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FDA Approves Botox to Treat Overactive Bladder (OAB)

January 29, 2013 2 min read

Adults who don’t respond to, or cannot take, anticholinergic drugs can now use Botox (onabotulinumtoxinA) to treat overactive bladder (OAB), the U.S. Food and Drug Administration (FDA) said on Jan. 18.

People suffering from OAB experience frequent urination, sudden urges to urinate, and uncontrollable urinary leakage. Botox, the same treatment that has been popular for treating wrinkles for many years, has previously been approved to treat OAB resulting from nerve damage, such as spinal cord injury and multiple sclerosis.

“Clinical studies have demonstrated Botox’s ability to significantly reduce the frequency of urinary incontinence,” said Hylton V. Joffe, MD, chief of the reproductive and urologic products division of the FDA’s Center for Drug Evaluation and Research, in a statement. “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.”

The new FDA approval was based on two clinical trials involving 1,105 patients with OAB. The patients were injected either 100 units of Botox (20 injections of 5 units each) or a placebo into their detrusor (bladder) muscle. After three months, results showed that those who received Botox had fewer daily urinary incontinence episodes, fewer daily urinations, but an average of 30 mL more urine expelled each day, compared to those on a placebo.

Botox relaxes the bladder muscles and increases the organ’s capacity to hold urine. Treatment can be repeated, but no more than once every 12 weeks. Common side effects reported during the clinical trials included: urinary tract infections (UTIs), painful urination, and incomplete bladder emptying. People who currently have a UTI should not use Botox as a treatment for OAB, the FDA said.

Disclaimer: This post does not contain medical advice and should not be taken as a treatment recommendation. People experiencing bladder control problems should check with their doctor about treatments for urinary incontinence.


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