Exploratory Trial of TAS-303 in Female Patients With Stress Urinary Incontinence

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

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

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Drug: TAS-303; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 337
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan
    • Taiho Pharmaceutical Co., Ltd selected site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Oral administration for 8 weeks, once daily.
Experimental: TAS-303 3mg	Drug: TAS-303; Oral administration for 8 weeks, once daily.
Experimental: TAS-303 6mg	Drug: TAS-303; Oral administration for 8 weeks, once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8	Baseline to Week 8 (8 weeks in treatment period)
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8	Baseline to Week 8 (8 weeks in treatment period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4		Baseline to Week 4 (4 weeks in treatment period)
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4		Baseline to Week 4 (4 weeks in treatment period)
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 in SUI Subgroup		Baseline to Week 4 (4 weeks in treatment period)
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4 in SUI Subgroup		Baseline to Week 4 (4 weeks in treatment period)
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 in SUI Subgroup		Baseline to Week 8 (8 weeks in treatment period)
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8 in SUI Subgroup		Baseline to Week 8 (8 weeks in treatment period)
Percentages of the Patients With an Incontinence Amount of ≤ 2.0 g (Deemed Dryness) in the 1-hour Pad Test at Week 8 in the Treatment Period		At Week 8 in the treatment period
Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8	PGI-I was used to evaluate the patients' impression of improvement of urinary incontinence. The improvement of PGI-I was defined as the selection of "Very much better", "Much better", or "A little better". The investigator or subinvestigator instructed patients to evaluate the improvement of urinary incontinence at the evaluation time point using the following 7-point scale: (1) "Very much better"; (2) "Much better"; (3) "A little better"; (4) "No change"; (5) "A little worse"; (6) "Much worse"; and (7) "Very much worse".	Baseline to Week 8 (8 weeks in treatment period)
Any Adverse Events	For tabulation of adverse events, the terms of diagnosis recorded in the eCRFs were converted according to the Medical Dictionary for Regulatory Activities (MedDRA) ver. 20.1 and were expressed as preferred terms of MedDRA.	Baseline to Week 8 (8 weeks in treatment period)
Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period	For tabulation of adverse events, the terms of diagnosis recorded in the eCRFs were converted according to the Medical Dictionary for Regulatory Activities (MedDRA) ver. 20.1 and were expressed as preferred terms of MedDRA.	Baseline to Week 8 (8 weeks in treatment period)
Adverse Drug Reactions	For tabulation of adverse events, the terms of diagnosis recorded in the eCRFs were converted according to the Medical Dictionary for Regulatory Activities (MedDRA) ver. 20.1 and were expressed as preferred terms of MedDRA.	Baseline to Week 8 (8 weeks in treatment period)
Serious Adverse Events		Baseline to Week 8 (8 weeks in treatment period)
Adverse Events Leading to Discontinuation of Administration		Baseline to Week 8 (8 weeks in treatment period)

Collaborators and Investigators

• Sponsor: Taiho Pharmaceutical Co., Ltd.
• Investigators: Study Director: Taiho Pharmaceutical Co., Ltd, Taiho Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2016
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: September 8, 2016
• First Submitted That Met QC Criteria: September 14, 2016
• First Posted (Estimated): September 20, 2016

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: May 27, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Lower Urinary Tract Symptoms; Urinary Incontinence, Stress; Urinary Incontinence
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 10060050