Herbal treatment for female stress urinary incontinence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot clinical trial aims to evaluate the efficacy and safety of a Chinese herbal medicine formula, S-2196, in treating stress urinary incontinence (SUI) in females aged 55 and older. Participants will undergo a one-week screening, followed by two weeks of treatment with the herbal decoction, taken twice daily. The primary outcomes will assess changes in urinary leakage and frequency of incontinence episodes, while secondary outcomes will include quality of life measures. Safety will also be monitored throughout the study.

Why it matters

Who can join: the full rules

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-week screening period
* The subject is informed and voluntarily signs the informed consent form

Exclusion Criteria:

* Patients with other types of urinary incontinence, such as neurogenic urinary incontinence, urge urinary incontinence, and overflow urinary incontinence.
* Subjects with the following urogenital system diseases (vesicoureteral reflux, detrusor instability, congenital urethral abnormalities, urinary tract infection or hematuria indicated by routine urinalysis or urine culture, urogenital fistula, urethral diverticulum, bladder stones, urinary system tumors, abnormal vaginal bleeding, pelvic malignant tumors, uterine prolapse grade II or above).
* History of SUI surgery or complex urethral surgery, including previous transvaginal tension-free mid-urethral sling, anterior wall prolapse repair, urethral injection therapy, etc.
* Previous pelvic radiotherapy, radical surgery for pelvic malignant tumors, and pelvic floor surgery.
* Currently receiving or needing to continue treatment related to urinary incontinence, including pelvic floor muscle training, physical therapy, pessary, and medication.
* If using medications that affect urination during the screening period (including but not limited to thiazolidinediones, sodium-glucose cotransporter 2 inhibitors, anticholinergics, alpha- and beta-adrenergic receptor antagonists, alpha- and beta-adrenergic receptor agonists, diuretic antihypertensive drugs, antihistamines, M receptor antagonists, calcium channel blockers, angiotensin-converting enzyme inhibitors, hormonal drugs, neurotransmitter drugs, intestinal flora regulating drugs, etc.), and unable to maintain a stable dose during the study period; or if considering using the above medications during the study period but not using them during the screening period.
* Presence of neurological disorders (including but not limited to central nervous system injury, motor neuron disease, neurodegenerative diseases), diabetes, connective tissue diseases, mental disorders, hypertension (defined as long-term monitored 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 chronic diseases 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 to psychological or physical reasons.

Where it's running

• Hong Kong Baptist University
  Hong Kong, Hong Kong Recruiting

Study contacts

• Study coordinator: ZhaoXiang Bian, Prof.
• Email: bzxiang@hkbu.edu.hk
• Phone: 85234116521

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.