CHM for Female Stress Urinary Incontinence

Inclusion Criteria:

• Females aged ≥55 years

• Meet the ICUD diagnostic criteria of stress urinary incontinence

• Measured urine leakage >10g in the 1-hour standard pad test

• Understand and can follow written and verbal instructions in Chinese

• Able to independently use and complete the electronic diary during the 1-weekscreening period

• The subject is informed and voluntarily signs the informed consent form

Exclusion Criteria:

• Patients with other types of urinary incontinence, such as neurogenic urinaryincontinence, urge urinary incontinence, and overflow urinary incontinence.

• Subjects with the following urogenital system diseases (vesicoureteral reflux,detrusor instability, congenital urethral abnormalities, urinary tract infection orhematuria indicated by routine urinalysis or urine culture, urogenital fistula,urethral diverticulum, bladder stones, urinary system tumors, abnormal vaginalbleeding, pelvic malignant tumors, uterine prolapse grade II or above).

• History of SUI surgery or complex urethral surgery, including previous transvaginaltension-free mid-urethral sling, anterior wall prolapse repair, urethral injectiontherapy, etc.

• Previous pelvic radiotherapy, radical surgery for pelvic malignant tumors, andpelvic floor surgery.

• Currently receiving or needing to continue treatment related to urinaryincontinence, including pelvic floor muscle training, physical therapy, pessary, andmedication.

• If using medications that affect urination during the screening period (includingbut not limited to thiazolidinediones, sodium-glucose cotransporter 2 inhibitors,anticholinergics, alpha- and beta-adrenergic receptor antagonists, alpha- andbeta-adrenergic receptor agonists, diuretic antihypertensive drugs, antihistamines,M receptor antagonists, calcium channel blockers, angiotensin-converting enzymeinhibitors, hormonal drugs, neurotransmitter drugs, intestinal flora regulatingdrugs, etc.), and unable to maintain a stable dose during the study period; or ifconsidering using the above medications during the study period but not using themduring the screening period.

• Presence of neurological disorders (including but not limited to central nervoussystem injury, motor neuron disease, neurodegenerative diseases), diabetes,connective tissue diseases, mental disorders, hypertension (defined as long-termmonitored systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg),severe cardiovascular and cerebrovascular diseases, severe liver or kidney diseases.

• Combined with chronic cough diseases such as chronic obstructive pulmonary disease (COPD), gastrointestinal diseases affecting drug absorption, or other chronicdiseases in an unstable state.

• History of adverse reactions to traditional Chinese medicine, or G6PD deficiency.

• Unable to complete exercises such as walking or climbing stairs.

• Deemed unsuitable for participation in this study by the researchers due topsychological or physical reasons.