Brubaker Linda, Cundiff Geoffrey W, Fine Paul, Nygaard Ingrid, Richter Holly E, Visco Anthony G, Zyczynski Halina, Brown Morton B, Weber Anne M
Department of Obstetrics and Gynecology, Loyola University Medical Center, Maywood, Ill, USA.
N Engl J Med. 2006 Apr 13;354(15):1557-66. doi: 10.1056/NEJMoa054208.
We designed this trial to assess whether the addition of standardized Burch colposuspension to abdominal sacrocolpopexy for the treatment of pelvic-organ prolapse decreases postoperative stress urinary incontinence in women without preoperative symptoms of stress incontinence.
Women who did not report symptoms of stress incontinence and who chose to undergo sacrocolpopexy to treat prolapse were randomly assigned to concomitant Burch colposuspension or to no Burch colposuspension (control) and were evaluated in a blinded fashion three months after the surgery. The primary outcomes included measures of stress incontinence (symptoms, stress testing, or treatment) and measures of urge symptoms. Enrollment was stopped after the first interim analysis because of a significantly lower frequency of stress incontinence in the group that underwent the Burch colposuspension.
Of 322 women who underwent randomization, 157 were assigned to Burch colposuspension and 165 to the control group. Three months after surgery, 33.6 percent of the women in the Burch group and 57.4 percent of the controls met one or more of the criteria for stress incontinence (P<0.001) [Corrected]. There was no significant difference between the Burch group and the control group in the frequency of urge incontinence (32.7 percent vs. 38.4 percent, P=0.48). After surgery, women in the control group were more likely to report bothersome symptoms of stress incontinence than those in the Burch group who had stress incontinence (24.5 percent vs. 6.1 percent, P<0.001).
In women without stress incontinence who are undergoing abdominal sacrocolpopexy for prolapse, Burch colposuspension significantly reduced postoperative symptoms of stress incontinence without increasing other lower urinary tract symptoms.
我们设计了这项试验,以评估在腹骶骨阴道固定术治疗盆腔器官脱垂时,加用标准化的Burch阴道悬吊术是否能降低术前无压力性尿失禁症状的女性术后压力性尿失禁的发生率。
未报告压力性尿失禁症状且选择接受骶骨阴道固定术治疗脱垂的女性被随机分配接受同期Burch阴道悬吊术或不接受Burch阴道悬吊术(对照组),并在术后三个月以盲法进行评估。主要结局包括压力性尿失禁的测量指标(症状、压力测试或治疗)和急迫性症状的测量指标。在首次中期分析后,由于接受Burch阴道悬吊术的组中压力性尿失禁的发生率显著较低,因此停止入组。
在322名接受随机分组的女性中,157名被分配至Burch阴道悬吊术组,165名被分配至对照组。术后三个月,Burch组中33.6%的女性和对照组中57.4%的女性符合一项或多项压力性尿失禁标准(P<0.001)[校正后]。Burch组和对照组在急迫性尿失禁发生率方面无显著差异(32.7%对38.4%,P=0.48)。术后,对照组中报告有困扰性压力性尿失禁症状的女性比Burch组中有压力性尿失禁的女性更常见(24.5%对6.1%,P<0.001)。
对于因脱垂而接受腹骶骨阴道固定术且无压力性尿失禁的女性,Burch阴道悬吊术可显著降低术后压力性尿失禁症状,且不会增加其他下尿路症状。