Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 619 19th Street South, Birmingham, AL, 35249, USA.
RTI International, 3040 E Cornwallis Rd, Research Triangle Park, NC, USA.
Int Urogynecol J. 2020 Oct;31(10):2155-2164. doi: 10.1007/s00192-020-04271-y. Epub 2020 Mar 7.
Limited data exist comparing different surgical approaches in women with advanced vaginal prolapse. This study compared 2-year surgical outcomes of uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) in women with advanced prolapse (stage III-IV) and stress urinary incontinence.
This was a secondary analysis of a multicenter 2 × 2 factorial randomized trial comparing (1) ULS versus SSLF and (2) behavioral therapy with pelvic floor muscle training versus usual care. Of 374 subjects, 117/188 (62.7%) in the ULS and 113/186 (60.7%) in the SSLF group had advanced prolapse. Two-year surgical success was defined by the absence of (1) apical descent > 1/3 into the vaginal canal, (2) anterior/posterior wall descent beyond the hymen, (3) bothersome bulge symptoms, and (4) retreatment for prolapse. Secondary outcomes included individual success outcome components, symptom severity measured by the Pelvic Organ Prolapse Distress Inventory, and adverse events. Outcomes were also compared in women with advanced prolapse versus stage II prolapse.
Success did not differ between groups (ULS: 58.2% [57/117] versus SSLF: 58.5% [55/113], aOR 1.0 [0.5-1.8]). No differences were detected in individual success components (p > 0.05 for all components). Prolapse symptom severity scores improved in both interventions with no intergroup differences (p = 0.82). Serious adverse events did not differ (ULS: 19.7% versus SSLF: 16.8%, aOR 1.2 [0.6-2.4]). Success was lower in women with advanced prolapse compared with stage II (58.3% versus 73.2%, aOR 0.5 [0.3-0.9]), with no retreatment in stage II.
Surgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse. ClinicalTrials.gov Identifier: NCT01166373.
在患有晚期阴道脱垂的女性中,比较不同手术方法的数据有限。本研究比较了经阴道子宫骶骨固定术(ULS)和骶棘韧带固定术(SSLF)在患有晚期脱垂(III-IV 期)和压力性尿失禁的女性中的 2 年手术结果。
这是一项多中心 2×2 析因随机试验的二次分析,比较了(1)ULS 与 SSLF,(2)行为疗法联合盆底肌训练与常规护理。在 374 名受试者中,ULS 组 117/188(62.7%)和 SSLF 组 113/186(60.7%)患有晚期脱垂。2 年手术成功定义为不存在(1)阴道顶端下降超过阴道 1/3,(2)前/后壁下降超过处女膜,(3)令人烦恼的膨出症状,和(4)脱垂再治疗。次要结局包括个别成功结局组成部分、盆腔器官脱垂困扰问卷测量的症状严重程度以及不良事件。还比较了晚期脱垂与 II 期脱垂女性的结局。
两组之间的成功率没有差异(ULS:58.2%[57/117] versus SSLF:58.5%[55/113],aOR 1.0[0.5-1.8])。个别成功成分无差异(所有成分 p>0.05)。两种干预措施均改善了脱垂症状严重程度评分,无组间差异(p=0.82)。严重不良事件无差异(ULS:19.7% versus SSLF:16.8%,aOR 1.2[0.6-2.4])。与 II 期相比,晚期脱垂女性的成功率较低(58.3% versus 73.2%,aOR 0.5[0.3-0.9]),且 II 期无再治疗。
在患有晚期脱垂的女性中,ULS 和 SSLF 的手术成功率、症状严重程度和总体严重不良事件无差异。临床试验.gov 标识符:NCT01166373。