Surgery versus Physiotherapy for Stress Urinary Incontinence
Surgery versus Physiotherapy for Stress Urinary Incontinence
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DOI：
10.1056/nejmoa1210627
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发表时间：
2013-09-19
影响因子：
158.5
通讯作者：
van der Vaart, Carl H.
中科院分区：
文献类型：
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作者：
Labrie, Julien;Berghmans, Bary L. C. M.;van der Vaart, Carl H.
研究背景压力性尿失禁的一线治疗方法是骨盆底肌肉训练的物理治疗;当物理治疗不成功时，通常建议进行尿道中段悬吊术。缺乏数据的随机试验比较这两种选择作为初始therapy.MethodsWe进行了多中心，随机试验比较物理治疗和midurethral吊带手术的妇女压力性尿失禁。允许组间交叉。主要结果是主观的改善，通过改善患者的总体印象在12 months.ResultsWe随机分配230名妇女的手术组和230名妇女的物理治疗组。物理治疗组中共有49.0%的女性和手术组中有11.2%的女性交叉接受替代治疗。在意向性治疗分析中，手术组90.8%的女性和物理治疗组64.4%的女性报告了主观改善（绝对差异，26.4个百分点; 95%置信区间[CI]，18.1至34.5）。主观治愈率手术组为85.2%，物理治疗组为53.4%（绝对差异，31.8个百分点; 95%CI，22.6 - 40.3）;客观治愈率分别为76.5%和58.8%（绝对差异，17.8个百分点; 95%CI，7.9 - 27.3）。一项事后按协议分析显示，妇女谁交叉到手术组的结果类似的妇女最初分配到手术，这两个群体的结果上级那些妇女谁没有交叉到surgical.ConclusionsFor妇女压力性尿失禁，初始尿道中段吊带手术，与初始物理治疗相比，导致1年时主观改善率以及主观和客观治愈率更高。
BackgroundPhysiotherapy involving pelvic-floor muscle training is advocated as first-line treatment for stress urinary incontinence; midurethral-sling surgery is generally recommended when physiotherapy is unsuccessful. Data are lacking from randomized trials comparing these two options as initial therapy.MethodsWe performed a multicenter, randomized trial to compare physiotherapy and midurethral-sling surgery in women with stress urinary incontinence. Crossover between groups was allowed. The primary outcome was subjective improvement, measured by means of the Patient Global Impression of Improvement at 12 months.ResultsWe randomly assigned 230 women to the surgery group and 230 women to the physiotherapy group. A total of 49.0% of women in the physiotherapy group and 11.2% of women in the surgery group crossed over to the alternative treatment. In an intention-to-treat analysis, subjective improvement was reported by 90.8% of women in the surgery group and 64.4% of women in the physiotherapy group (absolute difference, 26.4 percentage points; 95% confidence interval [CI], 18.1 to 34.5). The rates of subjective cure were 85.2% in the surgery group and 53.4% in the physiotherapy group (absolute difference, 31.8 percentage points; 95% CI, 22.6 to 40.3); rates of objective cure were 76.5% and 58.8%, respectively (absolute difference, 17.8 percentage points; 95% CI, 7.9 to 27.3). A post hoc per-protocol analysis showed that women who crossed over to the surgery group had outcomes similar to those of women initially assigned to surgery and that both these groups had outcomes superior to those of women who did not cross over to surgery.ConclusionsFor women with stress urinary incontinence, initial midurethral-sling surgery, as compared with initial physiotherapy, results in higher rates of subjective improvement and subjective and objective cure at 1 year.