Máxima Medisch Centrum, Veldhoven, the Netherlands; Grow-School for Oncology and Developmental Biology, Maastricht University, Maastricht, the Netherlands.
Imperial College, London, United Kingdom; St. Mary's Hospital, London, United Kingdom.
Eur J Obstet Gynecol Reprod Biol. 2019 Nov;242:122-125. doi: 10.1016/j.ejogrb.2019.09.013. Epub 2019 Sep 23.
Standard transcervical fibroid treatment via hysteroscopic myomectomy can result in a significant rate of intrauterine adhesiogenesis. The primary objective of this study was to document the incidence of de novo uterine adhesions after transcervical fibroid ablation (TFA) of symptomatic uterine fibroids with the Sonata® system.
In this European postmarket prospective, multicenter, single-arm interventional trial, patients were eligible for inclusion if they chose TFA with the Sonata System for symptomatic fibroids and had at least 1 type 1, type 2 or type 2-5 myoma. The presence or absence of intrauterine adhesions was assessed by diagnostic hysteroscopy at baseline and at 6 weeks post-ablation. The hysteroscopy videos were scored by a committee of 3 independent readers.
A total of 6 sites enrolled 37 patients. Fifty fibroids with a mean diameter of 3.4 ± 1.8 cm (range 1-8 cm) were ablated. Of the 37 enrolled subjects, 35 completed the study follow-up and 2 electively withdrew from the study prior to the completion of study follow-up. Thirty-four out of 35 pairs of baseline and 6-week hysteroscopies were evaluated by the independent readers with none having de novo adhesions at 6 weeks after treatment with Sonata, including 6 patients with apposing myomata. One patient was excluded from the analysis due to an unevaluable hysteroscopy video.
Intrauterine adhesiogenesis was not seen post-TFA with the Sonata system. These results suggest the potential for adhesiogenesis after TFA, including in women with apposing submucous and/or transmural myomata, may be minimal.
经宫腔镜子宫肌瘤切除术进行标准经宫颈子宫肌瘤治疗会导致宫腔粘连形成的发生率显著增加。本研究的主要目的是记录 Sonata®系统经宫颈子宫肌瘤消融术（TFA）治疗有症状子宫肌瘤后新发宫腔粘连的发生率。
在这项欧洲上市后前瞻性、多中心、单臂干预性试验中，符合以下条件的患者有资格入选：选择 Sonata 系统进行 TFA 治疗有症状的子宫肌瘤，且至少有 1 个 1 型、2 型或 2-5 型肌瘤；消融术前和术后 6 周通过诊断性宫腔镜检查评估宫腔粘连的发生情况。由 3 名独立读者组成的委员会对宫腔镜视频进行评分。
共 6 个中心入组了 37 例患者。消融了 50 个平均直径为 3.4±1.8cm（范围 1-8cm）的肌瘤。在 37 例入组患者中，35 例完成了研究随访，2 例在完成研究随访之前自愿退出研究。35 对基线和 6 周宫腔镜检查中有 34 对由独立读者进行了评估，在 Sonata 治疗后 6 周时，无新发粘连，包括 6 例对合性肌瘤患者。由于宫腔镜视频无法评估，1 例患者被排除在分析之外。
Sonata 系统治疗后 TFA 并未发生宫腔粘连形成。这些结果表明，TFA 后可能发生粘连形成，包括在对合性黏膜下和/或穿透性肌瘤的女性中，其发生率可能较低。
