The primary objective of the study was to investigate the efficacy of mirabegron versus placebo in male patients with OAB symptoms while taking the alpha blocker, tamsulosin, for BPH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
568
Change From Baseline to End of Treatment (EoT) in Mean Number of Micturitions Per 24 Hours
A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit.
Time frame: Baseline and EoT (up to 12 weeks)
Change From Baseline to Weeks 4, 8, 12 in Mean Number of Micturitions Per 24 Hours
A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit.
Time frame: Baseline and week 4, 8 and 12
Change From Baseline to EoT in Mean Number of Urgency Episodes Per 24 Hours
An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit.
Time frame: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
An urgency incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of urgency incontinence episodes per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit.
Time frame: Baseline and EoT (up to 12 weeks)
Change From Baseline to 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 participants on a 3-day micturition diary before each visit.
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Site JP81046
Aichi, Japan
Site JP81009
Chiba, Japan
Site JP81045
Chiba, Japan
Site JP81041
Fukuoka, Japan
Site JP81042
Fukuoka, Japan
Site JP81043
Fukuoka, Japan
Site JP81044
Fukuoka, Japan
Site JP81048
Fukuoka, Japan
Site JP81004
Gunma, Japan
Site JP81005
Gunma, Japan
...and 48 more locations
Time frame: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Mean Number of Nocturia Episodes
A nocturia episode was defined as a micturition episode initiated between night time. Night time was defined as the period between sleep onset time and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit.
Time frame: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Mean Volume Voided Per Micturition
The mean volume voided per micturition was calculated from data recorded by participants on a 3-day micturition diary before each visit.
Time frame: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Total Overactive Bladder Symptom Score (OABSS)
The OABSS is a 4-item questionnaire that assesses urinary frequency. Total score was the sum total of the score of each item (ranges: 0-15). Negative change means improvement.
Time frame: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in OABSS Subscale Scores
Each OABSS subscale score was based on each question in the questionnaire: Daytime Frequency ("How many times do you typically urinate from waking in the morning until sleeping at night?" where scores range from 0-2), Nighttime Frequency ("How many times do you typically wake up to urinate from sleeping at night until waking in the morning?" where scores range from 0-3), Urgency ("How often do you have a sudden desire to urinate, which is difficult to defer?" where scores range from 0-5), Urgency Incontinence ("How often do you leak urine because you cannot defer the sudden desire to urinate?" where scores range from 0-5). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement.
Time frame: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Total International Prostate Symptom Score (IPSS)
The IPSS included an 7-item questionnaire that assesses urinary frequency and incomplete voiding along with a QoL assessment. Total IPSS score was the sum total of the score (range: 0-35) of each item (Questions 1-7). Negative change means improvement.
Time frame: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in IPSS Subscale Scores
IPSS subscale scores was calculated by following each formula. Storage subscale was derived as sum of scores for questions 2, 4, and 7 (range: 1-15). Voiding subscale-1 was derived as sum of scores for questions 3, 5, and 6 (range: 1-15). Voiding subscale-2 was derived as sum of voiding subscale-1 and the score for question 1 (range: 1-20). Individual scores and IPSS Quality of Life (QoL) score was the score of each item (range: 1-6) (Questions 1-7 and QoL item). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement.
Time frame: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Symptom Bother as Assessed by the Overactive Bladder Questionnaire (OAB-q)
The OAB-q was a 33-item questionnaire, which consisted of an 8-item symptom bother scale and 25 health-related QoL items that form 4 subscales (coping, concern, sleep, and social interaction) and a total health-related QoL score. Symptom Bother was derived as sum of scores for questions 1-8 (range: 0-100). Higher Symptom Bother is indicative of greater symptom bother.
Time frame: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Total Health-Related QoL (HRQoL) Scores as Assessed by the OAB-q
The OAB-q was a 33-item questionnaire, which consisted of an 8-item symptom bother scale and 25 health-related QoL items that form 4 subscales (coping, concern, sleep, and social interaction) and a total health-related QoL score. Total HRQL score was derived as sum of HRQL subscale scores (range: 25-150). Higher total HRQL score is indicative of better HRQL.
Time frame: Baseline and EoT (up to 12 weeks)
Number of Participants With Adverse Events
Treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) with onset during the double-blind treatment period or an AE with onset during the screening period with worsening severity during the double-blind treatment period. The investigator assessed the severity of AEs as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator. Serious TEAE was an AE considered serious.
Time frame: From first dose of study drug up to Week 12
Change From Baseline to EoT in Postvoid Residual (PVR) Volume
PVR was measured by ultrasonography.
Time frame: Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Maximum Urine Flow Rate (Qmax)
Urine flow rate was volume voided per micturition (voided volume) divided by time for the micturition (flow time).
Time frame: Baseline and EoT (up to 12 weeks)