Actively Recruiting
A Single Arm Pilot Study of the Chinese Herbal Medicine Formula (S-2196) for Female Stress Urinary Incontinence
Led by Hong Kong Baptist University · Updated on 2025-11-20
15
Participants Needed
1
Research Sites
9 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effects and safety of the Chinese herbal medicine formula S-2196 in women aged 55 and older who have stress urinary incontinence. This condition causes involuntary urine leakage, and the study focuses on female patients who meet specific diagnostic criteria and experience significant urinary leakage. The trial is a single-arm, open-label pilot study involving 15 participants to explore the treatment's potential impact. Participants will receive the Chinese herbal medicine S-2196 as a decoction twice daily, each dose 150 milliliters, taken after meals for two weeks. The study includes a one-week screening period before treatment and a one-week follow-up after completing the intervention. During the treatment, all participants receive the same herbal medicine without a comparison group. Throughout the study, participants will be assessed for changes in urinary leakage amount and frequency, using a standard 1-hour pad test and daily incontinence episode tracking. They will also complete a questionnaire about urinary symptoms before and after treatment. Safety will be monitored through adverse event reporting and general physical exams. The entire study spans four weeks including screening, treatment, and follow-up.
CONDITIONS
Brief Title
CHM for Female Stress Urinary Incontinence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 55 years or older
- Meets the International Consultation on Urological Diseases (ICUD) diagnostic criteria for stress urinary incontinence
- Urine leakage greater than 10 grams in the 1-hour standard pad test
- Able to understand and follow written and verbal instructions in Chinese
- Able to use and complete the electronic diary independently during the 1-week screening period
- Has signed the informed consent form voluntarily
You will not qualify if you...
- Having other types of urinary incontinence such as neurogenic, urge, or overflow urinary incontinence
- Presence of urogenital system diseases including vesicoureteral reflux, detrusor instability, congenital urethral abnormalities, urinary tract infection or hematuria, urogenital fistula, urethral diverticulum, bladder stones, urinary tumors, abnormal vaginal bleeding, pelvic malignant tumors, or uterine prolapse grade II or above
- History of stress urinary incontinence surgery or complex urethral surgery
- Previous pelvic radiotherapy, radical surgery for pelvic malignant tumors, or pelvic floor surgery
- Currently receiving or requiring treatment for urinary incontinence including pelvic floor muscle training, physical therapy, pessary use, or medication
- Using medications that affect urination during screening and unable to maintain a stable dose during the study period
- Presence of neurological disorders, diabetes, connective tissue diseases, mental disorders, hypertension, severe cardiovascular or cerebrovascular diseases, severe liver or kidney diseases
- Having chronic cough diseases such as COPD, gastrointestinal diseases affecting drug absorption, or other unstable chronic diseases
- History of adverse reactions to traditional Chinese medicine or G6PD deficiency
- Unable to perform exercises like walking or climbing stairs
- Considered unsuitable for participation due to psychological or physical reasons by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants take the Chinese herbal medicine formula (S-2196) decoction twice daily for two weeks to treat stress urinary incontinence.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
Hong Kong Baptist University
Hong Kong, Hong Kong
Actively Recruiting
Research Team
Z
ZhaoXiang Bian, Prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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