Get the Facts About BOTOX® for (OAB) treatment
- The U.S. Food and Drug Administration has approved a new use for BOTOX® (onabotulinumtoxinA) to treat overactive bladder symptoms such as a strong need to urinate with leakage, urgency and frequency in adults when another type of medicine (anticholinergic) does not work well enough or cannot be taken. 1
- The availability of BOTOX® for the treatment of overactive bladder is important news for those who have tried other medications but still experience urge urinary incontinence – or leakage from the bladder.
- An estimated 14.7 million adults in the United States experience symptoms of OAB with urinary incontinence.2 Many people with OAB are prescribed anticholinergic medications, which are typically prescribed as pills, to manage their condition.3 It is estimated, however, that greater than 50 percent of these patients stop taking at least one oral medication within 12 months, likely due to an inadequate response to, or intolerance of, the medication.4
- For those patients who have not found adequate relief or can’t tolerate the side effects after taking an anticholinergic medicine, BOTOX® may be a treatment option. BOTOX® calms muscle contractions by temporarily blocking the transmission of nerve impulses to the bladder muscle.
- In two clinical studies, the safety and efficacy of BOTOX® (onabotulinumtoxinA) was evaluated in patients with overactive bladder whose symptoms were not adequately managed with anticholinergic medications, which are commonly prescribed as pills. BOTOX® reduced daily frequency of urinary leakage episodes from baseline by approximately 50% or more by week 12 compared to placebo (reduction of 2.5 episodes from baseline of 5.5 episodes in study 1 and reduction of 3 episodes from baseline of 5.5 episodes in study 2 for those treated with BOTOX® vs. a reduction of 0.9 episodes from a baseline of 5.1 episodes in study 1 and a reduction of 1.1 episodes from a baseline of 5.7 episodes in study 2 for those treated with placebo).1
- The efficacy of BOTOX® at reducing urinary leakage and other symptoms of overactive bladder was up to 6 months duration. The median duration of response in study 1 and study 2, based on patient qualification for retreatment, was 135-168 days for the BOTOX® 100 unit dose group compared to 88-92 days for placebo. To qualify for retreatment, at least 12 weeks must have passed since prior treatment, post void residual urine volume must have been less than 200 mL and patients must have reported at least two urinary incontinence episodes over three days.1
- Improvements in other symptoms of overactive bladder, daily frequency of urination and the amount of urine voided, also occurred with BOTOX® treatment compared to placebo at week 12.1
- The most common side effects reported with BOTOX® treatment in the clinical studies included: urinary tract infection (18%, vs. 6% with placebo), dysuria (9%, vs. 7% with placebo), which means painful or difficult urination; and urinary retention (6%, vs. 0% with placebo), which is a temporary inability to fully empty the bladder requiring clean intermittent catheterization.1 Clean intermittent catheterization is a way to manage incomplete bladder emptying.5 The patient will only need to insert the catheter when they need to drain urine and then remove it after use. Patients with diabetes mellitus treated with BOTOX® were more likely to develop urinary retention than non-diabetics. As with any medical treatment, it’s important to talk to your doctor about all the potential side effects as well as benefits, to evaluate if BOTOX® might be an option for you.
Contact the urologist doctors at Advanced Urology Associates for more information on BOTOX for Overactive Bladder (OAB) treatments. Our physicians also serve patients near Frankfort, IL. Give us a call at: (815) 409-4930
1 BOTOX® (onabotulinumtoxinA) Prescribing Information, updated January 2013.
2 Stewart WF, Van Rooyen JB, Cundiff GW, et al. Prevalence and burden of overactive bladder in the United States. World J Urol 2003:20:327-336; based on 2010 U.S. Census data and U.S. adult population [as of Jan 10, 2013].
3 National Patient Count, IMS Total Patient Tracker, USC 24100, MAT 11/12.
4 D’Souza et al. Persistence, Adherence, and Switch Rates Among Extended-Release and Immediate-Release Overactive Bladder Medications in a Regional Managed Care Plan. J. Managed Care Pharm. 2008;14(3):291-301
5 Wyndaele JJ, et al. Neurourol Urodyn. 2010;29(4):662-669.