Overactive Bladder and Benign Prostatic Hyperplasia (Men 40 and Older) - Valley Village CA

Summary:

The purpose of this study is to see if a drug called mirabegron (MYRBETRIQ) is effective, safe, and tolerated for reducing OAB symptoms while taking tamsulosin hydrochloride for LUTS due to BPH. MYRBETRIQ is approved by the U.S. Food and Drug Administration (FDA) for the treatment of OAB. However, mirabegron (MYRBETRIQ) is not approved by the FDA for use in men also taking tamsulosin hydrochloride. Therefore, its use in this study is considered investigational.

Mirabegron (MYRBETRIQ®) is a prescription drug for adults used to treat overactive bladder (OAB) with symptoms of urgency, frequency, and incontinence (involuntary leakage of urine).

Your participation in this study will last approximately 20 weeks and include 5 study visits to the research center and 1 follow up phone call after the last study visit. This is a randomized, double-blind study to compare mirabegron to placebo.

Qualified Participants Must:

• Must be at least 40 years old, men only
• Must have symptoms of overactive bladder (OAB) while taking the alpha-blocker tamsulosin hydrochloride or FLOMAX for Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH) for at least 2 months or 60 days
• Urinate at least 8 times per day within 24 hours, including waking up at night time
• NOT have diabetic neuopathy
• Be cancer free in the past 5 years
• Have overactive bladder symptoms, specifically urge incontinence symptoms at least 90 days
• Be willing to collect voiding diary by using a table
• NOT planning to have invasive prostate surgery in the next 7 months
• NOT planning to have children in the next 7 months

Qualified Participants May Receive:

1. Compensation of $75 per each completion of the clinic visit, total of 5 clinic visits
2. Complementary physical exam, ECG, Uroflowmetry, blood test. 
3. Receive complementary FLOMAX throughout the study.