Urinary Bladder Diseases, Urinary Bladder Overactive, Urologic Diseases
Conditions
Keywords
Vesitrim, Betanis, Urgency, Frequency, Mirabegron, YM178, Betmiga, Vesicare, Micturition, YM905, Solifenacin, Urinary incontinence, Overactive Bladder (OAB), Myrbetriq, Vesikur, Urgency incontinence
Brief summary
The purpose of this study was to see if adding a new type of medication recently approved to treat overactive bladder (mirabegron) to an antimuscarinic treatment (solifenacin) would be more effective in controlling incontinence than when using the antimuscarinic treatment alone.
Interventions
DRUGmirabegron 25 mg
Mirabegron was supplied as the marketed formulation in the 25 mg OCAS (Oral Controlled Absorption System) modified release tablets. Medication was taken orally with a glass of water, with or without food.
DRUGmirabegron 50 mg
Mirabegron was supplied as the marketed formulation in the 50 mg OCAS (Oral Controlled Absorption System) modified release tablets. Medication was taken orally with a glass of water, with or without food.
DRUGsolifenacin 5 mg
Solifenacin was provided as the marketed formulation in the 5 mg strength. Medication was taken orally with a glass of water, with or without food.
Solifenacin was provided as the marketed formulation in the 10 mg strength. Medication was taken orally with a glass of water, with or without food.
DRUGmirabegron 25 mg matching placebo
Matching placebo of mirabegron OCAS 25 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
DRUGmirabegron 50 mg matching placebo
Matching placebo of mirabegron OCAS 50 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
DRUGsolifenacin 5 mg matching placebo
Matching placebo of solifenacin succinate 5 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
DRUGsolifenacin 10 mg matching placebo
Matching placebo of solifenacin succinate 10 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
Sponsors
Astellas Pharma Europe Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Main Inclusion at Screening: 1. Subject has symptoms of OAB (urinary frequency and urgency with urgency incontinence) for \>= 3 months prior to the screening visit 2. Subject is willing and able to complete the micturition diary and questionnaires correctly, including collection and measurement of urine output for 3 days prior to each visit; 3. Subject has symptoms of wet OAB (urinary frequency and urgency with incontinence or mixed incontinence with predominant urgency incontinence), and reports an average of at least 2 incontinence episodes per day. * Main Inclusion at Run-in (Visit 2): 1. Subject experiences on average at least 1 episode of urgency (grade 3 or 4) with or without incontinence per 24-hour period during the 3-day micturition diary period. 2. Subject experiences on average at least 2 incontinence episodes per 24-hour period during the 3-day micturition diary period. 3. Subject experiences on average at least 8 micturitions (excluding incontinence episodes) per 24-hour period during the 3-day micturition diary period. * Main Inclusion at Randomization (Visit 3): 1. Subject experiences at least 1 incontinence episode during the 3-day micturition diary period and wishes to increase their treatment for OAB symptoms.
Exclusion criteria
* Main Exclusion at Screening: 1. Subject in the opinion of the investigator has clinically significant Bladder Outlet Obstruction (BOO). 2. Subject has significant Post-void residual (PVR) volume (PVR \> 150 ml). 3. Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator 4. Subject has an indwelling catheter or practices intermittent self catheterization. 5. Subject has evidence of a UTI. 6. Subject has chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs 7. Subject has moderate to severe hepatic impairment 8. Subject has severe renal impairment or End Stage Renal disease 9. Subject has a clinically significant abnormal Electrocardiogram (ECG) 10. Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening. 11. Subject has a QTcF interval \> 450 ms for males or \> 470 ms for females or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia). 12. Subject has received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin. 13. Subject has severe uncontrolled hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg. * Main Exclusion at Randomization (visit 3): 1. Subject has achieved 100% continence from Visit 2 to Visit 3 (no incontinence episodes are recorded in the 3 day diary administered for 3 days prior to Visit 3). 2. Subject does not desire an increase in study medication. 3. Subject has an average total daily urine volume \> 3000ml as recorded in the micturition diary. 4. Subject has severe uncontrolled hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg. 5. Subject has a clinically significant abnormal ECG
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and end of treatment (up to 12 weeks) | The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. The analysis population consisted of the Full Analysis Set (FAS) which comprised of all the Randomized Analysis Set's (RAS) participants who met the following criteria: took at least 1 dose of double-blind study drug after randomization, reported at least 1 micturition in the baseline diary & at least 1 micturition postbaseline & reported at least 1 incontinence episode in the baseline diary. For participants who withdrew before EoT (week 12) and have no measurement available for that diary period, the Last Observation Carried Forward (LOCF) value during the double-blind study period was used as EoT value to derive the primary variable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Number of Micturitions Per 24 Hours | Baseline and weeks 4, 8 & 12 | The average number of micturitions (voluntary urinations (excluding incontinence only episodes)) per 24 hours was derived from number of micturitions recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period (excluding incontinence only episodes). |
| Number of Incontinence Episodes Reported During the 3-Day Diary | Weeks 4, 8 and 12 | The number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from total number of incontinence episodes on valid diary days recorded during the 3-day micturition diary period. |
| Change From Baseline in Mean Volume Voided (MVV) Per Micturition | Baseline and weeks 4, 8 & 12 | MVV per micturition was defined as MVV (mL) per micturition during last 3 days of the 3-day micturition diary period. MVV per micturition was calculated as the sum of each volume voided for each record with volume voided \> 0 on valid diary days divided by the total number of records with a volume voided \> 0 on valid diary days during the 3-day micturition diary period. |
| Change From Baseline to EoT in Corrected Micturition Frequency (CMF) | Baseline and EoT (up to 12 weeks) | CMF was defined as the mean number of micturitions per 24 hours that participants would have at EoT if their fluid intake had remained unchanged since baseline. This was calculated by the MVV per Micturition at baseline multiplied by the mean number of micturitions per 24 hours at baseline divided by the MVV per micturition at EoT. |
| Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours | Baseline and weeks 4, 8 & 12 | UI was defined as the complaint of involuntary urine leakage accompanied by or immediately preceded by urgency. UI was measured using the Patient Perception of Intensity of Urgency Scale (PPIUS), a patient reported outcome validated 5-point categorical scale rating the degree of associated urinary urgency severity (0=No urgency, I felt no need to empty my bladder, but did so for other reasons. 1=Mild, I could postpone voiding as long as necessary, without fear of wetting myself. 2= Moderate, I could postpone voiding for a short while, without fear of wetting myself. 3=Severe, I could not postpone voiding, but had to rush to the toilet in order not to wet myself. 4=Urgency incontinence, I leaked before arriving to the toilet). One urgency incontinence episode was counted for each record of the diary in which the following occurred: incontinence episode or 'both' was recorded & severity of urinary urgency recorded was 3 or 4. |
| Number of UI Episodes Reported During the 3-Day Diary | Weeks 4, 8 and 12 | Number of UI episodes was calculated using the number of UI episodes recorded on valid diary days during the 3-day micturition diary period. NOTE: Only urgency incontinence episodes recorded on a valid diary day were counted. |
| Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Baseline and weeks 4, 8 & 12 | An urgency episode was defined as the complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes (severity of 3 or 4) per 24 hours was defined as the average number of times a participant recorded an urgency episode (severity of 3 or 4) with or without incontinence per day during the 3-day micturition diary period. Measured using the PPIUS scale. This was calculated using the sum of each record with an urgency episode (severity of 3 or 4) recorded on a valid diary day divided by the number of valid diary days during the 3-day micturition diary period. |
| Change From Baseline in Mean Number of Pads Per 24 Hours | Baseline and weeks 4, 8 & 12 | The mean number of pads per 24 hours was defined as the average number of times a participant recorded a new pad used per day during the 3-day micturition diary period. This was calculated using the number of new pads used during valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. |
| Number of Pads Used During the 3-Day Diary | Weeks 4, 8 and 12 | The number of pads used was defined as the number of times a participant recorded a new pad used during the 3-day micturition diary period. This was calculated using the sum of each record with new pad checked. Only records with new pad checked on a valid diary day were counted. |
| Change From Baseline in Mean Number of Nocturia Episodes | Baseline and weeks 4, 8 & 12 | Mean number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) while sleeping during the 3-day diary period, divided by the number of valid diary days during the diary period. Night time episode of incontinence only was not considered a nocturia episode. Nocturia episodes were counted for each micturition record which occurred between the date/time of going to bed with intention to sleep and the date/time of getting up with intention to stay awake on a valid diary day & which was accompanied by a sleep interruption. Nocturia only determined for those who were not night-shift workers. |
| Number of Nocturia Episodes Reported Over 3-Day Diary | Weeks 4, 8 and 12 | The number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) during sleeping time during the 3-day micturition diary period. This was calculated using the sum of each nocturia episode recorded on valid diary days during the 3-day micturition diary period. |
| Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Baseline and EoT (up to 12 weeks) | The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity. |
| Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Baseline and EoT (up to 12 weeks) | The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity. |
| Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Baseline and EoT (up to 12 weeks) | The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity. |
| Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Baseline and EoT (up to 12 weeks) | The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity. |
| Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Baseline and EoT (up to 12 weeks) | The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity. |
| Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score | Baseline and weeks 4, 8 & 12 | The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity). |
| Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and weeks 4, 8 & 12 | The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. |
| Change From Baseline in OAB-q HRQL Subscale Score: Coping | Baseline and weeks 4, 8 & 12 | The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). |
| Change From Baseline in OAB-q HRQL Subscale Score: Concern | Baseline and weeks 4, 8 & 12 | The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). |
| Change From Baseline in OAB-q HRQL Subscale Score: Sleep | Baseline and weeks 4, 8 & 12 | The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). |
| Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction | Baseline and weeks 4, 8 & 12 | The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). |
| Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score | Baseline and weeks 4, 8 & 12 | The TS-VAS rated participant satisfaction with treatment on a scale from 0 (No, not at all) to 10 (Yes, completely). |
| Change From Baseline in Patient Perception Bladder Control (PPBC) Score | Baseline and weeks 4, 8 & 12 | The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. PPBC score: 1-no problem, 2- some very minor problems, 3-some minor problems, 4-moderate problems, 5-severe problems, 6-many severe problems. |
| Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | End of treatment (up to 12 weeks) | The PGIC was a 2-part questionnaire, assessing both the change in the participant's overall condition (Patient Impression in General Health (PIBS)) and change in bladder condition since the start of the study (Patient Impression in General Health (PIGH)) (from very much worse to very much improved). The CGIC was a single questionnaire assessing the participant's change in bladder condition since the beginning of the study (Clinician Impression in Bladder Symptoms (CIBS)). |
| Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | Weeks 4, 8 and 12 | Incontinence was defined as any involuntary leakage of urine. |
| Percentage of Participants With Zero Incontinence Episodes Postbaseline | Weeks 4, 8 and 12 | Incontinence was defined as any involuntary leakage of urine. |
| Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline | Weeks 4, 8 and 12 | Micturitions were defined as voluntary urinations (excluding incontinence only episodes). |
| Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score | Weeks 4, 8 and 12 | The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity). |
| Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score | Weeks 4, 8 and 12 | HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). |
| Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC | Weeks 4, 8 and 12 | The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. |
| Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC | Weeks 4, 8 and 12 | The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. |
| Number of Participants With Adverse Events (AEs) | From first dose of double blind treatment until 30 days after last dose (up to 16 weeks) | AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures & which does not necessarily have a causal relationship with this treatment. Treatment-Emergent Adverse Event (TEAE) referred to an adverse event which started or worsened in the period from first double-blind medication intake until 30 days after the last double-blind medication intake. |
| Change From Baseline in Post Void Residual (PVR) Volume | Baseline and weeks 4, 8 & 12 | PVR Volume was assessed by bladder scan. |
| Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score | Baseline and weeks 4, 8 & 12 | The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life). |
Countries
Armenia, Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Georgia, Germany, Greece, Hungary, Ireland, Israel, Italy, Lebanon, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom, United States
Participant flow
Recruitment details
This multicenter study was conducted at 281 centers globally. Randomization was stratified by sex, age group (\< 65, ≥ 65 years), 4-week incontinence episode reduction group (\< 50%, ≥ 50%) and geographic region.
Pre-assignment details
Participants who met the screening inclusion/exclusion criteria went through a two week wash-out period and maintained a micturition diary during that the wash-out period. A total of 3815 participants were screened of which 2401 participants received solifenacin 5 mg run-in medication. A total of 2174 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Combination (Solifenacin + Mirabegron) Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. | 727 |
| Solifenacin 5 mg Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period | 728 |
| Solifenacin 10 mg Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period. | 719 |
| Total | 2,174 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 13 | 11 | 13 |
| Overall Study | Discontinued (no EoT page) | 2 | 0 | 0 |
| Overall Study | Lack of Efficacy | 1 | 3 | 2 |
| Overall Study | Lost to Follow-up | 4 | 2 | 1 |
| Overall Study | Miscellaneous | 0 | 2 | 0 |
| Overall Study | Protocol Violation | 2 | 2 | 0 |
| Overall Study | Randomized no double-blind drug received | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 26 | 29 | 22 |
Baseline characteristics
| Characteristic | Combination (Solifenacin + Mirabegron) | Solifenacin 5 mg | Solifenacin 10 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 58.2 Year STANDARD_DEVIATION 13.1 | 56.9 Year STANDARD_DEVIATION 13.5 | 57.4 Year STANDARD_DEVIATION 13.2 | 57.5 Year STANDARD_DEVIATION 13.3 |
| Sex: Female, Male Female | 604 Participants | 604 Participants | 600 Participants | 1808 Participants |
| Sex: Female, Male Male | 123 Participants | 124 Participants | 119 Participants | 366 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 43 / 725 | 41 / 728 | 68 / 719 |
| serious Total, serious adverse events | 13 / 725 | 10 / 728 | 15 / 719 |
Outcome results
Primary
Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. The analysis population consisted of the Full Analysis Set (FAS) which comprised of all the Randomized Analysis Set's (RAS) participants who met the following criteria: took at least 1 dose of double-blind study drug after randomization, reported at least 1 micturition in the baseline diary & at least 1 micturition postbaseline & reported at least 1 incontinence episode in the baseline diary. For participants who withdrew before EoT (week 12) and have no measurement available for that diary period, the Last Observation Carried Forward (LOCF) value during the double-blind study period was used as EoT value to derive the primary variable.
Time frame: Baseline and end of treatment (up to 12 weeks)
Population: The analysis population consisted of the FAS. LOCF was used for EoT.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours | -1.8 incontinence episodes | Standard Error 0.08 |
| Solifenacin 5 mg | Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours | -1.53 incontinence episodes | Standard Error 0.08 |
| Solifenacin 10 mg | Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours | -1.67 incontinence episodes | Standard Error 0.08 |
Comparison: Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% Confidence Intervals (CIs) are from an ANCOVA model with sex, age group (\< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.p-value: =0.00195% CI: [-0.47, -0.05]stratified rank ANCOVA
Secondary
Change From Baseline in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (voluntary urinations (excluding incontinence only episodes)) per 24 hours was derived from number of micturitions recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period (excluding incontinence only episodes).
Time frame: Baseline and weeks 4, 8 & 12
Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Mean Number of Micturitions Per 24 Hours | Week 4 | -0.95 micturitions | Standard Error 0.07 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Mean Number of Micturitions Per 24 Hours | Week 8 | -1.36 micturitions | Standard Error 0.08 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Mean Number of Micturitions Per 24 Hours | Week 12 | -1.63 micturitions | Standard Error 0.08 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Mean Number of Micturitions Per 24 Hours | EoT | -1.59 micturitions | Standard Error 0.08 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Micturitions Per 24 Hours | EoT | -1.14 micturitions | Standard Error 0.08 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Micturitions Per 24 Hours | Week 4 | -0.69 micturitions | Standard Error 0.07 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Micturitions Per 24 Hours | Week 12 | -1.16 micturitions | Standard Error 0.09 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Micturitions Per 24 Hours | Week 8 | -0.94 micturitions | Standard Error 0.08 |
| Solifenacin 10 mg | Change From Baseline in Mean Number of Micturitions Per 24 Hours | EoT | -1.12 micturitions | Standard Error 0.08 |
| Solifenacin 10 mg | Change From Baseline in Mean Number of Micturitions Per 24 Hours | Week 8 | -1.00 micturitions | Standard Error 0.08 |
| Solifenacin 10 mg | Change From Baseline in Mean Number of Micturitions Per 24 Hours | Week 12 | -1.11 micturitions | Standard Error 0.08 |
| Solifenacin 10 mg | Change From Baseline in Mean Number of Micturitions Per 24 Hours | Week 4 | -0.79 micturitions | Standard Error 0.07 |
Comparison: Week 4 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.0195% CI: [-0.47, -0.06]ANCOVA
Comparison: Week 8 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: <0.00195% CI: [-0.65, -0.19]ANCOVA
Comparison: Week 12 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: <0.00195% CI: [-0.7, -0.23]ANCOVA
Comparison: EoT adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: <0.00195% CI: [-0.67, -0.22]ANCOVA
Secondary
Change From Baseline in Mean Number of Nocturia Episodes
Mean number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) while sleeping during the 3-day diary period, divided by the number of valid diary days during the diary period. Night time episode of incontinence only was not considered a nocturia episode. Nocturia episodes were counted for each micturition record which occurred between the date/time of going to bed with intention to sleep and the date/time of getting up with intention to stay awake on a valid diary day & which was accompanied by a sleep interruption. Nocturia only determined for those who were not night-shift workers.
Time frame: Baseline and weeks 4, 8 & 12
Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one nocturia episode reported in baseline diary were included.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Mean Number of Nocturia Episodes | Week 4 | -0.28 nocturia episodes | Standard Error 0.03 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Mean Number of Nocturia Episodes | Week 8 | -0.37 nocturia episodes | Standard Error 0.03 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Mean Number of Nocturia Episodes | Week 12 | -0.46 nocturia episodes | Standard Error 0.03 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Mean Number of Nocturia Episodes | EoT | -0.43 nocturia episodes | Standard Error 0.03 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Nocturia Episodes | EoT | -0.37 nocturia episodes | Standard Error 0.03 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Nocturia Episodes | Week 4 | -0.27 nocturia episodes | Standard Error 0.03 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Nocturia Episodes | Week 12 | -0.38 nocturia episodes | Standard Error 0.03 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Nocturia Episodes | Week 8 | -0.35 nocturia episodes | Standard Error 0.03 |
| Solifenacin 10 mg | Change From Baseline in Mean Number of Nocturia Episodes | EoT | -0.41 nocturia episodes | Standard Error 0.03 |
| Solifenacin 10 mg | Change From Baseline in Mean Number of Nocturia Episodes | Week 8 | -0.37 nocturia episodes | Standard Error 0.03 |
| Solifenacin 10 mg | Change From Baseline in Mean Number of Nocturia Episodes | Week 12 | -0.41 nocturia episodes | Standard Error 0.03 |
| Solifenacin 10 mg | Change From Baseline in Mean Number of Nocturia Episodes | Week 4 | -0.29 nocturia episodes | Standard Error 0.03 |
Comparison: Week 4 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.83695% CI: [-0.1, 0.08]ANCOVA
Comparison: Week 8 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.61795% CI: [-0.12, 0.07]ANCOVA
Comparison: Week 12 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.13495% CI: [-0.17, 0.02]ANCOVA
Comparison: EOT adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.17495% CI: [-0.16, 0.03]ANCOVA
Secondary
Change From Baseline in Mean Number of Pads Per 24 Hours
The mean number of pads per 24 hours was defined as the average number of times a participant recorded a new pad used per day during the 3-day micturition diary period. This was calculated using the number of new pads used during valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period.
Time frame: Baseline and weeks 4, 8 & 12
Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with reported use of at least one pad reported in baseline diary were included.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Mean Number of Pads Per 24 Hours | Week 4 | -1.12 pads | Standard Error 0.07 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Mean Number of Pads Per 24 Hours | Week 8 | -1.50 pads | Standard Error 0.07 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Mean Number of Pads Per 24 Hours | Week 12 | -1.65 pads | Standard Error 0.07 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Mean Number of Pads Per 24 Hours | EoT | -1.66 pads | Standard Error 0.07 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Pads Per 24 Hours | EoT | -1.35 pads | Standard Error 0.07 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Pads Per 24 Hours | Week 4 | -0.86 pads | Standard Error 0.07 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Pads Per 24 Hours | Week 12 | -1.38 pads | Standard Error 0.07 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Pads Per 24 Hours | Week 8 | -1.17 pads | Standard Error 0.08 |
| Solifenacin 10 mg | Change From Baseline in Mean Number of Pads Per 24 Hours | EoT | -1.43 pads | Standard Error 0.07 |
| Solifenacin 10 mg | Change From Baseline in Mean Number of Pads Per 24 Hours | Week 8 | -1.36 pads | Standard Error 0.08 |
| Solifenacin 10 mg | Change From Baseline in Mean Number of Pads Per 24 Hours | Week 12 | -1.43 pads | Standard Error 0.07 |
| Solifenacin 10 mg | Change From Baseline in Mean Number of Pads Per 24 Hours | Week 4 | -1.04 pads | Standard Error 0.07 |
Comparison: Week 8 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group \& geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.00295% CI: [-0.55, -0.13]ANCOVA
Comparison: Week 4 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group \& geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.00895% CI: [-0.46, -0.07]ANCOVA
Comparison: Week 12 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group \& geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.00695% CI: [-0.47, -0.08]ANCOVA
Comparison: EoT adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group \& geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.00295% CI: [-0.51, -0.12]ANCOVA
Secondary
Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
An urgency episode was defined as the complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes (severity of 3 or 4) per 24 hours was defined as the average number of times a participant recorded an urgency episode (severity of 3 or 4) with or without incontinence per day during the 3-day micturition diary period. Measured using the PPIUS scale. This was calculated using the sum of each record with an urgency episode (severity of 3 or 4) recorded on a valid diary day divided by the number of valid diary days during the 3-day micturition diary period.
Time frame: Baseline and weeks 4, 8 & 12
Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one urgency episode reported in baseline diary were included.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 4 | -1.84 urgency episodes | Standard Error 0.09 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 8 | -2.64 urgency episodes | Standard Error 0.1 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 12 | -2.97 urgency episodes | Standard Error 0.11 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | EoT | -2.95 urgency episodes | Standard Error 0.1 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | EoT | -2.41 urgency episodes | Standard Error 0.1 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 4 | -1.39 urgency episodes | Standard Error 0.09 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 12 | -2.44 urgency episodes | Standard Error 0.11 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 8 | -2.00 urgency episodes | Standard Error 0.1 |
| Solifenacin 10 mg | Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | EoT | -2.54 urgency episodes | Standard Error 0.11 |
| Solifenacin 10 mg | Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 8 | -2.29 urgency episodes | Standard Error 0.1 |
| Solifenacin 10 mg | Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 12 | -2.55 urgency episodes | Standard Error 0.11 |
| Solifenacin 10 mg | Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 4 | -1.74 urgency episodes | Standard Error 0.1 |
Comparison: Week 4 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.00195% CI: [-0.72, -0.19]ANCOVA
Comparison: Week 8 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: <0.00195% CI: [-0.93, -0.35]ANCOVA
Comparison: Week 12 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.00195% CI: [-0.82, -0.22]ANCOVA
Comparison: EoT adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: <0.00195% CI: [-0.83, -0.25]ANCOVA
Secondary
Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours
UI was defined as the complaint of involuntary urine leakage accompanied by or immediately preceded by urgency. UI was measured using the Patient Perception of Intensity of Urgency Scale (PPIUS), a patient reported outcome validated 5-point categorical scale rating the degree of associated urinary urgency severity (0=No urgency, I felt no need to empty my bladder, but did so for other reasons. 1=Mild, I could postpone voiding as long as necessary, without fear of wetting myself. 2= Moderate, I could postpone voiding for a short while, without fear of wetting myself. 3=Severe, I could not postpone voiding, but had to rush to the toilet in order not to wet myself. 4=Urgency incontinence, I leaked before arriving to the toilet). One urgency incontinence episode was counted for each record of the diary in which the following occurred: incontinence episode or 'both' was recorded & severity of urinary urgency recorded was 3 or 4.
Time frame: Baseline and weeks 4, 8 & 12
Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one UI episode reported in baseline diary were included.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours | Week 4 | -1.26 UI episodes | Standard Error 0.07 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours | Week 8 | -1.70 UI episodes | Standard Error 0.07 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours | Week 12 | -1.84 UI episodes | Standard Error 0.07 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours | EoT | -1.82 UI episodes | Standard Error 0.07 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours | EoT | -1.54 UI episodes | Standard Error 0.07 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours | Week 4 | -0.91 UI episodes | Standard Error 0.07 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours | Week 12 | -1.58 UI episodes | Standard Error 0.07 |
| Solifenacin 5 mg | Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours | Week 8 | -1.25 UI episodes | Standard Error 0.07 |
| Solifenacin 10 mg | Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours | EoT | -1.63 UI episodes | Standard Error 0.07 |
| Solifenacin 10 mg | Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours | Week 8 | -1.45 UI episodes | Standard Error 0.07 |
| Solifenacin 10 mg | Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours | Week 12 | -1.62 UI episodes | Standard Error 0.07 |
| Solifenacin 10 mg | Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours | Week 4 | -1.14 UI episodes | Standard Error 0.07 |
Comparison: Week 4 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: <0.00195% CI: [-0.54, -0.17]stratified rank ANCOVA
Comparison: Week 8 djusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: <0.00195% CI: [-0.65, -0.25]stratified rank ANCOVA
Comparison: Week 12 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.00495% CI: [-0.47, -0.05]stratified rank ANCOVA
Comparison: EoT adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.00395% CI: [-0.47, -0.07]stratified rank ANCOVA
Secondary
Change From Baseline in Mean Volume Voided (MVV) Per Micturition
MVV per micturition was defined as MVV (mL) per micturition during last 3 days of the 3-day micturition diary period. MVV per micturition was calculated as the sum of each volume voided for each record with volume voided \> 0 on valid diary days divided by the total number of records with a volume voided \> 0 on valid diary days during the 3-day micturition diary period.
Time frame: Baseline and weeks 4, 8 & 12
Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Mean Volume Voided (MVV) Per Micturition | EoT | 28.05 mL | Standard Error 1.97 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Mean Volume Voided (MVV) Per Micturition | Week 8 | 25.21 mL | Standard Error 1.89 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Mean Volume Voided (MVV) Per Micturition | Week 12 | 29.54 mL | Standard Error 2.06 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Mean Volume Voided (MVV) Per Micturition | Week 4 | 15.06 mL | Standard Error 1.55 |
| Solifenacin 5 mg | Change From Baseline in Mean Volume Voided (MVV) Per Micturition | Week 8 | 14.02 mL | Standard Error 1.87 |
| Solifenacin 5 mg | Change From Baseline in Mean Volume Voided (MVV) Per Micturition | Week 4 | 11.20 mL | Standard Error 1.55 |
| Solifenacin 5 mg | Change From Baseline in Mean Volume Voided (MVV) Per Micturition | EoT | 16.52 mL | Standard Error 1.97 |
| Solifenacin 5 mg | Change From Baseline in Mean Volume Voided (MVV) Per Micturition | Week 12 | 17.16 mL | Standard Error 2.08 |
| Solifenacin 10 mg | Change From Baseline in Mean Volume Voided (MVV) Per Micturition | Week 4 | 14.99 mL | Standard Error 1.55 |
| Solifenacin 10 mg | Change From Baseline in Mean Volume Voided (MVV) Per Micturition | EoT | 20.30 mL | Standard Error 1.97 |
| Solifenacin 10 mg | Change From Baseline in Mean Volume Voided (MVV) Per Micturition | Week 12 | 20.99 mL | Standard Error 2.04 |
| Solifenacin 10 mg | Change From Baseline in Mean Volume Voided (MVV) Per Micturition | Week 8 | 21.08 mL | Standard Error 1.86 |
Comparison: Week 4 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: <0.07895% CI: [-0.43, 8.16]ANCOVA
Comparison: Week 8 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: <0.00195% CI: [5.98, 16.4]ANCOVA
Comparison: Week 12 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: <0.00195% CI: [6.65, 18.12]ANCOVA
Comparison: EoT adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: <0.00195% CI: [6.06, 16.99]ANCOVA
Secondary
Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score
The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).
Time frame: Baseline and weeks 4, 8 & 12
Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score | Week 4 | 12.95 units on a scale | Standard Error 0.59 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score | Week 8 | 17.58 units on a scale | Standard Error 0.63 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score | Week 12 | 21.40 units on a scale | Standard Error 0.66 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score | EoT | 20.78 units on a scale | Standard Error 0.65 |
| Solifenacin 5 mg | Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score | EoT | 17.63 units on a scale | Standard Error 0.65 |
| Solifenacin 5 mg | Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score | Week 4 | 11.03 units on a scale | Standard Error 0.59 |
| Solifenacin 5 mg | Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score | Week 12 | 17.91 units on a scale | Standard Error 0.67 |
| Solifenacin 5 mg | Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score | Week 8 | 15.26 units on a scale | Standard Error 0.63 |
| Solifenacin 10 mg | Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score | EoT | 17.40 units on a scale | Standard Error 0.65 |
| Solifenacin 10 mg | Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score | Week 8 | 14.60 units on a scale | Standard Error 0.64 |
| Solifenacin 10 mg | Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score | Week 12 | 17.72 units on a scale | Standard Error 0.66 |
| Solifenacin 10 mg | Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score | Week 4 | 12.44 units on a scale | Standard Error 0.59 |
Comparison: Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.02195% CI: [0.29, 3.55]ANCOVA
Comparison: Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.0195% CI: [0.56, 4.06]ANCOVA
Comparison: Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: <0.00195% CI: [1.65, 5.33]ANCOVA
Comparison: EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.00195% CI: [1.35, 4.95]ANCOVA
Secondary
Change From Baseline in OAB-q HRQL Subscale Score: Concern
The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).
Time frame: Baseline and weeks 4, 8 & 12
Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Change From Baseline in OAB-q HRQL Subscale Score: Concern | Week 4 | 13.79 units on a scale | Standard Error 0.68 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in OAB-q HRQL Subscale Score: Concern | Week 8 | 18.87 units on a scale | Standard Error 0.7 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in OAB-q HRQL Subscale Score: Concern | Week 12 | 22.85 units on a scale | Standard Error 0.74 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in OAB-q HRQL Subscale Score: Concern | Week EoT | 22.28 units on a scale | Standard Error 0.72 |
| Solifenacin 5 mg | Change From Baseline in OAB-q HRQL Subscale Score: Concern | Week EoT | 19.00 units on a scale | Standard Error 0.73 |
| Solifenacin 5 mg | Change From Baseline in OAB-q HRQL Subscale Score: Concern | Week 4 | 11.85 units on a scale | Standard Error 0.68 |
| Solifenacin 5 mg | Change From Baseline in OAB-q HRQL Subscale Score: Concern | Week 12 | 19.24 units on a scale | Standard Error 0.75 |
| Solifenacin 5 mg | Change From Baseline in OAB-q HRQL Subscale Score: Concern | Week 8 | 16.36 units on a scale | Standard Error 0.71 |
| Solifenacin 10 mg | Change From Baseline in OAB-q HRQL Subscale Score: Concern | Week EoT | 19.28 units on a scale | Standard Error 0.73 |
| Solifenacin 10 mg | Change From Baseline in OAB-q HRQL Subscale Score: Concern | Week 8 | 15.88 units on a scale | Standard Error 0.71 |
| Solifenacin 10 mg | Change From Baseline in OAB-q HRQL Subscale Score: Concern | Week 12 | 19.67 units on a scale | Standard Error 0.74 |
| Solifenacin 10 mg | Change From Baseline in OAB-q HRQL Subscale Score: Concern | Week 4 | 13.82 units on a scale | Standard Error 0.69 |
Comparison: Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.04495% CI: [0.05, 3.83]ANCOVA
Comparison: Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.01295% CI: [0.55, 4.46]ANCOVA
Comparison: Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.00195% CI: [1.54, 5.67]ANCOVA
Comparison: EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.00195% CI: [1.27, 5.29]ANCOVA
Secondary
Change From Baseline in OAB-q HRQL Subscale Score: Coping
The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).
Time frame: Baseline and weeks 4, 8 & 12
Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Change From Baseline in OAB-q HRQL Subscale Score: Coping | Week 4 | 15.17 units on a scale | Standard Error 0.68 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in OAB-q HRQL Subscale Score: Coping | Week 8 | 20.82 units on a scale | Standard Error 0.74 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in OAB-q HRQL Subscale Score: Coping | Week 12 | 25.16 units on a scale | Standard Error 0.78 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in OAB-q HRQL Subscale Score: Coping | EoT | 24.48 units on a scale | Standard Error 0.75 |
| Solifenacin 5 mg | Change From Baseline in OAB-q HRQL Subscale Score: Coping | EoT | 20.19 units on a scale | Standard Error 0.76 |
| Solifenacin 5 mg | Change From Baseline in OAB-q HRQL Subscale Score: Coping | Week 4 | 12.27 units on a scale | Standard Error 0.68 |
| Solifenacin 5 mg | Change From Baseline in OAB-q HRQL Subscale Score: Coping | Week 12 | 20.45 units on a scale | Standard Error 0.78 |
| Solifenacin 5 mg | Change From Baseline in OAB-q HRQL Subscale Score: Coping | Week 8 | 17.47 units on a scale | Standard Error 0.74 |
| Solifenacin 10 mg | Change From Baseline in OAB-q HRQL Subscale Score: Coping | EoT | 19.90 units on a scale | Standard Error 0.76 |
| Solifenacin 10 mg | Change From Baseline in OAB-q HRQL Subscale Score: Coping | Week 8 | 16.87 units on a scale | Standard Error 0.74 |
| Solifenacin 10 mg | Change From Baseline in OAB-q HRQL Subscale Score: Coping | Week 12 | 20.20 units on a scale | Standard Error 0.78 |
| Solifenacin 10 mg | Change From Baseline in OAB-q HRQL Subscale Score: Coping | Week 4 | 14.25 units on a scale | Standard Error 0.68 |
Comparison: Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.00395% CI: [1.02, 4.78]ANCOVA
Comparison: Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.00195% CI: [1.29, 5.4]ANCOVA
Comparison: Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: <0.00195% CI: [2.55, 6.87]ANCOVA
Comparison: EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: <0.00195% CI: [2.2, 6.39]ANCOVA
Secondary
Change From Baseline in OAB-q HRQL Subscale Score: Sleep
The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).
Time frame: Baseline and weeks 4, 8 & 12
Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Change From Baseline in OAB-q HRQL Subscale Score: Sleep | Week 4 | 11.58 units on a scale | Standard Error 0.68 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in OAB-q HRQL Subscale Score: Sleep | Week 8 | 16.18 units on a scale | Standard Error 0.71 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in OAB-q HRQL Subscale Score: Sleep | Week 12 | 20.00 units on a scale | Standard Error 0.74 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in OAB-q HRQL Subscale Score: Sleep | Week EoT | 19.16 units on a scale | Standard Error 0.72 |
| Solifenacin 5 mg | Change From Baseline in OAB-q HRQL Subscale Score: Sleep | Week EoT | 17.30 units on a scale | Standard Error 0.73 |
| Solifenacin 5 mg | Change From Baseline in OAB-q HRQL Subscale Score: Sleep | Week 4 | 11.04 units on a scale | Standard Error 0.68 |
| Solifenacin 5 mg | Change From Baseline in OAB-q HRQL Subscale Score: Sleep | Week 12 | 17.74 units on a scale | Standard Error 0.74 |
| Solifenacin 5 mg | Change From Baseline in OAB-q HRQL Subscale Score: Sleep | Week 8 | 14.57 units on a scale | Standard Error 0.71 |
| Solifenacin 10 mg | Change From Baseline in OAB-q HRQL Subscale Score: Sleep | Week EoT | 16.55 units on a scale | Standard Error 0.73 |
| Solifenacin 10 mg | Change From Baseline in OAB-q HRQL Subscale Score: Sleep | Week 8 | 13.72 units on a scale | Standard Error 0.71 |
| Solifenacin 10 mg | Change From Baseline in OAB-q HRQL Subscale Score: Sleep | Week 12 | 16.84 units on a scale | Standard Error 0.74 |
| Solifenacin 10 mg | Change From Baseline in OAB-q HRQL Subscale Score: Sleep | Week 4 | 11.16 units on a scale | Standard Error 0.69 |
Comparison: Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.57595% CI: [-1.35, 2.43]ANCOVA
Comparison: Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.10995% CI: [-0.36, 3.58]ANCOVA
Comparison: Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.03295% CI: [0.2, 4.32]ANCOVA
Comparison: EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.06995% CI: [-0.15, 3.87]ANCOVA
Secondary
Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction
The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).
Time frame: Baseline and weeks 4, 8 & 12
Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction | Week 4 | 9.58 units on a scale | Standard Error 0.59 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction | Week 8 | 11.93 units on a scale | Standard Error 0.6 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction | Week 12 | 14.70 units on a scale | Standard Error 0.61 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction | EoT | 14.39 units on a scale | Standard Error 0.6 |
| Solifenacin 5 mg | Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction | EoT | 11.91 units on a scale | Standard Error 0.6 |
| Solifenacin 5 mg | Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction | Week 4 | 7.85 units on a scale | Standard Error 0.59 |
| Solifenacin 5 mg | Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction | Week 12 | 12.08 units on a scale | Standard Error 0.61 |
| Solifenacin 5 mg | Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction | Week 8 | 10.84 units on a scale | Standard Error 0.6 |
| Solifenacin 10 mg | Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction | EoT | 11.72 units on a scale | Standard Error 0.61 |
| Solifenacin 10 mg | Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction | Week 8 | 10.16 units on a scale | Standard Error 0.6 |
| Solifenacin 10 mg | Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction | Week 12 | 11.98 units on a scale | Standard Error 0.61 |
| Solifenacin 10 mg | Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction | Week 4 | 8.95 units on a scale | Standard Error 0.59 |
Comparison: Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.03795% CI: [0.1, 3.36]ANCOVA
Comparison: Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.19995% CI: [-0.57, 2.76]ANCOVA
Comparison: Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.00395% CI: [0.92, 4.31]ANCOVA
Comparison: EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.00495% CI: [0.81, 4.15]ANCOVA
Secondary
Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score
The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity).
Time frame: Baseline and weeks 4, 8 & 12
Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score | Week 4 | -16.68 units on a scale | Standard Error 0.65 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score | Week 8 | -22.86 units on a scale | Standard Error 0.68 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score | Week 12 | -27.90 units on a scale | Standard Error 0.71 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score | EoT | -26.89 units on a scale | Standard Error 0.69 |
| Solifenacin 5 mg | Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score | EoT | -21.93 units on a scale | Standard Error 0.7 |
| Solifenacin 5 mg | Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score | Week 4 | -13.79 units on a scale | Standard Error 0.65 |
| Solifenacin 5 mg | Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score | Week 12 | -22.31 units on a scale | Standard Error 0.71 |
| Solifenacin 5 mg | Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score | Week 8 | -18.36 units on a scale | Standard Error 0.69 |
| Solifenacin 10 mg | Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score | EoT | -23.59 units on a scale | Standard Error 0.7 |
| Solifenacin 10 mg | Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score | Week 8 | -19.34 units on a scale | Standard Error 0.69 |
| Solifenacin 10 mg | Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score | Week 12 | -24.09 units on a scale | Standard Error 0.71 |
| Solifenacin 10 mg | Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score | Week 4 | -15.82 units on a scale | Standard Error 0.65 |
Comparison: Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.00295% CI: [-4.68, -1.1]ANCOVA
Comparison: Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: <0.00195% CI: [-6.4, -2.6]ANCOVA
Comparison: Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: <0.00195% CI: [-7.56, -3.62]ANCOVA
Comparison: EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: <0.00195% CI: [-6.88, -3.04]ANCOVA
Secondary
Change From Baseline in Patient Perception Bladder Control (PPBC) Score
The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. PPBC score: 1-no problem, 2- some very minor problems, 3-some minor problems, 4-moderate problems, 5-severe problems, 6-many severe problems.
Time frame: Baseline and weeks 4, 8 & 12
Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Patient Perception Bladder Control (PPBC) Score | Week 4 | -0.9 units on a scale | Standard Error 0 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Patient Perception Bladder Control (PPBC) Score | Week 8 | -1.2 units on a scale | Standard Error 0 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Patient Perception Bladder Control (PPBC) Score | Week 12 | -1.5 units on a scale | Standard Error 0 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Patient Perception Bladder Control (PPBC) Score | EoT | -1.5 units on a scale | Standard Error 0 |
| Solifenacin 5 mg | Change From Baseline in Patient Perception Bladder Control (PPBC) Score | EoT | -1.2 units on a scale | Standard Error 0 |
| Solifenacin 5 mg | Change From Baseline in Patient Perception Bladder Control (PPBC) Score | Week 4 | -0.6 units on a scale | Standard Error 0 |
| Solifenacin 5 mg | Change From Baseline in Patient Perception Bladder Control (PPBC) Score | Week 12 | -1.2 units on a scale | Standard Error 0 |
| Solifenacin 5 mg | Change From Baseline in Patient Perception Bladder Control (PPBC) Score | Week 8 | -1.0 units on a scale | Standard Error 0 |
| Solifenacin 10 mg | Change From Baseline in Patient Perception Bladder Control (PPBC) Score | EoT | -1.3 units on a scale | Standard Error 0 |
| Solifenacin 10 mg | Change From Baseline in Patient Perception Bladder Control (PPBC) Score | Week 8 | -1.0 units on a scale | Standard Error 0 |
| Solifenacin 10 mg | Change From Baseline in Patient Perception Bladder Control (PPBC) Score | Week 12 | -1.3 units on a scale | Standard Error 0 |
| Solifenacin 10 mg | Change From Baseline in Patient Perception Bladder Control (PPBC) Score | Week 4 | -0.7 units on a scale | Standard Error 0 |
Comparison: Week 4 adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: <0.00195% CI: [-0.4, -0.1]ANCOVA
Comparison: Week 8 adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: <0.00195% CI: [-0.4, -0.1]ANCOVA
Comparison: Week 12 adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: <0.00195% CI: [-0.4, -0.2]ANCOVA
Comparison: EoT adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: <0.00195% CI: [-0.4, -0.1]ANCOVA
Secondary
Change From Baseline in Post Void Residual (PVR) Volume
PVR Volume was assessed by bladder scan.
Time frame: Baseline and weeks 4, 8 & 12
Population: The analysis population consisted of the SAF with data available at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Post Void Residual (PVR) Volume | Week 4 | 1.545 mL | Standard Deviation 40.313 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Post Void Residual (PVR) Volume | Week 8 | 2.245 mL | Standard Deviation 38.347 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Post Void Residual (PVR) Volume | Week 12 | 6.356 mL | Standard Deviation 51.067 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Post Void Residual (PVR) Volume | EoT | 5.478 mL | Standard Deviation 51.595 |
| Solifenacin 5 mg | Change From Baseline in Post Void Residual (PVR) Volume | EoT | 3.046 mL | Standard Deviation 43.499 |
| Solifenacin 5 mg | Change From Baseline in Post Void Residual (PVR) Volume | Week 4 | 2.821 mL | Standard Deviation 38.588 |
| Solifenacin 5 mg | Change From Baseline in Post Void Residual (PVR) Volume | Week 12 | 2.337 mL | Standard Deviation 42.147 |
| Solifenacin 5 mg | Change From Baseline in Post Void Residual (PVR) Volume | Week 8 | 1.117 mL | Standard Deviation 36.47 |
| Solifenacin 10 mg | Change From Baseline in Post Void Residual (PVR) Volume | EoT | 7.354 mL | Standard Deviation 54.121 |
| Solifenacin 10 mg | Change From Baseline in Post Void Residual (PVR) Volume | Week 8 | 7.232 mL | Standard Deviation 60.096 |
| Solifenacin 10 mg | Change From Baseline in Post Void Residual (PVR) Volume | Week 12 | 6.552 mL | Standard Deviation 48.505 |
| Solifenacin 10 mg | Change From Baseline in Post Void Residual (PVR) Volume | Week 4 | 7.308 mL | Standard Deviation 72.122 |
Secondary
Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score
The TS-VAS rated participant satisfaction with treatment on a scale from 0 (No, not at all) to 10 (Yes, completely).
Time frame: Baseline and weeks 4, 8 & 12
Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score | Week 4 | 1.2 units on a scale | Standard Error 0.1 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score | Week 8 | 1.5 units on a scale | Standard Error 0.1 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score | Week 12 | 1.9 units on a scale | Standard Error 0.1 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score | EoT | 1.8 units on a scale | Standard Error 0.1 |
| Solifenacin 5 mg | Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score | EoT | 1.4 units on a scale | Standard Error 0.1 |
| Solifenacin 5 mg | Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score | Week 4 | 0.8 units on a scale | Standard Error 0.1 |
| Solifenacin 5 mg | Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score | Week 12 | 1.4 units on a scale | Standard Error 0.1 |
| Solifenacin 5 mg | Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score | Week 8 | 1.2 units on a scale | Standard Error 0.1 |
| Solifenacin 10 mg | Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score | EoT | 1.6 units on a scale | Standard Error 0.1 |
| Solifenacin 10 mg | Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score | Week 8 | 1.3 units on a scale | Standard Error 0.1 |
| Solifenacin 10 mg | Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score | Week 12 | 1.6 units on a scale | Standard Error 0.1 |
| Solifenacin 10 mg | Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score | Week 4 | 1.1 units on a scale | Standard Error 0.1 |
Comparison: Week 4 adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: <0.00195% CI: [0.2, 0.6]ANCOVA
Comparison: Week 8 adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.01995% CI: [0, 0.5]ANCOVA
Comparison: Week 12 adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: <0.00195% CI: [0.3, 0.7]ANCOVA
Comparison: EoT adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.00195% CI: [0.2, 0.6]ANCOVA
Secondary
Change From Baseline to EoT in Corrected Micturition Frequency (CMF)
CMF was defined as the mean number of micturitions per 24 hours that participants would have at EoT if their fluid intake had remained unchanged since baseline. This was calculated by the MVV per Micturition at baseline multiplied by the mean number of micturitions per 24 hours at baseline divided by the MVV per micturition at EoT.
Time frame: Baseline and EoT (up to 12 weeks)
Population: LOCF was used. The analysis population consisted of the FAS.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Change From Baseline to EoT in Corrected Micturition Frequency (CMF) | -0.96 micturitions | Standard Error 0.1 |
| Solifenacin 5 mg | Change From Baseline to EoT in Corrected Micturition Frequency (CMF) | -0.52 micturitions | Standard Error 0.1 |
| Solifenacin 10 mg | Change From Baseline to EoT in Corrected Micturition Frequency (CMF) | -0.71 micturitions | Standard Error 0.1 |
Comparison: Adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.p-value: =0.00395% CI: [-0.73, -0.16]ANCOVA
Secondary
Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours
The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period.
Time frame: Baseline and weeks 4, 8 & 12
Population: The analysis population consisted of the FAS with data available at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours | Week 8 | -1.68 incontinence episodes | Standard Error 0.07 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours | Week 4 | -1.24 incontinence episodes | Standard Error 0.07 |
| Combination (Solifenacin + Mirabegron) | Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours | Week 12 | -1.81 incontinence episodes | Standard Error 0.08 |
| Solifenacin 5 mg | Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours | Week 8 | -1.29 incontinence episodes | Standard Error 0.07 |
| Solifenacin 5 mg | Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours | Week 4 | -0.91 incontinence episodes | Standard Error 0.07 |
| Solifenacin 5 mg | Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours | Week 12 | -1.57 incontinence episodes | Standard Error 0.08 |
| Solifenacin 10 mg | Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours | Week 4 | -1.12 incontinence episodes | Standard Error 0.07 |
| Solifenacin 10 mg | Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours | Week 12 | -1.67 incontinence episodes | Standard Error 0.08 |
| Solifenacin 10 mg | Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours | Week 8 | -1.49 incontinence episodes | Standard Error 0.07 |
Comparison: Week 4 differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% CIs are from an ANCOVA model with sex, age group (\< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.p-value: <0.00195% CI: [-0.52, -0.14]stratified rank ANCOVA
Comparison: Week 8 differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% CIs are from an ANCOVA model with sex, age group (\< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.p-value: <0.00195% CI: [-0.6, -0.18]stratified rank ANCOVA
Comparison: Week 12 differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% CIs are from an ANCOVA model with sex, age group (\< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.p-value: =0.00195% CI: [-0.46, -0.03]stratified rank ANCOVA
Secondary
Number of Incontinence Episodes Reported During the 3-Day Diary
The number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from total number of incontinence episodes on valid diary days recorded during the 3-day micturition diary period.
Time frame: Weeks 4, 8 and 12
Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Number of Incontinence Episodes Reported During the 3-Day Diary | Week 12 | 4.03 incontinence episodes | Standard Error 0.29 |
| Combination (Solifenacin + Mirabegron) | Number of Incontinence Episodes Reported During the 3-Day Diary | Week 4 | 5.81 incontinence episodes | Standard Error 0.3 |
| Combination (Solifenacin + Mirabegron) | Number of Incontinence Episodes Reported During the 3-Day Diary | EoT | 4.25 incontinence episodes | Standard Error 0.29 |
| Combination (Solifenacin + Mirabegron) | Number of Incontinence Episodes Reported During the 3-Day Diary | Week 8 | 4.55 incontinence episodes | Standard Error 0.3 |
| Solifenacin 5 mg | Number of Incontinence Episodes Reported During the 3-Day Diary | Week 12 | 4.56 incontinence episodes | Standard Error 0.28 |
| Solifenacin 5 mg | Number of Incontinence Episodes Reported During the 3-Day Diary | Week 8 | 5.43 incontinence episodes | Standard Error 0.3 |
| Solifenacin 5 mg | Number of Incontinence Episodes Reported During the 3-Day Diary | EoT | 4.87 incontinence episodes | Standard Error 0.28 |
| Solifenacin 5 mg | Number of Incontinence Episodes Reported During the 3-Day Diary | Week 4 | 6.68 incontinence episodes | Standard Error 0.31 |
| Solifenacin 10 mg | Number of Incontinence Episodes Reported During the 3-Day Diary | EoT | 4.72 incontinence episodes | Standard Error 0.31 |
| Solifenacin 10 mg | Number of Incontinence Episodes Reported During the 3-Day Diary | Week 4 | 6.41 incontinence episodes | Standard Error 0.33 |
| Solifenacin 10 mg | Number of Incontinence Episodes Reported During the 3-Day Diary | Week 8 | 5.28 incontinence episodes | Standard Error 0.32 |
| Solifenacin 10 mg | Number of Incontinence Episodes Reported During the 3-Day Diary | Week 12 | 4.62 incontinence episodes | Standard Error 0.31 |
Comparison: Week 4 rate ratio, 95% CIs, \& p-value for number of incontinence episodes (IEs) during Week 4 3-day diary between combination \& solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate \& log of number of valid diary days as the offset variable.p-value: =0.00595% CI: [0.79, 0.96]Mixed Effects Poisson
Comparison: Week 8 rate ratio, 95% CIs, \& p-value for number of incontinence episodes (IEs) during Week 8 3-day diary between combination \& solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate \& log of number of valid diary days as the offset variable.p-value: <0.00195% CI: [0.66, 0.86]Mixed Effects Poisson
Comparison: Week 12 rate ratio, 95% CIs, \& p-value for number of incontinence episodes (IEs) during Week 12 3-day diary between combination \& solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate \& log of number of valid diary days as the offset variable.p-value: =0.02195% CI: [0.7, 0.97]Mixed Effects Poisson
Comparison: EoT rate ratio, 95% CIs, \& p-value for number of incontinence episodes (IEs) during EoT 3-day diary between combination \& solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate \& log of number of valid diary days as the offset variable.p-value: =0.01495% CI: [0.71, 0.96]Mixed Effects Poisson
Secondary
Number of Nocturia Episodes Reported Over 3-Day Diary
The number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) during sleeping time during the 3-day micturition diary period. This was calculated using the sum of each nocturia episode recorded on valid diary days during the 3-day micturition diary period.
Time frame: Weeks 4, 8 and 12
Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one nocturia episode reported in baseline diary were included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Number of Nocturia Episodes Reported Over 3-Day Diary | Week 4 | 3.63 nocturia episodes | Standard Error 0.12 |
| Combination (Solifenacin + Mirabegron) | Number of Nocturia Episodes Reported Over 3-Day Diary | Week 8 | 3.33 nocturia episodes | Standard Error 0.12 |
| Combination (Solifenacin + Mirabegron) | Number of Nocturia Episodes Reported Over 3-Day Diary | Week 12 | 3.12 nocturia episodes | Standard Error 0.13 |
| Combination (Solifenacin + Mirabegron) | Number of Nocturia Episodes Reported Over 3-Day Diary | EoT | 3.16 nocturia episodes | Standard Error 0.12 |
| Solifenacin 5 mg | Number of Nocturia Episodes Reported Over 3-Day Diary | EoT | 3.28 nocturia episodes | Standard Error 0.11 |
| Solifenacin 5 mg | Number of Nocturia Episodes Reported Over 3-Day Diary | Week 4 | 3.59 nocturia episodes | Standard Error 0.12 |
| Solifenacin 5 mg | Number of Nocturia Episodes Reported Over 3-Day Diary | Week 12 | 3.26 nocturia episodes | Standard Error 0.12 |
| Solifenacin 5 mg | Number of Nocturia Episodes Reported Over 3-Day Diary | Week 8 | 3.35 nocturia episodes | Standard Error 0.12 |
| Solifenacin 10 mg | Number of Nocturia Episodes Reported Over 3-Day Diary | EoT | 3.19 nocturia episodes | Standard Error 0.12 |
| Solifenacin 10 mg | Number of Nocturia Episodes Reported Over 3-Day Diary | Week 8 | 3.32 nocturia episodes | Standard Error 0.12 |
| Solifenacin 10 mg | Number of Nocturia Episodes Reported Over 3-Day Diary | Week 12 | 3.23 nocturia episodes | Standard Error 0.12 |
| Solifenacin 10 mg | Number of Nocturia Episodes Reported Over 3-Day Diary | Week 4 | 3.58 nocturia episodes | Standard Error 0.12 |
Comparison: Week 4 rate ratio, 95% CIs, \& p-value for number of nocturia episodes during 3-day diary between combination \& solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.p-value: =0.99395% CI: [0.93, 1.08]Mixed Effects Poisson
Comparison: Week 8 rate ratio, 95% CIs, \& p-value for number of nocturia episodes during 3-day diary between combination \& solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.p-value: =0.73695% CI: [0.9, 1.07]Mixed Effects Poisson
Comparison: Week 12 rate ratio, 95% CIs, \& p-value for number of nocturia episodes during 3-day diary between combination \& solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.p-value: =0.12195% CI: [0.85, 1.02]Mixed Effects Poisson
Comparison: EoT rate ratio, 95% CIs, \& p-value for number of nocturia episodes during 3-day diary between combination \& solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.p-value: =0.17295% CI: [0.86, 1.03]Mixed Effects Poisson
Secondary
Number of Pads Used During the 3-Day Diary
The number of pads used was defined as the number of times a participant recorded a new pad used during the 3-day micturition diary period. This was calculated using the sum of each record with new pad checked. Only records with new pad checked on a valid diary day were counted.
Time frame: Weeks 4, 8 and 12
Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants who reported use of at least one pad in baseline diary were included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Number of Pads Used During the 3-Day Diary | Week 4 | 4.80 pads | Standard Error 0.28 |
| Combination (Solifenacin + Mirabegron) | Number of Pads Used During the 3-Day Diary | Week 8 | 3.64 pads | Standard Error 0.24 |
| Combination (Solifenacin + Mirabegron) | Number of Pads Used During the 3-Day Diary | Week 12 | 3.23 pads | Standard Error 0.22 |
| Combination (Solifenacin + Mirabegron) | Number of Pads Used During the 3-Day Diary | EoT | 3.29 pads | Standard Error 0.22 |
| Solifenacin 5 mg | Number of Pads Used During the 3-Day Diary | EoT | 4.27 pads | Standard Error 0.28 |
| Solifenacin 5 mg | Number of Pads Used During the 3-Day Diary | Week 4 | 5.69 pads | Standard Error 0.36 |
| Solifenacin 5 mg | Number of Pads Used During the 3-Day Diary | Week 12 | 4.13 pads | Standard Error 0.28 |
| Solifenacin 5 mg | Number of Pads Used During the 3-Day Diary | Week 8 | 4.71 pads | Standard Error 0.37 |
| Solifenacin 10 mg | Number of Pads Used During the 3-Day Diary | EoT | 4.17 pads | Standard Error 0.29 |
| Solifenacin 10 mg | Number of Pads Used During the 3-Day Diary | Week 8 | 4.50 pads | Standard Error 0.29 |
| Solifenacin 10 mg | Number of Pads Used During the 3-Day Diary | Week 12 | 4.07 pads | Standard Error 0.28 |
| Solifenacin 10 mg | Number of Pads Used During the 3-Day Diary | Week 4 | 5.41 pads | Standard Error 0.29 |
Comparison: Week 4 rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination \& solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.p-value: =0.54595% CI: [0.87, 1.08]Mixed Effects Poisson
Comparison: Week 8 rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination \& solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.p-value: =0.0195% CI: [0.7, 0.95]Mixed Effects Poisson
Comparison: Week 12 rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination \& solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.p-value: =0.00795% CI: [0.67, 0.94]Mixed Effects Poisson
Comparison: EoT rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination \& solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.p-value: =0.00395% CI: [0.66, 0.92]Mixed Effects Poisson
Secondary
Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC)
The PGIC was a 2-part questionnaire, assessing both the change in the participant's overall condition (Patient Impression in General Health (PIBS)) and change in bladder condition since the start of the study (Patient Impression in General Health (PIGH)) (from very much worse to very much improved). The CGIC was a single questionnaire assessing the participant's change in bladder condition since the beginning of the study (Clinician Impression in Bladder Symptoms (CIBS)).
Time frame: End of treatment (up to 12 weeks)
Population: LOCF was used for EoT. The analysis population consisted of the FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIGH Very Much Improved | 144 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIBS Very Much Improved | 227 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | CIBS Very Much Improved | 184 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIGH Much Improved | 239 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIBS No Change | 25 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIGH Very Much Worse | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIGH Minimally Improved | 143 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | CIBS Very Much Worse | 3 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIGH Much Worse | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIGH No Change | 113 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | CIBS Minimally Worse | 4 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIGH Minimally Worse | 14 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIBS Minimally Worse | 7 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | CIBS Much Worse | 4 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | CIBS No Change | 23 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIBS Much Worse | 4 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIBS Minimally Improved | 135 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | CIBS Minimally Improved | 141 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIBS Very Much Worse | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIBS Much Improved | 257 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | CIBS Much Improved | 311 participants |
| Solifenacin 5 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | CIBS Minimally Worse | 8 participants |
| Solifenacin 5 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIBS Very Much Improved | 152 participants |
| Solifenacin 5 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIBS Much Improved | 264 participants |
| Solifenacin 5 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIBS Minimally Improved | 170 participants |
| Solifenacin 5 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIBS No Change | 55 participants |
| Solifenacin 5 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIBS Minimally Worse | 11 participants |
| Solifenacin 5 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIBS Much Worse | 4 participants |
| Solifenacin 5 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIBS Very Much Worse | 1 participants |
| Solifenacin 5 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIGH Very Much Improved | 104 participants |
| Solifenacin 5 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIGH Much Improved | 236 participants |
| Solifenacin 5 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIGH Minimally Improved | 147 participants |
| Solifenacin 5 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIGH No Change | 142 participants |
| Solifenacin 5 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIGH Minimally Worse | 23 participants |
| Solifenacin 5 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIGH Much Worse | 4 participants |
| Solifenacin 5 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIGH Very Much Worse | 1 participants |
| Solifenacin 5 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | CIBS Very Much Improved | 118 participants |
| Solifenacin 5 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | CIBS Much Improved | 316 participants |
| Solifenacin 5 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | CIBS Minimally Improved | 164 participants |
| Solifenacin 5 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | CIBS No Change | 56 participants |
| Solifenacin 5 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | CIBS Much Worse | 3 participants |
| Solifenacin 5 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | CIBS Very Much Worse | 3 participants |
| Solifenacin 10 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIGH Very Much Improved | 108 participants |
| Solifenacin 10 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIBS Much Improved | 284 participants |
| Solifenacin 10 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | CIBS Very Much Improved | 141 participants |
| Solifenacin 10 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIBS Very Much Worse | 1 participants |
| Solifenacin 10 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | CIBS Very Much Worse | 4 participants |
| Solifenacin 10 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | CIBS Much Improved | 329 participants |
| Solifenacin 10 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIBS Much Worse | 6 participants |
| Solifenacin 10 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | CIBS Much Worse | 5 participants |
| Solifenacin 10 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | CIBS Minimally Improved | 155 participants |
| Solifenacin 10 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIBS Minimally Worse | 4 participants |
| Solifenacin 10 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIBS Very Much Improved | 171 participants |
| Solifenacin 10 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | CIBS No Change | 40 participants |
| Solifenacin 10 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIGH No Change | 160 participants |
| Solifenacin 10 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIBS No Change | 56 participants |
| Solifenacin 10 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIGH Minimally Worse | 10 participants |
| Solifenacin 10 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIGH Minimally Improved | 146 participants |
| Solifenacin 10 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIBS Minimally Improved | 152 participants |
| Solifenacin 10 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIGH Much Worse | 4 participants |
| Solifenacin 10 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIGH Much Improved | 244 participants |
| Solifenacin 10 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | CIBS Minimally Worse | 5 participants |
| Solifenacin 10 mg | Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) | PIGH Very Much Worse | 2 participants |
Secondary
Number of Participants With Adverse Events (AEs)
AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures & which does not necessarily have a causal relationship with this treatment. Treatment-Emergent Adverse Event (TEAE) referred to an adverse event which started or worsened in the period from first double-blind medication intake until 30 days after the last double-blind medication intake.
Time frame: From first dose of double blind treatment until 30 days after last dose (up to 16 weeks)
Population: The analysis population consisted of the Safety Analysis Set, the SAF comprised all randomized participants who received at least 1 dose of double-blind treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Number of Participants With Adverse Events (AEs) | Drug-related AEs | 141 Participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Adverse Events (AEs) | AEs Leading to Perm. Disc. of Study Drug | 11 Participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Adverse Events (AEs) | Drug-related SAEs | 1 Participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Adverse Events (AEs) | AEs | 260 Participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Adverse Events (AEs) | Deaths | 0 Participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Adverse Events (AEs) | Drug-related AEs Leading to Perm. Disc. of Drug | 9 Participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Adverse Events (AEs) | Serious Adverse Events (SAEs) | 13 Participants |
| Solifenacin 5 mg | Number of Participants With Adverse Events (AEs) | Drug-related SAEs | 0 Participants |
| Solifenacin 5 mg | Number of Participants With Adverse Events (AEs) | AEs | 241 Participants |
| Solifenacin 5 mg | Number of Participants With Adverse Events (AEs) | Drug-related AEs | 125 Participants |
| Solifenacin 5 mg | Number of Participants With Adverse Events (AEs) | Serious Adverse Events (SAEs) | 10 Participants |
| Solifenacin 5 mg | Number of Participants With Adverse Events (AEs) | AEs Leading to Perm. Disc. of Study Drug | 11 Participants |
| Solifenacin 5 mg | Number of Participants With Adverse Events (AEs) | Drug-related AEs Leading to Perm. Disc. of Drug | 10 Participants |
| Solifenacin 5 mg | Number of Participants With Adverse Events (AEs) | Deaths | 0 Participants |
| Solifenacin 10 mg | Number of Participants With Adverse Events (AEs) | AEs Leading to Perm. Disc. of Study Drug | 11 Participants |
| Solifenacin 10 mg | Number of Participants With Adverse Events (AEs) | Drug-related AEs | 161 Participants |
| Solifenacin 10 mg | Number of Participants With Adverse Events (AEs) | Deaths | 0 Participants |
| Solifenacin 10 mg | Number of Participants With Adverse Events (AEs) | Drug-related AEs Leading to Perm. Disc. of Drug | 9 Participants |
| Solifenacin 10 mg | Number of Participants With Adverse Events (AEs) | Drug-related SAEs | 3 Participants |
| Solifenacin 10 mg | Number of Participants With Adverse Events (AEs) | Serious Adverse Events (SAEs) | 15 Participants |
| Solifenacin 10 mg | Number of Participants With Adverse Events (AEs) | AEs | 283 Participants |
Secondary
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression
The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.
Time frame: Baseline and EoT (up to 12 weeks)
Population: LOCF was used for EoT. The analysis population consisted of the FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Severely anxious -> extremely anxious | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Moderately anxious -> not anxious | 36 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Not anxious-> extremely anxious | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Severely anxious -> severely anxious | 5 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | No data -> extremely anxious | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Moderately anxious -> slightly anxious | 36 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | No data -> severely anxious | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Severely anxious -> moderately anxious | 6 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Moderately anxious -> moderately anxious | 22 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | No data -> not anxious | 5 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Severely anxious -> slightly anxious | 9 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Moderately anxious -> severely anxious | 3 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Not anxious -> no data | 4 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Severely anxious -> not anxious | 10 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Moderately anxious -> extremely anxious | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Not anxious -> moderately anxious | 11 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Moderately anxious -> no data | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Extremely anxious -> no data | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Slightly anxious -> not anxious | 107 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Not anxious -> slightly anxious | 43 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Extremely anxious -> extremely anxious | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Extremely anxious -> severely anxious | 4 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Slightly anxious -> slightly anxious | 56 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | No data -> moderately anxious | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Extremely anxious -> moderately anxious | 4 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Slightly anxious -> moderately anxious | 13 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Not anxious -> not anxious | 322 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Extremely anxious -> slightly anxious | 2 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Slightly anxious -> severely anxious | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Not anxious -> severely anxious | 2 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Extremely anxious -> not anxious | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Slightly anxious -> extremely anxious | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | No data -> no data | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Severely anxious -> no data | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Slightly anxious -> no data | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | No data -> slightly anxious | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Slightly anxious -> moderately anxious | 11 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Not anxious -> not anxious | 300 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Not anxious -> slightly anxious | 39 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Not anxious -> moderately anxious | 17 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Not anxious -> severely anxious | 2 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Not anxious-> extremely anxious | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Not anxious -> no data | 3 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Slightly anxious -> not anxious | 99 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Slightly anxious -> slightly anxious | 60 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Slightly anxious -> severely anxious | 2 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Slightly anxious -> extremely anxious | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Slightly anxious -> no data | 2 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Moderately anxious -> not anxious | 38 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Moderately anxious -> slightly anxious | 40 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Moderately anxious -> moderately anxious | 26 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Moderately anxious -> severely anxious | 7 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Moderately anxious -> extremely anxious | 3 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Moderately anxious -> no data | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Severely anxious -> not anxious | 8 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Severely anxious -> slightly anxious | 5 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Severely anxious -> moderately anxious | 6 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Severely anxious -> severely anxious | 8 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Severely anxious -> extremely anxious | 3 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Severely anxious -> no data | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Extremely anxious -> not anxious | 4 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Extremely anxious -> slightly anxious | 1 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Extremely anxious -> moderately anxious | 2 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Extremely anxious -> severely anxious | 1 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Extremely anxious -> extremely anxious | 2 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Extremely anxious -> no data | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | No data -> not anxious | 13 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | No data -> slightly anxious | 2 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | No data -> moderately anxious | 1 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | No data -> severely anxious | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | No data -> extremely anxious | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | No data -> no data | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Not anxious -> severely anxious | 3 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Severely anxious -> no data | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Slightly anxious -> severely anxious | 2 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | No data -> no data | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Extremely anxious -> not anxious | 1 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Slightly anxious -> moderately anxious | 23 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | No data -> slightly anxious | 5 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Extremely anxious -> slightly anxious | 1 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Slightly anxious -> slightly anxious | 69 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Not anxious -> moderately anxious | 15 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Extremely anxious -> moderately anxious | 3 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Slightly anxious -> not anxious | 90 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | No data -> extremely anxious | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Extremely anxious -> severely anxious | 1 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | No data -> severely anxious | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | No data -> moderately anxious | 1 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Extremely anxious -> extremely anxious | 1 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Moderately anxious -> extremely anxious | 1 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Not anxious -> no data | 3 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Moderately anxious -> no data | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Moderately anxious -> severely anxious | 1 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Not anxious -> slightly anxious | 43 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Severely anxious -> not anxious | 8 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Moderately anxious -> moderately anxious | 17 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Extremely anxious -> no data | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Severely anxious -> slightly anxious | 5 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Moderately anxious -> slightly anxious | 33 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Not anxious-> extremely anxious | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Severely anxious -> moderately anxious | 11 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Moderately anxious -> not anxious | 34 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Not anxious -> not anxious | 307 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Severely anxious -> severely anxious | 7 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Slightly anxious -> no data | 2 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | No data -> not anxious | 11 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Severely anxious -> extremely anxious | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression | Slightly anxious -> extremely anxious | 0 participants |
Secondary
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort
The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.
Time frame: Baseline and EoT (up to 12 weeks)
Population: LOCF was used for EoT. The analysis population consisted of the FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Moderate pain -> extreme pain | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No pain -> extreme pain | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No data -> moderate pain | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Moderate pain -> severe pain | 7 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No pain -> no data | 4 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Moderate pain -> no data | 2 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Moderate pain -> moderate pain | 34 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Slight pain -> no pain | 79 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Extreme pain -> no pain | 4 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Moderate pain -> slight pain | 37 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Slight pain -> slight pain | 58 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No data -> severe pain | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Moderate pain -> no pain | 39 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Slight pain -> moderate pain | 28 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Slight pain -> no data | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Slight pain -> severe pain | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Extreme pain -> severe pain | 6 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Slight pain -> extreme pain | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Severe pain -> no data | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No data -> extreme pain | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No data -> no pain | 4 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Severe pain -> extreme pain | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No data -> no data | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Extreme pain -> extreme pain | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Severe pain -> severe pain | 10 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No pain -> no pain | 299 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Extreme pain -> moderate pain | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Severe pain -> moderate pain | 11 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No pain -> slight pain | 45 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No data -> slight pain | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Severe pain -> slight pain | 12 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No pain -> moderate pain | 12 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Extreme pain -> no data | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Severe pain -> no pain | 7 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No pain -> severe pain | 3 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Extreme pain -> slight pain | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Severe pain -> slight pain | 7 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Extreme pain -> extreme pain | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Extreme pain -> no data | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No data -> no pain | 8 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No data -> slight pain | 3 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No data -> moderate pain | 5 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No data -> severe pain | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No data -> extreme pain | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No data -> no data | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No pain -> no pain | 290 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No pain -> slight pain | 62 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No pain -> moderate pain | 14 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No pain -> severe pain | 9 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No pain -> extreme pain | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No pain -> no data | 4 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Slight pain -> no pain | 82 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Slight pain -> slight pain | 64 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Slight pain -> severe pain | 2 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Slight pain -> extreme pain | 2 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Slight pain -> no data | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Moderate pain -> no pain | 36 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Moderate pain -> slight pain | 36 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Moderate pain -> moderate pain | 30 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Moderate pain -> severe pain | 4 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Moderate pain -> extreme pain | 1 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Moderate pain -> no data | 1 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Severe pain -> no pain | 4 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Slight pain -> moderate pain | 17 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Severe pain -> moderate pain | 16 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Severe pain -> severe pain | 4 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Severe pain -> extreme pain | 1 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Severe pain -> no data | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Extreme pain -> no pain | 1 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Extreme pain -> slight pain | 1 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Extreme pain -> moderate pain | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Extreme pain -> severe pain | 1 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No pain -> severe pain | 2 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Extreme pain -> no data | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Moderate pain -> extreme pain | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Extreme pain -> no pain | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Moderate pain -> no data | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No pain -> moderate pain | 17 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No data -> slight pain | 4 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Severe pain -> no pain | 10 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No pain -> slight pain | 51 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Extreme pain -> extreme pain | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Severe pain -> slight pain | 4 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No pain -> no pain | 283 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Extreme pain -> slight pain | 1 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Severe pain -> moderate pain | 16 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No data -> no data | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No data -> no pain | 11 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Severe pain -> severe pain | 9 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No data -> extreme pain | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Slight pain -> severe pain | 5 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Extreme pain -> severe pain | 1 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Slight pain -> extreme pain | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Slight pain -> moderate pain | 31 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Severe pain -> extreme pain | 1 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Slight pain -> no data | 2 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Slight pain -> slight pain | 55 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No data -> severe pain | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Moderate pain -> no pain | 21 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Slight pain -> no pain | 81 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Extreme pain -> moderate pain | 1 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Moderate pain -> slight pain | 39 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No pain -> no data | 3 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Severe pain -> no data | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Moderate pain -> moderate pain | 39 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No pain -> extreme pain | 1 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | No data -> moderate pain | 2 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort | Moderate pain -> severe pain | 8 participants |
Secondary
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care
The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.
Time frame: Baseline and EoT (up to 12 weeks)
Population: LOCF was used for EoT. The analysis population consisted of the FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Extreme problems -> moderate problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No problems -> severe problems | 3 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Slight problems -> extreme problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Moderate problems -> severe problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No problems -> extreme problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No data -> no data | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Extreme problems -> slight problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No problems -> no data | 6 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Severe problems -> moderate problems | 2 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Moderate problems -> moderate problems | 11 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Slight problems -> no problems | 37 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Slight problems -> no data | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Moderate problems -> slight problems | 9 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Slight problems -> slight problems | 23 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No data -> extreme problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Moderate problems -> no problems | 12 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Slight problems -> severe problems | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Severe problems -> severe problems | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Extreme problems -> extreme problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No data -> moderate problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Severe problems -> extreme problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Severe problems -> no problems | 7 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No data -> slight problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Severe problems -> no data | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No data -> severe problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No data -> no problems | 6 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Extreme problems -> no problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Slight problems -> moderate problems | 9 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No problems -> no problems | 548 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Moderate problems -> no data | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Extreme problems -> no data | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No problems -> slight problems | 28 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Moderate problems -> extreme problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Extreme problems -> severe problems | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No problems -> moderate problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Severe problems -> slight problems | 2 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Severe problems -> no problems | 5 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Slight problems -> moderate problems | 7 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No data -> severe problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Severe problems -> slight problems | 2 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Severe problems -> moderate problems | 1 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Severe problems -> severe problems | 4 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Severe problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Severe problems -> no data | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Extreme problems -> no problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No problems -> no problems | 541 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No problems -> slight problems | 26 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No problems -> moderate problems | 14 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No problems -> severe problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No problems -> no data | 5 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Slight problems -> no problems | 25 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Slight problems -> slight problems | 24 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Slight problems -> severe problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Slight problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Slight problems -> no data | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Moderate problems -> no problems | 16 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Moderate problems -> slight problems | 9 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Moderate problems -> moderate problems | 7 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Extreme problems -> slight problems | 1 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Moderate problems -> severe problems | 2 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Extreme problems -> moderate problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Extreme problems -> severe problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Extreme problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Extreme problems -> no data | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No data -> no problems | 14 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No data -> slight problems | 2 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No data -> moderate problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No data -> extreme problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No data -> no data | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Moderate problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Moderate problems -> no data | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No problems -> severe problems | 2 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No data -> extreme problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Moderate problems -> severe problems | 2 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No problems -> moderate problems | 7 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Severe problems -> slight problems | 2 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Extreme problems -> moderate problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No problems -> slight problems | 25 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Moderate problems -> no data | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Extreme problems -> severe problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No data -> no data | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Extreme problems -> extreme problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No problems -> no problems | 548 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Severe problems -> no problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Extreme problems -> no data | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Severe problems -> no data | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No data -> no problems | 17 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Severe problems -> extreme problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Slight problems -> moderate problems | 9 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Moderate problems -> extreme problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No data -> slight problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Slight problems -> extreme problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Severe problems -> severe problems | 1 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Slight problems -> no data | 1 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Slight problems -> slight problems | 22 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No data -> severe problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Moderate problems -> no problems | 7 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Slight problems -> no problems | 32 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No data -> moderate problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Moderate problems -> slight problems | 5 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Extreme problems -> no problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No problems -> no data | 4 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | No problems -> extreme problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Severe problems -> moderate problems | 2 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Moderate problems -> moderate problems | 12 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Slight problems -> severe problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care | Extreme problems -> slight problems | 0 participants |
Secondary
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities
The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.
Time frame: Baseline and EoT (up to 12 weeks)
Population: LOCF was used for EoT. The analysis population consisted of the FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Moderate problems -> no problems | 29 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No data -> extreme problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Extreme problems -> no problems | 2 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Moderate problems -> slight problems | 22 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No problems -> no problems | 397 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Severe problems -> no data | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Moderate problems -> moderate problems | 22 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No problems -> no data | 4 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Severe problems -> extreme problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Moderate problems -> severe problems | 3 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No problems -> moderate problems | 12 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Severe problems -> severe problems | 5 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Moderate problems -> extreme problems | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No data -> slight problems | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Severe problems -> moderate problems | 7 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Moderate problems -> no data | 2 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Slight problems -> no problems | 75 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Severe problems -> slight problems | 7 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Severe problems -> no problems | 9 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No problems -> slight problems | 38 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No data -> no problems | 5 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Slight problems -> slight problems | 46 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No data -> severe problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Extreme problems -> no data | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Slight problems -> moderate problems | 12 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No problems -> severe problems | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Extreme problems -> extreme problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Slight problems -> severe problems | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No data -> no data | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Extreme problems -> severe problems | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Slight problems -> extreme problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No data -> moderate problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Extreme problems -> moderate problems | 3 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Slight problems -> no data | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No problems -> extreme problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Extreme problems -> slight problems | 1 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No data -> slight problems | 4 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No problems -> no problems | 384 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No problems -> slight problems | 30 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No problems -> moderate problems | 19 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No problems -> severe problems | 4 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No problems -> no data | 3 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Slight problems -> no problems | 81 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Slight problems -> slight problems | 45 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Slight problems -> moderate problems | 16 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Slight problems -> severe problems | 1 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Slight problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Slight problems -> no data | 1 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Moderate problems -> no problems | 35 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Moderate problems -> slight problems | 20 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Moderate problems -> moderate problems | 18 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Moderate problems -> severe problems | 3 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Moderate problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Moderate problems -> no data | 1 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Severe problems -> no problems | 8 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Severe problems -> slight problems | 5 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Severe problems -> moderate problems | 6 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Severe problems -> severe problems | 7 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Severe problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Severe problems -> no data | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Extreme problems -> no problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Extreme problems -> slight problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Extreme problems -> moderate problems | 1 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Extreme problems -> severe problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Extreme problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Extreme problems -> no data | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No data -> no problems | 11 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No data -> moderate problems | 1 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No data -> severe problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No data -> extreme problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No data -> no data | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Moderate problems -> no problems | 25 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No data -> extreme problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Extreme problems -> no problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Slight problems -> no data | 2 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No data -> moderate problems | 1 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Extreme problems -> slight problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Slight problems -> extreme problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No problems -> moderate problems | 11 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Extreme problems -> moderate problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Slight problems -> severe problems | 3 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No problems -> no problems | 379 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Extreme problems -> severe problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Slight problems -> moderate problems | 15 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No data -> severe problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Extreme problems -> extreme problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Slight problems -> slight problems | 37 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No problems -> slight problems | 42 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Extreme problems -> no data | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Slight problems -> no problems | 78 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No data -> no data | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Severe problems -> no problems | 12 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Moderate problems -> no data | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No data -> no problems | 15 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Severe problems -> slight problems | 1 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Moderate problems -> extreme problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No problems -> no data | 3 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Severe problems -> moderate problems | 9 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Moderate problems -> severe problems | 4 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No problems -> extreme problems | 1 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Severe problems -> severe problems | 9 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Moderate problems -> moderate problems | 21 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No data -> slight problems | 1 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Severe problems -> extreme problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Moderate problems -> slight problems | 28 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | No problems -> severe problems | 1 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities | Severe problems -> no data | 0 participants |
Secondary
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility
The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.
Time frame: Baseline and EoT (up to 12 weeks)
Population: LOCF was used for EoT. The analysis population consisted of the FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Extreme problems -> extreme problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No problems -> extreme problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No data -> no problems | 4 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Moderate problems -> severe problems | 2 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No data -> slight problems | 2 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No problems -> no data | 2 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No data -> moderate problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Moderate problems -> no problems | 24 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Extreme problems -> no data | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Moderate problems -> slight problems | 25 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Slight problems -> no problems | 52 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Moderate problems -> moderate problems | 28 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Moderate problems -> no data | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Moderate problems -> extreme problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Slight problems -> slight problems | 43 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No data -> severe problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No problems -> no problems | 409 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No data -> extreme problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Slight problems -> moderate problems | 15 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No data -> no data | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Slight problems -> severe problems | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Slight problems -> extreme problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Slight problems -> no data | 2 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No problems -> slight problems | 33 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Severe problems -> no problems | 7 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Severe problems -> slight problems | 6 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Severe problems -> moderate problems | 17 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Severe problems -> severe problems | 12 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No problems -> moderate problems | 14 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Severe problems -> extreme problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Extreme problems -> no problems | 3 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Extreme problems -> slight problems | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No problems -> severe problems | 0 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Extreme problems -> moderate problems | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Extreme problems -> severe problems | 1 participants |
| Combination (Solifenacin + Mirabegron) | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Severe problems -> no data | 1 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No problems -> no problems | 370 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Severe problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Extreme problems -> no data | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Slight problems -> severe problems | 3 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No data -> no problems | 9 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Moderate problems -> severe problems | 3 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No problems -> moderate problems | 11 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No data -> slight problems | 4 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Slight problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Moderate problems -> no data | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No problems -> no data | 4 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Severe problems -> no data | 1 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Moderate problems -> no problems | 36 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Severe problems -> severe problems | 10 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Extreme problems -> moderate problems | 1 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Moderate problems -> slight problems | 18 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Severe problems -> no problems | 8 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No problems -> slight problems | 35 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Moderate problems -> moderate problems | 28 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Slight problems -> no problems | 58 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Extreme problems -> no problems | 2 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Severe problems -> slight problems | 7 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Moderate problems -> extreme problems | 1 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Slight problems -> no data | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No data -> moderate problems | 3 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Slight problems -> slight problems | 46 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No problems -> severe problems | 7 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No data -> severe problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Severe problems -> moderate problems | 11 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Extreme problems -> slight problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No data -> extreme problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Extreme problems -> extreme problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Extreme problems -> severe problems | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No data -> no data | 0 participants |
| Solifenacin 5 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Slight problems -> moderate problems | 28 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No data -> no data | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Severe problems -> moderate problems | 11 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Extreme problems -> no problems | 2 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No problems -> no problems | 374 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No problems -> slight problems | 36 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No problems -> moderate problems | 11 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No problems -> severe problems | 4 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No problems -> extreme problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No problems -> no data | 5 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Slight problems -> no problems | 60 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Slight problems -> slight problems | 40 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Slight problems -> moderate problems | 16 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Slight problems -> severe problems | 3 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Moderate problems -> no data | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Severe problems -> no problems | 2 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Severe problems -> slight problems | 7 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Severe problems -> severe problems | 14 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Severe problems -> extreme problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Severe problems -> no data | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Extreme problems -> slight problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Extreme problems -> moderate problems | 1 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Extreme problems -> severe problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Extreme problems -> extreme problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Extreme problems -> no data | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No data -> no problems | 13 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No data -> slight problems | 1 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Slight problems -> no data | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Moderate problems -> no problems | 25 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Moderate problems -> slight problems | 23 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Moderate problems -> moderate problems | 40 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Moderate problems -> severe problems | 7 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Moderate problems -> extreme problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No data -> moderate problems | 3 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No data -> severe problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | No data -> extreme problems | 0 participants |
| Solifenacin 10 mg | Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility | Slight problems -> extreme problems | 0 participants |
Secondary
Number of UI Episodes Reported During the 3-Day Diary
Number of UI episodes was calculated using the number of UI episodes recorded on valid diary days during the 3-day micturition diary period. NOTE: Only urgency incontinence episodes recorded on a valid diary day were counted.
Time frame: Weeks 4, 8 and 12
Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one UI episode reported in baseline diary were included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Number of UI Episodes Reported During the 3-Day Diary | Week 4 | 4.96 UI episodes | Standard Error 0.27 |
| Combination (Solifenacin + Mirabegron) | Number of UI Episodes Reported During the 3-Day Diary | Week 8 | 3.55 UI episodes | Standard Error 0.25 |
| Combination (Solifenacin + Mirabegron) | Number of UI Episodes Reported During the 3-Day Diary | Week 12 | 3.10 UI episodes | Standard Error 0.24 |
| Combination (Solifenacin + Mirabegron) | Number of UI Episodes Reported During the 3-Day Diary | EoT | 3.33 UI episodes | Standard Error 0.24 |
| Solifenacin 5 mg | Number of UI Episodes Reported During the 3-Day Diary | EoT | 4.00 UI episodes | Standard Error 0.25 |
| Solifenacin 5 mg | Number of UI Episodes Reported During the 3-Day Diary | Week 4 | 5.86 UI episodes | Standard Error 0.29 |
| Solifenacin 5 mg | Number of UI Episodes Reported During the 3-Day Diary | Week 12 | 3.78 UI episodes | Standard Error 0.25 |
| Solifenacin 5 mg | Number of UI Episodes Reported During the 3-Day Diary | Week 8 | 4.76 UI episodes | Standard Error 0.27 |
| Solifenacin 10 mg | Number of UI Episodes Reported During the 3-Day Diary | EoT | 3.96 UI episodes | Standard Error 0.29 |
| Solifenacin 10 mg | Number of UI Episodes Reported During the 3-Day Diary | Week 8 | 4.50 UI episodes | Standard Error 0.3 |
| Solifenacin 10 mg | Number of UI Episodes Reported During the 3-Day Diary | Week 12 | 3.91 UI episodes | Standard Error 0.3 |
| Solifenacin 10 mg | Number of UI Episodes Reported During the 3-Day Diary | Week 4 | 5.50 UI episodes | Standard Error 0.3 |
Comparison: Week 4 rate ratio, 95% CIs, and p-value for number of UI episodes during Week 4 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.p-value: =0.00395% CI: [0.76, 0.94]Mixed Effects Poisson
Comparison: Week 8 rate ratio, 95% CIs, and p-value for number of UI episodes during Week 8 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.p-value: <0.00195% CI: [0.63, 0.86]Mixed Effects Poisson
Comparison: Week 12 rate ratio, 95% CIs, and p-value for number of UI episodes during Week 12 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.p-value: =0.03895% CI: [0.69, 0.99]Mixed Effects Poisson
Comparison: EoT rate ratio, 95% CIs, and p-value for number of UI episodes during EoT 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.p-value: =0.02295% CI: [0.69, 0.97]Mixed Effects Poisson
Secondary
Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline
Micturitions were defined as voluntary urinations (excluding incontinence only episodes).
Time frame: Weeks 4, 8 and 12
Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline | Week 12 | 31.4 percentage of participants |
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline | Week 4 | 21.0 percentage of participants |
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline | EoT | 30.2 percentage of participants |
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline | Week 8 | 28.1 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline | Week 12 | 24.8 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline | Week 8 | 22.4 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline | Week 4 | 18.7 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline | EoT | 25.0 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline | EoT | 27.7 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline | Week 4 | 20.2 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline | Week 8 | 26.3 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline | Week 12 | 28.0 percentage of participants |
Comparison: Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: =0.30595% CI: [0.88, 1.5]Regression, Logistic
Comparison: Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: =0.01495% CI: [1.06, 1.76]Regression, Logistic
Comparison: Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: =0.01295% CI: [1.07, 1.76]Regression, Logistic
Comparison: EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: =0.03695% CI: [1.02, 1.64]Regression, Logistic
Secondary
Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score
HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).
Time frame: Weeks 4, 8 and 12
Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score | Week 4 | 52.6 percentage of participants |
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score | Week 8 | 63.6 percentage of participants |
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score | Week 12 | 70.5 percentage of participants |
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score | EoT | 68.6 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score | EoT | 60.6 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score | Week 4 | 44.5 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score | Week 12 | 60.8 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score | Week 8 | 54.8 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score | EoT | 60.1 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score | Week 8 | 53.8 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score | Week 12 | 60.4 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score | Week 4 | 48.1 percentage of participants |
Comparison: Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: =0.00395% CI: [1.14, 1.82]Regression, Logistic
Comparison: Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: =0.00195% CI: [1.18, 1.93]Regression, Logistic
Comparison: Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: <0.00195% CI: [1.27, 2.13]Regression, Logistic
Comparison: EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: =0.00195% CI: [1.17, 1.91]Regression, Logistic
Secondary
Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score
The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity).
Time frame: Weeks 4, 8 and 12
Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score | Week 4 | 67.9 percentage of participants |
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score | Week 8 | 77.2 percentage of participants |
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score | Week 12 | 83.5 percentage of participants |
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score | EoT | 81.7 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score | EoT | 71.7 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score | Week 4 | 58.2 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score | Week 12 | 72.1 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score | Week 8 | 66.4 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score | EoT | 74.6 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score | Week 8 | 69.1 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score | Week 12 | 75.4 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score | Week 4 | 61.9 percentage of participants |
Comparison: EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: <0.00195% CI: [1.34, 2.3]Regression, Logistic
Comparison: Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: =0.00195% CI: [1.18, 1.88]Regression, Logistic
Comparison: Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: <0.00195% CI: [1.31, 2.18]Regression, Logistic
Comparison: Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: <0.00195% CI: [1.47, 2.61]Regression, Logistic
Secondary
Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC
The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition.
Time frame: Weeks 4, 8 and 12
Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC | Week 4 | 61.1 percentage of participants |
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC | Week 8 | 70.1 percentage of participants |
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC | Week 12 | 77.9 percentage of participants |
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC | EoT | 76.5 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC | EoT | 69.5 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC | Week 4 | 52.1 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC | Week 12 | 70.4 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC | Week 8 | 62.1 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC | EoT | 71.9 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC | Week 8 | 64.6 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC | Week 12 | 72.7 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC | Week 4 | 56.3 percentage of participants |
Comparison: Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: =0.00395% CI: [1.13, 1.79]Regression, Logistic
Comparison: Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: =0.00495% CI: [1.12, 1.84]Regression, Logistic
Comparison: Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: =0.00395% CI: [1.15, 1.96]Regression, Logistic
Comparison: EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: =0.00695% CI: [1.11, 1.84]Regression, Logistic
Secondary
Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours
Incontinence was defined as any involuntary leakage of urine.
Time frame: Weeks 4, 8 and 12
Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | Week 4 | 52.5 percentage of participants |
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | Week 8 | 66.9 percentage of participants |
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | Week 12 | 72.4 percentage of participants |
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | EoT | 71.2 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | EoT | 63.1 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | Week 4 | 43.3 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | Week 12 | 64.0 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | Week 8 | 57.6 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | EoT | 66.6 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | Week 8 | 61.8 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | Week 12 | 66.9 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours | Week 4 | 49.0 percentage of participants |
Comparison: Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: <0.00195% CI: [1.19, 1.84]Regression, Logistic
Comparison: Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: <0.00195% CI: [1.25, 1.98]Regression, Logistic
Comparison: Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: =0.00195% CI: [1.21, 1.95]Regression, Logistic
Comparison: EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: <0.00195% CI: [1.2, 1.9]Regression, Logistic
Secondary
Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC
The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition.
Time frame: Weeks 4, 8 and 12
Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC | Week 4 | 26.6 percentage of participants |
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC | Week 8 | 39.5 percentage of participants |
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC | Week 12 | 51.8 percentage of participants |
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC | EoT | 49.8 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC | EoT | 39.1 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC | Week 4 | 21.6 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC | Week 12 | 39.8 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC | Week 8 | 31.5 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC | EoT | 43.2 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC | Week 8 | 31.8 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC | Week 12 | 43.8 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC | Week 4 | 21.6 percentage of participants |
Comparison: Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: =0.06595% CI: [0.99, 1.66]Regression, Logistic
Comparison: Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: =0.00495% CI: [1.11, 1.79]Regression, Logistic
Comparison: Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: <0.00195% CI: [1.3, 2.07]Regression, Logistic
Comparison: EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: <0.00195% CI: [1.24, 1.94]Regression, Logistic
Secondary
Percentage of Participants With Zero Incontinence Episodes Postbaseline
Incontinence was defined as any involuntary leakage of urine.
Time frame: Weeks 4, 8 and 12
Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With Zero Incontinence Episodes Postbaseline | Week 4 | 23.5 percentage of participants |
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With Zero Incontinence Episodes Postbaseline | Week 8 | 40.4 percentage of participants |
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With Zero Incontinence Episodes Postbaseline | Week 12 | 47.3 percentage of participants |
| Combination (Solifenacin + Mirabegron) | Percentage of Participants With Zero Incontinence Episodes Postbaseline | EoT | 46.0 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Zero Incontinence Episodes Postbaseline | EoT | 37.9 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Zero Incontinence Episodes Postbaseline | Week 4 | 20.0 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Zero Incontinence Episodes Postbaseline | Week 12 | 39.5 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Zero Incontinence Episodes Postbaseline | Week 8 | 31.6 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With Zero Incontinence Episodes Postbaseline | EoT | 40.2 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With Zero Incontinence Episodes Postbaseline | Week 8 | 34.3 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With Zero Incontinence Episodes Postbaseline | Week 12 | 40.7 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With Zero Incontinence Episodes Postbaseline | Week 4 | 22.1 percentage of participants |
Comparison: Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: =0.11995% CI: [0.95, 1.63]Regression, Logistic
Comparison: Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: <0.00195% CI: [1.23, 1.98]Regression, Logistic
Comparison: Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: =0.00295% CI: [1.14, 1.82]Regression, Logistic
Comparison: EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.p-value: =0.00195% CI: [1.17, 1.84]Regression, Logistic