Abstract

Aim: To evaluate the safety and efficacy of a radiofrequency ablation system with a novel endometrial tip (RFA-EMT) for the management of heavy menstrual bleeding (HMB) or abnormal uterine bleeding (AUB).

Methods: This is a prospective study including a total of 38 premenopausal women with heavy menstrual bleeding (HMB) or abnormal uterine bleeding (AUB) that failed to respond to medical therapy. Hysteroscopic evaluation and curettage biopsy were performed just before the procedure. The procedure was timed to occur during the early proliferative phase (cycle days 4–10). RFA-EMT procedures were performed by a single surgeon with the patient under general anesthesia with a laryngeal mask airway. Primary outcome was reduction in bleeding, reported as amenorrhea, hypomenorrhea, and eumenorrhea, which were measured via hemoglobin level and pictorial blood assessment chart (PBAC) score. Secondary outcomes were adverse events, dysmenorrhea with numeric rating scale (NRS) score, and endometrial thickening in the early proliferative phase, as assessed by transvaginal ultrasonography.

Results: There were no peri- or post-procedural complications. Combined amenorrhea, hypomenorrhea, and eumenorrhea rates at 3 and 6 months were 97.4% and 100%, respectively. The hemoglobin level was significantly increased, and the PBAC score, NRS score, and endometrial thickening were significantly decreased after 3 months. These trends were maintained for 6 months after the procedure.

Conclusion: RFA-EMT, a new technique, is safe and effective for women with HMB or AUB for which medical therapy has failed.

摘要

目的：评估具有新型子宫内膜尖端（RFA-EMT）的射频消融系统用于治疗月经大量出血（HMB）或子宫异常出血（AUB）的安全性和有效性。

方法：这是一项前瞻性研究，共纳入38名对药物治疗无效的月经严重出血（HMB）或子宫异常出血（AUB）的绝经前妇女。在手术前就进行了宫腔镜检查和刮宫活检。该程序被安排在增殖初期（周期4-10天）进行。RFA-EMT手术由一名外科医生在全麻下行喉罩气道的情况下进行。主要结果是出血减少，据报道为闭经，月经少和月经不全，通过血红蛋白水平和图画血评估图（PBAC）得分。次要结局为不良事件，痛经带数字评分量表（NRS）评分和增生期早期子宫内膜增厚（通过经阴道超声检查评估）。

结果：没有围手术期或术后并发症。3个月和6个月合并闭经，月经少和月经率分别为97.4％和100％。3个月后，血红蛋白水平显着升高，PBAC评分，NRS评分和子宫内膜增厚明显降低。这些趋势在手术后维持了6个月。

结论： RFA-EMT是一种新技术，对于药物治疗失败的HMB或AUB妇女安全有效。