Stress Urinary Incontinence
Conditions
Keywords
Urinary Incontinence, Urinary Incontinence, Stress, Lower Urinary Tract Symptoms
Brief summary
The purpose of this study is to evaluate the efficacy and safety of TAS-303 in female patients with stress urinary incontinence.
Detailed description
The main purpose of this study is to assess the efficacy of TAS-303 in female patients with stress urinary incontinence (SUI) compared with placebo as measured by the percent change in the average SUI episode frequency per 24 hours from baseline at week 12.
Interventions
DRUGTAS-303 18 mg/day
Oral administration for 12 weeks, once daily
DRUGPlacebo
Oral administration for 12 weeks, once daily
Sponsors
Taiho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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 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 |
|---|---|
| The percent change in the average SUI episode frequency per 24 hours | Baseline, week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The urinary incontinence volume measured in a 24-hour pad test | Baseline, week 12 | — |
| The change in the international Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) | Baseline, week 4, week 8, week 12 | — |
| The change in the Patient's Global Impressions of Improvement (PGI I) questionnaire. | Baseline, week 4, week 8, week 12 | — |
| The average urinary incontinence episode frequency per 24 hours | Baseline, week 4, week 8, week 12 | — |
| The changes in the overactive bladder symptom score (OABSS) | Baseline, week 4, week 8, week 12 | The minimum score is 0 points and the maximum is 15 points. The higher scores mean a worse outcome. |
| Incidence of adverse events and side effects | Up to 13 Weeks | — |
| The change in the incontinence quality of life instrument (I QOL) scores | Baseline, week 4, week 8, week 12 | The minimum score is 22 points and the maximum is 110 points. The higher scores mean a worse outcome. |
Countries
Japan
Outcome results
None listed