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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
231
Oral administration for 12 weeks, once daily
Oral administration for 12 weeks, once daily
A site selected by Taiho Pharmaceutical Co., Ltd.
Aichi, Japan
A site selected by Taiho Pharmaceutical Co., Ltd.
Fukuoka, Japan
A site selected by Taiho Pharmaceutical Co., Ltd.
Osaka, Japan
A site selected by Taiho Pharmaceutical Co., Ltd.
Tokyo, Japan
The percent change in the average SUI episode frequency per 24 hours
Time frame: Baseline, week 12
The average urinary incontinence episode frequency per 24 hours
Time frame: Baseline, week 4, week 8, week 12
The urinary incontinence volume measured in a 24-hour pad test
Time frame: Baseline, week 12
The change in the international Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Time frame: Baseline, week 4, week 8, week 12
The change in the Patient's Global Impressions of Improvement (PGI I) questionnaire.
Time frame: Baseline, week 4, week 8, week 12
The change in the incontinence quality of life instrument (I QOL) scores
The minimum score is 22 points and the maximum is 110 points. The higher scores mean a worse outcome.
Time frame: Baseline, week 4, week 8, week 12
The changes in the overactive bladder symptom score (OABSS)
The minimum score is 0 points and the maximum is 15 points. The higher scores mean a worse outcome.
Time frame: Baseline, week 4, week 8, week 12
Incidence of adverse events and side effects
Time frame: Up to 13 Weeks
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