A phase 2 study of TAS-303 in female patients with stress urinary incontinence
- Conditions
- Stress urinary incontinence
- Registration Number
- JPRN-jRCT2080225307
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Female
- Target Recruitment
- 186
Key Inclusion Criteria:
-Patient has symptoms of Stress Urinary Incontinence (SUI) for at least 12 weeks prior to study entry
-Urinary incontinence in the 1-hour pad weight test exceeds 2.0 g
-The average number of SUI episodes is 1 or more per day
- The average number of urge urinary incontinence (UUI) episodes is 0.43 or less per day
-The number of SUI episodes exceeds the number of other episodes
-The average number of urinary diurnal frequency is 10 or less per day and the average number of nocturia frequency is 2 or less per day
Key Exclusion Criteria:
- Patient has been diagnosed with mixed urinary incontinence (MUI) that is predominantly UUI
- Patient has treated medication or therapy for SUI within 14 days before prior to study entry
- Patient is considered to have SUI that would not be expected to improve unless treated with surgical therapy
- Patient had a history of surgical treatment for urinary incontinence (Trans-obturator tape surgery, Tension-free vaginal tape surgery, etc.)
- Patient has stage II or more of Pelvic Organ Prolapse (POP), or had a history of POP repair surgery within 180 days before prior to study entry
- Patient has a serious illness or medical condition
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method