Botox is a neurotoxin
Professional career of a neurotoxin
According to a study in six European countries, on average around 17 percent of people over 40 years of age suffer from the symptoms of an idiopathic, i.e., overactive bladder that has developed without any recognizable cause. "Symptoms of overactive bladder have the same prevalence in men and women and increase with age," reported Professor Dr. Klaus Jünemann, Director of the Urological Clinic at the University Medical Center Schleswig-Holstein, Kiel, and Chairman of the German Continence Society (2). The urologist spoke of an excruciating suffering with strong effects on everyday and professional life, which often lead to social isolation and loneliness. “Many of those affected no longer dare to go out into the street because they don't know whether they will make it to the nearest toilet. Their emotional well-being is shaped by feelings of shame, inferiority complexes and depression. "Nevertheless, the disease usually remains untreated.
According to Jünemann, women in particular report impaired sexual functions. They may even avoid all sexual activity because they fear leakage of urine during intercourse. The urologist spoke of a strong taboo on the subject. Many patients do not speak to their doctor about their bladder problems themselves. Therefore, they are often not informed about adequate therapy options.
Milestone in therapy
The exact causes of the idiopathically overactive bladder are mostly unknown. A neurophysiological and / or psychological malfunction of the bladder muscle is also discussed, which leads to a disturbed interaction between the bladder and pelvic floor muscles and to involuntary contractions of the bladder muscle.
The spectrum of therapy includes weight reduction, bladder and pelvic floor training, as well as the supply of incontinence products and intermittent self-catheterization. Medicines such as anticholinergics, flavoxate, impiramine and possibly estrogens are used as well as surgical measures.
According to Jünemann, only about 20 percent of patients are treated with medication (2). More than half of them stop taking it within the first twelve months due to a lack of effectiveness or undesirable side effects. Usually anticholinergics such as oxybutynin, propiverine, tolterodine or trospium chloride are used first. However, a clinical benefit was not demonstrable in 60 percent of the patients, explained the urologist. A quarter suffer side effects such as dry mouth or central nervous effects such as sleep and memory disorders or states of confusion. Other common therapy options also did not always show the expected effects.
Jünemann describes the approval of BoNT A as a »milestone« in the treatment of irritable bladder (2). In addition to a significant increase in the success of therapy, the quality of life of the patients increases, who often experience "finally peace" for the first time.
Good study data
The product-specific approval is based on two double-blind, placebo-controlled, randomized 24-week phase III studies (EMBARK) in 1105 patients with overactive bladder and the symptoms of urinary incontinence, urgency and urinary frequency. They complained of more than five urinary incontinence episodes per day and did not respond adequately to anticholinergics. The patients received 100 units of Botox injected locally into the bladder muscle.
Compared to the placebo group, the number of urinary incontinence episodes was significantly reduced and clinically relevant (1). After the first injection, more than a quarter of the patients in the verum group, three times more than in the placebo group (27 versus 8 percent), were completely continent; They did not experience any involuntary urine leakage in the following twelve weeks. 60 percent of the patients in the verum group achieved more than half of the urinary incontinence episodes (31 percent with placebo). Common symptoms of an overactive bladder, such as the urge to urinate and the frequency of urination, decreased significantly. Symptoms improved for an average of about 24 weeks (1).
The patients treated with botulinum toxin also reported a significant decrease in psychosocial impairments and feelings of shame. Jünemann sees the low drop-out rate of less than 2 percent as a sign of good tolerance. The primary side effects were urinary tract infections and painful urination.
Jünemann emphasized that the approvals were granted exclusively for the botulinum toxin preparation with which the study programs were carried out (Botox). The transfer of study results to other biological preparations, which are also obtained and purified differently, is not possible.
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