FDA Gives Approval For Botox As Overactive Bladder Treatment

Overactive Bladder

The FDA announced on Friday its expanded approval of the use of Botox as treatment for adults suffering from overactive bladder. The treatment may provide relief for patients who are unable to use or do not positively respond to medications commonly prescribed for the condition.

Affecting millions of people in the United States alone, overactive bladder causes frequent squeezing of the bladder, often without warning. Symptoms may consist of frequent urination or the sudden and urgent need to urinate. Some sufferers may experience urinary incontinence.

According to a press release by the US Food and Drug Administration, Botox can be injected into the bladder muscle, causing it to relax. This technique can reduce incontinence episodes by increasing the bladder’s storage capacity through muscle relaxation.

Hylton V. Joffe, MD, director of the Division of Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research was quoted in Friday’s press release:

“Clinical studies have demonstrated Botox’s ability to significantly reduce the frequency of urinary incontinence. 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 Food and Drug Administration’s approval of the Botox treatment was given after results from two clinical trials were established. The trials were comprised of 1,105 participants with overactive bladder symptoms. The group was randomly divided between patients who were given Botox injections and those who received placebo.

At the end of a twelve week period, patients who received Botox had fewer daily instances of urinary incontinence than the placebo group. The Botox participants also showed a decrease in the number of times each day that they voided their bladder and expelled a larger amount of urine.

Friday’s press release 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.”

Do you have experience with overactive bladder? Would you consider using Botox as a treatment for the condition now that it has FDA approval?