Stress urinary incontinence
Conditions
Interventions
investigational material(s)
Generic name etc : TAS-303
INN of investigational material : -
Therapeutic category code : 259 Other agents for uro-genital and anal organ
Dosage and Administration for Inv
Sponsors
Taiho Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy The percent change in the average SUI episode frequency per 24 hours from baseline at week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy -The average urinary incontinence episode frequency per 24 hours - The urinary incontinence volume measured in a 24-hour pad test -Various questionnaire scores (ICIQ-SF, PGI-I, I-QOL, OABSS) -Incidence of adverse events and side effects etc | — |
Countries
Japan
Outcome results
None listed