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An Open Multicenter Study of Clinical Efficacy and Safety of Urolastic an Injectable Implant for the Treatment of Stress Urinary Incontinence: One-Year Observation

机译:一个开放的多中心临床研究和有效性的尿毒症的临床疗效和安全性注射性植入物治疗压力性尿失禁:一年的观察。

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摘要

The prevalence of stress urinary incontinence rises and affects up to 30% of women after 50 years of age. Midurethral slings are currently the mainstay of surgical anti-incontinence therapy. Some patients experience recurrent SUI (RSUI) which is defined as a failure of anti-incontinence surgery after a period of time or persistence of SUI after the procedure aimed at correcting it. The urethral bulking agent application decreases invasiveness of treatment and meets patients requirements. The objective of this study was to assess the safety and clinical efficacy of Urolastic injection. One hundred and five patients with SUI (including 91 patients with RSUI) were treated with Urolastic in three tertiary gynecological clinics. The efficacy of the procedure was assessed objectively at each follow-up visit by means of cough test and a standard 1-hour pad test. Objective success rate after 12 months after primary procedure in RSUI patients was found in 59.3% of patients. In 14 patients with primary SUI improvement after 1 year was found in 71.4% of patients. Although cure rates after MUS are up to 90% there is still place for less invasive treatment option like periurethral injection of bulking agents, especially in patients with previous SUI surgical management.
机译:压力性尿失禁的患病率上升,并在50岁以后影响多达30%的女性。尿道中段吊带术目前是外科抗失禁疗法的主要手段。一些患者会出现复发性SUI(RSUI),这被定义为经过一段时间的SUI持续性或在针对SUI进行纠正后仍持续存在而导致的失禁手术失败。尿道填充剂的应用降低了治疗的侵入性并满足了患者的需求。这项研究的目的是评估尿弹注射的安全性和临床疗效。在三所三级妇科诊所对155例SUI患者(包括91例RSUI患者)进行了Urolastic治疗。在每次随访中,通过咳嗽试验和标准的1小时垫试验客观地评估该手术的有效性。在RSUI患者中,初次手术后12个月后的客观成功率是59.3%。在11.4年后的SUI改善的14例患者中,发现71.4%的患者。尽管MUS后的治愈率高达90%,但仍存在侵入性较小的治疗选择,如尿道周围注射填充剂,尤其是在先前进行过SUI手术治疗的患者中。

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