Long Term Effectiveness of Uterine Sparing Fibroid Treatments

在黑人妇女中，子宫平滑肌瘤（肌瘤或UF）的终生累积发病率>80%， 白色女性约70%。UF是美国子宫切除术最常见的原因，可导致严重的并发症。 需要输血的月经出血、盆腔疼痛、泌尿和肠道问题、不孕症，以及 严重损害生活质量（QOL）。虽然子宫切除术的替代方法包括 子宫肌瘤切除术（肌瘤切除）、子宫动脉栓塞术（UAE）、子宫内膜消融术（EA），以及 射频消融（RFA），存在重大的知识差距，阻碍了 循证临床指南，以选择适当的UF治疗。先前的UF处理研究 几个关键缺陷，包括随访时间有限（<2年）和未能评估重要混杂因素， 如术前肌瘤特征、基线QOL和妊娠意向。两个多中心登记中心 通过协调数据，COMPARE-UF（肌瘤切除术、EA和UAE患者）和ULTRA（RFA患者） 解决关键证据差距和显著改善UF妇女护理的能力。 该项目将由COMPARE-UF/ULTRA研究者（MPI）领导，并延长700例随访 接受保留子宫肌瘤治疗长达10年的COMPARE-UF和ULTRA受试者 在索引程序之后。绝经期的长期随访对于评估 症状改善和指数后子宫切除术或其他子宫手术的比率 治疗目前，COMPARE-UF/ULTRA中的女性仅在治疗后随访1-3年; 在此建议中追加随访，将对临床决策产生重大影响，提供相关数据 在种族多样性（>40%黑人）人群中，并包括详细的成像信息（UF大小、数量和 位置），以及在指数纤维瘤治疗之前获得的对未来生育能力的自我报告的愿望。妇女 接受过四种子宫保留手术（肌瘤切除术、EA、UAE和RFA）之一的患者， 术前的问卷调查将每年重复一次，直至术后10年，以实现 以下：目的1：比较术前至10年期间肌瘤症状和生活质量的变化 四种子宫保留手术中的术后：肌瘤切除术、EA、UAE和RFA。目标2：比较 在有以下情况的参与者中，在索引治疗后长达10年的治疗失败率和时间 子宫肌瘤切除术、EA、UAE和RFA。目标3：确定预测治疗后临床有效性的基线因素 子宫肌瘤切除术、EA、UAE和RFA以及患者和提供者的输入，创建临床预测工具（肌瘤 治疗计算器），支持知情决策。我们的初步数据显示 积极参与这些活动。这个项目是一个有时间限制的机会，使用两个精心设计的 纵向队列，使用经验证的问卷收集全面的基线信息，并将 产生的结果立即应用于临床护理。

The lifetime cumulative incidence of uterine leiomyomas (fibroids or UF) is >80% among Black women and ~70% in White women. UF are the most common reason for hysterectomy in the U.S. and can cause heavy menstrual bleeding requiring blood transfusion(s), pelvic pain, urinary and bowel problems, infertility, and substantial impairment of quality of life (QOL). While alternatives to hysterectomy are available including myomectomy (fibroid removal), uterine artery embolization (UAE), endometrial ablation (EA), and radiofrequency ablation (RFA), there are significant knowledge gaps that preclude the development of evidence-based clinical guidelines to select an appropriate UF treatment. Prior studies of UF treatments have several key deficits including limited follow-up time (<2 years) and failure to assess important confounders, such as pre-procedure fibroid characteristics, baseline QOL, and pregnancy intention. Two multisite registries with harmonized data, COMPARE-UF (Myomectomy, EA and UAE patients) and ULTRA (RFA patients), have the capacity to address critical evidence gaps and significantly improve care for women with UF. This project will be led by COMPARE-UF/ULTRA investigators (MPIs) and extend the follow-up of 700 COMPARE-UF and ULTRA participants who have had a uterine-sparing fibroid treatment for up to 10 years after the index procedure. Long term follow-up through menopause is critical to assess the durability of symptom improvement and the rates of hysterectomy or other uterine procedures following the index treatment. Currently, women in COMPARE-UF/ULTRA are followed only for 1-3 years post treatment; the additional follow-up in this proposal, will have a major impact on clinical decision-making, provide relevant data in a racially diverse (>40% Black) population, and include detailed imaging information (UF size, number and location), and self-reported desire for future fertility obtained prior to the index fibroid treatment. Among women who have undergone one of four uterine-sparing procedures (myomectomy, EA, UAE and RFA), validated questionnaires from pre-procedure will be repeated annually up to 10 years post-procedure, to achieve the following: Aim 1: Compare changes in fibroid symptoms and quality of life from pre-procedure up to 10 years post-procedure among four uterine-sparing procedures: myomectomy, EA, UAE, and RFA. Aim 2: Compare the rate of and time until treatment failure up to 10 years after the index treatment among participants who had myomectomy, EA, UAE, and RFA. Aim 3: Identify baseline factors that predict clinical effectiveness after myomectomy, EA, UAE, and RFA and with patient and provider input, create a clinical prediction tool (Fibroid Treatment Calculator) that supports informed decision-making. Our preliminary data demonstrate ongoing active engagement of these participants. This project is a time-limited opportunity that uses two well-designed longitudinal cohorts with comprehensive baseline information collected with validated questionnaires and will yield results for immediate application in clinical care.