Trial · NCT02906683

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

NCT02906683, Phase 2, Completed, Taiho Pharmaceutical Co., Ltd.; results first posted 2024-09-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Exploratory Trial of TAS-303 in Female Patients With Stress Urinary Incontinence. Trials, record NCT02906683. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02906683

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Exploratory Trial of TAS-303 in Female Patients With Stress Urinary Incontinence
NCT number: NCT02906683
Status: Completed
Phases: Phase 2
Enrollment: 337 participants, actual
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Conditions: Stress Urinary Incontinence
Interventions: TAS-303, Placebo
First posted: 2016-09-20
Last updated: 2024-09-26
Results first posted: 2024-09-26

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8	Baseline to Week 8 (8 weeks in treatment period)
Primary	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	Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4	Baseline to Week 4 (4 weeks in treatment period)
Secondary	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)
Secondary	Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 in SUI Subgroup	Baseline to Week 4 (4 weeks in treatment period)
Secondary	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)
Secondary	Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 in SUI Subgroup	Baseline to Week 8 (8 weeks in treatment period)
Secondary	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)
Secondary	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
Secondary	Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8	Baseline to Week 8 (8 weeks in treatment period)	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".

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8	Baseline to Week 8 (8 weeks in treatment period)	PPS was used for the analysis.	episodes	MEAN
PRIMARY	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)	PPS was used for the analysis.	Percentage change	MEAN
SECONDARY	Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4	Baseline to Week 4 (4 weeks in treatment period)	PPS was used for the analysis.	episodes	MEAN
SECONDARY	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)	PPS was used for the analysis.	Percentage change	MEAN
SECONDARY	Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 in SUI Subgroup	Baseline to Week 4 (4 weeks in treatment period)	PPS was used for the analysis. This analysis was conducted in SUI subgroup. This subgroup includes patients with only SUI but excludes those with MUI.	episodes	MEAN
SECONDARY	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)	PPS was used for the analysis. This analysis was conducted in SUI subgroup. This subgroup includes patients with only SUI but excludes those with MUI.	Percentage change	MEAN
SECONDARY	Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 in SUI Subgroup	Baseline to Week 8 (8 weeks in treatment period)	PPS was used for the analysis. This analysis was conducted in SUI subgroup. This subgroup includes patients with only SUI but excludes those with MUI.	episodes	MEAN
SECONDARY	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)	PPS was used for the analysis. This analysis was conducted in SUI subgroup. This subgroup includes patients with only SUI but excludes those with MUI.	Percentage change	MEAN
SECONDARY	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	PPS was used for the analysis.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8	Baseline to Week 8 (8 weeks in treatment period)	PPS was used for the analysis.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group303

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8	TAS-303 3 mg	IEF per 24 hours at baseline	2.9	Standard Deviation 2.3	episodes
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8	TAS-303 6 mg	IEF per 24 hours at baseline	2.5	Standard Deviation 1.5	episodes
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8	Placebo	IEF per 24 hours at baseline	2.6	Standard Deviation 1.7	episodes
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8	TAS-303 3 mg	IEF per 24 hours at Week 8	2.0	Standard Deviation 2.3	episodes
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8	TAS-303 6 mg	IEF per 24 hours at Week 8	1.7	Standard Deviation 1.7	episodes
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8	Placebo	IEF per 24 hours at Week 8	1.9	Standard Deviation 1.9	episodes
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8	TAS-303 3 mg		-34.7	Standard Deviation 39.9	Percentage change
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8	TAS-303 6 mg		-35.4	Standard Deviation 39.0	Percentage change
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8	Placebo		-28.1	Standard Deviation 47.3	Percentage change
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4	TAS-303 3 mg	IEF per 24 hours at baseline	2.9	Standard Deviation 2.3	episodes

1 to 10 of 303Source ClinicalTrials.gov

See all 303 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	TAS-303 3 mg	85
Overall Study	STARTED	TAS-303 6 mg	86
Overall Study	STARTED	Placebo	85
Overall Study	COMPLETED	TAS-303 3 mg	84
Overall Study	COMPLETED	TAS-303 6 mg	81
Overall Study	COMPLETED	Placebo	82
Overall Study	NOT COMPLETED	TAS-303 3 mg	1
Overall Study	NOT COMPLETED	TAS-303 6 mg	5
Overall Study	NOT COMPLETED	Placebo	3

Source ClinicalTrials.gov

Adverse events189

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Palpitations	Cardiac disorders	TAS-303 3 mg	1	85	1
other	Palpitations	Cardiac disorders	TAS-303 6 mg	0	86	0
other	Palpitations	Cardiac disorders	Placebo	0	85	0
other	Vertigo	Ear and labyrinth disorders	TAS-303 3 mg	0	85	0
other	Vertigo	Ear and labyrinth disorders	TAS-303 6 mg	0	86	0
other	Vertigo	Ear and labyrinth disorders	Placebo	1	85	1
other	Sudden hearing loss	Ear and labyrinth disorders	TAS-303 3 mg	0	85	0
other	Sudden hearing loss	Ear and labyrinth disorders	TAS-303 6 mg	0	86	0
other	Sudden hearing loss	Ear and labyrinth disorders	Placebo	1	85	1
other	Abdominal pain lower	Gastrointestinal disorders	TAS-303 3 mg	1	85	1

1 to 10 of 189Source ClinicalTrials.gov

See all 189 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	TAS-303 3 mg	0	85
Total, all-cause mortality	TAS-303 6 mg	0	86
Total, all-cause mortality	Placebo	0	85
Total, other adverse events	TAS-303 3 mg	31	85
Total, other adverse events	TAS-303 6 mg	20	86
Total, other adverse events	Placebo	26	85
Total, serious adverse events	TAS-303 3 mg	0	85
Total, serious adverse events	TAS-303 6 mg	0	86
Total, serious adverse events	Placebo	0	85

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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