The proportion of male patients who participated in the phase III study of mirabegron was about 28% and the data on the efficacy and safety of mirabegron in Korean male OAB patients have limits. For this reason, this study will assess the efficacy and safety of mirabegron in Korean male OAB patients.
About 50 to 75% of men with LUTS secondary to BPH also have overactive bladder symptoms. As a major drug for the treatment of overactive bladder symptoms, muscarinic receptor antagonists are used, but precautions should be taken by a specialist when using muscarinic receptor antagonists due to possibilities of dry mouth, constipation, blurred vision and post-dose dysuria and acute ischuria. Mirabegron is a selective β3-adrenoceptor agonist that relax the detrusor smooth muscle and increase functional bladder capacity to improve overactive bladder symptoms. This study will examine the efficacy and safety of mirabegron, a new drug, for improvement of urinary frequency. The efficacy of mirabegron compared to the placebo has been demonstrated by the phase III study, but the analysis of only patients in Korea has not obtained significant difference from the placebo. The prevalence of overactive bladder was 9.7% in men and 11.6% in women, which showed similar rates 1), but the cure rate is higher in men than in women (OR 1.891, CI 1.362, 2.2627, p=0.0001). Male patients are important customers for the OAB market and low-dose anticholinergic agents with relatively low risk of urinary retention are preferred for the treatment of male overactive bladder (OAB) in Korea. We will conduct this clinical study because we think mirabegron will be an alternative for the therapy for male OAB patients with a risk of urinary retention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
462
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do, South Korea
RECRUITINGSeoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Change in mean number of micturitions per 24 hours
Time frame: after 12 weeks of treatment
Change in mean number of urgency episodes per 24 hours
Time frame: after 12 weeks of treatment
Change in mean number of urgency incontinence episodes per 24 hours
Time frame: after 12 weeks of treatment
Change in a total of OABSS
Time frame: after 12 weeks of treatment
Change in residual volume and maximal urinary flow rate
Time frame: after 12 weeks of treatment
Change in IPSS storage subscore
Time frame: after 12 weeks of treatment
Change in IPSS-QOL symptom score
Time frame: after 12 weeks of treatment
Number of Adverse Events of study drug
Time frame: after 12 and 24 weeks of treatment
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