A Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adults With Overactive Bladder (OAB)
The purpose of this study is to assess the efficacy, safety and tolerability of mirabegron versus placebo in the treatment of older adult subjects with OAB.
Men and women are welcome to participate. You must be over the age of 65 and have symptoms of wet overactive bladder (OAB) (urinary frequency and urgency with incontinence) for greater than or equal to 3 months prior to Screening. You must be willing and able to complete the micturition diary and questionnaires correctly.
You may not participate if:
- You have ongoing symptoms suggestive of bladder outlet obstruction (BOO) or history of BOO that is currently not well controlled.
- You have a Post-Void Residual Volume (PVR) greater than 150 mL.
- You have neurogenic bladder or neurological dysfunction or injury which could affect the lower urinary tract or nerve supply.
- You have significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the Investigator (for female subjects confirmed by a cough provocation test). Subjects with a history of stress incontinence that is currently treated (e.g. remote history of surgery for stress incontinence) may be included as long as they pass cough provocation test.
- You have an indwelling catheter or practices intermittent self-catheterization.
Clinical trial centers are located throughout the USA