New study aims to uncover hidden clues about bladder control in older women
NCT ID NCT07243223
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study will look at 1,100 older women in Hong Kong, including 1,000 with urinary incontinence and 100 without, to better understand the condition. Researchers will explore how common different types of incontinence are, what traditional Chinese medicine patterns appear, and whether certain biomarkers in blood, urine, or stool can help diagnose or classify the problem. The goal is to improve knowledge and care, not to test a new treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could identify biomarkers and TCM patterns that help diagnose and classify urinary incontinence more accurately in older women.
- What could go wrong
- This is an observational study, not a treatment trial. It will not test any therapy, so it cannot directly improve symptoms or outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2025
An estimate. Start dates often move.
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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55 years and older
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Diagnostic Criteria: 1\. Urinary Incontinence (UI):Urinary incontinence will be diagnosed according to the definition of the International Continence Society (ICS), that is, 'any involuntary leakage of urine'. In addition, participants must have experienced this symptom continuously for at least six months to exclude cases of transient urinary incontinence. 2\. Stress Urinary Incontinence (SUI):The clinical diagnosis of SUI will be made with reference to the guidelines of the European Association of Urology (EAU) and the International Continence Society (ICS): 1. 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. 2. 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). 3. 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. 3\. Urge Urinary Incontinence (UUI):The clinical diagnosis of UUI will follow the guidelines of the European Association of Urology (EAU) and the International Continence Society (ICS): 1. Symptoms: Involuntary leakage of urine accompanied by or immediately preceded by urgency (a sudden, compelling desire to void that is difficult to defer). 2. Cases of pure stress urinary 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 B) Final confirmation will be based on a one-week bladder diary recorded by the participant (showing only urgency-related leakage). 4\. Mixed Urinary Incontinence (MUI):The clinical diagnosis of MUI will follow the guidelines of the European Association of Urology (EAU) and the International Continence Society (ICS): 1. Symptoms: The presence of stress urinary incontinence symptoms, such as involuntary leakage of urine during activities that increase intra-abdominal pressure (e.g., exercise, laughing, coughing, walking), with urine flow ceasing immediately upon stopping the activity; and, at the same time, the presence of urge urinary incontinence symptoms, such as urgency (a sudden, compelling desire to void that is difficult to defer) accompanied by or immediately followed by involuntary leakage of urine. 2. Signs: Positive result on the cough stress test or a positive 1-hour pad test (the procedure will follow the standardized protocol of the ICS; leakage \>1g is considered positive). 3. Cases of pure urge urinary incontinence and pure stress 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 D) Final confirmation will be based on a one-week bladder diary recorded by the participant (showing both urgency- and stress-related leakage) and a positive 1-hour pad test. 5\. Inclusion Criteria for Patients with Urinary Incontinence 1. Females aged ≥55 years 2. Has been living in Hong Kong for one year or more. 3. Meet the diagnostic criteria for SUI, UUI, or MUI, and the symptoms of urinary incontinence have persisted for at least 6 months. 4. Able to understand and follow written and verbal instructions in Chinese or English. 5. Provide informed consent voluntarily after being fully informed 6\. Exclusion Criteria for Patients with Urinary Incontinence 1. 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. 2. Active or structural urogenital diseases (such as unrepaired vesicoureteral reflux, congenital urethral malformations, urogenital fistula, urethral diverticulum, or active pelvic malignancies). 3. Deemed by researchers to be unable to cooperate with assessments due to severe mental or physical illness. 7\. Eligible Urinary Incontinence Patients for Bio-Sample Collection 1. The first 300 urinary incontinence patients (100 each with SUI, UUI, and MUI) enrolled in the study. 2. 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. 3. 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.). 8\. Inclusion Criteria for Healthy Volunteers 1. Female, aged ≥55 years; 2. Has been living in Hong Kong for one year or more; 3. Able to understand and follow written and verbal instructions in Chinese or English; 4. Fully informed and voluntarily signs the informed consent form. 9\. Exclusion Criteria for Healthy Volunteers 1. Meet the diagnostic criteria for urinary incontinence; 2. Has a history of involuntary urine leakage, or has sought medical consultation for symptoms related to urinary incontinence; 3. Has chronic comorbidities (except for well-controlled hypertension, defined as systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg, and hyperlipidemia). 4. Uses 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, and gut microbiota modulators, etc.). 5. Deemed by researchers to be unable to cooperate with assessments due to severe mental or physical illness.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
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