Rogers Rebecca G, Nolen Tracy L, Weidner Alison C, Richter Holly E, Jelovsek J Eric, Shepherd Jonathan P, Harvie Heidi S, Brubaker Linda, Menefee Shawn A, Myers Deborah, Hsu Yvonne, Schaffer Joseph I, Wallace Dennis, Meikle Susan F
Department of Women's Health, Dell Medical School, University of Texas, 1301 W 38th Street, Suite 705, Austin, TX, 78756, USA.
Department of Obstetrics and Gynecology, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, USA.
Int Urogynecol J. 2018 Aug;29(8):1101-1110. doi: 10.1007/s00192-018-3666-7. Epub 2018 May 25.
We compared treatment success and adverse events between women undergoing open abdominal sacrocolpopexy (ASC) vs vaginal repair (VAR) using data from women enrolled in one of three multicenter trials. We hypothesized that ASC would result in better outcomes than VAR.
Participants underwent apical repair of stage 2-4 prolapse. Vaginal repair included uterosacral, sacrospinous, and iliococcygeal suspensions; sacrocolpopexies were via laparotomy. Success was defined as no bothersome bulge symptoms, no prolapse beyond the hymen, and no retreatment up to 24 months. Adverse events were collected at multiple time points. Outcomes were analyzed using longitudinal mixed-effects models to obtain valid outcome estimates at specific visit times, accounting for data missing at random. Comparisons were controlled for center, age, body mass index (BMI), initial Pelvic Organ Prolapse Quantification (POP-Q) stage, baseline scores, prior prolapse repair, and concurrent repairs.
Of women who met inclusion criteria (1022 of 1159 eligibile), 701 underwent vaginal repair. The ASC group (n = 321) was older, more likely white, had prior prolapse repairs, and stage 4 prolapse (all p < 0.05). While POP-Q measurements and symptoms improved in both groups, treatment success was higher in the ASC group [odds ratio (OR) 6.00, 95% confidence interval (CI) 3.45-10.44). The groups did not differ significantly in most questionnaire responses at 12 months and overall improvement in bowel and bladder function. By 24 months, fewer patients had undergone retreatment (2% ASC vs 5% VAR); serious adverse events did not differ significantly through 6 weeks (13% vs 5%, OR 2.0, 95% CI 0.9-4.7), and 12 months (26% vs 13%, OR 1.6, 95% CI 0.9-2.9), respectively.
Open sacrocolpopexy resulted in more successful prolapse treatment at 2 years.
我们利用三项多中心试验中入组女性的数据，比较了接受开放性腹式骶骨阴道固定术（ASC）与阴道修复术（VAR）的女性的治疗成功率和不良事件。我们假设ASC的治疗效果优于VAR。
参与者接受2-4期脱垂的顶端修复。阴道修复包括子宫骶骨固定术、骶棘肌固定术和髂尾肌悬吊术；骶骨阴道固定术通过剖腹手术进行。成功定义为无烦人的膨出症状、处女膜外无脱垂且24个月内无需再次治疗。在多个时间点收集不良事件。使用纵向混合效应模型分析结果，以在特定访视时间获得有效的结果估计，同时考虑随机缺失的数据。比较时对中心、年龄、体重指数（BMI）、初始盆腔器官脱垂定量（POP-Q）分期、基线评分、既往脱垂修复情况和同期修复情况进行了控制。
符合纳入标准的女性（1159名 eligible中的1022名）中，701名接受了阴道修复。ASC组（n = 321）年龄较大，更可能为白人，有既往脱垂修复史且为4期脱垂（所有p < 0.05）。虽然两组的POP-Q测量值和症状均有所改善，但ASC组的治疗成功率更高[比值比（OR）6.00，95%置信区间（CI）3.45 - 10.44]。两组在12个月时的大多数问卷回答以及肠道和膀胱功能的总体改善方面无显著差异。到24个月时，接受再次治疗的患者较少（ASC组为2%，VAR组为5%）；严重不良事件在6周时（13%对5%，OR 2.0，95% CI 0.9 - 4.7）和12个月时（26%对13%，OR 1.6，95% CI 0.9 - 2.9）分别无显著差异。
开放性骶骨阴道固定术在2年时脱垂治疗更成功。
