A Phase 3 interventional study of Solifenacin succinate and Mirabegron in Urinary Bladder Overactive, Overactive Bladder and Urgency Incontinence, sponsored by Astellas Pharma Europe B.V.. Completed at 251 sites in 32 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-31.
Sponsored by Astellas Pharma Europe B.V. (part of Astellas Pharma Inc) · Phase 3, Interventional, and Treatment
The purpose of this study was to examine how well the combination of two medicines (solifenacin succinate and mirabegron) worked compared to each medicine alone in the treatment of bladder problems, and how safe they were for long term use.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's enrollment of 1,829 is above the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Astellas Pharma Europe B.V. is the lead sponsor of 94 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Main Inclusion at Screening (Visit 1):
Main Inclusion at Randomization (Visit 2):
Exclusion Criteria:
Main Exclusion at Screening (Visit 1):
Main Exclusion at Randomization (Visit 2):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received mirabegron 50 mg once a day for 52 weeks.
Drug: Mirabegron · Drug: Placebo to match solifenacin
Participants received solifenacin 5 mg once a day for 52 weeks.
Drug: Solifenacin succinate · Drug: Placebo to match mirabegron
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Drug: Solifenacin succinate · Drug: Mirabegron
Participants received solifenacin 5 mg orally once a day at the same time each day.
Also known as: Vesicare, Vesitrim, YM905, Vesikur
Participants received mirabegron 50 mg orally once a day at the same time each day.
Also known as: Myrbetriq, YM178, Betmiga, Betanis
Participants received placebo to match solifenacin 5 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study.
Participants received placebo to match mirabegron 50 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
A TEAE was defined as an adverse event (AE) observed after taking the first dose of double-blind treatment until 14 days after taking the last dose of double-blind treatment for non-serious AEs and until 30 days after taking the last dose of double-blind treatment for serious adverse events (SAEs). This included abnormal laboratory tests, vital signs or electrocardiogram data that were defined as AEs if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant in the investigator's opinion. The severity of each AE was defined according to the following: Mild (No disruption of normal daily activities); Moderate (Affected normal daily activities) and Severe (Inability to perform daily activities).
Time frame: From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks)
Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the baseline and week 52 clinic visits.
Time frame: Baseline and Week 52
Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours
A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and week 52 clinic visits.
Time frame: Baseline and Week 52
Change From Baseline to EoT in Mean Volume Voided Per Micturition
The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period.
Time frame: Baseline and Week 52
Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.
Time frame: Baseline and Week 52
Change From Baseline to EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS)
The TS-VAS is a visual analogue scale which asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.
Time frame: Baseline and Week 52
Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the baseline and prior to each visit.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit.
Time frame: Months 1, 3, 6, 9, 12
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit
The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period prior to each visit with no incontinence episodes recorded.
Time frame: Months 1, 3, 6, 9, 12
Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit
The number of incontinence-free days with \< 8 micturitions per day was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with \< 8 micturitions per day.
Time frame: Months 1, 3, 6, 9, 12
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceeded by urgency. The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit.
Time frame: Months 1, 3, 6, 9, 12
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours
A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and prior to each visit.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)
The number of days with \< 8 micturitions was the number of valid diary days during the 7-day micturition diary period with with less than 8 micturitions per day.
Time frame: Months 1, 3, 6, 9, 12
Change From Baseline to EoT in Corrected Micturition Frequency
Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline. Corrected micturition frequency was calculated as the baseline mean volume voided per micturition multiplied by the baseline mean number of micturitions per 24 hours divided by the mean volume voided per micturition at EoT.
Time frame: Baseline and Month 12
Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition
The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period prior to each visit.
Time frame: Baseline and Months 3, 6, 12
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours
Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode recorded by the participant in the micturition diary for 7 days prior to each visit as 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS), where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours
A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The mean number of nocturia episodes was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit."
Time frame: Baseline and Months 1, 3, 6, 9, 12
Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit
A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode during the 7-day micturition diary period prior to each visit.
Time frame: Months 1, 3, 6, 9, 12
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode during the 7-day micturition diary period prior to each visit
Time frame: Baseline and Months 1, 3, 6, 9, 12
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours
The mean number of pads used per 24 hours was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit
The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit.
Time frame: Months 1, 3, 6, 9, 12
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit
The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score
The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consisted of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each time was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS
The TS-VAS is a visual analogue scale which asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)
The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT
The PGIC is a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).
Time frame: Month 12
Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT
The PGIC is a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).
Time frame: Month 12
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility
The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Time frame: Baseline and 12 Months
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care
The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Time frame: Baseline and Month 12
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities
The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Time frame: Baseline and Month 12
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort
The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and had 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Time frame: Baseline and Month 12
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression
The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and had 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Time frame: Baseline and Month 12
Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed
The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.
Time frame: Baseline and Months 6,12
Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working
The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.
Time frame: Baseline and Months 6, 12
Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment
The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes arre expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.
Time frame: Baseline and Months 6, 12
Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment
The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.
Time frame: Baseline and Months 6, 12
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the last 3 days of the 7-day micturition diary is reported.
Time frame: Months 1, 3, 6, 9, 12
Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the 7-day micturition diary is reported.
Time frame: Months 1, 3, 6, 9, 12
Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT
The percentage of participants with micturition frequency normalization was defined as participants who had ≥ 8 micturitions/24 hours at baseline and \< 8 micturitions/24 hours postbaseline at months 1, 3, 6, 9, 12 and EoT.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT
The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT
The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Months 1, 3, 6, 9, 12 and EoT
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Months 1, 3, 6, 9, 12 and EoT
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT
The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The symptom bother portion of the OAB-q consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT
The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The HRQoL portion of the OAB-q consists of 25 HRQoL items comprising 4 HRQoL subscales, each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume
PVR volume was assessed by ultrasonography or a bladder scanner.
Time frame: Baseline and Months 1, 3, 6, 9, 12
Participants who had symptoms of "wet" overactive bladder (OAB) (urgency, urinary frequency and urgency incontinence) for ≥ 3 months were enrolled in 251 centers globally. A majority of the participants were recruited from participants who enrolled and completed studies 178-CL-101 (NCT01972841) or 905-EC-012 (NCT01908829).
| Milestone | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Started | 306 | 305 | 1218 |
| Treated | 306 | 303 | 1210 |
| Completed | 267 | 265 | 1092 |
| Not completed | 39 | 40 | 126 |
| Withdrew: Death | 0 | 0 | 1 |
| Withdrew: Miscellaneous | 5 | 0 | 8 |
| Withdrew: Withdrawal by patient | 18 | 27 | 57 |
| Withdrew: Protocol violation | 0 | 0 | 6 |
| Withdrew: Lack of efficacy | 8 | 4 | 13 |
| Withdrew: Randomized but not received study drug | 0 | 2 | 8 |
| Withdrew: Adverse event | 7 | 5 | 27 |
| Withdrew: Lost to follow-up | 1 | 2 | 6 |
A TEAE was defined as an adverse event (AE) observed after taking the first dose of double-blind treatment until 14 days after taking the last dose of double-blind treatment for non-serious AEs and until 30 days after taking the last dose of double-blind treatment for serious adverse events (SAEs). This included abnormal laboratory tests, vital signs or electrocardiogram data that were defined as AEs if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant in the investigator's opinion. The severity of each AE was defined according to the following: Mild (No disruption of normal daily activities); Moderate (Affected normal daily activities) and Severe (Inability to perform daily activities).
| Participants | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Any TEAEs | 126 | 134 | 596 |
| Mild TEAEs | 61 | 69 | 306 |
| Moderate TEAEs | 52 | 58 | 238 |
| Severe TEAEs | 13 | 7 | 52 |
| Drug-related TEAEs | 35 | 42 | 200 |
| Serious TEAEs | 8 | 8 | 51 |
| Drug-related Serious TEAEs | 1 | 0 | 0 |
| TEAEs Leading to Discontuation of Study Drug | 7 | 5 | 25 |
| Drug-related TEAEs Leading to Discont. of Drug | 4 | 4 | 17 |
| TEAEs Leading to Death | 0 | 0 | 1 |
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the baseline and week 52 clinic visits.
| incontinence episodes | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours | -1.58 ± 0.11 | -1.90 ± 0.11 | -2.03 ± 0.05 |
A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and week 52 clinic visits.
| micturitions | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours | -2.10 ± 0.13 | -2.16 ± 0.13 | -2.58 ± 0.07 |
The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period.
| mL | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Change From Baseline to EoT in Mean Volume Voided Per Micturition | 21.83 ± 3.12 | 24.90 ± 3.10 | 37.67 ± 1.55 |
The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.
| units on a scale | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score | -21.96 ± 1.14 | -24.91 ± 1.13 | -29.51 ± 0.57 |
The TS-VAS is a visual analogue scale which asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.
| units on a scale | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Change From Baseline to EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS) | 2.19 ± 0.12 | 2.15 ± 0.12 | 2.73 ± 0.06 |
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the baseline and prior to each visit.
| incontinence episodes | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | -0.97 ± 0.10 | -1.29 ± 0.11 | -1.45 ± 0.05 |
| Month 3 | -1.31 ± 0.11 | -1.71 ± 0.11 | -1.78 ± 0.05 |
| Month 6 | -1.42 ± 0.11 | -1.78 ± 0.11 | -1.93 ± 0.05 |
| Month 9 | -1.53 ± 0.11 | -1.90 ± 0.11 | -2.00 ± 0.06 |
| Month 12 | -1.67 ± 0.11 | -1.92 ± 0.11 | -2.06 ± 0.06 |
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit.
| incontinence episodes | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 14.88 ± 1.52 | 12.41 ± 1.22 | 10.80 ± 0.58 |
| Month 3 | 12.23 ± 1.12 | 9.23 ± 1.02 | 8.33 ± 0.52 |
| Month 6 | 10.62 ± 1.08 | 8.18 ± 1.01 | 7.28 ± 0.48 |
| Month 9 | 10.53 ± 1.19 | 7.28 ± 0.91 | 6.74 ± 0.45 |
| Month 12 | 9.09 ± 1.10 | 7.06 ± 0.94 | 6.10 ± 0.46 |
| EoT | 10.32 ± 1.08 | 8.09 ± 0.94 | 6.85 ± 0.47 |
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit.
| incontinence episodes | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | -6.77 ± 0.73 | -9.17 ± 0.73 | -10.31 ± 0.36 |
| Month 3 | -9.21 ± 0.76 | -12.05 ± 0.75 | -12.55 ± 0.38 |
| Month 6 | -10.36 ± 0.76 | -12.50 ± 0.75 | -13.49 ± 0.37 |
| Month 9 | -10.62 ± 0.76 | -13.51 ± 0.77 | -14.06 ± 0.38 |
| Month 12 | -11.84 ± 0.77 | -13.47 ± 0.77 | -14.43 ± 0.38 |
| EoT | -11.17 ± 0.75 | -13.37 ± 0.75 | -14.29 ± 0.37 |
The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period prior to each visit with no incontinence episodes recorded.
| incontinence-free days | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 2.73 ± 0.15 | 3.35 ± 0.17 | 3.46 ± 0.08 |
| Month 3 | 3.30 ± 0.17 | 3.98 ± 0.17 | 4.17 ± 0.08 |
| Month 6 | 3.64 ± 0.17 | 4.08 ± 0.17 | 4.44 ± 0.08 |
| Month 9 | 3.97 ± 0.18 | 4.33 ± 0.17 | 4.56 ± 0.08 |
| Month 12 | 4.23 ± 0.18 | 4.5 ± 0.18 | 4.81 ± 0.08 |
| EoT | 3.98 ± 0.17 | 4.29 ± 0.16 | 4.64 ± 0.08 |
The number of incontinence-free days with \< 8 micturitions per day was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with \< 8 micturitions per day.
| days | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 1.03 ± 0.10 | 1.01 ± 0.10 | 1.33 ± 0.06 |
| Month 3 | 1.24 ± 0.12 | 1.48 ± 0.13 | 1.91 ± 0.07 |
| Month 6 | 1.56 ± 0.14 | 1.66 ± 0.14 | 2.13 ± 0.08 |
| Month 9 | 1.56 ± 0.14 | 1.64 ± 0.14 | 2.20 ± 0.08 |
| Month 12 | 1.87 ± 0.15 | 1.92 ± 0.15 | 2.54 ± 0.08 |
| EoT | 1.75 ± 0.14 | 1.90 ± 0.14 | 2.43 ± 0.07 |
An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit.
| urgency incontinence episodes | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | -0.93 ± 0.10 | -1.25 ± 0.10 | -1.43 ± 0.05 |
| Month 3 | -1.30 ± 0.10 | -1.64 ± 0.10 | -1.71 ± 0.05 |
| Month 6 | -1.40 ± 0.10 | -1.67 ± 0.10 | -1.86 ± 0.05 |
| Month 9 | -1.60 ± 0.11 | -1.78 ± 0.11 | -1.92 ± 0.05 |
| Month 12 | -1.60 ± 0.10 | -1.82 ± 0.10 | -1.98 ± 0.05 |
| EoT | -1.51 ± 0.10 | -1.81 ± 0.10 | -1.94 ± 0.05 |
An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceeded by urgency. The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit.
| urgency incontinence episodes | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 13.14 ± 1.42 | 11.21 ± 1.19 | 8.99 ± 0.47 |
| Month 3 | 10.37 ± 1.00 | 8.12 ± 0.98 | 6.95 ± 0.44 |
| Month 6 | 8.97 ± 0.95 | 7.31 ± 0.96 | 5.88 ± 0.41 |
| Month 9 | 8.08 ± 1.01 | 6.51 ± 0.89 | 5.47 ± 0.40 |
| Month 12 | 7.73 ± 1.00 | 6.06 ± 0.85 | 4.88 ± 0.38 |
| EoT | 8.86 ± 0.98 | 7.04 ± 0.86 | 5.57 ± 0.40 |
An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit.
| urgency incontinence episodes | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | -6.45 ± 0.69 | -8.77 ± 0.69 | -10.1 ± 0.34 |
| Month 3 | -9.06 ± 0.72 | -11.48 ± 0.71 | -11.99 ± 0.36 |
| Month 6 | -10.09 ± 0.72 | -11.71 ± 0.71 | -13.0 ± 0.35 |
| Month 9 | -11.1 ± 0.72 | -12.6 ± 0.73 | -13.44 ± 0.36 |
| Month 12 | -11.27 ± 0.71 | -12.8 ± 0.71 | -13.8 ± 0.35 |
| EoT | -10.61 ± 0.7 | 12.66 ± 0.7 | -13.59 ± 0.35 |
A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and prior to each visit.
| micturitions | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | -1.09 ± 0.12 | -1.36 ± 0.12 | -1.64 ± 0.06 |
| Month 3 | -1.63 ± 0.13 | -1.87 ± 0.12 | 2.16 ± 0.06 |
| Month 6 | -1.85 ± 0.13 | -2.04 ± 0.13 | -2.39 ± 0.06 |
| Month 9 | -2.03 ± 0.13 | -2.03 ± 0.13 | -2.42 ± 0.06 |
| Month 12 | -2.20 ± 0.13 | -2.13 ± 0.14 | -2.64 ± 0.07 |
The number of days with \< 8 micturitions was the number of valid diary days during the 7-day micturition diary period with with less than 8 micturitions per day.
| days | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 1.90 ± 0.13 | 1.60 ± 0.12 | 2.08 ± 0.07 |
| Month 3 | 2.07 ± 0.14 | 2.14 ± 0.14 | 2.66 ± 0.08 |
| Month 6 | 2.35 ± 0.15 | 2.34 ± 0.15 | 2.87 ± 0.08 |
| Month 9 | 2.38 ± 0.16 | 2.33 ± 0.15 | 2.93 ± 0.08 |
| Month 12 | 2.61 ± 0.16 | 2.58 ± 0.16 | 3.17 ± 0.08 |
| EoT | 2.52 ± 0.15 | 2.58 ± 0.15 | 3.10 ± 0.08 |
Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline. Corrected micturition frequency was calculated as the baseline mean volume voided per micturition multiplied by the baseline mean number of micturitions per 24 hours divided by the mean volume voided per micturition at EoT.
| micturitions | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Change From Baseline to EoT in Corrected Micturition Frequency | -0.72 ± 0.17 | -1.11 ± 0.17 | -1.51 ± 0.08 |
The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period prior to each visit.
| mL | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 3 | 15.34 ± 2.96 | 23.71 ± 2.92 | 34.89 ± 1.45 |
| Month 6 | 20.87 ± 3.21 | 27.08 ± 3.19 | 38.56 ± 1.57 |
| Month 12 | 21.85 ± 3.42 | 24.05 ± 3.37 | 38.72 ± 1.67 |
Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode recorded by the participant in the micturition diary for 7 days prior to each visit as 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS), where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet.
| urgency episodes | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | -1.93 ± 0.17 | -2.31 ± 0.17 | -2.68 ± 0.09 |
| Month 3 | -2.68 ± 0.17 | -3.02 ± 0.17 | -3.36 ± 0.08 |
| Month 6 | -2.93 ± 0.17 | -3.17 ± 0.17 | -3.72 ± 0.08 |
| Month 9 | -3.40 ± 0.18 | -3.55 ± 0.18 | -3.87 ± 0.09 |
| Month 12 | -3.40 ± 0.17 | -3.56 ± 0.17 | -3.95 ± 0.09 |
| EoT | -3.11 ± 0.17 | -3.45 ± 0.17 | -3.84 ± 0.08 |
A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The mean number of nocturia episodes was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit."
| nocturia episodes | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | -0.20 ± 0.04 | -0.22 ± 0.04 | -0.34 ± 0.02 |
| Month 3 | -0.34 ± 0.04 | -0.38 ± 0.04 | -0.46 ± 0.02 |
| Month 6 | -0.41 ± 0.05 | -0.39 ± 0.05 | -0.49 ± 0.02 |
| Month 9 | -0.42 ± 0.05 | -0.44 ± 0.05 | -0.50 ± 0.02 |
| Month 12 | -0.46 ± 0.05 | -0.44 ± 0.05 | -0.56 ± 0.02 |
| EoT | -0.45 ± 0.04 | -0.45 ± 0.04 | -0.55 ± 0.02 |
A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode during the 7-day micturition diary period prior to each visit.
| nocturia episodes | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 8.76 ± 0.41 | 9.23 ± 0.44 | 8.00 ± 0.20 |
| Month 3 | 7.93 ± 0.39 | 7.92 ± 0.40 | 7.17 ± 0.19 |
| Month 6 | 7.12 ± 0.35 | 7.86 ± 0.43 | 6.96 ± 0.20 |
| Month 9 | 7.40 ± 0.38 | 7.48 ± 0.41 | 6.84 ± 0.20 |
| Month 12 | 6.88 ± 0.38 | 7.39 ± 0.44 | 6.33 ± 0.19 |
| EoT | 7.13 ± 0.37 | 7.47 ± 0.42 | 6.51 ± 0.19 |
A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode during the 7-day micturition diary period prior to each visit
| nocturia episodes | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | -1.56 ± 0.29 | -1.58 ± 0.29 | -2.39 ± 0.15 |
| Month 3 | -2.45 ± 0.29 | -2.78 ± 0.30 | -3.26 ± 0.15 |
| Month 6 | -3.08 ± 0.33 | -2.81 ± 0.33 | -3.44 ± 0.16 |
| Month 9 | -2.91 ± 0.32 | -3.13 ± 0.32 | -3.55 ± 0.16 |
| Month 12 | -3.29 ± 0.32 | -3.08 ± 0.33 | -3.97 ± 0.16 |
| EoT | -3.24 ± 0.31 | -3.20 ± 0.32 | -3.90 ± 0.16 |
The mean number of pads used per 24 hours was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit.
| pads | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | -0.67 ± 0.10 | -0.96 ± 0.11 | -1.25 ± 0.05 |
| Month 3 | -1.12 ± 0.11 | -1.30 ± 0.11 | -1.49 ± 0.06 |
| Month 6 | -1.30 ± 0.12 | -1.24 ± 0.12 | -1.59 ± 0.06 |
| Month 9 | -1.38 ± 0.12 | -1.31 ± 0.13 | -1.65 ± 0.06 |
| Month 12 | -1.35 ± 0.12 | -1.37 ± 0.13 | -1.67 ± 0.06 |
| EoT | -1.23 ± 0.12 | -1.38 ± 0.12 | -1.66 ± 0.06 |
The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit.
| pads | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 12.67 ± 1.98 | 12.55 ± 1.59 | 8.75 ± 0.50 |
| Month 3 | 9.61 ± 1.12 | 9.47 ± 1.28 | 7.23 ± 0.5 |
| Month 6 | 7.99 ± 1.03 | 9.16 ± 1.28 | 6.51 ± 0.47 |
| Month 9 | 7.65 ± 1.08 | 8.91 ± 1.28 | 6.18 ± 0.46 |
| Month 12 | 7.60 ± 1.05 | 8.09 ± 1.23 | 5.70 ± 0.44 |
| EoT | 9.09 ± 1.07 | 8.54 ± 1.10 | 6.33 ± 0.45 |
The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit.
| pads | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | -4.74 ± 0.71 | -6.72 ± 0.72 | -8.89 ± 0.36 |
| Month 3 | -7.83 ± 0.77 | -9.21 ± 0.78 | 10.47 ± 0.39 |
| Month 6 | -9.09 ± 0.85 | -8.86 ± 0.85 | -11.12 ± 0.42 |
| Month 9 | -9.59 ± 0.87 | -9.33 ± 0.89 | -11.44 ± 0.43 |
| Month 12 | -9.39 ± 0.85 | -9.92 ± 0.87 | -11.66 ± 0.42 |
| EoT | -8.59 ± 0.82 | -9.89 ± 0.84 | -11.58 ± 0.42 |
The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.
| units on a scale | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | -16.37 ± 1.08 | -20.82 ± 1.07 | -22.86 ± 0.54 |
| Month 3 | -19.69 ± 1.08 | -23.13 ± 1.07 | -26.88 ± 0.53 |
| Month 6 | -20.97 ± 1.14 | -24.27 ± 1.12 | -27.73 ± 0.55 |
| Month 9 | -21.41 ± 1.15 | -25.82 ± 1.14 | -28.45 ± 0.56 |
| Month 12 | -23.41 ± 1.19 | -25.38 ± 1.18 | -30.18 ± 0.58 |
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
| units on a scale | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 11.67 ± 0.92 | 14.01 ± 0.91 | 15.69 ± 0.45 |
| Month 3 | 15.25 ± 0.95 | 16.41 ± 0.94 | 19.26 ± 0.47 |
| Month 6 | 16.63 ± 1.02 | 17.96 ± 1.00 | 20.03 ± 0.49 |
| Month 9 | 16.69 ± 1.02 | 18.53 ± 1.01 | 20.75 ± 0.50 |
| Month 12 | 17.33 ± 1.04 | 18.80 ± 1.03 | 21.82 ± 0.51 |
| EoT | 16.57 ± 1.00 | 18.47 ± 0.99 | 21.33 ± 0.50 |
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
| units on a scale | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 13.05 ± 1.09 | 15.40 ± 1.08 | 17.58 ± 0.54 |
| Month 3 | 17.57 ± 1.14 | 18.38 ± 1.13 | 21.64 ± 0.56 |
| Month 6 | 19.68 ± 1.22 | 20.53 ± 1.19 | 22.73 ± 0.59 |
| Month 9 | 19.54 ± 1.21 | 21.21 ± 1.20 | 23.58 ± 0.59 |
| Month 12 | 19.47 ± 1.25 | 21.90 ± 1.23 | 24.86 ± 0.61 |
| EoT | 18.54 ± 1.19 | 21.13 ± 1.18 | 24.14 ± 0.59 |
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
| units on a scale | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 13.24 ± 1.03 | 15.49 ± 1.02 | 17.60 ± 0.51 |
| Month 3 | 16.37 ± 1.05 | 17.64 ± 1.04 | 21.23 ± 0.52 |
| Month 6 | 17.77 ± 1.10 | 19.05 ± 1.07 | 21.73 ± 0.53 |
| Month 9 | 18.15 ± 1.11 | 19.74 ± 1.10 | 22.30 ± 0.54 |
| Month 12 | 19.10 ± 1.12 | 19.40 ± 1.10 | 23.30 ± 0.54 |
| EoT | 17.98 ± 1.08 | 19.22 ± 1.07 | 23.00 ± 0.54 |
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consisted of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each time was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
| units on a scale | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 10.96 ± 1.08 | 14.24 ± 1.07 | 15.82 ± 0.54 |
| Month 3 | 14.09 ± 1.12 | 16.71 ± 1.10 | 19.75 ± 0.55 |
| Month 6 | 14.84 ± 1.22 | 17.70 ± 1.19 | 20.09 ± 0.59 |
| Month 9 | 14.86 ± 1.22 | 17.73 ± 1.21 | 21.15 ± 0.60 |
| Month 12 | 16.53 ± 1.29 | 18.28 ± 1.27 | 22.17 ± 0.63 |
| EoT | 16.44 ± 1.22 | 18.32 ± 1.21 | 21.59 ± 0.61 |
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
| units on a scale | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 7.99 ± 0.84 | 9.41 ± 0.83 | 9.89 ± 0.42 |
| Month 3 | 11.14 ± 0.85 | 11.19 ± 0.84 | 12.22 ± 0.42 |
| Month 6 | 11.89 ± 0.89 | 12.54 ± 0.87 | 13.30 ± 0.43 |
| Month 9 | 11.92 ± 0.90 | 13.33 ± 0.89 | 13.64 ± 0.44 |
| Month 12 | 12.25 ± 0.90 | 13.47 ± 0.89 | 14.52 ± 0.44 |
| EoT | 11.57 ± 0.87 | 13.22 ± 0.87 | 14.25 ± 0.43 |
The TS-VAS is a visual analogue scale which asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.
| units on a scale | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 1.88 ± 0.12 | 1.95 ± 0.12 | 2.27 ± 0.06 |
| Month 3 | 2.10 ± 0.11 | 2.06 ± 0.11 | 2.57 ± 0.06 |
| Month 6 | 2.22 ± 0.12 | 2.25 ± 0.12 | 2.72 ± 0.06 |
| Month 9 | 2.24 ± 0.12 | 2.28 ± 0.12 | 2.74 ± 0.06 |
| Month 12 | 2.33 ± 0.12 | 2.34 ± 0.12 | 2.89 ± 0.06 |
The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
| units on a scale | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | -0.84 ± 0.07 | -0.89 ± 0.07 | -1.05 ± 0.03 |
| Month 3 | -1.09 ± 0.07 | -1.08 ± 0.07 | -1.33 ± 0.03 |
| Month 6 | -1.11 ± 0.07 | -1.18 ± 0.07 | -1.42 ± 0.04 |
| Month 9 | -1.25 ± 0.07 | -1.31 ± 0.07 | -1.48 ± 0.04 |
| Month 12 | -1.29 ± 0.08 | -1.36 ± 0.07 | -1.59 ± 0.04 |
| EoT | -1.22 ± 0.07 | -1.34 ± 0.07 | -1.54 ± 0.04 |
The PGIC is a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).
| percentage of participants | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 12: Very much improved | 25.5 | 23.4 | 33.8 |
| Month 12: Much improved | 30.5 | 35.8 | 34.0 |
| Month 12: Minimally improved | 21.9 | 19.7 | 16.1 |
| Month 12: No change | 5.0 | 6.4 | 4.5 |
| Month 12: Minimally worse | 0.7 | 0.7 | 0.4 |
| Month 12: Much worse | 1.0 | 0.3 | 0.1 |
| Month 12: Very much worse | 0.3 | 0.3 | 0.5 |
| EoT: Very much improved | 25.8 | 24.4 | 34.1 |
| EoT: Much improved | 31.5 | 37.1 | 34.7 |
| EoT: Minimally improved | 22.2 | 20.4 | 16.6 |
| EoT: No change | 6.3 | 7.0 | 5.1 |
| EoT: Minimally worse | 0.7 | 0.7 | 0.4 |
| EoT: Much worse | 1.3 | 0.7 | 0.1 |
| EoT: Very much worse | 0.3 | 0.3 | 0.5 |
The PGIC is a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).
| percentage of participants | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 12: Very much improved | 12.9 | 14.7 | 18.0 |
| Month 12: Much improved | 23.8 | 26.8 | 28.7 |
| Month 12: Minimally improved | 18.9 | 17.1 | 18.7 |
| Month 12: No change | 24.2 | 24.7 | 20.7 |
| Month 12: Minimally worse | 3.6 | 2.7 | 2.7 |
| Month 12: Much worse | 0.7 | 0 | 0.4 |
| Month 12: Very much worse | 0.7 | 0.7 | 0.3 |
| EoT: Very much improved | 13.2 | 15.1 | 18.3 |
| EoT: Much improved | 24.5 | 27.8 | 28.9 |
| EoT: Minimally improved | 19.2 | 18.1 | 19.1 |
| EoT: No change | 25.8 | 25.8 | 21.6 |
| EoT: Minimally worse | 3.6 | 3.0 | 2.8 |
| EoT: Much worse | 1.0 | 0.3 | 0.5 |
| EoT: Very much worse | 0.7 | 0.7 | 0.3 |
The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
| Participants | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| No problems -> no problems | 164 | 164 | 675 |
| No problems -> slight problems | 15 | 15 | 56 |
| No problems -> moderate problems | 10 | 4 | 26 |
| No problems -> severe problems | 1 | 1 | 2 |
| No problems -> unable to walk about | 1 | 0 | 0 |
| No problems -> no data | 3 | 0 | 7 |
| Slight problems -> no problems | 19 | 24 | 83 |
| Slight problems -> slight problems | 18 | 29 | 87 |
| Slight problems -> moderate problems | 4 | 6 | 26 |
| Slight problems -> severe problems | 3 | 1 | 2 |
| Slight problems -> unable to walk about | 0 | 0 | 0 |
| Slight problems -> no data | 2 | 1 | 0 |
| Moderate problems -> no problems | 14 | 11 | 38 |
| Moderate problems -> slight problems | 13 | 17 | 47 |
| Moderate problems -> moderate problems | 9 | 5 | 50 |
| Moderate problems -> severe problems | 2 | 4 | 8 |
| Moderate problems -> unable to walk about | 0 | 0 | 0 |
| Moderate problems -> no data | 0 | 0 | 1 |
| Severe problems -> no problems | 2 | 4 | 15 |
| Severe problems -> slight problems | 2 | 2 | 13 |
| Severe problems -> moderate problems | 6 | 4 | 16 |
| Severe problems -> severe problems | 5 | 3 | 15 |
| Severe problems -> unable to walk about | 1 | 0 | 2 |
| Severe problems -> no data | 0 | 0 | 0 |
| Unable to walk about -> no problems | 0 | 0 | 1 |
| Unable to walk about -> slight problems | 0 | 0 | 1 |
| Unable to walk about -> moderate problems | 0 | 0 | 0 |
| Unable to walk about -> severe problems | 0 | 0 | 0 |
| Unable to walk about -> unable to walk about | 0 | 0 | 0 |
| Unable to walk about -> no data | 0 | 0 | 0 |
| No data -> no problems | 4 | 3 | 19 |
| No data -> slight problems | 4 | 1 | 3 |
| No data -> moderate problems | 0 | 0 | 0 |
| No data -> severe problems | 0 | 0 | 0 |
| No data -> unable to walk about | 0 | 0 | 0 |
| No data -> no data | 0 | 0 | 0 |
The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
| Participants | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| No problems -> no problems | 223 | 232 | 906 |
| No problems -> slight problems | 12 | 9 | 40 |
| No problems -> moderate problems | 8 | 0 | 12 |
| No problems -> severe problems | 0 | 1 | 2 |
| No problems -> unable to wash/dress myself | 0 | 0 | 0 |
| No problems -> no data | 5 | 1 | 7 |
| Slight problems -> no problems | 16 | 18 | 64 |
| Slight problems -> slight problems | 9 | 14 | 44 |
| Slight problems -> moderate problems | 0 | 4 | 12 |
| Slight problems -> severe problems | 0 | 1 | 1 |
| Slight problems -> unable to wash/dress myself | 0 | 0 | 0 |
| Slight problems -> no data | 0 | 0 | 1 |
| Moderate problems -> no problems | 5 | 4 | 18 |
| Moderate problems -> slight problems | 5 | 6 | 20 |
| Moderate problems -> moderate problems | 5 | 3 | 21 |
| Moderate problems -> severe problems | 0 | 0 | 2 |
| Moderate problems -> unable to wash/dress myself | 0 | 0 | 0 |
| Moderate problems -> no data | 0 | 0 | 0 |
| Severe problems -> no problems | 0 | 1 | 8 |
| Severe problems -> slight problems | 1 | 0 | 3 |
| Severe problems -> moderate problems | 3 | 1 | 4 |
| Severe problems -> severe problems | 1 | 0 | 5 |
| Severe problems -> unable to wash/dress myself | 0 | 0 | 0 |
| Severe problems -> no data | 0 | 0 | 0 |
| Unable to wash/dress myself -> no problems | 0 | 0 | 0 |
| Unable to wash/dress myself -> slight problems | 0 | 0 | 1 |
| Unable to wash/dress myself -> moderate problems | 0 | 0 | 0 |
| Unable to wash/dress myself -> severe problems | 0 | 0 | 0 |
| Unable to wash/dress myself -> unable to wash/dres | 1 | 0 | 0 |
| Unable to wash/dress myself -> no data | 0 | 0 | 0 |
| No data -> no problems | 6 | 3 | 22 |
| No data -> slight problems | 2 | 1 | 0 |
| No data -> moderate problems | 0 | 0 | 0 |
| No data -> severe problems | 0 | 0 | 0 |
| No data -> unable to wash/dress myself | 0 | 0 | 0 |
| No data -> no data | 0 | 0 | 0 |
The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
| Participants | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| No problems -> No problems | 165 | 160 | 672 |
| No problems -> Slight problems | 13 | 16 | 65 |
| No problems -> Moderate problems | 8 | 4 | 15 |
| No problems -> Severe problems | 1 | 0 | 1 |
| No problems -> unable to do usual activities | 0 | 0 | 0 |
| No problems -> no data | 4 | 0 | 7 |
| Slight problems -> no problems | 27 | 39 | 131 |
| Slight problems -> slight problems | 28 | 33 | 85 |
| Slight problems -> moderate problems | 5 | 6 | 26 |
| Slight problems -> severe problems | 2 | 1 | 1 |
| Slight problems ->unable to do usual activities | 0 | 0 | 0 |
| Slight problems -> no data | 1 | 0 | 0 |
| Moderate problems -> no problems | 12 | 12 | 40 |
| Moderate problems -> slight problems | 11 | 9 | 44 |
| Moderate problems -> moderate problems | 7 | 4 | 43 |
| Moderate problems -> severe problems | 2 | 0 | 2 |
| Moderate problems ->unable to do usual activities | 0 | 0 | 0 |
| Moderate problems -> no data | 0 | 1 | 1 |
| Severe problems -> no problems | 2 | 1 | 10 |
| Severe problems -> slight problems | 0 | 2 | 9 |
| Severe problems -> moderate problems | 0 | 6 | 7 |
| Severe problems -> severe problems | 4 | 1 | 6 |
| Severe problems -> unable to do usual activities | 0 | 0 | 1 |
| Severe problems -> no data | 0 | 0 | 0 |
| Unable to do usual activities -> no problems | 0 | 0 | 0 |
| Unable to do usual activities -> slight problems | 0 | 0 | 1 |
| Unable to do usual activities -> moderate problems | 1 | 0 | 4 |
| Unable to do usual activities -> severe problems | 0 | 0 | 0 |
| Unable to do usual activities -> unable to do | 1 | 0 | 0 |
| Unable to do usual activities -> no data | 0 | 0 | 0 |
| No data -> no problems | 6 | 2 | 20 |
| No data -> slight problems | 1 | 2 | 2 |
| No data -> moderate problems | 1 | 0 | 0 |
| No data -> severe problems | 0 | 0 | 0 |
| No data -> unable to do usual activities | 0 | 0 | 0 |
| No data -> no data | 0 | 0 | 0 |
The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and had 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
| Participants | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| No pain/discomfort -> no pain/discomfort | 120 | 119 | 495 |
| No pain/discomfort -> slight pain/discomfort | 21 | 19 | 70 |
| No pain/discomfort -> moderate pain/discomfort | 7 | 1 | 20 |
| No pain/discomfort -> severe pain/discomfort | 1 | 0 | 3 |
| No pain/discomfort -> extreme pain/discomfort | 0 | 0 | 0 |
| No pain/discomfort -> no data | 2 | 1 | 6 |
| Slight pain/discomfort -> no pain/discomfort | 44 | 37 | 132 |
| Slight pain/discomfort -> slight pain/discomfort | 24 | 48 | 152 |
| Slight pain/discomfort -> moderate pain/discomfort | 11 | 9 | 26 |
| Slight pain/discomfort -> severe pain/discomfort | 2 | 1 | 5 |
| Slight pain/discomfort -> extreme pain/discomfort | 0 | 0 | 1 |
| Slight pain/discomfort -> no data | 0 | 0 | 1 |
| Moderate pain/discomfort -> no pain/discomfort | 9 | 11 | 49 |
| Moderate pain/discomfort -> slight pain/discomfort | 19 | 17 | 78 |
| Moderate pain/discomfort -> moderate pain/discomf | 16 | 10 | 65 |
| Moderate pain/discomfort -> severe pain/discomfort | 2 | 3 | 8 |
| Moderate pain/discomfort -> extreme pain/discomf | 0 | 0 | 1 |
| Moderate pain/discomfort -> no data | 1 | 0 | 1 |
| Severe pain/discomfort -> no pain/discomfort | 3 | 6 | 15 |
| Severe pain/discomfort -> slight pain/discomfort | 2 | 3 | 9 |
| Severe pain/discomfort -> moderate pain/discomfort | 5 | 5 | 13 |
| Severe pain/discomfort -> severe pain/discomfort | 2 | 3 | 11 |
| Severe pain/discomfort -> extreme pain/discomfort | 0 | 0 | 1 |
| Severe pain/discomfort -> no data | 1 | 0 | 0 |
| Extreme pain/discomfort -> no pain/discomfort | 0 | 0 | 0 |
| Extreme pain/discomfort -> slight pain/discomfort | 0 | 0 | 3 |
| Extreme pain/discomfort -> moderate pain/discomf | 1 | 0 | 2 |
| Extreme pain/discomfort -> severe pain/discomfort | 0 | 2 | 2 |
| Extreme pain/discomfort -> extreme pain/discomfort | 0 | 0 | 2 |
| Extreme pain/discomfort -> no data | 1 | 0 | 0 |
| No data -> no pain/discomfort | 5 | 1 | 11 |
| No data -> slight pain/discomfort | 3 | 3 | 11 |
| No data -> moderate pain/discomfort | 0 | 0 | 0 |
| No data -> extreme pain/discomfort | 0 | 0 | 0 |
| No data -> severe pain/discomfort | 0 | 0 | 0 |
| No data -> no data | 0 | 0 | 0 |
The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and had 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
| Participants | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Not anxious -> not anxious | 137 | 142 | 588 |
| Not anxious -> slightly anxious | 22 | 18 | 68 |
| Not anxious -> moderately anxious | 4 | 1 | 7 |
| Not anxious -> severely anxious | 1 | 0 | 1 |
| Not anxious -> extremely anxious | 0 | 0 | 0 |
| Not anxious -> no data | 3 | 1 | 5 |
| Slightly anxious -> not anxious | 35 | 43 | 177 |
| Slightly anxious -> slightly anxious | 30 | 33 | 106 |
| Slightly anxious -> moderately anxious | 4 | 8 | 21 |
| Slightly anxious -> severely anxious | 3 | 1 | 0 |
| Slightly anxious -> extremely anxious | 0 | 1 | 1 |
| Slightly anxious -> no data | 1 | 0 | 1 |
| Moderately anxious -> not anxious | 15 | 11 | 37 |
| Moderately anxious -> slightly anxious | 11 | 14 | 55 |
| Moderately anxious -> moderately anxious | 12 | 8 | 35 |
| Moderately anxious -> severely anxious | 1 | 1 | 5 |
| Moderately anxious -> extremely anxious | 0 | 0 | 0 |
| Moderately anxious -> no data | 0 | 0 | 1 |
| Severely anxious -> not anxious | 2 | 2 | 10 |
| Severely anxious -> slightly anxious | 3 | 2 | 14 |
| Severely anxious -> moderately anxious | 5 | 3 | 13 |
| Severely anxious -> severely anxious | 2 | 1 | 7 |
| Severely anxious -> extremely anxious | 1 | 0 | 1 |
| Severely anxious -> no data | 1 | 0 | 1 |
| Extremely anxious -> not anxious | 0 | 1 | 4 |
| Extremely anxious -> slightly anxious | 0 | 2 | 2 |
| Extremely anxious -> moderately anxious | 1 | 0 | 8 |
| Extremely anxious -> severely anxious | 0 | 2 | 2 |
| Extremely anxious -> extremely anxious | 0 | 0 | 1 |
| Extremely anxious -> no data | 0 | 0 | 0 |
| No data -> not anxious | 6 | 3 | 14 |
| No data -> slightly anxious | 1 | 1 | 7 |
| No data -> moderately anxious | 1 | 0 | 0 |
| No data -> severely anxious | 0 | 0 | 0 |
| No data -> extremely anxious | 0 | 0 | 1 |
| No data -> no data | 0 | 0 | 0 |
The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.
| percentage of work time missed | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 6 | -0.49 ± 17.12 | -0.59 ± 15.67 | -3.11 ± 20.68 |
| Month 12 | 0.39 ± 15.55 | -1.95 ± 18.51 | -3.74 ± 23.83 |
| EoT | -0.45 ± 18.51 | -1.30 ± 18.04 | -3.26 ± 22.88 |
The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.
| percentage of impairment while working | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 6 | -16.94 ± 24.10 | -12.97 ± 21.05 | -13.41 ± 24.37 |
| Month 12 | -19.16 ± 23.38 | -14.72 ± 27.32 | -16.68 ± 24.16 |
| EoT | -17.81 ± 23.45 | -13.90 ± 27.18 | -15.63 ± 25.61 |
The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes arre expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.
| percentage of overall work impairment | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 6 | -16.33 ± 27.58 | -12.09 ± 22.26 | -13.99 ± 26.04 |
| Month 12 | -17.83 ± 26.90 | -15.38 ± 27.97 | -17.27 ± 27.25 |
| EoT | -16.83 ± 27.63 | -14.16 ± 27.51 | -16.15 ± 28.51 |
The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.
| percentage of activity Impairment | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 6 | -15.04 ± 27.08 | -16.25 ± 24.78 | -16.94 ± 28.49 |
| Month 12 | -16.85 ± 27.57 | -14.12 ± 29.87 | -18.91 ± 29.26 |
| EoT | -16.02 ± 27.63 | -14.02 ± 30.29 | -18.75 ± 29.14 |
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the last 3 days of the 7-day micturition diary is reported.
| percentage of participants | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 24.4 | 39.9 | 38.3 |
| Month 3 | 40.1 | 44.8 | 49.6 |
| Month 6 | 40.6 | 50.5 | 54.7 |
| Month 9 | 47.0 | 54.4 | 55.8 |
| Month 12 | 51.6 | 55.5 | 61.2 |
| EoT | 47.8 | 53.2 | 58.8 |
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.
| percentage of participants | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 63.7 | 67.5 | 72.8 |
| Month 3 | 69.1 | 71.3 | 81.8 |
| Month 6 | 70.4 | 74.6 | 80.5 |
| Month 9 | 70.1 | 76.1 | 82.9 |
| Month 12 | 72.8 | 74.1 | 84.4 |
| EoT | 70.7 | 72.4 | 82.9 |
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
| percentage of participants | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 46.6 | 53.8 | 57.0 |
| Month 3 | 53.6 | 59.4 | 64.6 |
| Month 6 | 56.9 | 62.9 | 66.1 |
| Month 9 | 57.1 | 62.9 | 67.7 |
| Month 12 | 58.4 | 62.4 | 69.0 |
| EoT | 56.2 | 61.6 | 68.4 |
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit.
| percentage of participants | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 46.7 | 55.2 | 62.0 |
| Month 3 | 58.2 | 67.0 | 73.3 |
| Month 6 | 63.2 | 71.8 | 76.6 |
| Month 9 | 67.0 | 73.6 | 77.8 |
| Month 12 | 72.9 | 75.4 | 81.3 |
| EoT | 69.1 | 73.1 | 79.5 |
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the 7-day micturition diary is reported.
| percentage of participants | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 17.2 | 26.4 | 27.9 |
| Month 3 | 27.0 | 35.1 | 40.0 |
| Month 6 | 32.3 | 39.9 | 44.7 |
| Month 9 | 37.1 | 43.7 | 46.9 |
| Month 12 | 41.9 | 47.3 | 52.5 |
| EoT | 38.9 | 45.1 | 49.7 |
The percentage of participants with micturition frequency normalization was defined as participants who had ≥ 8 micturitions/24 hours at baseline and \< 8 micturitions/24 hours postbaseline at months 1, 3, 6, 9, 12 and EoT.
| percentage of participants | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 34.5 | 29.3 | 36.8 |
| Month 3 | 36.7 | 36.6 | 46.6 |
| Month 6 | 42.3 | 43.4 | 51.4 |
| Month 9 | 44.5 | 41.9 | 52.5 |
| Month 12 | 46.3 | 44.7 | 56.4 |
| EoT | 46.0 | 46.3 | 55.9 |
The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
| percentage of participants | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 53.0 | 59.2 | 64.1 |
| Month 3 | 61.9 | 65.7 | 72.5 |
| Month 6 | 64.6 | 68.8 | 73.8 |
| Month 9 | 65.5 | 68.9 | 75.1 |
| Month 12 | 69.7 | 73.7 | 76.9 |
| EoT | 66.2 | 71.4 | 76.0 |
The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
| percentage of participants | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 24.9 | 28.2 | 30.7 |
| Month 3 | 31.3 | 33.9 | 42.8 |
| Month 6 | 35.0 | 38.2 | 45.4 |
| Month 9 | 37.5 | 40.9 | 47.0 |
| Month 12 | 40.6 | 40.4 | 51.9 |
| EoT | 38.3 | 39.8 | 50.3 |
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.
| percentage of participants | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 36.1 | 46.6 | 52.6 |
| Month 3 | 47.8 | 55.5 | 65.1 |
| Month 6 | 50.4 | 56.9 | 65.8 |
| Month 9 | 53.1 | 61.9 | 69.2 |
| Month 12 | 59.2 | 60.9 | 73.2 |
| EoT | 55.7 | 58.2 | 70.8 |
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
| percentage of participants | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 28.5 | 36.6 | 40.9 |
| Month 3 | 39.6 | 43.8 | 52.3 |
| Month 6 | 41.6 | 47.9 | 55.3 |
| Month 9 | 43.7 | 51.2 | 57.6 |
| Month 12 | 46.9 | 50.4 | 60.6 |
| EoT | 44.3 | 49.0 | 59.2 |
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
| percentage of participants | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 32.1 | 37.1 | 46.0 |
| Month 3 | 43.3 | 47.7 | 57.6 |
| Month 6 | 46.8 | 52.1 | 60.6 |
| Month 9 | 49.6 | 53.2 | 63.0 |
| Month 12 | 57.6 | 60.1 | 67.0 |
| EoT | 52.9 | 57.5 | 65.1 |
The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The symptom bother portion of the OAB-q consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
| percentage of participants | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 29.9 | 35.5 | 42.8 |
| Month 3 | 38.9 | 44.8 | 54.1 |
| Month 6 | 42.4 | 46.1 | 55.9 |
| Month 9 | 46.5 | 50.8 | 59.2 |
| Month 12 | 51.4 | 53.6 | 63.7 |
| EoT | 47.4 | 51.4 | 61.7 |
The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The HRQoL portion of the OAB-q consists of 25 HRQoL items comprising 4 HRQoL subscales, each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
| percentage of participants | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 25.2 | 29.0 | 35.5 |
| Month 3 | 33.3 | 39.1 | 45.9 |
| Month 6 | 36.8 | 41.2 | 49.6 |
| Month 9 | 39.0 | 44.0 | 51.3 |
| Month 12 | 44.1 | 47.6 | 54.6 |
| EoT | 40.1 | 45.2 | 53.3 |
PVR volume was assessed by ultrasonography or a bladder scanner.
| mL | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Month 1 | 3.179 ± 27.491 | 4.549 ± 33.973 | 7.894 ± 38.369 |
| Month 3 | 4.686 ± 29.354 | 3.233 ± 32.679 | 7.033 ± 37.328 |
| Month 6 | 1.596 ± 29.399 | 3.418 ± 31.864 | 6.708 ± 35.881 |
| Month 9 | 3.074 ± 32.897 | 3.436 ± 32.170 | 8.229 ± 40.313 |
| Month 12 | 2.002 ± 32.453 | 4.818 ± 33.764 | 7.946 ± 38.118 |
| EoT | 1.747 ± 32.400 | 7.382 ± 42.916 | 8.522 ± 39.501 |
Collected over From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mirabegron 50 mg | 1/305 (0.3%) | 8/305 (2.6%) | 27/305 (8.9%) |
| Solifenacin 5 mg | 0/303 (0%) | 8/303 (2.6%) | 33/303 (10.9%) |
| Solifenacin 5 mg + Mirabegron 50 mg | 1/1,206 (0.1%) | 51/1,206 (4.2%) | 115/1,206 (9.5%) |
| Event | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Abdominal pain upperGastrointestinal disorders | 0/305 | 1/303 | 0/1206 |
| Pancreatitis acuteGastrointestinal disorders | 0/305 | 1/303 | 1/1206 |
| ErysipelasInfections and infestations | 0/305 | 1/303 | 0/1206 |
| Incisional herniaInjury, poisoning and procedural complications | 0/305 | 1/303 | 0/1206 |
| Sternal fractureInjury, poisoning and procedural complications | 0/305 | 1/303 | 0/1206 |
| Blood glucose increasedInvestigations | 0/305 | 1/303 | 0/1206 |
| ExostosisMusculoskeletal and connective tissue disorders | 0/305 | 1/303 | 0/1206 |
| Lumbar spinal stenosisMusculoskeletal and connective tissue disorders | 0/305 | 1/303 | 0/1206 |
| HypertensionVascular disorders | 0/305 | 1/303 | 0/1206 |
| Atrial fibrillationCardiac disorders | 1/305 | 0/303 | 2/1206 |
| Event | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg |
|---|---|---|---|
| Dry mouthGastrointestinal disorders | 12/305 | 18/303 | 74/1206 |
| NasopharyngitisInfections and infestations | 16/305 | 15/303 | 43/1206 |
The analysis population was the randomized analysis set (RAS), which comprised of all randomized participants.
| Age, Continuous(years) | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg | Total |
|---|---|---|---|---|
| Mean | 58.8 ± 12.7 | 59.0 ± 13.3 | 58.3 ± 13.0 | 58.5 ± 13.0 |
| Sex: Female, Male(Participants) | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg | Total |
|---|---|---|---|---|
| Female | 243 | 245 | 973 | 1461 |
| Male | 63 | 60 | 245 | 368 |
| Race/Ethnicity, Customized(Participants) | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg | Total |
|---|---|---|---|---|
| White | 266 | 265 | 1066 | 1597 |
| Black or African American | 5 | 4 | 27 | 36 |
| Asian | 31 | 33 | 119 | 183 |
| Other | 4 | 3 | 6 | 13 |
| Race/Ethnicity, Customized(Participants) | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg | Total |
|---|---|---|---|---|
| Hispanic or Latino | 15 | 15 | 54 | 84 |
| Not Hispanic or Latino | 291 | 290 | 1164 | 1745 |
| Mean Number of Incontinence Episodes per 24 Hours(incontinence episodes/24 hours) | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg | Total |
|---|---|---|---|---|
| Mean | 3.15 ± 3.56 | 3.10 ± 3.58 | 3.04 ± 3.17 | 3.07 ± 3.31 |
| Mean Number of Micturitions per 24 Hours(micturitions/24 hours) | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg | Total |
|---|---|---|---|---|
| Mean | 10.51 ± 2.41 | 10.76 ± 2.83 | 10.55 ± 2.73 | 10.58 ± 2.70 |
| Mean Volume Voided per Micturition(mL) | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg | Total |
|---|---|---|---|---|
| Mean | 161.00 ± 60.16 | 160.70 ± 58.49 | 159.29 ± 58.40 | 159.82 ± 58.69 |
| Number of Incontinence Episodes per Week(incontinence episodes/week) | Mirabegron 50 mg | Solifenacin 5 mg | Solifenacin 5 mg + Mirabegron 50 mg | Total |
|---|---|---|---|---|
| Mean | 21.8 ± 24.8 | 21.6 ± 25.0 | 20.9 ± 21.9 | 21.2 ± 22.9 |
7 further baseline measures are reported on the registry.
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Plan to share: Yes — Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Data sharing details ↗ · www.clinicaltrials.astellas.com
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Studies of the drugs tested here: Solifenacin · Mirabegron