Baseline visit Classification of TCM syndromes identified through standardized symptom and sign assessment, using consensus or statistical grouping approaches.
- Secondary Outcome Measures
Name Time Method Urinary Incontinence Knowledge Score Baseline assessment Assessment of UI knowledge using the Urinary Incontinence Questionnaire (UIQ) in patients and healthy controls.
Quality of Life Scores (IIQ-7, ICIQ-UI-SF) Baseline assessment Patient-reported impact of urinary incontinence on daily life measured with the Incontinence Impact Questionnaire-7 (IIQ-7) and International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF).
Barriers to Incontinence Care Seeking Baseline assessment Barriers to Incontinence Care Seeking Questionnaire (BICS-Q) total and subscale scores.
Hand Grip Strength Baseline assessment Hand grip strength measurement in UI patients and healthy controls.