About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Symptoms: Involuntary leakage of urine during activities that increase intra-abdominal pressure, such as physical exertion, laughing, coughing, or walking; urine leakage stops immediately when the activity ceases.
Signs: Positive result on the cough stress test or a positive 1-hour pad test (the procedure will follow the standardized ICS protocol; leakage >1g is considered positive).
Pure urge incontinence and mixed urinary incontinence will be excluded. This subtype will be preliminarily identified using the Chinese version of the "3 Incontinence Questions" (3IQ): "During the past three months, in which of the following situations did you most often experience urine leakage? (single choice) A. During physical activities such as coughing, sneezing, lifting, or exercise; B. When you had the urge to urinate or felt the need to empty your bladder but could not reach the toilet in time; C. Without physical activity or urge; D. Equally during physical activity and urgency." (Selection of option A) SUI will be finally confirmed by a one-week bladder diary (showing only stress-related leakage) and a positive 1-hour pad test.
Symptoms: Involuntary leakage of urine accompanied by or immediately preceded by urgency (a sudden, compelling desire to void that is difficult to defer).
Disqualifiers
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.
The first 300 urinary incontinence patients (100 each with SUI, UUI, and MUI) enrolled in the study.
Trial 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.
Trial design
Other
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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).
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.
Distribution of TCM Syndromes
Classification of TCM syndromes identified through standardized symptom and sign assessment, using consensus or statistical grouping approaches.
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
Secondary outcomes
Urinary Incontinence Knowledge Score
Assessment of UI knowledge using the Urinary Incontinence Questionnaire (UIQ) in patients and healthy controls.
Barriers to Incontinence Care Seeking
Barriers to Incontinence Care Seeking Questionnaire (BICS-Q) total and subscale scores.
Quality of Life Scores (IIQ-7, ICIQ-UI-SF)
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).
Hand Grip Strength
Hand grip strength measurement in UI patients and healthy controls.
Locations
Sponsors and contacts
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