Obstetrics/Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, Ohio.
Departments of Obstetrics and Gynecology and Urology, Loyola University Chicago Stritch School of Medicine, Chicago, Illinois.
JAMA. 2018 Apr 17;319(15):1554-1565. doi: 10.1001/jama.2018.2827.
Uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) are commonly performed pelvic organ prolapse procedures despite a lack of long-term efficacy data.
To compare outcomes in women randomized to (1) ULS or SSLF and (2) usual care or perioperative behavioral therapy and pelvic floor muscle training (BPMT) for vaginal apical prolapse.
DESIGN, SETTING, AND PARTICIPANTS: This 2 × 2 factorial randomized clinical trial was conducted at 9 US medical centers. Eligible participants who completed the Operations and Pelvic Muscle Training in the Management of Apical Support Loss Trial enrolled between January 2008 and March 2011 and were followed up 5 years after their index surgery from April 2011 through June 2016.
Two randomizations: (1) BPMT (n = 186) or usual care (n = 188) and (2) surgical intervention (ULS: n = 188 or SSLF: n = 186).
The primary surgical outcome was time to surgical failure. Surgical failure was defined as (1) apical descent greater than one-third of total vaginal length or anterior or posterior vaginal wall beyond the hymen or retreatment for prolapse (anatomic failure), or (2) bothersome bulge symptoms. The primary behavioral outcomes were time to anatomic failure and Pelvic Organ Prolapse Distress Inventory scores (range, 0-300).
The original study randomized 374 patients, of whom 309 were eligible for this extended trial. For this study, 285 enrolled (mean age, 57.2 years), of whom 244 (86%) completed the extended trial. By year 5, the estimated surgical failure rate was 61.5% in the ULS group and 70.3% in the SSLF group (adjusted difference, -8.8% [95% CI, -24.2 to 6.6]). The estimated anatomic failure rate was 45.6% in the BPMT group and 47.2% in the usual care group (adjusted difference, -1.6% [95% CI, -21.2 to 17.9]). Improvements in Pelvic Organ Prolapse Distress Inventory scores were -59.4 in the BPMT group and -61.8 in the usual care group (adjusted mean difference, 2.4 [95% CI, -13.7 to 18.4]).
Among women who had undergone vaginal surgery for apical pelvic organ vaginal prolapse, there was no significant difference between ULS and SSLF in rates of surgical failure and no significant difference between perioperative behavioral muscle training and usual care on rates of anatomic success and symptom scores at 5 years. Compared with outcomes at 2 years, rates of surgical failure increased during the follow-up period, although prolapse symptom scores remained improved.
clinicaltrials.gov Identifier: NCT01166373.
尽管缺乏长期疗效数据，但子宫骶骨韧带悬吊术（ULS）和骶棘韧带固定术（SSLF）仍是常用的治疗盆腔器官脱垂的方法。
比较随机分配至（1）ULS 或 SSLF 和（2）常规护理或围手术期行为治疗和盆底肌肉训练（BPMT）的女性的结局，这些女性患有阴道顶端脱垂。
设计、设置和参与者：这是一项在美国 9 家医疗中心进行的 2×2 析因随机临床试验。2008 年 1 月至 2011 年 3 月完成“手术和盆底肌肉训练在治疗阴道顶端支持丧失中的应用”试验的合格参与者被招募，并在其索引手术后的 5 年（2011 年 4 月至 2016 年 6 月）进行随访。
两项随机化：（1）BPMT（n=186）或常规护理（n=188）和（2）手术干预（ULS：n=188 或 SSLF：n=186）。
主要手术结局是手术失败的时间。手术失败定义为（1）阴道顶端下降超过阴道总长度的三分之一或阴道前壁或后壁超出处女膜或因脱垂而再次治疗（解剖学失败），或（2）出现令人烦恼的膨出症状。主要行为学结局是解剖学失败和盆腔器官脱垂困扰评分的时间（范围，0-300）。
原始研究随机分配了 374 名患者，其中 309 名符合本扩展试验的条件。在这项研究中，有 285 名患者入组（平均年龄为 57.2 岁），其中 244 名（86%）完成了扩展试验。在第 5 年，ULS 组的估计手术失败率为 61.5%，SSLF 组为 70.3%（调整差异，-8.8%[95%CI，-24.2 至 6.6]）。BPMT 组的估计解剖学失败率为 45.6%，常规护理组为 47.2%（调整差异，-1.6%[95%CI，-21.2 至 17.9]）。BPMT 组的盆腔器官脱垂困扰评分改善了-59.4，常规护理组改善了-61.8（调整后的平均差异，2.4[95%CI，-13.7 至 18.4]）。
在因阴道顶端盆腔器官脱垂而接受阴道手术的女性中，ULS 和 SSLF 在手术失败率方面无显著差异，围手术期行为肌肉训练与常规护理在 5 年时的解剖学成功率和症状评分方面也无显著差异。与 2 年时的结果相比，尽管脱垂症状评分仍有所改善，但在随访期间手术失败率有所增加。
clinicaltrials.gov 标识符：NCT01166373。
