Botox Approved for Overactive Bladder

Overactive bladder symptoms may be alleviated with Botox treatment

/ Author:  / Reviewed by: Chris Galloway, M.D.

(RxWiki News) When the typical medicine for frequent bathroom visits doesn't work, Botox may be the answer.

Botox was approved by the FDA last week to treat adults with overactive bladders.

The medicine, known also as onabotulinumtoxinA, serves as another option to those who do not respond to or cannot use anticholinergic medications that help with nerve cell communication. 

"Ask your doctor about Botox bladder treatments."

Botox causes the bladder to relax when it is injected into the bladder muscle. The medicine increases how much the bladder can store and reduces urine leakage.

“Clinical studies have demonstrated Botox’s ability to significantly reduce the frequency of urinary incontinence,” said Hylton Joffe, MD, director of the Division of Reproductive and Urologic Products in FDA’s Center for Drug Evaluation and Research, in a press release.

“[The] 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.”

Botox was approved after two clinical studies involving more than 1,000 patients. The patients received injections of the medicine or a placebo (fake medication).

Urinary tract infections (UTI), pain while urinating and being unable to empty the bladder completely were the common side effects with Botox treatment. Patients who have a UTI cannot use the medicine.

Researchers said that Botox treatments could be repeated every three months. The treatments decrease urine leakage on average 1.6 to 1.9 times less each day than those on the placebo. They also urinated one to two times less each day.

Overactive bladder patients also urinated one to almost two times less each day with 30 milliliters less urine than with placebo.

Reviewed by: 
Review Date: 
January 26, 2013
Last Updated:
December 31, 2013