Overactive Bladder Treatment with Botox Gets FDA Approval

An overactive bladder treatment with botox recently received approval from the Food and Drug Administration (FDA). Individuals who experience a leaky bladder not helped by anticholinergic drugs can now be prescribed Botox (onabotulinumtoxinA).

This is not the first time Botox gained FDA approval. In 2011, Botox was approved for urinary incontinence associated with nerve damage, such as a spinal cord injury.

What is overactive bladder?

An overactive bladder is a type of urinary incontinence in which the bladder contracts or squeezes without warning or too often. Urinary incontinence symptoms associated with overactive bladder include feeling an urgent need to urinate, leaking or dribbling urine, and needing to urinate often. Although an overactive bladder is often associated with women, millions of men also suffer with this condition.

Common causes of overactive bladder in men can include treatments for prostate conditions such as BPH (benign prostatic hyperplasia, or enlarged prostate), prostatitis, or prostate cancer.

Doctors often prescribe urinary incontinence medications called anticholinergics for an overactive bladder. Anticholinergics are drugs that help reduce muscle spasms in the bladder. Common anticholinergics for overactive bladder include oxybutynin (Ditropan), solifenacin (Vesicare), tolterodine (Detrol), fesoterodine (Toviaz), and trospium (Sanctura).

What is Botox?

Botox is a medication that contains a tiny amount of a toxin from a bacterium. The drug is commonly thought of as a treatment to reduce facial wrinkles. For this cosmetic use, Botox is injected into the muscles of the face. The toxin relaxes the facial muscles, and wrinkles are temporarily reduced or disappear.

For overactive bladder treatment with Botox, the drug is injected into the bladder muscle using cystoscopy. This allows the doctor to see inside the bladder to inject the drug correctly. The Botox causes the bladder muscles to relax. In turn, the bladder increases its capacity and thus reduces the urgent need to urinate.

Botox for overactive bladder

The FDA approved Botox for overactive bladder treatment based on the results of two clinical studies that included more than 1,100 patients. These patients had not responded to previous anticholinergic treatment.

The patients were given either 20 injections of Botox or placebo. After three months, this is what the researchers found:

  • People treated with Botox experienced a 50% reduction in daily urinary incontinence compared with the placebo group
  • Complete elimination of urinary incontinence occurred in 22.9% and 31.4% of patients treated with Botox in the two trials. This compared with 6.5% and 10.% of those who received placebo.
  • Patients treated with Botox eliminated less urine per day than did individuals in the placebo group
  • Botox helped reduce symptoms of overactive bladder for an average of 135 to 168 days compared with 88 to 92 days in the placebo group

Overactive bladder treatment with Botox was associated with some side effects. Common side effects included painful urination, an inability to completely empty the bladder (urinary retention), and urinary tract infections. Patients who develop urinary retention may need a urinary catheter to resolve the problem.

Botox was first approved in 1989 to treat two different eye disorders. With this new FDA approval for overactive bladder, the drug can be used for 26 different indications, including chronic migraine, excessive underarm sweating, and a condition characterized by head tilting and neck pain.