FDA Approves Botox as Effective, Safe Treatment for Incontinence


Kathleen Hennis

After months of distressing news about vaginal mesh failures and vaginal mesh lawsuits, the latest announcement of the Food and Drug Agency should bring cheers to millions of women suffering from stress urinary incontinence (SUI) throughout the world. The FDA, in January of this year, approved the use of Botox as a treatment for adults with incontinence problems.

Known also Botulinum Toxin Type A, Botox is a toxin derived from a bacterium called Clostridium Botulinum. Used originally as a cosmetic aid for the smoothening of wrinkles, doctors have found a way of creating a sterile type of toxin which can be directly injected into the muscles.


Botox works by making the bladder relax and preventing spasms which triggers bladder problems. This also increases the storage capacity of the bladder resulting to fewer episodes of urine leakage. Injecting Botox into the urinary sphincter tends to relax this muscle allowing a free flow of urine. This procedure is done by injecting Botox into the bladder through cystoscopy where a doctor views the entire image of the bladder while performing the whole process.

The safety and effectiveness of Botox as a treatment for incontinence was established in two clinical trials under the guidance of the FDA Center for Drug Evaluation and Research specifically the Division of Reproductive and Urologic Products. A total of 1,105 patients suffering from symptoms of an overactive bladder were used in these trials. Patients chosen at random were given injections of 100 units of Botox or placebo.

After two weeks, the results indicated that those treated with Botox experienced urinary incontinence 1.6 to 1.9 times lesser than those treated with placebo. The need for urination for those treated with Botox was 1.0 to 1.7 time lesser per day and were able to release a higher quantity of urine than those given placebo by as much as 30 milliliters.

Like any form of medication, the use of Botox may also have side effects or complications. It was noted during the trials that there were cases of urinary tract infections, painful urination, and urinary retention. It is recommended that patients opting for Botox treatment must first resolve any infections involving the urinary tract. Furthermore, patients are advised to take antibiotics prior, during, and for a number of days after receiving Botox treatment to lessen the chances of developing an infection.

The approval of Botox as a treatment for incontinence will surely be very welcome to an estimated 33 million Americans suffering from this condition. Other methods of treatment are also being developed and some have shown very promising results. These innovations together with lifestyle changes and other conservative means of treatment may eliminate the need for vaginal mesh devices which may only cause further injuries.

Serious complications have been reported as a result of using transvaginal mesh devices. Litigation for compensatory damage claims are scheduled to be heard this year To learn more about this, please visit transvaginal mesh at vaginalmeshlawsuitcenter.us

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