Herbal treatment for female stress urinary incontinence

A Single Arm Pilot Study of the Chinese Herbal Medicine Formula (S-2196) for the Female Stress Urinary Incontinence (SUI)

This study is testing a Chinese herbal medicine to see if it can help women over 55 with stress urinary incontinence feel better and have fewer leaks.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 55 Years and up
• Sex: Female
• Sponsor: Hong Kong Baptist University (other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT06855602 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are females aged 55 and above who have been diagnosed with stress urinary incontinence and meet specific clinical criteria.

Not a fit: Patients with other types of urinary incontinence or significant urogenital system diseases may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a non-invasive option for alleviating urinary incontinence in older women.

How similar studies have performed: While this approach is novel, other studies have explored herbal treatments for urinary incontinence with varying degrees of success.

Eligibility criteria

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 this trial is running

Hong Kong

• Hong Kong Baptist University — Hong Kong, Hong Kong (RECRUITING)

Study contacts

• Study coordinator: ZhaoXiang Bian, Prof.

Conditions: Stress Urinary Incontinence, stress urinary incontinence, female