Nov. 23, 2004 -- The FDA has approved a new, once-daily drug to treat overactive bladder, an often embarrassing disorder that affects up to 20 million men and women in the U.S.
In people with overactive bladder, one of the muscles that surrounds the bladder contracts spastically. People with the condition experience an urge to urinate more frequently and often without warning, and lose control of urine before reaching a restroom.
The symptoms of overactive bladder include:
- Urgency: an immediate and strong urge to urinate
- Frequency: the need to frequently urinate
- Urge incontinence: involuntary loss of urine.
The FDA based its approval on the results of four clinical trials involving 3,000 people with these symptoms.
The studies showed that the 5-milligram and 10-milligram doses both significantly improved all major symptoms of overactive bladder.