Albo Michael E, Richter Holly E, Brubaker Linda, Norton Peggy, Kraus Stephen R, Zimmern Philippe E, Chai Toby C, Zyczynski Halina, Diokno Ananias C, Tennstedt Sharon, Nager Charles, Lloyd L Keith, FitzGerald MaryPat, Lemack Gary E, Johnson Harry W, Leng Wendy, Mallett Veronica, Stoddard Anne M, Menefee Shawn, Varner R Edward, Kenton Kimberly, Moalli Pam, Sirls Larry, Dandreo Kimberly J, Kusek John W, Nyberg Leroy M, Steers William
Division of Urology, University of California, San Diego, San Diego, CA 92103-8897, USA.
N Engl J Med. 2007 May 24;356(21):2143-55. doi: 10.1056/NEJMoa070416. Epub 2007 May 21.
Many surgical procedures are available for women with urinary stress incontinence, yet few randomized clinical trials have been conducted to provide a basis for treatment recommendations.
We performed a multicenter, randomized clinical trial comparing two procedures--the pubovaginal sling, using autologous rectus fascia, and the Burch colposuspension--among women with stress incontinence. Women were eligible for the study if they had predominant symptoms associated with the condition, a positive stress test, and urethral hypermobility. The primary outcomes were success in terms of overall urinary-incontinence measures, which required a negative pad test, no urinary incontinence (as recorded in a 3-day diary), a negative cough and Valsalva stress test, no self-reported symptoms, and no retreatment for the condition, and success in terms of measures of stress incontinence specifically, which required only the latter three criteria. We also assessed postoperative urge incontinence, voiding dysfunction, and adverse events.
A total of 655 women were randomly assigned to study groups: 326 to undergo the sling procedure and 329 to undergo the Burch procedure; 520 women (79%) completed the outcome assessment. At 24 months, success rates were higher for women who underwent the sling procedure than for those who underwent the Burch procedure, for both the overall category of success (47% vs. 38%, P=0.01) and the category specific to stress incontinence (66% vs. 49%, P<0.001). However, more women who underwent the sling procedure had urinary tract infections, difficulty voiding, and postoperative urge incontinence.
The autologous fascial sling results in a higher rate of successful treatment of stress incontinence but also greater morbidity than the Burch colposuspension. (ClinicalTrials.gov number, NCT00064662 [ClinicalTrials.gov] .).
对于患有压力性尿失禁的女性，有多种外科手术可供选择，但很少有随机临床试验可为治疗建议提供依据。
我们进行了一项多中心随机临床试验，比较两种手术——使用自体腹直肌筋膜的耻骨后阴道吊带术和Burch阴道悬吊术——对压力性尿失禁女性的治疗效果。如果女性具有与该疾病相关的主要症状、压力试验阳性以及尿道活动过度，则符合该研究的入选标准。主要结局指标为总体尿失禁测量指标的成功，这要求护垫试验阴性、无尿失禁（如3天日记中记录）、咳嗽和瓦尔萨尔瓦动作压力试验阴性、无自我报告症状且无需对该疾病进行再次治疗；以及压力性尿失禁测量指标的成功，这仅要求满足后三项标准。我们还评估了术后急迫性尿失禁、排尿功能障碍和不良事件。
共有655名女性被随机分配至研究组：326名接受吊带手术，329名接受Burch手术；520名女性（79%）完成了结局评估。在24个月时，接受吊带手术的女性在总体成功类别（47%对38%，P=0.01）和压力性尿失禁特定类别（66%对49%，P<0.001）中的成功率均高于接受Burch手术的女性。然而，接受吊带手术的女性中有更多出现尿路感染、排尿困难和术后急迫性尿失禁。
自体筋膜吊带术治疗压力性尿失禁的成功率较高，但与Burch阴道悬吊术相比，发病率也更高。（临床试验注册号，NCT00064662 [ClinicalTrials.gov] 。）
