Medical Management and Unmet Need Sample Clauses

Medical Management and Unmet Need. The goals of treatment of NDO are: • Treating UI and thus improving QoL • Reducing bladder pressure to prevent upper urinary tract damage. The current first line pharmacologic treatment for NDO consists of oral medications such as anticholinergics, which are often used in conjunction with CIC. However, long term treatment may be suboptimal, with patients stopping medication due to lack of efficacy and/or bothersome side-effects, particularly at the high doses required to control NDO symptoms [2]. For a long time, surgical bladder augmentation represented the only therapeutic option for patients who failed to respond to oral medications. However, this is major reconstructive surgery, which carries with it the associated risks of significant invasive open surgery and requires a long hospital stay. It is also frequently associated with serious postoperative complications such as metabolic disturbance and renal function deterioration [3]. Intradetrusor injection of BTX-A as a treatment for NDO was first reported in 1991 [4]. Subsequently there have been many publications of studies in this indication, using different BTX-A compounds [5, 6, 7]. This growing evidence supporting the efficacy and safety of BTX- A led to international recommendations supporting its use as a second-line therapy. Recently, two positive pivotal phase III studies led to the approval of onabotulinumtoxinA in NDO to treat UI in many countries including the United States of America (USA) and a number of European countries [8, 9].
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Related to Medical Management and Unmet Need

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