Stress Urinary Incontinence
Conditions
Keywords
Urinary Incontinence, Urinary Incontinence, Stress, Lower Urinary Tract Symptoms
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 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.
Interventions
DRUGTAS-303
Oral administration for 8 weeks, once daily.
DRUGPlacebo
Oral administration for 8 weeks, once daily.
Sponsors
Taiho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 | Baseline to Week 4 (4 weeks in treatment period) | — |
| Any Adverse Events | Baseline to Week 8 (8 weeks in 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. |
| Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Baseline to Week 8 (8 weeks in 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. |
| Adverse Drug Reactions | Baseline to Week 8 (8 weeks in 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. |
| 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) | — |
| 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. |
| 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) | — |
Countries
Japan
Participant flow
Recruitment details
This study was undertaken at 31 centers in Japan between 17 October 2016 and 25 April 2018. Of the 386 patients who gave informed consent and received screening tests, 49 patients were withdrawn at screening. The number of patients enrolled in the observation period was 337 patients, but after the end of the observation period, 256 patients were deemed to be eligible for enrollment in the treatment period.
Participants by arm
| Arm | Count |
|---|---|
| TAS-303 3 mg Female patients with stress urinary incontinence (SUI) orally received 3 mg of TAS-303 once daily for 8 weeks. | 84 |
| TAS-303 6 mg Female patients with SUI orally received 6 mg of TAS-303 once daily for 8 weeks. | 80 |
| Placebo Female patients with SUI orally received placebo once daily for 8 weeks. | 81 |
| Total | 245 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 |
| Overall Study | Patient did not meet the eligibility criteria for the study | 1 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 1 | 1 |
| Overall Study | Study treatment becomes impossible due to changing hospital or other reasons | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | TAS-303 3 mg | Total | Placebo | TAS-303 6 mg |
|---|---|---|---|---|
| 1-hour Pad weight Test | 33.85 gram STANDARD_DEVIATION 70.98 | 33.65 gram STANDARD_DEVIATION 60.67 | 37.92 gram STANDARD_DEVIATION 60.49 | 29.12 gram STANDARD_DEVIATION 48.26 |
| Age, Continuous | 57.0 years STANDARD_DEVIATION 11.8 | 56.3 years STANDARD_DEVIATION 12.2 | 55.9 years STANDARD_DEVIATION 11.3 | 56.0 years STANDARD_DEVIATION 13.4 |
| Number of Urinary Incontinence episodes per 24 hours | 2.853 episodes per 24hr STANDARD_DEVIATION 2.322 | 2.648 episodes per 24hr STANDARD_DEVIATION 1.874 | 2.582 episodes per 24hr STANDARD_DEVIATION 1.673 | 2.499 episodes per 24hr STANDARD_DEVIATION 1.507 |
| Prior surgery for pelvic organ prolapse | 10 Participants | 20 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 84 Participants | 245 Participants | 81 Participants | 80 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 84 participants | 245 participants | 81 participants | 80 participants |
| Sex: Female, Male Female | 84 Participants | 245 Participants | 81 Participants | 80 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Type of Urinary Incontinence Mixed Urinary Incontinence (MUI) | 21 Participants | 60 Participants | 20 Participants | 19 Participants |
| Type of Urinary Incontinence Stress Urinary Incontinence (SUI) | 63 Participants | 185 Participants | 61 Participants | 61 Participants |
| Urinary Incontinence episodes of <2 per 24 hours | 39 Participants | 120 Participants | 41 Participants | 40 Participants |
| Urinary Incontinence episodes of ≥2 per 24 hours | 45 Participants | 125 Participants | 40 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 85 | 0 / 86 | 0 / 85 |
| other Total, other adverse events | 31 / 85 | 20 / 86 | 26 / 85 |
| serious Total, serious adverse events | 0 / 85 | 0 / 86 | 0 / 85 |
Outcome results
Primary
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Population: PPS was used for the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAS-303 3 mg | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 | IEF per 24 hours at baseline | 2.9 episodes | Standard Deviation 2.3 |
| TAS-303 3 mg | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 | IEF per 24 hours at Week 8 | 2.0 episodes | Standard Deviation 2.3 |
| TAS-303 6 mg | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 | IEF per 24 hours at baseline | 2.5 episodes | Standard Deviation 1.5 |
| TAS-303 6 mg | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 | IEF per 24 hours at Week 8 | 1.7 episodes | Standard Deviation 1.7 |
| Placebo | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 | IEF per 24 hours at baseline | 2.6 episodes | Standard Deviation 1.7 |
| Placebo | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 | IEF per 24 hours at Week 8 | 1.9 episodes | Standard Deviation 1.9 |
Primary
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Population: PPS was used for the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAS-303 3 mg | Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8 | -34.7 Percentage change | Standard Deviation 39.9 |
| TAS-303 6 mg | Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8 | -35.4 Percentage change | Standard Deviation 39 |
| Placebo | Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8 | -28.1 Percentage change | Standard Deviation 47.3 |
Comparison: TAS-303 3 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8p-value: 0.32995% CI: [-20.1, 6.7]t-test, 2 sided
Comparison: TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8p-value: 0.28595% CI: [-20.9, 6.2]t-test, 2 sided
Secondary
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.
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Population: All treated population was used for the analysis. This analysis set includes all patients enrolled in the observation period who received at least 1 dose of the study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TAS-303 3 mg | Adverse Drug Reactions | Constipation | 1 Participants |
| TAS-303 3 mg | Adverse Drug Reactions | Alanine aminotransferase increased | 1 Participants |
| TAS-303 3 mg | Adverse Drug Reactions | Any Events | 6 Participants |
| TAS-303 3 mg | Adverse Drug Reactions | Aspartate aminotransferase increased | 1 Participants |
| TAS-303 3 mg | Adverse Drug Reactions | Blood creatine phosphokinase increased | 1 Participants |
| TAS-303 3 mg | Adverse Drug Reactions | White blood cell count increased | 1 Participants |
| TAS-303 3 mg | Adverse Drug Reactions | Liver function test increased | 1 Participants |
| TAS-303 3 mg | Adverse Drug Reactions | Rash | 1 Participants |
| TAS-303 6 mg | Adverse Drug Reactions | Alanine aminotransferase increased | 0 Participants |
| TAS-303 6 mg | Adverse Drug Reactions | Liver function test increased | 0 Participants |
| TAS-303 6 mg | Adverse Drug Reactions | Aspartate aminotransferase increased | 0 Participants |
| TAS-303 6 mg | Adverse Drug Reactions | Blood creatine phosphokinase increased | 0 Participants |
| TAS-303 6 mg | Adverse Drug Reactions | White blood cell count increased | 0 Participants |
| TAS-303 6 mg | Adverse Drug Reactions | Constipation | 0 Participants |
| TAS-303 6 mg | Adverse Drug Reactions | Rash | 0 Participants |
| TAS-303 6 mg | Adverse Drug Reactions | Any Events | 0 Participants |
| Placebo | Adverse Drug Reactions | Any Events | 0 Participants |
| Placebo | Adverse Drug Reactions | Alanine aminotransferase increased | 0 Participants |
| Placebo | Adverse Drug Reactions | Constipation | 0 Participants |
| Placebo | Adverse Drug Reactions | Aspartate aminotransferase increased | 0 Participants |
| Placebo | Adverse Drug Reactions | Liver function test increased | 0 Participants |
| Placebo | Adverse Drug Reactions | White blood cell count increased | 0 Participants |
| Placebo | Adverse Drug Reactions | Blood creatine phosphokinase increased | 0 Participants |
| Placebo | Adverse Drug Reactions | Rash | 0 Participants |
Secondary
Adverse Events Leading to Discontinuation of Administration
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Population: All treated population was used for the analysis. This analysis set includes all patients enrolled in the observation period who received at least 1 dose of the study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TAS-303 3 mg | Adverse Events Leading to Discontinuation of Administration | Radius fracture | 0 Participants |
| TAS-303 3 mg | Adverse Events Leading to Discontinuation of Administration | Any adverse events leading to discontinuation of administration | 0 Participants |
| TAS-303 3 mg | Adverse Events Leading to Discontinuation of Administration | Spinal compression fracture | 0 Participants |
| TAS-303 6 mg | Adverse Events Leading to Discontinuation of Administration | Radius fracture | 1 Participants |
| TAS-303 6 mg | Adverse Events Leading to Discontinuation of Administration | Any adverse events leading to discontinuation of administration | 1 Participants |
| TAS-303 6 mg | Adverse Events Leading to Discontinuation of Administration | Spinal compression fracture | 1 Participants |
| Placebo | Adverse Events Leading to Discontinuation of Administration | Any adverse events leading to discontinuation of administration | 0 Participants |
| Placebo | Adverse Events Leading to Discontinuation of Administration | Spinal compression fracture | 0 Participants |
| Placebo | Adverse Events Leading to Discontinuation of Administration | Radius fracture | 0 Participants |
Secondary
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.
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Population: All treated population was used for the analysis. This analysis set includes all patients enrolled in the observation period who received at least 1 dose of the study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TAS-303 3 mg | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Alanine aminotransferase increased | 2 Participants |
| TAS-303 3 mg | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Constipation | 2 Participants |
| TAS-303 3 mg | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Nasopharyngitis | 9 Participants |
| TAS-303 3 mg | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Eczema | 0 Participants |
| TAS-303 3 mg | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Diarrhoea | 0 Participants |
| TAS-303 3 mg | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Headache | 0 Participants |
| TAS-303 3 mg | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Cough | 0 Participants |
| TAS-303 3 mg | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Decreased appetite | 0 Participants |
| TAS-303 3 mg | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Cystitis | 2 Participants |
| TAS-303 6 mg | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Decreased appetite | 2 Participants |
| TAS-303 6 mg | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Headache | 2 Participants |
| TAS-303 6 mg | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Alanine aminotransferase increased | 0 Participants |
| TAS-303 6 mg | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Cystitis | 0 Participants |
| TAS-303 6 mg | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Eczema | 0 Participants |
| TAS-303 6 mg | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Cough | 2 Participants |
| TAS-303 6 mg | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Nasopharyngitis | 4 Participants |
| TAS-303 6 mg | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Diarrhoea | 2 Participants |
| TAS-303 6 mg | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Constipation | 1 Participants |
| Placebo | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Eczema | 2 Participants |
| Placebo | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Nasopharyngitis | 8 Participants |
| Placebo | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Constipation | 0 Participants |
| Placebo | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Headache | 0 Participants |
| Placebo | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Cough | 0 Participants |
| Placebo | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Diarrhoea | 0 Participants |
| Placebo | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Decreased appetite | 0 Participants |
| Placebo | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Alanine aminotransferase increased | 0 Participants |
| Placebo | Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period | Cystitis | 1 Participants |
Secondary
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.
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Population: All treated population was used for the analysis. This analysis set includes all patients enrolled in the observation period who received at least 1 dose of the study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TAS-303 3 mg | Any Adverse Events | Pyuria | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Blood potassium increased | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Allergy to arthropod bite | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Sleep disorder | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Blood creatine phosphokinase increased | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Bronchitis | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Diarrhoea | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Gingivitis | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Aspartate aminotransferase increased | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Herpes zoster | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Headache | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Alanine aminotransferase increased | 2 Participants |
| TAS-303 3 mg | Any Adverse Events | Hordeolum | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Tenosynovitis | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Ear abrasion | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Influenza | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Cystitis | 2 Participants |
| TAS-303 3 mg | Any Adverse Events | Skin injury | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Nasopharyngitis | 9 Participants |
| TAS-303 3 mg | Any Adverse Events | Any adverse events | 31 Participants |
| TAS-303 3 mg | Any Adverse Events | Wound | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Otitis media | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Dermatitis contact | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Spinal compression fracture | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Periodontitis | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Radius fracture | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Upper respiratory tract infection | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Myalgia | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Muscle injury | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Cystitis bacterial | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Palpitations | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Arthropod sting | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Hypertension | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Musculoskeletal pain | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Vertigo | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Upper respiratory tract inflammation | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Back pain | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Sudden hearing loss | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Eczema | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Arthralgia | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Abdominal pain lower | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Dermatitis atopic | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Decreased appetite | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Constipation | 2 Participants |
| TAS-303 3 mg | Any Adverse Events | Cough | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Dyslipidaemia | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Dental caries | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Gastritis | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Rash | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Liver function test increased | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Nausea | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Oropharyngeal pain | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | White blood cell count increased | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Stomatitis | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Hypotonic urinary bladder | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Eosinophil count increased | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Vomiting | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Skin discomfort | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Electrocardiogram QT prolonged | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Malaise | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Thirst | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | C-reactive protein increased | 1 Participants |
| TAS-303 3 mg | Any Adverse Events | Pyrexia | 0 Participants |
| TAS-303 3 mg | Any Adverse Events | Proteinuria | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Gastritis | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Periodontitis | 1 Participants |
| TAS-303 6 mg | Any Adverse Events | Pyuria | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Dermatitis contact | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Eczema | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Rash | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Skin discomfort | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Dental caries | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Diarrhoea | 2 Participants |
| TAS-303 6 mg | Any Adverse Events | Any adverse events | 20 Participants |
| TAS-303 6 mg | Any Adverse Events | Palpitations | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Vertigo | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Sudden hearing loss | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Abdominal pain lower | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Constipation | 1 Participants |
| TAS-303 6 mg | Any Adverse Events | Cystitis | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Nausea | 1 Participants |
| TAS-303 6 mg | Any Adverse Events | Stomatitis | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Vomiting | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Malaise | 1 Participants |
| TAS-303 6 mg | Any Adverse Events | Pyrexia | 1 Participants |
| TAS-303 6 mg | Any Adverse Events | Thirst | 1 Participants |
| TAS-303 6 mg | Any Adverse Events | Allergy to arthropod bite | 1 Participants |
| TAS-303 6 mg | Any Adverse Events | Bronchitis | 1 Participants |
| TAS-303 6 mg | Any Adverse Events | Gingivitis | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Herpes zoster | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Hordeolum | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Influenza | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Nasopharyngitis | 4 Participants |
| TAS-303 6 mg | Any Adverse Events | Otitis media | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Upper respiratory tract infection | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Cystitis bacterial | 1 Participants |
| TAS-303 6 mg | Any Adverse Events | Arthropod sting | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Muscle injury | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Radius fracture | 1 Participants |
| TAS-303 6 mg | Any Adverse Events | Spinal compression fracture | 1 Participants |
| TAS-303 6 mg | Any Adverse Events | Wound | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Skin injury | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Ear abrasion | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Alanine aminotransferase increased | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Aspartate aminotransferase increased | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Blood creatine phosphokinase increased | 1 Participants |
| TAS-303 6 mg | Any Adverse Events | Blood potassium increased | 1 Participants |
| TAS-303 6 mg | Any Adverse Events | C-reactive protein increased | 1 Participants |
| TAS-303 6 mg | Any Adverse Events | Electrocardiogram QT prolonged | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Eosinophil count increased | 1 Participants |
| TAS-303 6 mg | Any Adverse Events | White blood cell count increased | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Liver function test increased | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Dyslipidaemia | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Decreased appetite | 2 Participants |
| TAS-303 6 mg | Any Adverse Events | Arthralgia | 1 Participants |
| TAS-303 6 mg | Any Adverse Events | Back pain | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Musculoskeletal pain | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Myalgia | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Tenosynovitis | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Headache | 2 Participants |
| TAS-303 6 mg | Any Adverse Events | Sleep disorder | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Proteinuria | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Hypotonic urinary bladder | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Cough | 2 Participants |
| TAS-303 6 mg | Any Adverse Events | Upper respiratory tract inflammation | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Oropharyngeal pain | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Dermatitis atopic | 0 Participants |
| TAS-303 6 mg | Any Adverse Events | Hypertension | 0 Participants |
| Placebo | Any Adverse Events | Blood potassium increased | 0 Participants |
| Placebo | Any Adverse Events | Malaise | 0 Participants |
| Placebo | Any Adverse Events | Skin discomfort | 1 Participants |
| Placebo | Any Adverse Events | C-reactive protein increased | 1 Participants |
| Placebo | Any Adverse Events | Vomiting | 1 Participants |
| Placebo | Any Adverse Events | Oropharyngeal pain | 1 Participants |
| Placebo | Any Adverse Events | Electrocardiogram QT prolonged | 0 Participants |
| Placebo | Any Adverse Events | Stomatitis | 0 Participants |
| Placebo | Any Adverse Events | Proteinuria | 1 Participants |
| Placebo | Any Adverse Events | Eosinophil count increased | 0 Participants |
| Placebo | Any Adverse Events | Nausea | 0 Participants |
| Placebo | Any Adverse Events | Rash | 0 Participants |
| Placebo | Any Adverse Events | White blood cell count increased | 0 Participants |
| Placebo | Any Adverse Events | Gastritis | 1 Participants |
| Placebo | Any Adverse Events | Periodontitis | 0 Participants |
| Placebo | Any Adverse Events | Liver function test increased | 0 Participants |
| Placebo | Any Adverse Events | Constipation | 0 Participants |
| Placebo | Any Adverse Events | Hypotonic urinary bladder | 1 Participants |
| Placebo | Any Adverse Events | Dyslipidaemia | 0 Participants |
| Placebo | Any Adverse Events | Abdominal pain lower | 0 Participants |
| Placebo | Any Adverse Events | Eczema | 2 Participants |
| Placebo | Any Adverse Events | Decreased appetite | 0 Participants |
| Placebo | Any Adverse Events | Sudden hearing loss | 1 Participants |
| Placebo | Any Adverse Events | Hypertension | 0 Participants |
| Placebo | Any Adverse Events | Arthralgia | 0 Participants |
| Placebo | Any Adverse Events | Vertigo | 1 Participants |
| Placebo | Any Adverse Events | Cough | 0 Participants |
| Placebo | Any Adverse Events | Back pain | 1 Participants |
| Placebo | Any Adverse Events | Palpitations | 0 Participants |
| Placebo | Any Adverse Events | Dermatitis contact | 1 Participants |
| Placebo | Any Adverse Events | Musculoskeletal pain | 1 Participants |
| Placebo | Any Adverse Events | Any adverse events | 26 Participants |
| Placebo | Any Adverse Events | Cystitis bacterial | 0 Participants |
| Placebo | Any Adverse Events | Dermatitis atopic | 0 Participants |
| Placebo | Any Adverse Events | Arthropod sting | 1 Participants |
| Placebo | Any Adverse Events | Upper respiratory tract infection | 0 Participants |
| Placebo | Any Adverse Events | Myalgia | 1 Participants |
| Placebo | Any Adverse Events | Muscle injury | 0 Participants |
| Placebo | Any Adverse Events | Pyuria | 0 Participants |
| Placebo | Any Adverse Events | Bronchitis | 1 Participants |
| Placebo | Any Adverse Events | Radius fracture | 0 Participants |
| Placebo | Any Adverse Events | Otitis media | 0 Participants |
| Placebo | Any Adverse Events | Upper respiratory tract inflammation | 0 Participants |
| Placebo | Any Adverse Events | Spinal compression fracture | 0 Participants |
| Placebo | Any Adverse Events | Nasopharyngitis | 8 Participants |
| Placebo | Any Adverse Events | Tenosynovitis | 1 Participants |
| Placebo | Any Adverse Events | Wound | 1 Participants |
| Placebo | Any Adverse Events | Influenza | 0 Participants |
| Placebo | Any Adverse Events | Diarrhoea | 0 Participants |
| Placebo | Any Adverse Events | Skin injury | 1 Participants |
| Placebo | Any Adverse Events | Hordeolum | 0 Participants |
| Placebo | Any Adverse Events | Pyrexia | 0 Participants |
| Placebo | Any Adverse Events | Ear abrasion | 0 Participants |
| Placebo | Any Adverse Events | Herpes zoster | 1 Participants |
| Placebo | Any Adverse Events | Headache | 0 Participants |
| Placebo | Any Adverse Events | Alanine aminotransferase increased | 0 Participants |
| Placebo | Any Adverse Events | Gingivitis | 1 Participants |
| Placebo | Any Adverse Events | Dental caries | 1 Participants |
| Placebo | Any Adverse Events | Aspartate aminotransferase increased | 0 Participants |
| Placebo | Any Adverse Events | Allergy to arthropod bite | 0 Participants |
| Placebo | Any Adverse Events | Cystitis | 1 Participants |
| Placebo | Any Adverse Events | Blood creatine phosphokinase increased | 0 Participants |
| Placebo | Any Adverse Events | Thirst | 0 Participants |
| Placebo | Any Adverse Events | Sleep disorder | 0 Participants |
Secondary
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4
Time frame: Baseline to Week 4 (4 weeks in treatment period)
Population: PPS was used for the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAS-303 3 mg | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 | IEF per 24 hours at baseline | 2.9 episodes | Standard Deviation 2.3 |
| TAS-303 3 mg | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 | IEF per 24 hours at Week 4 | 2.3 episodes | Standard Deviation 2.2 |
| TAS-303 6 mg | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 | IEF per 24 hours at baseline | 2.5 episodes | Standard Deviation 1.5 |
| TAS-303 6 mg | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 | IEF per 24 hours at Week 4 | 2.0 episodes | Standard Deviation 1.5 |
| Placebo | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 | IEF per 24 hours at baseline | 2.6 episodes | Standard Deviation 1.7 |
| Placebo | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 | IEF per 24 hours at Week 4 | 2.2 episodes | Standard Deviation 1.7 |
Secondary
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 in SUI Subgroup
Time frame: Baseline to Week 4 (4 weeks in treatment period)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAS-303 3 mg | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 in SUI Subgroup | IEF per 24 hours at baseline | 2.7 episodes | Standard Deviation 2.4 |
| TAS-303 3 mg | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 in SUI Subgroup | IEF per 24 hours at Week 4 | 2.0 episodes | Standard Deviation 1.9 |
| TAS-303 6 mg | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 in SUI Subgroup | IEF per 24 hours at baseline | 2.5 episodes | Standard Deviation 1.5 |
| TAS-303 6 mg | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 in SUI Subgroup | IEF per 24 hours at Week 4 | 1.9 episodes | Standard Deviation 1.5 |
| Placebo | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 in SUI Subgroup | IEF per 24 hours at baseline | 2.6 episodes | Standard Deviation 1.7 |
| Placebo | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 in SUI Subgroup | IEF per 24 hours at Week 4 | 2.3 episodes | Standard Deviation 1.9 |
Secondary
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 in SUI Subgroup
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAS-303 3 mg | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 in SUI Subgroup | IEF per 24 hours at baseline | 2.7 episodes | Standard Deviation 2.4 |
| TAS-303 3 mg | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 in SUI Subgroup | IEF per 24 hours at Week 8 | 1.8 episodes | Standard Deviation 2.1 |
| TAS-303 6 mg | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 in SUI Subgroup | IEF per 24 hours at baseline | 2.5 episodes | Standard Deviation 1.5 |
| TAS-303 6 mg | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 in SUI Subgroup | IEF per 24 hours at Week 8 | 1.8 episodes | Standard Deviation 1.8 |
| Placebo | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 in SUI Subgroup | IEF per 24 hours at baseline | 2.6 episodes | Standard Deviation 1.7 |
| Placebo | Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 in SUI Subgroup | IEF per 24 hours at Week 8 | 2.0 episodes | Standard Deviation 2 |
Secondary
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4
Time frame: Baseline to Week 4 (4 weeks in treatment period)
Population: PPS was used for the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAS-303 3 mg | Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4 | -23.1 Percentage change | Standard Deviation 37.3 |
| TAS-303 6 mg | Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4 | -23.9 Percentage change | Standard Deviation 33.8 |
| Placebo | Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4 | -11.7 Percentage change | Standard Deviation 45.4 |
Comparison: TAS-303 3 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4p-value: 0.08295% CI: [-24.1, 1.5]t-test, 2 sided
Comparison: TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4p-value: 0.05795% CI: [-24.7, 0.4]t-test, 2 sided
Secondary
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4 in SUI Subgroup
Time frame: Baseline to Week 4 (4 weeks in treatment period)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAS-303 3 mg | Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4 in SUI Subgroup | -26.5 Percentage change | Standard Deviation 34.8 |
| TAS-303 6 mg | Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4 in SUI Subgroup | -25.8 Percentage change | Standard Deviation 33.5 |
| Placebo | Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4 in SUI Subgroup | -8.9 Percentage change | Standard Deviation 46.3 |
Comparison: TAS-303 3 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4p-value: 0.01995% CI: [-32.2, -3]t-test, 2 sided
Comparison: TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4p-value: 0.02395% CI: [-31.5, -2.3]t-test, 2 sided
Secondary
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8 in SUI Subgroup
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAS-303 3 mg | Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8 in SUI Subgroup | -37.4 Percentage change | Standard Deviation 33.1 |
| TAS-303 6 mg | Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8 in SUI Subgroup | -35.7 Percentage change | Standard Deviation 37.8 |
| Placebo | Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8 in SUI Subgroup | -26.1 Percentage change | Standard Deviation 47.8 |
Comparison: TAS-303 3 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8p-value: 0.12595% CI: [-25.9, 3.2]t-test, 2 sided
Comparison: TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8p-value: 0.22195% CI: [-25.1, 5.9]t-test, 2 sided
Secondary
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.
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Population: PPS was used for the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TAS-303 3 mg | Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8 | Week 4 | 49 Participants |
| TAS-303 3 mg | Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8 | Baseline | 28 Participants |
| TAS-303 3 mg | Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8 | Week 8 | 61 Participants |
| TAS-303 6 mg | Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8 | Week 4 | 58 Participants |
| TAS-303 6 mg | Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8 | Baseline | 29 Participants |
| TAS-303 6 mg | Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8 | Week 8 | 55 Participants |
| Placebo | Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8 | Baseline | 26 Participants |
| Placebo | Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8 | Week 8 | 53 Participants |
| Placebo | Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8 | Week 4 | 44 Participants |
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
Time frame: At Week 8 in the treatment period
Population: PPS was used for the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAS-303 3 mg | 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 | 25 Participants |
| TAS-303 6 mg | 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 | 27 Participants |
| Placebo | 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 | 13 Participants |
Secondary
Serious Adverse Events
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Population: All treated population was used for the analysis. This analysis set includes all patients enrolled in the observation period who received at least 1 dose of the study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAS-303 3 mg | Serious Adverse Events | 0 Participants |
| TAS-303 6 mg | Serious Adverse Events | 0 Participants |
| Placebo | Serious Adverse Events | 0 Participants |