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首页> 外文期刊>BJU international >A double-blind randomized controlled trial of electromagnetic stimulation of the pelvic floor vs sham therapy in the treatment of women with stress urinary incontinence.
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A double-blind randomized controlled trial of electromagnetic stimulation of the pelvic floor vs sham therapy in the treatment of women with stress urinary incontinence.

机译:骨盆地板电磁刺激的双盲随机对照试验VS假疗法治疗患有压力尿失禁的妇女。

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OBJECTIVE: To compare the efficacy of extracorporeal electromagnetic stimulation (ES) of the pelvic floor for treating stress urinary incontinence (SUI) vs sham ES. PATIENTS AND METHODS: In all, 70 women with urodynamically confirmed SUI were randomized to receive active (35) or sham (35) ES. The NeoControl chair (NeoTonus, Marietta, GA, USA) was used, and treatment consisted of three sessions per week for 6 weeks. data were collected before and after treatment on all women, including a 20-min provocative pad-test with a predetermined bladder volume (primary outcome measure), a 3-day bladder diary and 24 h pad-test. Circumvaginal muscle (CVM) rating score, perineometry using two separate instruments and video-urodynamics were also used, and the Urinary Incontinence Quality of Life Scale (I-QOL) and King's Health Questionnaires. Patients were fully re-evaluated 8 weeks after treatment, and the bladder diary, pad-test and questionnaires were repeated at 6 months. The urotherapist and physician were unaware to which treatment group the patient was assigned. RESULTS: In the overall group of 70 patients there were significant improvements in each of the primary and secondary outcome measures at 8 weeks. There were also significant improvements in primary and secondary outcome measures in the active treatment group when compared with baseline measures. At 8 weeks, there were improvements in the mean (sd) values for the 20-min pad-test, of 39.5 (5.1) vs 19.4 (4.6) g (P < 0.001); the 24-h pad-test, of 24.0 (4.7) vs 10.1 (3.1) g (P < 0.01); the number of pads/day, of 0.9 (0.1) vs 0.6 (0.1) (P < 0.01), the I-QOL score, of 63.7 (2.8) vs 71.2 (3.3) (P < 0.001); and King's Health Questionnaire score, of 9.6 (0.8) vs 6.9 (0.7) (P < 0.001). However, these improvements were not statistically significant when compared with the sham-treatment group. In those patients on active treatment who had a poor pelvic floor contraction at the initial assessment (defined by the CVM score and perineometry), there was a significantreduction (P < 0.05) in the 20-min pad-test leakage when compared with the sham-treatment group. CONCLUSIONS: ES was no more effective overall than sham treatment in this patient group. However, in those women who were unable to generate adequate pelvic floor muscle contractions, there was an objective improvement in provocative pad testing when compared to sham treatment.
机译:目的:比较骨盆地板体外电磁刺激治疗应激尿失禁(SUI)的疗效VS假。患者和方法:总而言之,70名借氧动力学证实SUI的女性随机分配接受活性(35)或假(35)ES。使用了Neocontrol椅(NeoTonus,Marietta,Ga,USA),并且治疗由每周三个课程组成6周。在所有女性的治疗前后收集数据,包括具有预定膀胱体积的20分钟的诱捕垫测试(主要结果测量),3天膀胱日记和24小时垫试验。使用两种单独的仪器和视频尿动力学的Circenginal肌肉(CVM)评级得分,Perineometry和尿失禁质量(i-QOL)和国王的健康问卷。治疗后8周完全重新评估患者,并在6个月内重复膀胱日记,垫试验和问卷。泌尿科医师和医生不知道患者被分配的治疗组。结果:在70例患者的总体组中,每次初级和次要结果措施的显着改善在8周内。与基线措施相比,活性治疗组中的初级和次要结果措施也有显着改善。在8周后,20分钟焊盘试验的平均值(SD)值有39.5(5.1)Vs 19.4(4.6)g(p <0.001); 24-H垫试验为24.0(4.7)Vs 10.1(3.1)g(P <0.01);垫/天的数量为0.9(0.1)vs 0.6(0.1)(P <0.01),I-QOL得分为63.7(2.8)Vs 71.2(3.3)(P <0.001);和国王的健康问卷评分为9.6(0.8)Vs 6.9(0.7)(P <0.001)。然而,与假治疗组相比,这些改进并不统计学意义。在初步评估中患有较差的骨盆楼收缩(由CVM评分和Perineometry定义)的活跃治疗患者中,与假的假液相比,在20分钟的焊盘 - 试验泄漏中存在明显(P <0.05) - 治疗组。结论:ES在本患者组中的假治疗方面没有更有效。然而,在无法产生足够的盆底肌肉收缩的那些女性中,与假治疗相比,挑衅性垫测试有客观改善。

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