This was a Phase 4 trial of an investigational medication for the treatment of Overactive Bladder. The purpose of this study was to evaluate the efficacy, safety and tolerability of (study drug) compared with Placebo in older adult subjects with Overactive Bladder (OAB).
Approximately 800 subjects were enrolled into the study across all sites, with 400 receiving (study drug) and 400 receiving placebo. Visit procedures included vital signs, blood draws, physical exams, ECGs, medical history, medication review and bladder ultrasound assessments.
Total duration of the trial was 20 weeks and included 6 clinic visits, 2 visits to a urology clinic, a follow up phone call and keeping an electronic diary.
Overactive bladder (OAB) is a common condition that affects millions of Americans. Overactive bladder isn’t a disease. It’s the name of a group of urinary symptoms. The most common symptom of OAB is a sudden urge to urinate that you can’t control. Some people will leak urine when they feel the urge. Having to go to the bathroom many times during the day and night is another symptom of OAB.
Overactive bladder happens mostly in women but may occur in men. Aging, an enlarged prostate, and diabetes are all risk factors. The urge to urinate may be difficult to control and lead to the involuntary loss of urine (incontinence). It may be embarrassing or limit activity.
OAB affects over 33 million Americans and 200 million people worldwide. But the real number of people with OAB is most likely much larger. That’s because many people living with OAB don’t ask for help. Some are embarrassed. They don’t know how to talk to their healthcare provider about their symptoms. Other people don’t ask for help because they think there aren’t any treatments for OAB.
You don’t have to let OAB symptoms change your life. There are treatments available to help.