FDA approves Botox as effective treatment for overactive bladder

Botox may be more synonymous with the Real Housewives reality franchise than long-term care residents, but it could soon be a treatment of choice for urinary incontinence.

The Food and Drug Administration recently approved onabotulinumtoxinA, manufactured under the name Botox by Allergan Inc., as a treatment for overactive bladder, following two clinical trials involving more than 1,100 patients.

Study participants whose bladder muscles received Botox injections showed between 1.6 and 1.9 times fewer episodes of urinary incontinence daily compared with those who received a placebo injection, according to the FDA. Botox recipients also had less frequent urges to urinate and produced more urine than people who received a placebo. The treatment works by relaxing the bladder muscle, thereby increasing the bladder's storage capacity.

“Clinical studies have demonstrated Botox's ability to significantly reduce the frequency of urinary incontinence,” said Hylton V. Joffe, M.D., director of the Division of Reproductive and Urologic Products in FDA's Center for Drug Evaluation and Research. “Today's approval provides an important additional treatment option for patients with overactive bladder, a condition that affects an estimated 33 million men and women in the United States.”