JPRN-jRCT2080225307
Completed
Phase 2
A phase 2, randomized, placebo-controlled, double-blind study of TAS-303 in female patients with stress urinary incontinence
ConditionsStress urinary incontinence
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Stress urinary incontinence
- Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Enrollment
- 186
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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