Significant improvements compared to placebo in the primary efficacy variable of change from baseline in daily frequency of incontinence episodes were observed for BOTOX® (100 Units) at the primary efficacy time point at week 6. Increases in maximum cystometric capacity and reductions in maximum detrusor pressure during the first involuntary detrusor contraction were also observed. These primary and secondary endpoints are shown in Table 23.
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On average, each BOTOX treatment requires 32 injections, though individual patients may require fewer or more. You’ll receive injections every twelve weeks, and each session only takes a few minutes. BOTOX begins to work as soon as it’s injected, and you should see full results within a week of your first injections. Most patients who benefit from BOTOX treatments receive five rounds of injections over 15 months. BOTOX is injected using a very fine needle. Most patients describe it as feeling like a tiny pinprick.
The cosmetic benefits came to light in the 1990s by happy coincidence. “The aesthetic indications were purely happenstance,” says board-certified surgeon and clinical professor Seth L. Matarasso, MD, who has been treating his clients with Botox since the 1990s but is not affiliated with the brand. “Dr. [Jean] Carruthers was working with patients with strabismus...[and] with diplopia [double vision], and her patients were coming in and saying, ‘Gee, my wrinkles are better.'" Soon enough, doctors were using Botox for what it is most commonly associated with today — nixing lines.
After working out techniques for freeze-drying, buffering with albumin, and assuring sterility, potency, and safety, Scott applied to the FDA for investigational drug use, and began manufacturing botulinum type A neurotoxin in his San Francisco lab. He injected the first strabismus patients in 1977, reported its clinical utility in 1980, and had soon trained hundreds of ophthalmologists in EMG-guided injection of the drug he named Oculinum ("eye aligner").
Onabotulinumtoxin A (trade name Botox) received FDA approval for treatment of chronic migraines on October 15, 2010. The toxin is injected into the head and neck to treat these chronic headaches. Approval followed evidence presented to the agency from two studies funded by Allergan showing a very slight improvement in incidence of chronic migraines for migraine sufferers undergoing the Botox treatment.
As with the injection of any medication, your body's immune system can develop antibodies to the medication, which render the drug less effective or possibly cause development of an allergy to the drug. The more frequently the drug is injected or the more quantity that is injected, the higher the risk for these antibodies to be formed against the drug.
There have been reports following administration of BOTOX® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.
Just like any medical procedure the Botox treatment rarely comes with a few possible side-effects that are temporary. The frequency of complications generally decreases the more knowledge of facial anatomy that your injector possesses and the greater the experience of knowing where and how much to inject.That is not to say that complications can occur in anyones hands but the incidence decreases with greater experience.Allergic reactions to Botox or Dysport is exceedingly rare in my experience.
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There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX in pregnant women. In animal studies, administration of BOTOX during pregnancy resulted in adverse effects on fetal growth (decreased fetal weight and skeletal ossification) at clinically relevant doses, which were associated with maternal toxicity [see Data)].