Overactive Bladder
Conditions
Brief summary
To assess the long term safety, tolerability and efficacy of fesoterodine in patients with OAB.
Interventions
4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult OAB patients who present with OAB symptoms, including micturitions \>= 8 per day and urinary urgency episodes \>=1 per day.
Exclusion criteria
* Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients. * Patient has a known neurological disease influencing bladder function. * Patient has a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | 52 Weeks | The number of subjects who experienced AEs (all causality and treatment-related ) based on safety assessment during the study were summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | Week 4, 8, 28 and 52 | The number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean number of micturitions per 24 hours was calculated as the total number of micturitions for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline |
| Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 4, 8, 28 and 52 | The number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean number of urgency episodes per 24 hours was calculated as the total number of urgency episodes for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline |
| Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 4, 8, 28 and 52 | The number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean number of incontinence episodes per 24 hours was calculated as the total number of incontinence episodes for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline |
| Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | Week 4, 8, 28 and 52 | The number of nighttime micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean number of nighttime micturitions per 24 hours was calculated as the total number of nighttime micturitions for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline |
| Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 4, 8, 28 and 52 | The number of UUI episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean number of UUI episodes per 24 hours was calculated as the total number of UUI episodes for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline |
| Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Week 28 and 52 | KHQ was used to assess the impact of bladder problems on quality of life. The scores ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response. A negative change indicates improvement. KHQ consists of the following domains: * General health perceptions (GHP) * Impact on life * Role limitations * Physical limitations * Social limitations * Personal relationships (PR) * Emotions * Sleep/energy * Incontinence severity measures (ISM) Change: mean at Week 28 and 52 minus mean at Baseline |
| Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | Week 28 and 52 | OAB-q was used to assess the extent of subjects who had been botehred by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL). OAB-q consists of the symptom bother score(SBS), the HRQL total score and subscale scores (Coping, Concern, Sleep and Social). The SBS ranges from 0 to 100, where 0=minimal severity and 100=greatest severity (negative change indicates improvement). The HRQL scores range from 0 to 100, where 0=worst outcome and 100=best outcome (positive change indicates improvement). Change: mean at Week 28 and 52 minus mean at baseline |
| The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage | Week 28 and 52 | The number of subjects whose perception of bladder condition improved at least by one grade on PPBC from baseline at Week 28 and 52. The PPBC was rated on a 6-point scale as follows: 1. no problems at all 2. some very minor problems 3. some minor problems 4. some moderate problems 5. severe problems 6. many severe problems |
| Change From Baseline in Grade of PPBC at Week 28 and 52 | Week 28 and 52 | The PPBC assessment was rated on a 6-point scale as follows: 1. no problems at all 2. some very minor problems 3. some minor problems 4. some moderate problems 5. severe problems 6. many severe problems Change: mean at Week 28 and 52 minus mean at baseline A negative change indicates improvement. |
| Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Week 4, 8, 28 and 52 | Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean voided volume per micturitions was calculated as the total voided volume for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline |
Countries
Japan
Participant flow
Recruitment details
Subjects were screened at 12 centers in Japan.
Pre-assignment details
After screening, eligible subjects entered a run-in phase during which they completed a 3-day micturition diary for 3 consecutive days in 7 days prior to Baseline visit. At Baseline visit, the diary data and screening laboratory data were checked against the entry criteria to identify subjects eligible for study participation.
Participants by arm
| Arm | Count |
|---|---|
| 4 mg Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg) | 99 |
| 4 mg > 8 mg > 4 mg Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg) | 25 |
| 4 mg > 8 mg Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained) | 28 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 10 | 8 | 2 | 0 |
| Overall Study | Lack of Efficacy | 1 | 1 | 0 | 0 |
| Overall Study | Pregnancy | 1 | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 4 | 1 | 1 |
Baseline characteristics
| Characteristic | 4 mg | 4 mg > 8 mg > 4 mg | 4 mg > 8 mg | Total |
|---|---|---|---|---|
| Age Continuous | 51.0 years STANDARD_DEVIATION 13.1 | 54.7 years STANDARD_DEVIATION 10.5 | 57.0 years STANDARD_DEVIATION 11.7 | 52.7 years STANDARD_DEVIATION 12.6 |
| Sex: Female, Male Female | 88 Participants | 21 Participants | 24 Participants | 133 Participants |
| Sex: Female, Male Male | 11 Participants | 4 Participants | 4 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 138 / 152 | 91 / 99 | 25 / 25 | 22 / 28 |
| serious Total, serious adverse events | 1 / 152 | 1 / 99 | 0 / 25 | 0 / 28 |
Outcome results
Primary
Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume
The number of subjects who experienced AEs (all causality and treatment-related ) based on safety assessment during the study were summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized.
Time frame: 52 Weeks
Population: The safety analysis set (all subjects who took at least one dose of study drug) was analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | All-causality AEs | 138 Number of subjects |
| Total | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | Discontinuations due to all-causlity AEs | 10 Number of subjects |
| Total | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | Treatment-related AEs | 102 Number of subjects |
| Total | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | Discontinuations due to treatment-related AEs | 7 Number of subjects |
| Total | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | Serious AEs | 1 Number of subjects |
| Total | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | DR/TD due to treatment-related AEs | 23 Number of subjects |
| Total | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | Severe AEs | 0 Number of subjects |
| Total | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | DR/TD due to all-causality AEs | 30 Number of subjects |
| 4 mg | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | All-causality AEs | 91 Number of subjects |
| 4 mg | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | Severe AEs | 0 Number of subjects |
| 4 mg | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | Discontinuations due to all-causlity AEs | 8 Number of subjects |
| 4 mg | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | DR/TD due to treatment-related AEs | 0 Number of subjects |
| 4 mg | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | Serious AEs | 1 Number of subjects |
| 4 mg | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | DR/TD due to all-causality AEs | 6 Number of subjects |
| 4 mg | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | Discontinuations due to treatment-related AEs | 6 Number of subjects |
| 4 mg | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | Treatment-related AEs | 61 Number of subjects |
| 4 mg > 8 mg > 4 mg | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | Discontinuations due to treatment-related AEs | 1 Number of subjects |
| 4 mg > 8 mg > 4 mg | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | DR/TD due to all-causality AEs | 23 Number of subjects |
| 4 mg > 8 mg > 4 mg | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | Treatment-related AEs | 25 Number of subjects |
| 4 mg > 8 mg > 4 mg | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | DR/TD due to treatment-related AEs | 23 Number of subjects |
| 4 mg > 8 mg > 4 mg | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | Serious AEs | 0 Number of subjects |
| 4 mg > 8 mg > 4 mg | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | All-causality AEs | 25 Number of subjects |
| 4 mg > 8 mg > 4 mg | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | Severe AEs | 0 Number of subjects |
| 4 mg > 8 mg > 4 mg | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | Discontinuations due to all-causlity AEs | 2 Number of subjects |
| 4 mg > 8 mg | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | DR/TD due to treatment-related AEs | 0 Number of subjects |
| 4 mg > 8 mg | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | All-causality AEs | 22 Number of subjects |
| 4 mg > 8 mg | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | Treatment-related AEs | 16 Number of subjects |
| 4 mg > 8 mg | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | Serious AEs | 0 Number of subjects |
| 4 mg > 8 mg | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | Severe AEs | 0 Number of subjects |
| 4 mg > 8 mg | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | Discontinuations due to all-causlity AEs | 0 Number of subjects |
| 4 mg > 8 mg | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | Discontinuations due to treatment-related AEs | 0 Number of subjects |
| 4 mg > 8 mg | Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume | DR/TD due to all-causality AEs | 1 Number of subjects |
Secondary
Change From Baseline in Grade of PPBC at Week 28 and 52
The PPBC assessment was rated on a 6-point scale as follows: 1. no problems at all 2. some very minor problems 3. some minor problems 4. some moderate problems 5. severe problems 6. many severe problems Change: mean at Week 28 and 52 minus mean at baseline A negative change indicates improvement.
Time frame: Week 28 and 52
Population: The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=analyzable subjects)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total | Change From Baseline in Grade of PPBC at Week 28 and 52 | Baseline (n=150, 97, 25, 28) | 4.3 Scores on a scale | Standard Deviation 0.51 |
| Total | Change From Baseline in Grade of PPBC at Week 28 and 52 | Week 52 (n=134, 85, 22, 27) | -1.78 Scores on a scale | Standard Deviation 1.141 |
| Total | Change From Baseline in Grade of PPBC at Week 28 and 52 | Week 28 (n=137, 87, 23, 27) | -1.66 Scores on a scale | Standard Deviation 1.166 |
| 4 mg | Change From Baseline in Grade of PPBC at Week 28 and 52 | Baseline (n=150, 97, 25, 28) | 4.2 Scores on a scale | Standard Deviation 0.43 |
| 4 mg | Change From Baseline in Grade of PPBC at Week 28 and 52 | Week 52 (n=134, 85, 22, 27) | -1.85 Scores on a scale | Standard Deviation 1.139 |
| 4 mg | Change From Baseline in Grade of PPBC at Week 28 and 52 | Week 28 (n=137, 87, 23, 27) | -1.74 Scores on a scale | Standard Deviation 1.094 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Grade of PPBC at Week 28 and 52 | Week 28 (n=137, 87, 23, 27) | -1.83 Scores on a scale | Standard Deviation 0.937 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Grade of PPBC at Week 28 and 52 | Baseline (n=150, 97, 25, 28) | 4.5 Scores on a scale | Standard Deviation 0.65 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Grade of PPBC at Week 28 and 52 | Week 52 (n=134, 85, 22, 27) | -1.59 Scores on a scale | Standard Deviation 1.054 |
| 4 mg > 8 mg | Change From Baseline in Grade of PPBC at Week 28 and 52 | Baseline (n=150, 97, 25, 28) | 4.4 Scores on a scale | Standard Deviation 0.56 |
| 4 mg > 8 mg | Change From Baseline in Grade of PPBC at Week 28 and 52 | Week 52 (n=134, 85, 22, 27) | -1.70 Scores on a scale | Standard Deviation 1.235 |
| 4 mg > 8 mg | Change From Baseline in Grade of PPBC at Week 28 and 52 | Week 28 (n=137, 87, 23, 27) | -1.26 Scores on a scale | Standard Deviation 1.483 |
Secondary
Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52
The number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean number of incontinence episodes per 24 hours was calculated as the total number of incontinence episodes for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
Time frame: Week 4, 8, 28 and 52
Population: Of the efficacy analysis set, the subjects whose mean number of incontinence episodes per 24 hours at baseline was greater than 0 were analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n= number of analyzable subjects)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total | Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Baseilne (n=103, 62, 17,24) | 1.8 Number of episodes | Standard Deviation 1.74 |
| Total | Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 4 (n=103, 62, 17,24) | -0.84 Number of episodes | Standard Deviation 1.14 |
| Total | Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 8 (n=102, 61, 17, 24) | -1.23 Number of episodes | Standard Deviation 1.354 |
| Total | Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 28 (n= 97, 58, 16, 23) | -1.39 Number of episodes | Standard Deviation 1.476 |
| Total | Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (n=94, 56, 15, 23) | -1.37 Number of episodes | Standard Deviation 1.589 |
| Total | Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (LOCF) (n=103, 62, 17,24) | -1.38 Number of episodes | Standard Deviation 1.557 |
| 4 mg | Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (LOCF) (n=103, 62, 17,24) | -1.24 Number of episodes | Standard Deviation 1.282 |
| 4 mg | Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 28 (n= 97, 58, 16, 23) | -1.26 Number of episodes | Standard Deviation 1.322 |
| 4 mg | Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Baseilne (n=103, 62, 17,24) | 1.6 Number of episodes | Standard Deviation 1.34 |
| 4 mg | Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 8 (n=102, 61, 17, 24) | -1.16 Number of episodes | Standard Deviation 1.272 |
| 4 mg | Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 4 (n=103, 62, 17,24) | -0.99 Number of episodes | Standard Deviation 1.166 |
| 4 mg | Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (n=94, 56, 15, 23) | -1.26 Number of episodes | Standard Deviation 1.331 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 4 (n=103, 62, 17,24) | -0.80 Number of episodes | Standard Deviation 1.225 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 8 (n=102, 61, 17, 24) | -1.43 Number of episodes | Standard Deviation 1.504 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 28 (n= 97, 58, 16, 23) | -1.31 Number of episodes | Standard Deviation 1.542 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (LOCF) (n=103, 62, 17,24) | -1.20 Number of episodes | Standard Deviation 1.74 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (n=94, 56, 15, 23) | -1.16 Number of episodes | Standard Deviation 1.847 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Baseilne (n=103, 62, 17,24) | 1.8 Number of episodes | Standard Deviation 1.33 |
| 4 mg > 8 mg | Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (n=94, 56, 15, 23) | -1.75 Number of episodes | Standard Deviation 1.962 |
| 4 mg > 8 mg | Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (LOCF) (n=103, 62, 17,24) | -1.86 Number of episodes | Standard Deviation 1.99 |
| 4 mg > 8 mg | Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 4 (n=103, 62, 17,24) | -0.49 Number of episodes | Standard Deviation 0.963 |
| 4 mg > 8 mg | Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 28 (n= 97, 58, 16, 23) | -1.77 Number of episodes | Standard Deviation 1.779 |
| 4 mg > 8 mg | Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Baseilne (n=103, 62, 17,24) | 2.5 Number of episodes | Standard Deviation 2.63 |
| 4 mg > 8 mg | Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 8 (n=102, 61, 17, 24) | -1.28 Number of episodes | Standard Deviation 1.486 |
Secondary
Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52
The number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean number of micturitions per 24 hours was calculated as the total number of micturitions for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
Time frame: Week 4, 8, 28 and 52
Population: The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n=number of anlyzable subjects)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total | Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | Baseline (n=150, 97, 25, 28) | 11.3 Number of micturitions | Standard Deviation 2.85 |
| Total | Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | Week 4 (n=150, 97, 25, 28) | -1.42 Number of micturitions | Standard Deviation 1.855 |
| Total | Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | Week 8 (n=148, 95, 25, 28) | -2.11 Number of micturitions | Standard Deviation 1.946 |
| Total | Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | Week 28 (n=137, 87, 23, 27) | -2.33 Number of micturitions | Standard Deviation 2.338 |
| Total | Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | Week 52 (n=133, 84, 22, 27) | -2.63 Number of micturitions | Standard Deviation 2.22 |
| Total | Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | Week 52 (LOCF) (n=150, 97, 25, 28) | -2.49 Number of micturitions | Standard Deviation 2.172 |
| 4 mg | Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | Week 52 (LOCF) (n=150, 97, 25, 28) | -2.35 Number of micturitions | Standard Deviation 1.97 |
| 4 mg | Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | Week 28 (n=137, 87, 23, 27) | -2.18 Number of micturitions | Standard Deviation 2.351 |
| 4 mg | Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | Baseline (n=150, 97, 25, 28) | 11.0 Number of micturitions | Standard Deviation 2.69 |
| 4 mg | Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | Week 8 (n=148, 95, 25, 28) | -2.03 Number of micturitions | Standard Deviation 1.897 |
| 4 mg | Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | Week 4 (n=150, 97, 25, 28) | -1.73 Number of micturitions | Standard Deviation 1.899 |
| 4 mg | Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | Week 52 (n=133, 84, 22, 27) | -2.48 Number of micturitions | Standard Deviation 2.02 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | Week 4 (n=150, 97, 25, 28) | -1.28 Number of micturitions | Standard Deviation 1.403 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | Week 8 (n=148, 95, 25, 28) | -1.81 Number of micturitions | Standard Deviation 2.035 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | Week 28 (n=137, 87, 23, 27) | -2.06 Number of micturitions | Standard Deviation 2.26 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | Week 52 (LOCF) (n=150, 97, 25, 28) | -2.04 Number of micturitions | Standard Deviation 2.135 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | Week 52 (n=133, 84, 22, 27) | -2.21 Number of micturitions | Standard Deviation 2.196 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | Baseline (n=150, 97, 25, 28) | 11.2 Number of micturitions | Standard Deviation 2.71 |
| 4 mg > 8 mg | Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | Week 52 (n=133, 84, 22, 27) | -3.44 Number of micturitions | Standard Deviation 2.683 |
| 4 mg > 8 mg | Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | Week 52 (LOCF) (n=150, 97, 25, 28) | -3.36 Number of micturitions | Standard Deviation 2.673 |
| 4 mg > 8 mg | Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | Week 4 (n=150, 97, 25, 28) | -0.45 Number of micturitions | Standard Deviation 1.757 |
| 4 mg > 8 mg | Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | Week 28 (n=137, 87, 23, 27) | -3.02 Number of micturitions | Standard Deviation 2.315 |
| 4 mg > 8 mg | Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | Baseline (n=150, 97, 25, 28) | 12.3 Number of micturitions | Standard Deviation 3.31 |
| 4 mg > 8 mg | Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 | Week 8 (n=148, 95, 25, 28) | -2.63 Number of micturitions | Standard Deviation 2.005 |
Secondary
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52
The number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean number of urgency episodes per 24 hours was calculated as the total number of urgency episodes for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
Time frame: Week 4, 8, 28 and 52
Population: The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n=number of analyzable subjects)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Baseline (n=150, 97, 25, 28) | 4.5 Number of episodes | Standard Deviation 3.4 |
| Total | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 4 (n=150, 97, 25, 28) | -1.69 Number of episodes | Standard Deviation 2.009 |
| Total | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 8 (n=148, 95, 25, 28) | -2.44 Number of episodes | Standard Deviation 2.194 |
| Total | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 28 (n=137, 87, 23, 27) | -2.54 Number of episodes | Standard Deviation 2.597 |
| Total | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (n=133, 84, 22, 27) | -2.76 Number of episodes | Standard Deviation 2.901 |
| Total | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (LOCF) (n=150, 97, 25, 28) | -2.61 Number of episodes | Standard Deviation 2.885 |
| 4 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (LOCF) (n=150, 97, 25, 28) | -2.30 Number of episodes | Standard Deviation 2.531 |
| 4 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 28 (n=137, 87, 23, 27) | -2.41 Number of episodes | Standard Deviation 1.855 |
| 4 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Baseline (n=150, 97, 25, 28) | 3.9 Number of episodes | Standard Deviation 3.31 |
| 4 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 8 (n=148, 95, 25, 28) | -2.32 Number of episodes | Standard Deviation 1.881 |
| 4 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 4 (n=150, 97, 25, 28) | -1.77 Number of episodes | Standard Deviation 1.856 |
| 4 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (n=133, 84, 22, 27) | -2.55 Number of episodes | Standard Deviation 2.579 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 4 (n=150, 97, 25, 28) | -1.75 Number of episodes | Standard Deviation 2.572 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 8 (n=148, 95, 25, 28) | -2.59 Number of episodes | Standard Deviation 2.94 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 28 (n=137, 87, 23, 27) | -3.12 Number of episodes | Standard Deviation 3.304 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (LOCF) (n=150, 97, 25, 28) | -2.93 Number of episodes | Standard Deviation 3.319 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (n=133, 84, 22, 27) | -2.80 Number of episodes | Standard Deviation 3.193 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Baseline (n=150, 97, 25, 28) | 6.2 Number of episodes | Standard Deviation 3.72 |
| 4 mg > 8 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (n=133, 84, 22, 27) | -3.37 Number of episodes | Standard Deviation 3.565 |
| 4 mg > 8 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (LOCF) (n=150, 97, 25, 28) | -3.40 Number of episodes | Standard Deviation 3.504 |
| 4 mg > 8 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 4 (n=150, 97, 25, 28) | -1.37 Number of episodes | Standard Deviation 2.001 |
| 4 mg > 8 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 28 (n=137, 87, 23, 27) | -2.46 Number of episodes | Standard Deviation 3.78 |
| 4 mg > 8 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Baseline (n=150, 97, 25, 28) | 5.1 Number of episodes | Standard Deviation 2.87 |
| 4 mg > 8 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 8 (n=148, 95, 25, 28) | -2.70 Number of episodes | Standard Deviation 2.463 |
Secondary
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52
The number of UUI episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean number of UUI episodes per 24 hours was calculated as the total number of UUI episodes for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
Time frame: Week 4, 8, 28 and 52
Population: Of the efficacy analysis set, the subjects whose mean number of UUI episodes per 24 hours at baseline was greater than 0 were analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using last observation carried forward (LOCF) were analyzed. (n=number of analyzable subjects)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Baseline (n=101, 60, 17, 24) | 1.6 Number of episodes | Standard Deviation 1.48 |
| Total | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 4 (n=101, 60, 17, 24) | -0.86 Number of episodes | Standard Deviation 1.104 |
| Total | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 8 (n=100, 59, 17, 24) | -1.15 Number of episodes | Standard Deviation 1.293 |
| Total | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 28 (n=95, 56, 16, 23) | -1.28 Number of episodes | Standard Deviation 1.282 |
| Total | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (n= 92, 54, 15, 23) | -1.34 Number of episodes | Standard Deviation 1.553 |
| Total | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (LOCF) (n=101, 60, 17, 24) | -1.35 Number of episodes | Standard Deviation 1.521 |
| 4 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (LOCF) (n=101, 60, 17, 24) | -1.19 Number of episodes | Standard Deviation 1.176 |
| 4 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 28 (n=95, 56, 16, 23) | -1.24 Number of episodes | Standard Deviation 1.185 |
| 4 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Baseline (n=101, 60, 17, 24) | 1.4 Number of episodes | Standard Deviation 1.23 |
| 4 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 8 (n=100, 59, 17, 24) | -1.16 Number of episodes | Standard Deviation 1.173 |
| 4 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 4 (n=101, 60, 17, 24) | -0.99 Number of episodes | Standard Deviation 1.117 |
| 4 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (n= 92, 54, 15, 23) | -1.23 Number of episodes | Standard Deviation 1.228 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 4 (n=101, 60, 17, 24) | -0.73 Number of episodes | Standard Deviation 1.281 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 8 (n=100, 59, 17, 24) | -1.31 Number of episodes | Standard Deviation 1.45 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 28 (n=95, 56, 16, 23) | -1.25 Number of episodes | Standard Deviation 1.518 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (LOCF) (n=101, 60, 17, 24) | -1.22 Number of episodes | Standard Deviation 1.568 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (n= 92, 54, 15, 23) | -1.18 Number of episodes | Standard Deviation 1.661 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Baseline (n=101, 60, 17, 24) | 1.7 Number of episodes | Standard Deviation 1.24 |
| 4 mg > 8 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (n= 92, 54, 15, 23) | -1.71 Number of episodes | Standard Deviation 2.097 |
| 4 mg > 8 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (LOCF) (n=101, 60, 17, 24) | -1.82 Number of episodes | Standard Deviation 2.12 |
| 4 mg > 8 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 4 (n=101, 60, 17, 24) | -0.63 Number of episodes | Standard Deviation 0.918 |
| 4 mg > 8 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 28 (n=95, 56, 16, 23) | -1.41 Number of episodes | Standard Deviation 1.385 |
| 4 mg > 8 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Baseline (n=101, 60, 17, 24) | 2.1 Number of episodes | Standard Deviation 2.04 |
| 4 mg > 8 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 | Week 8 (n=100, 59, 17, 24) | -1.00 Number of episodes | Standard Deviation 1.491 |
Secondary
Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52
Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean voided volume per micturitions was calculated as the total voided volume for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
Time frame: Week 4, 8, 28 and 52
Population: The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were analyzed. (n=number of analyzable subjects)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total | Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Baseline (n=150, 97, 25, 28) | 158.1 mL | Standard Deviation 48.09 |
| Total | Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Week 4 (n=150, 97, 25, 28) | 16.67 mL | Standard Deviation 41.908 |
| Total | Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Week 8 (n=148, 95, 25, 28) | 22.34 mL | Standard Deviation 51.339 |
| Total | Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Week 28 (n=137, 87, 23, 27) | 32.59 mL | Standard Deviation 46.389 |
| Total | Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Week 52 (n=133, 84, 22, 27) | 35.92 mL | Standard Deviation 44.007 |
| Total | Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Week 52 (LOCF) (n=150, 97, 25, 28) | 33.42 mL | Standard Deviation 45.175 |
| 4 mg | Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Week 52 (LOCF) (n=150, 97, 25, 28) | 37.08 mL | Standard Deviation 49.276 |
| 4 mg | Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Week 28 (n=137, 87, 23, 27) | 31.98 mL | Standard Deviation 50.365 |
| 4 mg | Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Baseline (n=150, 97, 25, 28) | 162.8 mL | Standard Deviation 48.78 |
| 4 mg | Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Week 8 (n=148, 95, 25, 28) | 21.86 mL | Standard Deviation 58.194 |
| 4 mg | Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Week 4 (n=150, 97, 25, 28) | 20.58 mL | Standard Deviation 44.357 |
| 4 mg | Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Week 52 (n=133, 84, 22, 27) | 40.21 mL | Standard Deviation 47.646 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Week 4 (n=150, 97, 25, 28) | 12.18 mL | Standard Deviation 43.399 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Week 8 (n=148, 95, 25, 28) | 23.00 mL | Standard Deviation 35.061 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Week 28 (n=137, 87, 23, 27) | 40.20 mL | Standard Deviation 41.613 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Week 52 (LOCF) (n=150, 97, 25, 28) | 28.22 mL | Standard Deviation 40.693 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Week 52 (n=133, 84, 22, 27) | 33.02 mL | Standard Deviation 40.772 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Baseline (n=150, 97, 25, 28) | 156.1 mL | Standard Deviation 42.75 |
| 4 mg > 8 mg | Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Week 52 (n=133, 84, 22, 27) | 24.95 mL | Standard Deviation 32.414 |
| 4 mg > 8 mg | Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Week 52 (LOCF) (n=150, 97, 25, 28) | 25.38 mL | Standard Deviation 31.89 |
| 4 mg > 8 mg | Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Week 4 (n=150, 97, 25, 28) | 7.16 mL | Standard Deviation 29.231 |
| 4 mg > 8 mg | Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Week 28 (n=137, 87, 23, 27) | 28.10 mL | Standard Deviation 36.431 |
| 4 mg > 8 mg | Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Baseline (n=150, 97, 25, 28) | 143.6 mL | Standard Deviation 48.73 |
| 4 mg > 8 mg | Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 | Week 8 (n=148, 95, 25, 28) | 23.37 mL | Standard Deviation 38.273 |
Secondary
Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52
The number of nighttime micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. The mean number of nighttime micturitions per 24 hours was calculated as the total number of nighttime micturitions for valid diary days divided by the total number of valid diary days collected at that visit. Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
Time frame: Week 4, 8, 28 and 52
Population: Of the efficacy analysis set, the subjects whose mean number of nighttime micturitions per 24 hours at baseline was greater than 0 were analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n=number of analyzable subjects)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total | Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | Baseline (n=116, 69, 23, 24) | 1.4 Number of micturitions | Standard Deviation 1.04 |
| Total | Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | Week 4 (n=116, 69, 23, 24) | -0.31 Number of micturitions | Standard Deviation 0.727 |
| Total | Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | Week 8 (n=115, 68, 23, 24) | -0.43 Number of micturitions | Standard Deviation 0.797 |
| Total | Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | Week 28 (n=106, 62, 21, 23) | -0.47 Number of micturitions | Standard Deviation 0.752 |
| Total | Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (n=103, 60, 20, 23) | -0.57 Number of micturitions | Standard Deviation 0.807 |
| Total | Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (LOCF) (n=116, 69, 23, 24) | -0.50 Number of micturitions | Standard Deviation 0.826 |
| 4 mg | Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (LOCF) (n=116, 69, 23, 24) | -0.38 Number of micturitions | Standard Deviation 0.908 |
| 4 mg | Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | Week 28 (n=106, 62, 21, 23) | -0.36 Number of micturitions | Standard Deviation 0.788 |
| 4 mg | Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | Baseline (n=116, 69, 23, 24) | 1.2 Number of micturitions | Standard Deviation 1.04 |
| 4 mg | Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | Week 8 (n=115, 68, 23, 24) | -0.33 Number of micturitions | Standard Deviation 0.812 |
| 4 mg | Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | Week 4 (n=116, 69, 23, 24) | -0.34 Number of micturitions | Standard Deviation 0.752 |
| 4 mg | Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (n=103, 60, 20, 23) | -0.46 Number of micturitions | Standard Deviation 0.904 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | Week 4 (n=116, 69, 23, 24) | -0.45 Number of micturitions | Standard Deviation 0.556 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | Week 8 (n=115, 68, 23, 24) | -0.55 Number of micturitions | Standard Deviation 0.845 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | Week 28 (n=106, 62, 21, 23) | -0.56 Number of micturitions | Standard Deviation 0.694 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (LOCF) (n=116, 69, 23, 24) | -0.62 Number of micturitions | Standard Deviation 0.614 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (n=103, 60, 20, 23) | -0.68 Number of micturitions | Standard Deviation 0.546 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | Baseline (n=116, 69, 23, 24) | 1.6 Number of micturitions | Standard Deviation 0.93 |
| 4 mg > 8 mg | Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (n=103, 60, 20, 23) | -0.75 Number of micturitions | Standard Deviation 0.698 |
| 4 mg > 8 mg | Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | Week 52 (LOCF) (n=116, 69, 23, 24) | -0.71 Number of micturitions | Standard Deviation 0.718 |
| 4 mg > 8 mg | Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | Week 4 (n=116, 69, 23, 24) | -0.08 Number of micturitions | Standard Deviation 0.776 |
| 4 mg > 8 mg | Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | Week 28 (n=106, 62, 21, 23) | -0.71 Number of micturitions | Standard Deviation 0.661 |
| 4 mg > 8 mg | Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | Baseline (n=116, 69, 23, 24) | 1.6 Number of micturitions | Standard Deviation 1.05 |
| 4 mg > 8 mg | Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 | Week 8 (n=115, 68, 23, 24) | -0.60 Number of micturitions | Standard Deviation 0.688 |
Secondary
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52
KHQ was used to assess the impact of bladder problems on quality of life. The scores ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response. A negative change indicates improvement. KHQ consists of the following domains: * General health perceptions (GHP) * Impact on life * Role limitations * Physical limitations * Social limitations * Personal relationships (PR) * Emotions * Sleep/energy * Incontinence severity measures (ISM) Change: mean at Week 28 and 52 minus mean at Baseline
Time frame: Week 28 and 52
Population: The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=number of analyzable subjects)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | GHP: Baseline (n=150, 97, 25, 28) | 37.5 Scores on a ascle | Standard Deviation 21.63 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Role limitations: Week 28 (n=137, 87, 23, 27) | -28.10 Scores on a ascle | Standard Deviation 24.733 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | PR: Week 52 (n=109, 70, 16, 23) | -14.68 Scores on a ascle | Standard Deviation 19.342 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | GHP: Week 52 (n=134, 85, 22, 27) | -5.22 Scores on a ascle | Standard Deviation 22.751 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Social limitations: Week 52 (n=134, 85, 22, 27) | -22.35 Scores on a ascle | Standard Deviation 22.661 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Role limitations: Week 52 (n=134, 85, 22, 27) | -29.85 Scores on a ascle | Standard Deviation 26.732 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Impact on life: Week 28 (n=137, 87, 23, 27) | -32.85 Scores on a ascle | Standard Deviation 27.112 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | ISM: Week 28 (n=137, 87, 23, 27) | -16.25 Scores on a ascle | Standard Deviation 17.223 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Sleep/energy: Week 52 (n=134, 85, 22, 27) | -21.27 Scores on a ascle | Standard Deviation 23.338 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Physical limitations: Baseline (n=150, 97, 25, 28 | 51.9 Scores on a ascle | Standard Deviation 26.93 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Emotions: Baseline (n=150, 97, 25, 28) | 51.2 Scores on a ascle | Standard Deviation 28.38 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | PR: Week 28 (n=110, 71, 16, 23) | -13.18 Scores on a ascle | Standard Deviation 18.354 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Impact on life: Week 52 (n=134, 85, 22, 27) | -33.08 Scores on a ascle | Standard Deviation 29.333 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Physical limitations: Week 28 (n=137, 87, 23, 27) | -27.25 Scores on a ascle | Standard Deviation 26.031 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Emotions: Week 52 (n=134, 85, 22, 27) | -30.27 Scores on a ascle | Standard Deviation 26.434 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | PR: Baseline (n=124, 82, 18, 24) | 19.5 Scores on a ascle | Standard Deviation 22.46 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Sleep/energy: Week 28 (n=137, 87, 23, 27) | -18.61 Scores on a ascle | Standard Deviation 21.586 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Physical limitations: Week 52 (n=134, 85, 22, 27) | -30.10 Scores on a ascle | Standard Deviation 25.071 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | ISM: Baseline (n=150, 97, 25, 28) | 34.8 Scores on a ascle | Standard Deviation 20.39 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Impact on life: Baseline (n=150, 97, 25, 28) | 64.0 Scores on a ascle | Standard Deviation 23.97 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Role limitations: Baseline (n=150, 97, 25, 28) | 47.9 Scores on a ascle | Standard Deviation 24.75 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Social limitations: Baseline (n=150, 97, 25, 28) | 30.3 Scores on a ascle | Standard Deviation 24.36 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Emotions: Week 28 (n=137, 87, 23, 27) | -27.49 Scores on a ascle | Standard Deviation 24.219 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | ISM: Week 52 (n=134, 85, 22, 27) | -19.00 Scores on a ascle | Standard Deviation 19.199 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Sleep/energy: Baseline (n=150, 97, 25, 28) | 37.0 Scores on a ascle | Standard Deviation 27.44 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Social limitations: Week 28 (n=137, 87, 23, 27) | -19.63 Scores on a ascle | Standard Deviation 19.41 |
| Total | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | GHP: Week 28 (n=137, 87, 23, 27) | -2.19 Scores on a ascle | Standard Deviation 24.903 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Social limitations: Week 28 (n=137, 87, 23, 27) | -17.37 Scores on a ascle | Standard Deviation 19.241 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Emotions: Week 52 (n=134, 85, 22, 27) | -32.42 Scores on a ascle | Standard Deviation 24.799 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Social limitations: Week 52 (n=134, 85, 22, 27) | -20.72 Scores on a ascle | Standard Deviation 22.245 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | PR: Baseline (n=124, 82, 18, 24) | 17.3 Scores on a ascle | Standard Deviation 20.86 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Emotions: Week 28 (n=137, 87, 23, 27) | -27.84 Scores on a ascle | Standard Deviation 23.163 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | PR: Week 28 (n=110, 71, 16, 23) | -11.74 Scores on a ascle | Standard Deviation 18.558 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Impact on life: Week 28 (n=137, 87, 23, 27) | -32.18 Scores on a ascle | Standard Deviation 24.084 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | PR: Week 52 (n=109, 70, 16, 23) | -13.57 Scores on a ascle | Standard Deviation 19.514 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | GHP: Week 28 (n=137, 87, 23, 27) | -0.57 Scores on a ascle | Standard Deviation 26.131 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Emotions: Baseline (n=150, 97, 25, 28) | 49.1 Scores on a ascle | Standard Deviation 27.49 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | ISM: Baseline (n=150, 97, 25, 28) | 32.6 Scores on a ascle | Standard Deviation 18.83 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Impact on life: Week 52 (n=134, 85, 22, 27) | -32.94 Scores on a ascle | Standard Deviation 26.97 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | GHP: Baseline (n=150, 97, 25, 28) | 37.1 Scores on a ascle | Standard Deviation 21.38 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Role limitations: Baseline (n=150, 97, 25, 28) | 46.0 Scores on a ascle | Standard Deviation 23.05 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Role limitations: Week 28 (n=137, 87, 23, 27) | -28.16 Scores on a ascle | Standard Deviation 22.777 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Sleep/energy: Week 52 (n=134, 85, 22, 27) | -20.59 Scores on a ascle | Standard Deviation 22.219 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Role limitations: Week 52 (n=134, 85, 22, 27) | -30.98 Scores on a ascle | Standard Deviation 26.371 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | GHP: Week 52 (n=134, 85, 22, 27) | -5.88 Scores on a ascle | Standard Deviation 23.981 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Physical limitations: Baseline (n=150, 97, 25, 28 | 49.8 Scores on a ascle | Standard Deviation 26.73 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | ISM: Week 52 (n=134, 85, 22, 27) | -18.43 Scores on a ascle | Standard Deviation 18.392 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Sleep/energy: Week 28 (n=137, 87, 23, 27) | -17.43 Scores on a ascle | Standard Deviation 19.998 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Physical limitations: Week 28 (n=137, 87, 23, 27) | -26.63 Scores on a ascle | Standard Deviation 25.727 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | ISM: Week 28 (n=137, 87, 23, 27) | -14.87 Scores on a ascle | Standard Deviation 16.541 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Physical limitations: Week 52 (n=134, 85, 22, 27) | -32.16 Scores on a ascle | Standard Deviation 24.504 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Sleep/energy: Baseline (n=150, 97, 25, 28) | 33.2 Scores on a ascle | Standard Deviation 24 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Social limitations: Baseline (n=150, 97, 25, 28) | 27.5 Scores on a ascle | Standard Deviation 23.38 |
| 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Impact on life: Baseline (n=150, 97, 25, 28) | 61.2 Scores on a ascle | Standard Deviation 21.88 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Sleep/energy: Week 52 (n=134, 85, 22, 27) | -15.91 Scores on a ascle | Standard Deviation 22.7 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | GHP: Baseline (n=150, 97, 25, 28) | 37.0 Scores on a ascle | Standard Deviation 24.07 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | GHP: Week 28 (n=137, 87, 23, 27) | 0.00 Scores on a ascle | Standard Deviation 22.613 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | GHP: Week 52 (n=134, 85, 22, 27) | -5.68 Scores on a ascle | Standard Deviation 21.729 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Impact on life: Baseline (n=150, 97, 25, 28) | 68.0 Scores on a ascle | Standard Deviation 31.15 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Impact on life: Week 28 (n=137, 87, 23, 27) | -37.68 Scores on a ascle | Standard Deviation 33.791 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Impact on life: Week 52 (n=134, 85, 22, 27) | -31.82 Scores on a ascle | Standard Deviation 33.297 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Role limitations: Baseline (n=150, 97, 25, 28) | 52.0 Scores on a ascle | Standard Deviation 30.55 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Role limitations: Week 28 (n=137, 87, 23, 27) | -33.33 Scores on a ascle | Standard Deviation 28.427 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Role limitations: Week 52 (n=134, 85, 22, 27) | -31.06 Scores on a ascle | Standard Deviation 28.31 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Physical limitations: Baseline (n=150, 97, 25, 28 | 54.0 Scores on a ascle | Standard Deviation 29.38 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Physical limitations: Week 28 (n=137, 87, 23, 27) | -31.16 Scores on a ascle | Standard Deviation 29.432 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Physical limitations: Week 52 (n=134, 85, 22, 27) | -28.03 Scores on a ascle | Standard Deviation 25.915 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Social limitations: Baseline (n=150, 97, 25, 28) | 31.1 Scores on a ascle | Standard Deviation 25.86 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Social limitations: Week 28 (n=137, 87, 23, 27) | -22.71 Scores on a ascle | Standard Deviation 19.955 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Social limitations: Week 52 (n=134, 85, 22, 27) | -24.75 Scores on a ascle | Standard Deviation 21.668 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | PR: Baseline (n=124, 82, 18, 24) | 16.7 Scores on a ascle | Standard Deviation 22.87 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | PR: Week 28 (n=110, 71, 16, 23) | -10.42 Scores on a ascle | Standard Deviation 17.078 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | PR: Week 52 (n=109, 70, 16, 23) | -12.50 Scores on a ascle | Standard Deviation 17.743 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Emotions: Baseline (n=150, 97, 25, 28) | 52.0 Scores on a ascle | Standard Deviation 32.19 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Emotions: Week 28 (n=137, 87, 23, 27) | -27.54 Scores on a ascle | Standard Deviation 26.137 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Emotions: Week 52 (n=134, 85, 22, 27) | -26.26 Scores on a ascle | Standard Deviation 28.595 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Sleep/energy: Baseline (n=150, 97, 25, 28) | 37.3 Scores on a ascle | Standard Deviation 29.77 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Sleep/energy: Week 28 (n=137, 87, 23, 27) | -18.12 Scores on a ascle | Standard Deviation 26.07 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | ISM: Baseline (n=150, 97, 25, 28) | 31.5 Scores on a ascle | Standard Deviation 18.51 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | ISM: Week 28 (n=137, 87, 23, 27) | -16.81 Scores on a ascle | Standard Deviation 17.623 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | ISM: Week 52 (n=134, 85, 22, 27) | -14.55 Scores on a ascle | Standard Deviation 19.37 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Social limitations: Week 28 (n=137, 87, 23, 27) | -24.28 Scores on a ascle | Standard Deviation 19.006 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | ISM: Week 52 (n=134, 85, 22, 27) | -24.44 Scores on a ascle | Standard Deviation 21.001 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Emotions: Week 52 (n=134, 85, 22, 27) | -26.75 Scores on a ascle | Standard Deviation 29.76 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Social limitations: Baseline (n=150, 97, 25, 28) | 39.3 Scores on a ascle | Standard Deviation 25.03 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Physical limitations: Week 52 (n=134, 85, 22, 27) | -25.31 Scores on a ascle | Standard Deviation 26.3 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | ISM: Week 28 (n=137, 87, 23, 27) | -20.25 Scores on a ascle | Standard Deviation 18.99 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Sleep/energy: Baseline (n=150, 97, 25, 28) | 50.0 Scores on a ascle | Standard Deviation 33.02 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Physical limitations: Week 28 (n=137, 87, 23, 27) | -25.93 Scores on a ascle | Standard Deviation 24.605 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Physical limitations: Baseline (n=150, 97, 25, 28 | 57.1 Scores on a ascle | Standard Deviation 25.43 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | GHP: Week 28 (n=137, 87, 23, 27) | -9.26 Scores on a ascle | Standard Deviation 22.088 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Sleep/energy: Week 28 (n=137, 87, 23, 27) | -22.84 Scores on a ascle | Standard Deviation 22.715 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Role limitations: Week 52 (n=134, 85, 22, 27) | -25.31 Scores on a ascle | Standard Deviation 27.1 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Role limitations: Week 28 (n=137, 87, 23, 27) | -23.46 Scores on a ascle | Standard Deviation 27.448 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Role limitations: Baseline (n=150, 97, 25, 28) | 50.6 Scores on a ascle | Standard Deviation 25.04 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Sleep/energy: Week 52 (n=134, 85, 22, 27) | -27.78 Scores on a ascle | Standard Deviation 26.554 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Impact on life: Week 52 (n=134, 85, 22, 27) | -34.57 Scores on a ascle | Standard Deviation 33.945 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Impact on life: Week 28 (n=137, 87, 23, 27) | -30.86 Scores on a ascle | Standard Deviation 30.559 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | GHP: Baseline (n=150, 97, 25, 28) | 39.3 Scores on a ascle | Standard Deviation 20.89 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | ISM: Baseline (n=150, 97, 25, 28) | 45.7 Scores on a ascle | Standard Deviation 24.05 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | PR: Week 52 (n=109, 70, 16, 23) | -19.57 Scores on a ascle | Standard Deviation 19.881 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Impact on life: Baseline (n=150, 97, 25, 28) | 70.2 Scores on a ascle | Standard Deviation 22.84 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Emotions: Baseline (n=150, 97, 25, 28) | 57.5 Scores on a ascle | Standard Deviation 27.89 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | PR: Week 28 (n=110, 71, 16, 23) | -19.57 Scores on a ascle | Standard Deviation 17.875 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | PR: Baseline (n=124, 82, 18, 24) | 29.2 Scores on a ascle | Standard Deviation 25.66 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | GHP: Week 52 (n=134, 85, 22, 27) | -2.78 Scores on a ascle | Standard Deviation 20.016 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Emotions: Week 28 (n=137, 87, 23, 27) | -26.34 Scores on a ascle | Standard Deviation 26.714 |
| 4 mg > 8 mg | Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 | Social limitations: Week 52 (n=134, 85, 22, 27) | -25.51 Scores on a ascle | Standard Deviation 25 |
Secondary
Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52
OAB-q was used to assess the extent of subjects who had been botehred by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL). OAB-q consists of the symptom bother score(SBS), the HRQL total score and subscale scores (Coping, Concern, Sleep and Social). The SBS ranges from 0 to 100, where 0=minimal severity and 100=greatest severity (negative change indicates improvement). The HRQL scores range from 0 to 100, where 0=worst outcome and 100=best outcome (positive change indicates improvement). Change: mean at Week 28 and 52 minus mean at baseline
Time frame: Week 28 and 52
Population: The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=analyzable subjects)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Concern: Baseline (n=150, 97, 25, 28) | 71.0 Scores on a scale | Standard Deviation 21.54 |
| Total | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Coping: Week 52 (n=134, 85, 22, 27) | 21.75 Scores on a scale | Standard Deviation 23.773 |
| Total | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Total: Week 52 (n=134, 85, 22, 27) | 16.92 Scores on a scale | Standard Deviation 16.461 |
| Total | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Social: Week 52 (n=134, 85, 22, 27) | 7.22 Scores on a scale | Standard Deviation 12.277 |
| Total | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Coping: Week 28 (n=137, 87, 23, 27) | 20.86 Scores on a scale | Standard Deviation 20.008 |
| Total | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Coping: Baseline (n=150, 97, 25, 28) | 61.6 Scores on a scale | Standard Deviation 26.07 |
| Total | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Social: Baseline (n=150, 97, 25, 28) | 89.2 Scores on a scale | Standard Deviation 14.17 |
| Total | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Sleep: Week 52 (n=134, 85, 22, 27) | 14.90 Scores on a scale | Standard Deviation 21.467 |
| Total | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | SBS: Week 52 (n=134, 85, 22, 27) | -25.24 Scores on a scale | Standard Deviation 20.287 |
| Total | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | SBS: Baseline (n=150, 97, 25, 28) | 42.7 Scores on a scale | Standard Deviation 22.53 |
| Total | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Sleep: Week 28 (n=137, 87, 23, 27) | 12.41 Scores on a scale | Standard Deviation 21.808 |
| Total | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Sleep: Baseline (n=150, 97, 25, 28) | 66.5 Scores on a scale | Standard Deviation 23.95 |
| Total | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Total: Baseline (n=150, 97, 25, 28) | 70.7 Scores on a scale | Standard Deviation 18.31 |
| Total | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQ- Social: Week 28 (n=137, 87, 23, 27) | 6.66 Scores on a scale | Standard Deviation 11.461 |
| Total | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Concern: Week 52 (n=134, 85, 22, 27) | 19.77 Scores on a scale | Standard Deviation 18.4 |
| Total | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Concern: Week 28 (n=137, 87, 23, 27) | 18.48 Scores on a scale | Standard Deviation 18.18 |
| Total | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Total: Week 28 (n=137, 87, 23, 27) | 15.66 Scores on a scale | Standard Deviation 14.711 |
| Total | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | SBS: Week 28 (n=137, 87, 23, 27) | -25.13 Scores on a scale | Standard Deviation 19.835 |
| 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | SBS: Week 52 (n=134, 85, 22, 27) | -22.41 Scores on a scale | Standard Deviation 17.616 |
| 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | SBS: Baseline (n=150, 97, 25, 28) | 37.4 Scores on a scale | Standard Deviation 19.74 |
| 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | SBS: Week 28 (n=137, 87, 23, 27) | -22.30 Scores on a scale | Standard Deviation 18.588 |
| 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Total: Baseline (n=150, 97, 25, 28) | 73.9 Scores on a scale | Standard Deviation 16.66 |
| 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Total: Week 28 (n=137, 87, 23, 27) | 14.26 Scores on a scale | Standard Deviation 13.366 |
| 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Total: Week 52 (n=134, 85, 22, 27) | 15.99 Scores on a scale | Standard Deviation 14.717 |
| 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Coping: Baseline (n=150, 97, 25, 28) | 65.6 Scores on a scale | Standard Deviation 24.59 |
| 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Coping: Week 28 (n=137, 87, 23, 27) | 19.66 Scores on a scale | Standard Deviation 17.871 |
| 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Coping: Week 52 (n=134, 85, 22, 27) | 20.91 Scores on a scale | Standard Deviation 21.821 |
| 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Concern: Baseline (n=150, 97, 25, 28) | 73.9 Scores on a scale | Standard Deviation 19.7 |
| 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Concern: Week 28 (n=137, 87, 23, 27) | 16.95 Scores on a scale | Standard Deviation 17.142 |
| 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Concern: Week 52 (n=134, 85, 22, 27) | 19.23 Scores on a scale | Standard Deviation 16.946 |
| 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Sleep: Baseline (n=150, 97, 25, 28) | 69.9 Scores on a scale | Standard Deviation 22.3 |
| 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Sleep: Week 28 (n=137, 87, 23, 27) | 11.13 Scores on a scale | Standard Deviation 21.579 |
| 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Sleep: Week 52 (n=134, 85, 22, 27) | 13.32 Scores on a scale | Standard Deviation 19.629 |
| 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Social: Baseline (n=150, 97, 25, 28) | 91.2 Scores on a scale | Standard Deviation 12.31 |
| 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQ- Social: Week 28 (n=137, 87, 23, 27) | 5.01 Scores on a scale | Standard Deviation 10.064 |
| 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Social: Week 52 (n=134, 85, 22, 27) | 6.26 Scores on a scale | Standard Deviation 10.537 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Total: Week 28 (n=137, 87, 23, 27) | 16.00 Scores on a scale | Standard Deviation 14.787 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Concern: Baseline (n=150, 97, 25, 28) | 72.5 Scores on a scale | Standard Deviation 20.9 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Concern: Week 28 (n=137, 87, 23, 27) | 21.24 Scores on a scale | Standard Deviation 17.943 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Total: Baseline (n=150, 97, 25, 28) | 72.2 Scores on a scale | Standard Deviation 18.97 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Social: Week 52 (n=134, 85, 22, 27) | 6.55 Scores on a scale | Standard Deviation 12.802 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Concern: Week 52 (n=134, 85, 22, 27) | 16.49 Scores on a scale | Standard Deviation 17.961 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQ- Social: Week 28 (n=137, 87, 23, 27) | 8.00 Scores on a scale | Standard Deviation 13.156 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Sleep: Baseline (n=150, 97, 25, 28) | 65.8 Scores on a scale | Standard Deviation 25.61 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | SBS: Week 52 (n=134, 85, 22, 27) | -21.25 Scores on a scale | Standard Deviation 16.597 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Sleep: Week 28 (n=137, 87, 23, 27) | 13.22 Scores on a scale | Standard Deviation 19.313 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | SBS: Baseline (n=150, 97, 25, 28) | 45.2 Scores on a scale | Standard Deviation 21.04 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Sleep: Week 52 (n=134, 85, 22, 27) | 13.09 Scores on a scale | Standard Deviation 19.873 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | SBS: Week 28 (n=137, 87, 23, 27) | -27.07 Scores on a scale | Standard Deviation 16.231 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Coping: Baseline (n=150, 97, 25, 28) | 64.6 Scores on a scale | Standard Deviation 26.49 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Total: Week 52 (n=134, 85, 22, 27) | 13.35 Scores on a scale | Standard Deviation 14.961 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Coping: Week 28 (n=137, 87, 23, 27) | 18.15 Scores on a scale | Standard Deviation 18.605 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Social: Baseline (n=150, 97, 25, 28) | 90.6 Scores on a scale | Standard Deviation 13.71 |
| 4 mg > 8 mg > 4 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Coping: Week 52 (n=134, 85, 22, 27) | 15.00 Scores on a scale | Standard Deviation 18.127 |
| 4 mg > 8 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Coping: Baseline (n=150, 97, 25, 28) | 45.1 Scores on a scale | Standard Deviation 25.04 |
| 4 mg > 8 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Social: Baseline (n=150, 97, 25, 28) | 81.0 Scores on a scale | Standard Deviation 17.81 |
| 4 mg > 8 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Sleep: Week 28 (n=137, 87, 23, 27) | 15.85 Scores on a scale | Standard Deviation 24.769 |
| 4 mg > 8 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Concern: Baseline (n=150, 97, 25, 28) | 59.5 Scores on a scale | Standard Deviation 24.98 |
| 4 mg > 8 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Total: Baseline (n=150, 97, 25, 28) | 58.4 Scores on a scale | Standard Deviation 18.64 |
| 4 mg > 8 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | SBS: Baseline (n=150, 97, 25, 28) | 58.7 Scores on a scale | Standard Deviation 25.55 |
| 4 mg > 8 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | SBS: Week 28 (n=137, 87, 23, 27) | -32.59 Scores on a scale | Standard Deviation 24.578 |
| 4 mg > 8 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Concern: Week 28 (n=137, 87, 23, 27) | 21.06 Scores on a scale | Standard Deviation 21.515 |
| 4 mg > 8 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Total: Week 28 (n=137, 87, 23, 27) | 19.88 Scores on a scale | Standard Deviation 18.191 |
| 4 mg > 8 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Social: Week 52 (n=134, 85, 22, 27) | 10.81 Scores on a scale | Standard Deviation 16.222 |
| 4 mg > 8 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Sleep: Week 52 (n=134, 85, 22, 27) | 21.33 Scores on a scale | Standard Deviation 27.197 |
| 4 mg > 8 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Concern: Week 52 (n=134, 85, 22, 27) | 24.13 Scores on a scale | Standard Deviation 22.669 |
| 4 mg > 8 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | SBS: Week 52 (n=134, 85, 22, 27) | -37.41 Scores on a scale | Standard Deviation 26.206 |
| 4 mg > 8 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Total: Week 52 (n=134, 85, 22, 27) | 22.76 Scores on a scale | Standard Deviation 21.365 |
| 4 mg > 8 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Coping: Week 52 (n=134, 85, 22, 27) | 29.91 Scores on a scale | Standard Deviation 31.259 |
| 4 mg > 8 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Sleep: Baseline (n=150, 97, 25, 28) | 55.6 Scores on a scale | Standard Deviation 25.45 |
| 4 mg > 8 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQL-Coping: Week 28 (n=137, 87, 23, 27) | 27.04 Scores on a scale | Standard Deviation 26.339 |
| 4 mg > 8 mg | Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 | HRQ- Social: Week 28 (n=137, 87, 23, 27) | 10.81 Scores on a scale | Standard Deviation 13.304 |
Secondary
The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage
The number of subjects whose perception of bladder condition improved at least by one grade on PPBC from baseline at Week 28 and 52. The PPBC was rated on a 6-point scale as follows: 1. no problems at all 2. some very minor problems 3. some minor problems 4. some moderate problems 5. severe problems 6. many severe problems
Time frame: Week 28 and 52
Population: The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=number of analyzable subjects)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total | The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage | Week 28 (n=137, 87, 23, 27) | 115 Number of subjects |
| Total | The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage | Week 52 (n=134, 85, 22, 27) | 116 Number of subjects |
| 4 mg | The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage | Week 52 (n=134, 85, 22, 27) | 75 Number of subjects |
| 4 mg | The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage | Week 28 (n=137, 87, 23, 27) | 75 Number of subjects |
| 4 mg > 8 mg > 4 mg | The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage | Week 28 (n=137, 87, 23, 27) | 21 Number of subjects |
| 4 mg > 8 mg > 4 mg | The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage | Week 52 (n=134, 85, 22, 27) | 18 Number of subjects |
| 4 mg > 8 mg | The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage | Week 28 (n=137, 87, 23, 27) | 19 Number of subjects |
| 4 mg > 8 mg | The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage | Week 52 (n=134, 85, 22, 27) | 23 Number of subjects |