FDA Approves Botox Injections for Overactive Bladder Treatment

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FDA Approves Botox for Overactive Bladder

Botox has been approved by the the U.S. Food and Drug Administration to be used on adults with overactive bladders.

About 33 million people in the U.S. have the problem, according to the FDA. The an overactive bladder is typically treated with nervous system-acting drugs called anticholinergics, but those don’t work for everyone. So, Botox injections will now be used on those patients that can’t tolerate the nervous system-acting drugs.

Botox injections will help overactive bladder patients by relaxing the bladder muscles and allowing there to be more space for urine to be stored. Botox works by blocking the connections between nerves and muscle, in which temporarily paralyzes the muscle.

“Clinical studies have demonstrated Botox’s ability to significantly reduce the frequency of urinary incontinence,” Hylton Joffe, director of the FDA’s Division of Reproductive and Urologic Products, said 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 approval for Botox to be used, was based primarily on two clinical trials involving a total of 1,105 patients, the FDA said. Patients received 20 injections of either 5 units of Botox or placebo.

After 12 weeks, patients receiving the active drug had 1.6 to 1.9 fewer daily incontinence episodes relative to the placebo group, and 1.0 to 1.7 fewer daily urinations. Average urine volume was higher by 30 mL with Botox versus placebo.

Treatments can be repeated when the effects wear off, but the FDA said that they should not be given more frequently than every 12 weeks.

A press release from the FDA also cautions patients about common side effects of the Botox treatment as seen in clinical trials:

“Common side effects reported during clinical trials included urinary tract infections, painful urination, and incomplete emptying of the bladder (urinary retention). Patients who develop urinary retention may need to use a catheter until the urinary retention resolves. Patients being treated for overactive bladder with Botox should not have a urinary tract infection and should take antibiotics before, during, and for a few days after Botox treatment to lower the chance of developing an infection from the procedure.”

Overactive bladder, or OAB, is a condition in which the bladder squeezes too often or squeezes without warning. Symptoms include leaking urine (urinary incontinence), feeling the sudden and urgent need to urinate, and frequent urination.

Botox had previously been approved for other non-cosmetic uses, such as migraine headaches, severe underarm sweating and loss of bladder control due to nerve damage, reports Fox News.

Botox Benefits Overactive Bladders

Botox is already widely used to smooth away wrinkles and reduce the signs of aging. Now, the popular neurotoxin also may bring relief to people with overactive bladder syndrome, a new study shows.

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