Exploratory Trial of TAS-303 in Female Patients With Stress Urinary Incontinence

A Phase IIa Study of TAS-303 in Female Patients With Stress Urinary Incontinence

The purpose of this study is to evaluate the efficacy and safety of TAS-303 in female patients with stress urinary incontinence.

The main purpose of this study is to assess the efficacy of TAS-303 for 8 weeks in female patients with stress urinary incontinence (SUI) compared with placebo as measured by the percent change in incontinence episode frequency (IEF) from baseline.

Inclusion Criteria:

• Patient has symptoms of Stress Urinary Incontinence (SUI) for at least 12 weeks prior to study entry
• Patient has at least 1 incontinence episodes per day, and urinary diurnal frequency of 10 or less per day and nocturia of 2 or less per day.
• Patient is positive in 1-hour pad weight test

Exclusion Criteria:

• Patient has predominant or primary urge incontinence according to investigator judgment
• Patient had a prior surgical SUI treatment
• Patient is diagnosed stageII or more of Pelvic Organ Prolapse
• Patient has symptoms of Urinary tract infection (UTI)
• Patient is positive pregnancy test
• Patient has on physical examination, neurological and/or vaginal examination results which, in the opinion of the investigator, should exclude the subject.