Division of Urogynecology, Department of Obstetrics & Gynecology, Kaiser Permanente Downey, Downey, California; the Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Diego, La Jolla, California; the Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina; the Division of Urogynecology, Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center; the Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama; the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland; and Social, Statistical, & Environmental Sciences, RTI International, Research Triangle Park, North Carolina.
Obstet Gynecol. 2020 Nov;136(5):933-941. doi: 10.1097/AOG.0000000000004092.
To assess independent risk factors for surgical failure and worsening pelvic floor symptoms within 5 years after vaginal prolapse surgery.
This secondary analysis includes OPTIMAL (Operations and Pelvic Muscle Training in the Management of Apical Support Loss) (n=374) and E-OPTIMAL (Extended) (n=285) trial participants. Surgical failure was defined as apical descent greater than one third of the total vaginal length, anterior or posterior vaginal wall past the hymen, subsequent surgery or bothersome vaginal bulge. Worsening pelvic floor symptoms were defined as increases from baseline as large as the minimally important difference for subscale scores of the Pelvic Floor Distress Inventory: 11 for the Urinary Distress Inventory and Colorectal-Anal Distress Inventory and 34.3 for the Pelvic Organ Prolapse Distress Inventory. Outcomes were measured at 6 months then 1, 2, 3, 4, and 5 years. Chi-square and t test results from bivariate models and clinical relevance were used to inform final models.
Baseline risk factors for surgical failure were Hispanic ethnicity (adjusted odds ratio [aOR] 1.92, 95% CI 1.17-3.15), perineal body (aOR 1.34, 95% CI 1.09-1.63), and pretreatment Pelvic Organ Prolapse Distress Inventory score (aOR 1.16, 95% CI 1.05-1.28). Risk factors for worsening of pelvic floor symptoms were pretreatment Pelvic Organ Prolapse Distress Inventory score (aOR 0.75, 95% CI 0.60-0.94) for worsening Pelvic Organ Prolapse Distress Inventory score, vaginal deliveries (aOR 1.26, 95% CI 1.10-1.44) and pretreatment Urinary Distress Inventory score (aOR 0.86, 95% CI 0.80-0.93) for worsening Urinary Distress Inventory score, and age (aOR 1.03, 95% CI 1.01-1.05) and pretreatment Colorectal-Anal Distress Inventory score (aOR 0.95, 95% CI 0.92-0.98) for worsening Colorectal-Anal Distress Inventory score.
Hispanic ethnicity, larger preoperative perineal body, and higher pretreatment Pelvic Organ Prolapse Distress Inventory scores were risk factors for surgical failure up to 5 years after vaginal prolapse repair. Participants with higher baseline Pelvic Floor Distress Inventory scores were less likely to worsen. Risk factors for worsening Urinary Distress Inventory and Colorectal-Anal Distress Inventory scores included more vaginal deliveries and increased age, respectively.
NCT00597935, NCT01166373.
评估阴道膨出手术后 5 年内手术失败和盆底症状恶化的独立危险因素。
本二次分析包括 OPTIMAL（手术和盆底肌肉训练治疗顶端支撑丧失）（n=374）和 E-OPTIMAL（扩展）（n=285）试验参与者。手术失败定义为阴道顶端下降超过阴道总长度的三分之一、阴道前壁或后壁超过处女膜、随后进行手术或出现令人烦恼的阴道膨出。盆底症状恶化定义为与基线相比，盆底窘迫量表亚量表评分的最小有意义差异增加：尿失禁窘迫量表、肛肠窘迫量表为 11，盆腔器官脱垂窘迫量表为 34.3。术后 6 个月、1、2、3、4 和 5 年测量结果。二变量模型的卡方和 t 检验结果及临床相关性用于确定最终模型。
手术失败的基线危险因素为西班牙裔（调整比值比[aOR]1.92，95%置信区间[CI]1.17-3.15）、会阴体（aOR 1.34，95%CI 1.09-1.63）和术前盆腔器官脱垂窘迫量表评分（aOR 1.16，95%CI 1.05-1.28）。盆底症状恶化的危险因素为术前盆腔器官脱垂窘迫量表评分（aOR 0.75，95%CI 0.60-0.94）、阴道分娩（aOR 1.26，95%CI 1.10-1.44）和术前尿失禁窘迫量表评分（aOR 0.86，95%CI 0.80-0.93）。年龄（aOR 1.03，95%CI 1.01-1.05）和术前肛肠窘迫量表评分（aOR 0.95，95%CI 0.92-0.98）为肛肠窘迫量表评分恶化的危险因素。
西班牙裔、更大的术前会阴体和更高的术前盆腔器官脱垂窘迫量表评分是阴道膨出修复后 5 年内手术失败的危险因素。基线盆底窘迫量表评分较高的患者不太可能恶化。尿失禁窘迫量表和肛肠窘迫量表评分恶化的危险因素分别包括更多的阴道分娩和年龄增长。
NCT00597935，NCT01166373。
