The FDA has approved onabotulinumtoxinA (Botox) injection for treating urinary incontinence in patients with neurologic conditions such as spinal cord injury and multiple sclerosis, who have overactivity of the bladder.

Current management of this condition includes medications to relax the bladder and use of a catheter to regularly empty the bladder.

Treatment consists of injecting Botox into the bladder, which results in relaxation of the bladder, an increase in its storage capacity, and a decrease in urinary incontinence.

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The effectiveness of the treatment for this type of incontinence was demonstrated in two clinical studies involving 691 patients. The patients had urinary incontinence resulting from spinal cord injury or multiple sclerosis. Both studies showed statistically significant decreases in the weekly frequency of incontinence episodes in the Botox A group compared with placebo.

The most common adverse reactions observed following injection of Botox into the bladder were urinary tract infection and urinary retention. Patients who develop urinary retention after treatment may require self-catheterization to empty the bladder.

Onabotulinumtoxin A is marketed in the United States by Allergan Inc., of Irvine, Calif. This is the seventh medical use of BOTOX to be approved in the United States. In addition, BOTOX is the first neurotoxin to undergo formal clinical evaluation and receive FDA approval for a urological indication.