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Neuroscience: FDA Approves Botox for Some Forms of Overactive Bladder

by Robert Fay

The U.S. Food and Drug Administration (FDA) has approved onabotulinumtoxinA (Botox) injection to treat urinary incontinence caused by overactive bladder in patients with neurological conditions, such as spinal cord injury and multiple sclerosis (MS). The treatment consists of onabotulinumtoxinA being injected into the bladder using cystoscopy, and its effects typically last for nine months.

The approval is based on the results of two clinical trials with a total of 691 patients who had urinary incontinence caused by spinal cord injury or MS. In both studies, the onabotulinumtoxinA patients had statistically significant decreased weekly frequency and incontinence episodes compared to control patients. The most common adverse effects were urinary tract infection and urinary retention. Patients who experience urinary retention after injection may need self-catheterization.

Source: U.S. Food and Drug Administration. 2011. FDA approves Botox to treat specific form of urinary incontinence. Published on August 24, 2011 on the FDA website.