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
Qualifiers
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 design
Treatments tested in this trial
- Not listed