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