Trabuco Emanuel C, Klingele Christopher J, Blandon Roberta E, Occhino John A, Weaver Amy L, McGree Michaela E, Lemens Maureen A, Gebhart John B
Divisions of Gynecologic Surgery and Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota; and the Department of Obstetrics and Gynecology, University of Missouri, Kansas City, Missouri.
Obstet Gynecol. 2016 Oct;128(4):828-35. doi: 10.1097/AOG.0000000000001651.
To compare efficacy and safety of retropubic Burch urethropexy and a midurethral sling in women with stress urinary incontinence (SUI) undergoing concomitant pelvic floor repair with sacrocolpopexy.
Women were randomly assigned to Burch retropubic urethropexy (n=56) or retropubic midurethral sling (n=57) through dynamic allocation balancing age, body mass index, history of prior incontinence surgery, intrinsic sphincter deficiency, preoperative incontinence diagnosis, and prolapse stage. Overall and stress-specific continence primary outcomes were ascertained with validated questionnaires and a blinded cough stress test.
Enrollment was June 1, 2009, through August 31, 2013. At 6 months, no difference was found in overall (29 midurethral sling [51%] compared with 23 Burch [41%]; P=.30) (odds ratio [OR] 1.49, 95% confidence interval [CI] 0.71-3.13) or stress-specific continence rates (42 midurethral sling [74%] compared with 32 Burch [57%]; P=.06) (OR 2.10, 95% CI 0.95-4.64) between groups. However, the midurethral sling group reported greater satisfaction (78% compared with 57%; P=.04) and were more likely to report successful surgery for SUI (71% compared with 50%; P=.04) and to resolve pre-existing urgency incontinence (72% compared with 41%; P=.03). No difference was found in patient global impression of severity or symptom improvement, complication rates, or mesh exposures.
There was no difference in overall or stress-specific continence rates between midurethral sling and Burch urethropexy groups at 6 months. However, the midurethral sling group reported better patient-centered secondary outcomes.
比较耻骨后Burch尿道悬吊术与经耻骨后中段尿道吊带术在接受骶棘韧带固定术联合盆底修复的压力性尿失禁(SUI)女性患者中的疗效和安全性。
通过动态分配平衡年龄、体重指数、既往尿失禁手术史、固有括约肌缺陷、术前尿失禁诊断和脱垂分期,将患者随机分为耻骨后Burch尿道悬吊术组(n = 56)或耻骨后中段尿道吊带术组(n = 57)。通过经过验证的问卷和盲法咳嗽压力试验确定总体及压力性尿失禁特异性的控尿主要结局。
入组时间为2009年6月1日至2013年8月31日。6个月时,两组在总体控尿率(中段尿道吊带术组29例[51%],Burch尿道悬吊术组23例[41%];P = 0.30)(优势比[OR] 1.49,95%置信区间[CI] 0.71 - 3.13)或压力性尿失禁特异性控尿率(中段尿道吊带术组42例[74%],Burch尿道悬吊术组32例[57%];P = 0.06)(OR 2.10,9%置信区间CI 0.95 - 4.64)方面未发现差异。然而,中段尿道吊带术组报告的满意度更高(78%对比57%;P = 0.04),更有可能报告SUI手术成功(71%对比50%;P = 0.04),且更有可能解决既往存在的急迫性尿失禁(72%对比41%;P = .03)。在患者对严重程度的总体印象或症状改善、并发症发生率或网片暴露方面未发现差异。
6个月时,中段尿道吊带术组与Burch尿道悬吊术组在总体或压力性尿失禁特异性控尿率方面无差异。然而,中段尿道吊带术组报告了更好的以患者为中心的次要结局。