Background

Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery in the Vaginal hysterectomy with Native Tissue Vault Suspension vs Sacrospinous Hysteropexy with Graft Suspension (Study for Uterine Prolapse Procedures Randomized Trial) trial, sacrospinous hysteropexy with graft (hysteropexy) resulted in a lower composite surgical failure rate than vaginal hysterectomy with uterosacral suspension over 5 years.

Objective

This study aimed to identify factors associated with the rate of surgical failure over 5 years among women undergoing sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral suspension for uterovaginal prolapse.

Study Design

This planned secondary analysis of a comparative effectiveness trial of 2 transvaginal apical suspensions (NCT01802281) defined surgical failure as either retreatment of prolapse, recurrence of prolapse beyond the hymen, or bothersome prolapse symptoms. Baseline clinical and sociodemographic factors for eligible participants receiving the randomized surgery (N=173) were compared across categories of failure (≤1 year, >1 year, and no failure) with rank-based tests. Factors with adequate prevalence and clinical relevance were assessed for minimally adjusted bivariate associations using piecewise exponential survival models adjusting for randomized apical repair and clinical site. The multivariable model included factors with bivariate P<.2, additional clinically important variables, apical repair, and clinical site. Backward selection determined final retained risk factors (P<.1) with statistical significance evaluated by Bonferroni correction (P<.005). Final factors were assessed for interaction with type of apical repair at P<.1. Association is presented by adjusted hazard ratios and further illustrated by categorization of risk factors.

Results

In the final multivariable model, body mass index (increase of 5 kg/m²: adjusted hazard ratio, 1.7; 95% confidence interval, 1.3–2.2; P<.001) and duration of prolapse symptoms (increase of 1 year: adjusted hazard ratio, 1.1; 95% confidence interval, 1.0–1.1; P<.005) were associated with composite surgical failure, where rates of failure were 2.9 and 1.8 times higher in women with obesity and women who are overweight than women who have normal weight and women who are underweight (95% confidence intervals, 1.5–5.8 and 0.9–3.5) and 3.0 times higher in women experiencing >5 years prolapse symptoms than women experiencing ≤5 years prolapse symptoms (95% confidence interval, 1.8–5.0). Sacrospinous hysteropexy with graft had a lower rate of failure than hysterectomy with uterosacral suspension (adjusted hazard ratio, 0.6; 95% confidence interval, 0.4–1.0; P=.05). The interaction between symptom duration and apical repair (P=.07) indicated that failure was less likely after hysteropexy than hysterectomy for those with ≤5 years symptom duration (adjusted hazard ratio, 0.5; 95% confidence interval, 0.2–0.9), but not for those with >5 years symptom duration (adjusted hazard ratio, 1.0; 95% confidence interval 0.5–2.1).

Conclusion

Obesity and duration of prolapse symptoms have been determined as risk factors associated with surgical failure over 5 years from transvaginal prolapse repair, regardless of approach. Providers and patients should consider these modifiable risk factors when discussing treatment plans for bothersome prolapse.

中文翻译：

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在一项随机试验中，比较 5 年以上妇女的复合手术失败的特征，该试验涉及移植物骶棘子宫固定术与子宫骶韧带悬吊阴道子宫切除术

 背景

在阴道子宫切除术与天然组织穹窿悬吊术与骶棘肌子宫固定术与移植物悬吊术（子宫脱垂手术随机试验研究）试验中，在接受阴道手术的有症状子宫阴道脱垂的女性中，骶棘皮子宫固定术与移植物（子宫固定术）的复合手术失败率较低比阴道子宫切除术联合子宫骶骨悬吊术 5 年以上。

 客观的

本研究旨在确定接受骶棘皮子宫固定术与阴道子宫切除术和子宫骶骨悬吊术治疗子宫阴道脱垂的女性 5 年内手术失败率相关的因素。

 研究设计

这项计划对 2 次经阴道顶端悬吊术 (NCT01802281) 的有效性比较试验进行二次分析，将手术失败定义为脱垂的再治疗、脱垂超出处女膜的复发或令人烦恼的脱垂症状。通过基于等级的测试，对接受随机手术的合格参与者 (N=173) 的基线临床和社会人口学因素进行了跨失败类别（≤1 年、>1 年和无失败）的比较。使用分段指数生存模型调整随机根尖修复和临床部位，评估具有足够患病率和临床相关性的因素的最小调整双变量关联。多变量模型包括双变量P <.2 的因素、其他临床重要变量、根尖修复和临床部位。向后选择确定最终保留的风险因素 ( P <.1)，并通过 Bonferroni 校正评估统计显着性 ( P <.005)。最终因素与根尖修复类型的相互作用进行评估， P <.1。关联性通过调整后的风险比来呈现，并通过风险因素的分类进一步说明。

 结果

在最终的多变量模型中，体重指数（增加 5 kg/m ² ：调整后的风险比，1.7；95% 置信区间，1.3–2.2； P <.001）和脱垂症状的持续时间（增加 1 年：调整后的风险比）风险比，1.1；95% 置信区间， 1.0–1.1 ）与复合手术失败相关，其中肥胖女性和超重女性的失败率比正常女性高 2.9 倍和 1.8 倍体重不足的女性（95% 置信区间，1.5–5.8 和 0.9–3.5），并且经历 >5 年脱垂症状的女性比经历 ≤5 年脱垂症状的女性高 3.0 倍（95% 置信区间，1.8–5.0） 。骶棘肌子宫固定术与子宫骶骨悬吊术相比，失败率较低（调整后的风险比，0.6；95% 置信区间，0.4-1.0； P =.05）。症状持续时间和根尖修复之间的相互作用 ( P =.07) 表明，对于症状持续时间 ≤ 5 年的患者，子宫固定术失败的可能性低于子宫切除术（调整后的风险比，0.5；95% 置信区间，0.2-0.9），但不适用于症状持续时间 >5 年的患者（调整后的风险比，1.0；95% 置信区间 0.5–2.1）。

 结论

肥胖和脱垂症状持续时间已被确定为与经阴道脱垂修复术 5 年以上手术失败相关的危险因素，无论采用何种方法。医疗服务提供者和患者在讨论脱垂的治疗计划时应考虑这些可改变的风险因素。