Clinical trial NCT04512053: A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence
Official title: A Phase 2, Randomized, Placebo-controlled, Double-blind Study of TAS-303 in Female Patients With Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stress Urinary Incontinence
Keywords: Urinary Incontinence
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-08-13
Enrollment: 231
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: The percent change in the average SUI episode frequency per 24 hours
timeFrame: Baseline, week 12
Secondary outcomes:
measure: The average urinary incontinence episode frequency per 24 hours
timeFrame: Baseline, week 4, week 8, week 12
measure: The urinary incontinence volume measured in a 24-hour pad test
timeFrame: Baseline, week 12
measure: The change in the international Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
timeFrame: Baseline, week 4, week 8, week 12
measure: The change in the Patient's Global Impressions of Improvement (PGI I) questionnaire.
timeFrame: Baseline, week 4, week 8, week 12
measure: The change in the incontinence quality of life instrument (I QOL) scores
timeFrame: Baseline, week 4, week 8, week 12
measure: The changes in the overactive bladder symptom score (OABSS)
timeFrame: Baseline, week 4, week 8, week 12
measure: Incidence of adverse events and side effects
timeFrame: Up to 13 Weeks
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: A site selected by Taiho Pharmaceutical Co., Ltd.
city: Fukuoka
country: Japan
facility: A site selected by Taiho Pharmaceutical Co., Ltd.
city: Osaka
country: Japan
facility: A site selected by Taiho Pharmaceutical Co., Ltd.
city: Tokyo
country: Japan
facility: A site selected by Taiho Pharmaceutical Co., Ltd.
Study officials:
affiliation: Taiho Pharmaceutical Co., Ltd.
name: Taiho Pharmaceutical Co., Ltd.
role: STUDY_DIRECTOR
References: