A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of TAS-303 in female patients with stress urinary incontinence.

Detailed Description
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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.

Official Title
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A Phase 2, Randomized, Placebo-controlled, Double-blind Study of TAS-303 in Female Patients With Stress Urinary Incontinence

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Drug: TAS-303 18 mg/day
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAS-303<br> | Drug: TAS-303 18 mg/day<br>* Oral administration for 12 weeks, once daily<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral administration for 12 weeks, once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent change in the average SUI episode frequency per 24 hours |  | Baseline, week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The average urinary incontinence episode frequency per 24 hours |  | Baseline, week 4, week 8, week 12 | 
| 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 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. | 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. | Baseline, week 4, week 8, week 12 | 
| Incidence of adverse events and side effects |  | Up to 13 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Incontinence, Urinary Incontinence, Stress, Lower Urinary Tract Symptoms