Exploratory Trial 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 for 8 weeks in female patients with stress urinary incontinence (SUI) compared with placebo as measured by the percent change in incontinence episode frequency (IEF) from baseline.

Official Title
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A Phase IIa 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
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has symptoms of Stress Urinary Incontinence (SUI) for at least 12 weeks prior to study entry Patient has at least 1 incontinence episodes per day, and urinary diurnal frequency of 10 or less per day and nocturia of 2 or less per day. Patient is positive in 1-hour pad weight test Exclusion Criteria: Patient has predominant or primary urge incontinence according to investigator judgment Patient had a prior surgical SUI treatment Patient is diagnosed stageII or more of Pelvic Organ Prolapse Patient has symptoms of Urinary tract infection (UTI) Patient is positive pregnancy test Patient has on physical examination, neurological and/or vaginal examination results which, in the opinion of the investigator, should exclude the subject.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 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 3mg<br> | Drug: TAS-303<br>* Oral administration for 8 weeks, once daily.<br>|
| Experimental: TAS-303 6mg<br> | Drug: TAS-303<br>* Oral administration for 8 weeks, once daily.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral administration for 8 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 incontinence episode frequency |  | Baseline, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the incontinence episode frequency |  | Baseline, 4 weeks, 8 weeks | 
| The change in the incontinence amount in 1-hour pad weight test |  | Baseline, 8 weeks | 
| The change in the international Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF) |  | Baseline, 4 weeks, 8 weeks | 
| The change in the Patient's Global Impressions of Improvement (PGI I) questionnaire. |  | Baseline, 4 weeks, 8 weeks | 
| The change in the incontinence quality of life instrument (I QOL) scores |  | Baseline and 4 and 8 weeks after the administration | 
| Safety assessed by incidence and severity of adverse events |  | 12 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