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New treatment option for Stress Urinary Incontinence (SUI)
Official title CHM for Female Stress Urinary Incontinence
ClinicalTrials.gov ID: NCT06855602
What this study is testing
What is Chinese herbal medicine formula (S-2196)?
Chinese herbal medicine formula (S-2196) is an investigational medicine, given as an once-daily, being studied as a potential treatment for stress urinary incontinence (sui).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This single-arm, open-label pilot clinical trial will test the hypothesis that S-2196, a Chinese herbal medicine formula, will show efficacy and safety in alleviating the amount and frequency of urinary incontinence in female individuals with stress urinary incontinence. All participants (n=15) will receive 1 week of screening, 2 weeks of intervention, and 1 week of follow-up.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older, women only
You may be able to join if
- 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
You likely can't join if
- Patients with other types of urinary incontinence, such as neurogenic urinary incontinence, urge urinary incontinence, and overflow urinary...
- people with the following urogenital system diseases (vesicoureteral reflux, detrusor instability, congenital urethral abnormalities, urinary tract...
- History of SUI surgery or complex urethral surgery, including previous transvaginal tension-free mid-urethral sling, anterior wall prolapse repair...
- 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...
- If using medications that affect urination during the screening period (including but not limited to thiazolidinediones, sodium-glucose cotransporter...
See the full eligibility 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
- Patients with other types of urinary incontinence, such as neurogenic urinary incontinence, urge urinary incontinence, and overflow urinary incontinence.
- people with the following urogenital system diseases (vesicoureteral reflux, detrusor instability, congenital urethral abnormalities, urinary tract infection or hematuria indicated by routine urinalysis or urine...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.