压力性尿失禁初始治疗：悬吊术优于理疗

根据9月18日《新英格兰医学杂志》在线发表的一则报道，在中至重度压力性尿失禁的女患者中，将尿道中段悬吊术作为一线治疗方案者1年后的病情与初始接受理疗的患者相比明显好转。

目前标准做法是推荐将理疗作为一线治疗，只有在这种方法无效时再进行手术，之前也从未对尿道中段悬吊术与理疗的结局进行过直接比较，鉴于此，乌得勒支（荷兰）大学医学中心的Julien Labrie医生及其合作者进行了这项荷兰随机试验。这项研究涉及460例患者、49位有经验的妇科医生兼泌尿科医生，83位执业盆腔理疗师。所纳入的女患者年龄介于30~85岁之间，按照山特维克指数（Sandvic index）属于中度或重度尿失禁。在2年当中，这些研究对象被随机分配接受手术初治（230例）或理疗初治（230例），参与机构包括4家大学医疗中心和19家全科医院。耻骨后与经闭孔尿道中段悬吊术均允许使用。理疗包括在18周内平均9次的治疗，可能包括生物反馈辅助治疗或功能性电刺激疗法。如果这些女患者对所分配的治疗方式不满意，允许其转到另一组。基于意向性治疗分析数据。由于在平均31周之后，约有半数的理疗组患者自愿转到手术组中，因此研究者们还进行了一次post hoc符合方案数据分析。

主要结局指标是第12个月压力性尿失禁症状的主观好转，按照患者总体印象-改善量表（PGI-I）衡量。在意向性治疗分析中，直接手术组该结局的发生率是90.8%，明显高于直接理疗组的64.4%。使用咳嗽压力测试对结局进行客观评价时得到了相同结果。两个试验组均显示按照泌尿生殖系统疾病量表（UDI）衡量的泌尿生殖道症状和按照尿失禁影响问卷（IIQ）衡量的疾病特异性生活质量均随时间有所好转。直接手术组的尿失禁和膀胱过度活动症的好转程度更显著，“但仅为中等效应”。与此类似，直接手术组中关于患者行动能力和受窘情况的子项评分也有更明显的提高，“但同样仅为中等效应”。在post hoc符合方案数据分析中，他们比较了103例仅进行理疗的女患者、99例进行过理疗但后来转到手术组的女患者及215例仅进行手术的女患者。结果显示， 1年过后，仅进行理疗组的好转率比转换方案组降低大约62%，比仅进行手术组降低59%。

研究中发生的65例不良事件均与手术有关，包括6例膀胱穿孔、10例阴道上皮穿孔、6例因吊带暴露而重新手术、1例为放松过紧的合成吊带而重新手术、20例血肿、18例新发的急迫性尿失禁和3例失血过多。

本研究可能存在选择偏倚，这是由于“倾向于手术的女性可能更希望参与这项研究，因为按照荷兰相关指南，她们本该初始接受理疗”。

这项研究由荷兰健康研究和发展组织（Netherlands Organization for Health Research and Development ，ZonMW）支持，未获得尿道中段吊带生产商的支持或参与。有几名合著者报告与爱惜康公司、美国医疗系统（American Medical Systems）和AMS有经济联系。其余作者未报告相关的经济利益冲突。

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By: MARY ANN MOON, Ob.Gyn. News Digital Network

Among women who had moderate to severe stress urinary incontinence, those who underwent midurethral-sling surgery as the first line of treatment showed significantly more improvement 1 year later than did women whose initial treatment was physiotherapy, according to a report published online Sept. 18 in the New England Journal of Medicine.

In a randomized Dutch trial involving 460 patients, 49 experienced gynecologists and urologists, and 83 certified pelvic physiotherapists, 1-year rates of both subjective and objective improvement, as well as rates of subjective and objective cure, were markedly higher for women who had immediate surgery than for those who had immediate physiotherapy, reported Dr. Julien Labrie of the University of Utrecht (the Netherlands) Medical Center and his associates.

Improvement in all secondary outcomes also was significantly better with initial surgery than with initial physiotherapy. These included urogenital symptoms, disease-specific quality of life, and the development of new urinary symptoms. However, all 65 adverse events that occurred in the study were related to surgery, including intraoperative bladder perforations, vaginal epithelial perforations, excessive blood loss, and four cases in which reoperation was required.

"Our findings suggest that women with this condition should be counseled regarding both pelvic-floor muscle training and midurethral-sling surgery as initial treatment options. Information on expected outcomes with both interventions, as well as on the potential, albeit infrequent, complications of surgery, will allow for individualized decision making by each woman and her health care provider," the investigators noted.

Dr. Labrie and his colleagues performed this study because standard practice is to recommend physiotherapy as first-line treatment, and to proceed to surgery only if that fails. Yet outcomes from midurethral-sling surgery and physiotherapy have never been directly compared.

Their study involved women aged 35-80 years whose stress urinary incontinence was classified as moderate or severe according to the Sandvik index. These subjects were randomly assigned to receive either initial surgery (230 women) or initial physiotherapy (230 women) at four university medical centers and 19 general hospitals over a 2-year period.

Both retropubic and transobturator midurethral-sling surgical approaches were allowed. Physiotherapy included an average of nine sessions delivered over 18 weeks, and could include biofeedback assistance or functional electrostimulation therapy.

The women were allowed to cross over to the other group if they were not satisfied with their assigned treatment, as "is consistent with usual clinical practice." The data were analyzed on an intention-to-treat basis. However, because approximately half of the physiotherapy group crossed over to surgery after a mean of 31 weeks, the investigators also performed a post hoc per-protocol analysis.

The primary outcome was subjective improvement in symptoms of stress urinary incontinence at 12 months, as measured by the Patient Global Impression of Improvement (PGI-I) scale. In the intention-to-treat analysis, the rate of this outcome was 90.8% with immediate surgery, significantly higher than the 64.4% rate with immediate physiotherapy, Dr. Labrie and his associates reported (New Engl. J. Med. 2013;369:1124-33 [doi: 10.1056/NEJMoa1210627]).

The pattern was the same when outcomes were assessed objectively using a cough stress test.

Both study groups showed improvement over time in urogenital symptoms as measured by the Urogenital Distress Inventory (UDI) and in disease-specific quality of life as measured by the Incontinence Impact Questionnaire (IIQ). The improvements were significantly greater in the immediate-surgery group for incontinence and overactive bladder, "but with only moderate effect sizes," the authors said.

Similarly, improvements were significantly greater in the immediate-surgery group for subscores regarding patients’ mobility and embarrassment, "but again with only moderate effect sizes," the researchers said.

In the post hoc per-protocol analysis, they compared the 103 women who only had physiotherapy, the 99 who had physiotherapy but crossed over to surgery, and the 215 who only had surgery. At 1 year, improvement in the physiotherapy-only group was lower by approximately 62% than in the crossover group and by 59% in the surgery-only group.

Adverse events, which occurred only in women who underwent surgery, included 6 cases of bladder perforation, 10 cases of vaginal epithelial perforation, 6 reoperations for tape exposure, 1 reoperation to loosen a too-tight synthetic sling, 20 hematomas, 18 cases of new-onset urge urinary incontinence, and 3 cases of excessive blood loss.

This study may have been limited by selection bias, because "women with a preference for surgery may have been more likely to participate in the study, because they otherwise would have received initial physiotherapy according to Dutch guidelines," Dr. Labrie and his associates said.

The study was supported by the Netherlands Organization for Health Research and Development (ZonMW) and was performed "without the support or involvement of manufacturers of midurethral slings." Several coauthors reported financial ties to Ethicon, American Medical Systems, and AMS. The remainder of the authors reported no relevant financial conflicts of interest.