Pilot Study of Chinese Herbal Medicine Formula S-2196 for Treating Stress Urinary Incontinence in Women Aged 55 and Older

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 treatments 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.

CHM for Female Stress Urinary Incontinence