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

• Status: Active, not recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

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