The purpose of this study is to investigate the safety and efficacy of combination therapy involving β3-adrenoceptor agonist, mirabegron, and α-blockers for the treatment of OAB symptoms in male patients with BPH.
Mirabegron (MyrbetriqTM, Astellas Pharma Inc.) is a drug that is approved by the FDA for the treatment of overactive bladder (OAB) with symptoms of urinary frequency, urgency and urgency incontinence. Multiple studies have shown that this drug also has the potential to improve patient tolerability, compliance and subsequent patient quality of life without inducing unfavourable adverse events commonly associated with antimuscarinic medications. These adverse events include, but are not limited to, dry mouth, constipation, confusion, and acute urinary retention (AUR). Studies now have shown that mirabegron may also provide an effective treatment option for OAB in men with benign prostatic hyperplasia (BPH) without inducing the above mentioned adverse events. This study will look at the combination therapy of Mirabegron and Tamsulosin, versus Tamsulosin and placebo alone to prove that this treatment (Mirabegron and Tamsulosin) is effective for those men who suffer from both overactive bladder along with benign prostatic hyperplasia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
50mg of mirabegron per day will be given.
0.4mg of flomax per day.
St. Joseph's Healthcare Hamilton - McMaster Institute of Urology
Hamilton, Ontario, Canada
International Prostate Symptom Score (IPSS)
Measured before and after combination therapy.
Time frame: Treatment period: 4 weeks
Quality of Life Score (QoLS)
Measured before and after combination therapy
Time frame: Treatment period: 4 weeks
Overactive Bladder Symptom Score (OABSS)
Measured before and after combination therapy
Time frame: Treatment period: 4 weeks
Adverse Events
Measured during treatment of combination therapy.
Time frame: Timeline: 4 weeks
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