Trommelen Lisa M, Semmler Annika, de Bruijn Annefleur M, Harmsen Marissa, Smink Marieke, Janssen Petra F, van Rooij Ilse, van Bavel Jeroen, Geomini Peggy, Maas Jacques W M, Radder Celine M, van Kesteren Paul, Kwee Janet, Bakkum Erica, de Lange Marleen, de Leeuw Robert A, Groenman Freek, Mijatovic Velja, Timmermans Anne, Lely Rutger, Lamers Armand, Vos Douwe, van Hoecke Gretel, Elgersma Otto, van Vliet Huib A A M, Yo Lonneke S F, Twijnstra Andries R H, Jansen Frank W, van Rijswijk Catharina S P, Kruimer Han, Tseng Carroll M E S N, Coppus Sjors, Arntz Mark, Wust Aloys F J, Blomjous Joost G A M, van Boven Laurens, Venmans Alexander, Twisk Jos W R, Huirne Judith A F, Lohle Paul N M, Hehenkamp Wouter J K
Department of Obstetrics and Gynecology, Amsterdam UMC, Location VUMC and AMC, Amsterdam, The Netherlands.
Amsterdam Reproduction and Development (AR&D), Research Institute, Amsterdam, The Netherlands.
Acta Obstet Gynecol Scand. 2025 Aug;104(8):1558-1574. doi: 10.1111/aogs.15165. Epub 2025 May 26.
Uterine artery embolization (UAE) is a less-invasive alternative for hysterectomy in therapy-resistant symptomatic adenomyosis. Comparative data are lacking. Our objective is to evaluate the non-inferiority of UAE compared with hysterectomy in improving health-related quality of life (HRQOL) for symptomatic adenomyosis, 1 year post-treatment.
This multicenter randomized controlled trial was converted into a prospective cohort study. It was prospectively registered at 27-07-2015 (NL-OMON55436, https://onderzoekmetmensen.nl/en/trial/55436). From November 2015 to March 2022 participants with symptomatic adenomyosis eligible for hysterectomy were included and offered UAE as an alternative treatment. Primary endpoint was difference in 1-year HRQOL scores between UAE and hysterectomy, using WHO-QOL-Bref and SF-12. Non-inferiority margin was set at five points. Secondary endpoints: WHO-QOL-100 facets "Pain and Discomfort" and "Sexual Activity", adenomyosis-related symptoms, and satisfaction. Multivariable linear mixed models were used. All outcomes were analyzed in the per-protocol population, and repeated in the intention-to-treat population.
Of 101 participants, 51 chose hysterectomy and 50 UAE. Both treatment groups were comparable at baseline, except for employment status, dysmenorrhea score, uterine volume, hemoglobin and CA125 (all adjusted for). Both treatments led to a significant increase in all HRQOL scores after 1 year. The effect differences between UAE and hysterectomy on all HRQOL domains in the per-protocol population were: SF-12 physical β -4.20, (95% CI -9.53 to 1.12), SF-12 mental β -4.95 (95% CI -10.83 to 0.94); WHO-QOL-Bref physical β -7.42 (95% CI -18.51 to 3.68), psychological β -4.28 (95% CI -13.30 to 4.74), social relations β -2.23 (95% CI -13.09 to 8.63) and environment β 0.35 (95% CI -8.39 to 9.09). Non-inferiority of UAE was not demonstrated within the predefined margin. Both hysterectomy and UAE improved "Pain and Discomfort" and "Sexual Activity", with greater effect on pain after hysterectomy (β 17.17, 95% CI 4.94 to 29.41, p = 0.007). More participants were satisfied after hysterectomy (95%) than after UAE (73%).
Both UAE and hysterectomy significantly increased HRQOL for symptomatic adenomyosis. Neither non-inferiority nor inferiority of UAE could be established. One-year HRQOL scores were comparable; some secondary outcomes were in favor of hysterectomy. UAE is a valid less-invasive alternative to hysterectomy, with preservation of the uterus. Hysterectomy remains the treatment of choice for patients seeking a definite solution.
子宫动脉栓塞术（UAE）是治疗耐药性症状性子宫腺肌病时子宫切除术的一种侵入性较小的替代方法。目前缺乏对比数据。我们的目的是评估UAE与子宫切除术相比，在治疗后1年改善症状性子宫腺肌病患者健康相关生活质量（HRQOL）方面的非劣效性。
这项多中心随机对照试验转变为一项前瞻性队列研究。于2015年7月27日进行前瞻性注册（NL-OMON55436，https://onderzoekmetmensen.nl/en/trial/55436）。从2015年11月至2022年3月，纳入符合子宫切除术条件的症状性子宫腺肌病患者，并提供UAE作为替代治疗。主要终点是使用世界卫生组织生活质量简表（WHO-QOL-Bref）和SF-12量表，比较UAE和子宫切除术1年后HRQOL评分的差异。非劣效性界值设定为5分。次要终点：WHO-QOL-100量表中的“疼痛与不适”和“性活动”、子宫腺肌病相关症状以及满意度。采用多变量线性混合模型。所有结局在符合方案人群中进行分析，并在意向性治疗人群中重复分析。
101名参与者中，51人选择子宫切除术，50人选择UAE。除就业状况、痛经评分、子宫体积、血红蛋白和CA125（均进行了校正）外，两个治疗组在基线时具有可比性。两种治疗均使1年后所有HRQOL评分显著提高。在符合方案人群中，UAE与子宫切除术在所有HRQOL领域的效应差异为：SF-12身体维度β为-4.20（95%CI为-9.53至1.12），SF-12心理维度β为-4.95（95%CI为-10.83至0.94）；WHO-QOL-Bref身体维度β为-7.42（95%CI为-18.51至3.68），心理维度β为-4.28（95%CI为-13.30至4.74），社会关系维度β为-2.23（95%CI为-13.09至8.63），环境维度β为0.35（95%CI为-8.39至9.09）。未在预定义界值内证明UAE的非劣效性。子宫切除术和UAE均改善了“疼痛与不适”和“性活动”，子宫切除术后对疼痛的改善作用更大（β为17.17，95%CI为4.94至29.41，p = 0.007）。子宫切除术后满意的参与者（95%）多于UAE术后（73%）。
UAE和子宫切除术均显著提高了症状性子宫腺肌病患者的HRQOL。既未证实UAE的非劣效性，也未证实其劣效性。1年的HRQOL评分相当；一些次要结局有利于子宫切除术。UAE是一种有效的侵入性较小的子宫切除术替代方法，可保留子宫。子宫切除术仍然是寻求彻底解决方案的患者的首选治疗方法。
