FDA gives nod to botox to treat overactive bladder

FDA gives nod to botox to treat overactive bladder
Injections of the drug into bladder muscle appear to ease incontinence, agency says.

(HealthDay)—The U.S. Food and Drug Administration on Friday gave its approval for the use of Botox against a form of urinary incontinence known as overactive bladder.

"Clinical studies have demonstrated Botox's ability to significantly reduce the frequency of urinary incontinence," Dr. Hylton Joffe, director of the Division of Reproductive and Urologic Products in the FDA's Center for and Research, said in an agency news release.

"Today's approval provides an important additional treatment option for patients with , a condition that affects an estimated 33 million men and women in the United States," he added.

Overactive bladder is a condition where the bladder contracts too frequently or without warning, causing incontinence, sudden/urgent urge to urinate and frequent urination.

However, injections of Botox (onabotulinumtoxinA) into the can trigger a relaxation of the bladder, boost the organ's and make incontinence episodes less frequent, the FDA said.

Physicians inject the drug while using cytoscopy, a procedure that allows the doctor to visualize the interior of the bladder as injection occurs.

The FDA said the safety and effectiveness of Botox for this use was verified in two clinical trials involving more than 1,100 patients with overactive bladder, with patients receiving either 100 units of Botox (20 injections of 5 units each) or a placebo.

Lasting more than three months, the trials found that Botox patients experienced close to two fewer bouts of a day compared to those on a placebo, had fewer urinations per day, and an average of 30 milliliters more urine expelled each day, compared to those on a placebo.

Side effects included , painful urination and incomplete emptying of the bladder, the FDA said. People who already have a urinary tract infection should not take Botox for overactive bladder, and people who do take the drug should take antibiotics before, during and for a few days after the procedure, the agency added.

Botox, best known for its ability to temporarily smooth away facial lines and wrinkles, is made by Allergan Inc. of Irvine, Calif.

More information: Find out more about overactive bladder at the American Urological Association.

add to favorites email to friend print save as pdf

Related Stories

US approves Botox for bladder control

Aug 24, 2011

The face-freezing pharmaceutical injection Botox gained another medical use on Wednesday when the US government approved it for use in some patients with overactive bladder.

Botox now used for urinary incontinence

Mar 14, 2012

When you think of Botox injections, you probably think of getting rid of unwanted wrinkles around the eyes or forehead, but recently the U.S. Food and Drug Administration (FDA) approved using the injections to help patients ...

Myrbetriq approved for overactive bladder

Jun 28, 2012

(HealthDay) -- Myrbetriq (mirabegron) has been approved to treat adults with overactive bladder, a condition affecting some 33 million Americans, the U.S. Food and Drug Administration said Thursday in a news release.

Recommended for you

Two expats die of MERS in Saudi commercial hub

21 hours ago

Two foreigners died of MERS in the Saudi city of Jeddah, the health ministry said Saturday, as fears rise over the spreading respiratory virus in the kingdom's commercial hub.

UAE reports 12 new cases of MERS

21 hours ago

Health authorities in the United Arab Emirates have announced 12 new cases of infection by the MERS coronavirus, but insisted the patients would be cured within two weeks.

Filipino tests negative for Middle East virus

Apr 19, 2014

A Filipino nurse who tested positive for the Middle East virus has been found free of infection in a subsequent examination after he returned home, Philippine health officials said Saturday.

User comments