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

Phase 2

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Drug: TAS-303 18 mg/day; Drug: Placebo

• Registration Number: NCT04512053
• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2020-08-07
• Study First Submitted QC: 2020-08-11
• Study First Posted: 2020-08-13
• Study Start: 2020-09-04
• Primary Completion: 2021-12-22
• Study Completion: 2021-12-22
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-08
• Last Update Posted: 2022-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 231

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAS-303	TAS-303 18 mg/day	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
The percent change in the average SUI episode frequency per 24 hours	Baseline, week 12

Secondary Outcome Measures

Name	Time	Method
The change in the Patient's Global Impressions of Improvement (PGI I) questionnaire.	Baseline, week 4, week 8, 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 incontinence quality of life instrument (I QOL) scores	Baseline, week 4, week 8, week 12	The minimum score is 22 points and the maximum is 110 points. The higher scores mean a worse outcome.
The changes in the overactive bladder symptom score (OABSS)	Baseline, week 4, week 8, week 12	The minimum score is 0 points and the maximum is 15 points. The higher scores mean a worse outcome.
Incidence of adverse events and side effects	Up to 13 Weeks
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

Trial Locations

Locations (1)

A site selected by Taiho Pharmaceutical Co., Ltd.; 🇯🇵 Tokyo, Japan