Abstract：
OBJECTIVE: To assess the efficacy of Uterine Myoma Position-based Radiofrequency Ablation (UMP-b RFA) at 36 months. An analysis of a new uterine fibroid ablation technique that allows personalized access of delivering radiofrequency energy (transvaginal, hysteroscopic or laparoscopic) based on myoma localization.
METHODS: Prospective observational cohort study in a community-based secondary care medical center enrolled 61 premenopausal women with 112 symptomatic uterine myomas. 112 fibroids were ablated in 5 ways with single or combined accesses: 82 Vaginal Ultrasound (VU)-guided RFA, 19 Laparoscopic (L)-RFA, 5 Hysteroscopic (H)-RFA, 5 VU+H-RFA, and 1 VU+L-RFA. The primary endpoint of this study was to evaluate the 3-year clinical outcome of UMP-b RFA. The secondary endpoint was the possible identification of predictors of its success. The outcomes evaluated at 12, 24, and 36 months after UMP-b RFA were myoma size, type of symptomatology suffered, quality of life based on the \"Uterine Fibroid Symptom and Quality of Life\" questionnaire, and interviews on the degree of satisfaction with this surgery. The reintervention and complication rates were also recorded and analyzed.
RESULTS: Fibroids volume and diameter were significantly reduced by -90.2 % / -55.7 % at 36 months post-intervention (p < 0.001) and the reduction of Symptom Severity scores was -71.8 % three years after UMP-b RA (p < 0.001). The overall improvement in the quality of life was demonstrated by an increase in the Quality-of-Life score of + 26.0 % at the third follow-up (p < 0.001). 88.5 % of the patients interviewed would have the surgery done again if they went back in time. The reintervention rate was 10/61 (16.4 %): 3 hysterectomies, 3 myomectomies, 3 operative hysteroscopies and 1 VU-RFA reoperation. In this group of unsuccessful surgeries, the mean diameter of the dominant myomas was found to be greater than that of the successes (5.3 vs 4.4 cm.). Out of the 61 cases, no major complications occurred, and the 2 minor complications observed were self-limiting.
CONCLUSIONS: Uterine Myoma Position-based Radiofrequency Ablation is a safe, effective, and minimally invasive solution for the treatment of symptomatic fibroids. Indeed, these clinical outcome data at 36 months shows how UMP-b RFA can treat the symptomatology of uterine fibromatosis. Hysterectomies or myomectomies were successfully avoided in more than 80 % of women bearing myomas with an average diameter of less than 5 cm.
METHODS: Prospective observational cohort study in a community-based secondary care medical center enrolled 61 premenopausal women with 112 symptomatic uterine myomas. 112 fibroids were ablated in 5 ways with single or combined accesses: 82 Vaginal Ultrasound (VU)-guided RFA, 19 Laparoscopic (L)-RFA, 5 Hysteroscopic (H)-RFA, 5 VU+H-RFA, and 1 VU+L-RFA. The primary endpoint of this study was to evaluate the 3-year clinical outcome of UMP-b RFA. The secondary endpoint was the possible identification of predictors of its success. The outcomes evaluated at 12, 24, and 36 months after UMP-b RFA were myoma size, type of symptomatology suffered, quality of life based on the \"Uterine Fibroid Symptom and Quality of Life\" questionnaire, and interviews on the degree of satisfaction with this surgery. The reintervention and complication rates were also recorded and analyzed.
RESULTS: Fibroids volume and diameter were significantly reduced by -90.2 % / -55.7 % at 36 months post-intervention (p < 0.001) and the reduction of Symptom Severity scores was -71.8 % three years after UMP-b RA (p < 0.001). The overall improvement in the quality of life was demonstrated by an increase in the Quality-of-Life score of + 26.0 % at the third follow-up (p < 0.001). 88.5 % of the patients interviewed would have the surgery done again if they went back in time. The reintervention rate was 10/61 (16.4 %): 3 hysterectomies, 3 myomectomies, 3 operative hysteroscopies and 1 VU-RFA reoperation. In this group of unsuccessful surgeries, the mean diameter of the dominant myomas was found to be greater than that of the successes (5.3 vs 4.4 cm.). Out of the 61 cases, no major complications occurred, and the 2 minor complications observed were self-limiting.
CONCLUSIONS: Uterine Myoma Position-based Radiofrequency Ablation is a safe, effective, and minimally invasive solution for the treatment of symptomatic fibroids. Indeed, these clinical outcome data at 36 months shows how UMP-b RFA can treat the symptomatology of uterine fibromatosis. Hysterectomies or myomectomies were successfully avoided in more than 80 % of women bearing myomas with an average diameter of less than 5 cm.
摘要：
目的：评估基于位置的子宫肌瘤射频消融（UMP-bRFA）在36个月时的疗效。对一种新的子宫肌瘤消融技术的分析，该技术允许个性化地获取射频能量（经阴道，宫腔镜或腹腔镜）基于肌瘤定位。
方法：一项基于社区的二级保健医疗中心的前瞻性观察性队列研究纳入了61名绝经前妇女，有112例有症状的子宫肌瘤。通过单次或联合访问以5种方式消融112个肌瘤：82个阴道超声（VU）引导的RFA，19腹腔镜（L）-RFA，5宫腔镜（H）-RFA，5VU+H-RFA,和1个VU+L-RFA。这项研究的主要终点是评估UMP-bRFA的3年临床结局。次要终点是可能确定其成功的预测因子。在UMP-bRFA后12、24和36个月评估的结果是肌瘤大小，类型的症状，基于“子宫肌瘤症状和生活质量”问卷的生活质量，以及对该手术的满意度的访谈。记录并分析再干预和并发症发生率。
结果：干预后36个月，肌瘤体积和直径显着减少-90.2％/-55.7％（p<0.001），症状严重程度评分降低-71.8％UMP-bRA后三年（p<0.001）。生活质量的总体改善在第三次随访时表现为生活质量评分增加+26.0%(p<0.001)。如果回到过去，接受采访的患者中有88.5％会再次进行手术。再干预率为10/61(16.4%):3次子宫切除术,3个子宫肌瘤切除术,3次宫腔镜手术和1次VU-RFA再次手术。在这组不成功的手术中，发现显性肌瘤的平均直径大于成功肌瘤的平均直径（5.3对4.4cm。).在61个案例中，无重大并发症发生,观察到的2个次要并发症是自限性的。
结论：基于位置的子宫肌瘤射频消融是一种安全的，有效,和微创解决方案用于治疗有症状的肌瘤。的确,这些36个月时的临床结局数据显示了UMP-bRFA如何治疗子宫纤维瘤病的症状.在80％以上的平均直径小于5厘米的肌瘤患者中，成功避免了子宫切除术或子宫肌瘤切除术。
方法：一项基于社区的二级保健医疗中心的前瞻性观察性队列研究纳入了61名绝经前妇女，有112例有症状的子宫肌瘤。通过单次或联合访问以5种方式消融112个肌瘤：82个阴道超声（VU）引导的RFA，19腹腔镜（L）-RFA，5宫腔镜（H）-RFA，5VU+H-RFA,和1个VU+L-RFA。这项研究的主要终点是评估UMP-bRFA的3年临床结局。次要终点是可能确定其成功的预测因子。在UMP-bRFA后12、24和36个月评估的结果是肌瘤大小，类型的症状，基于“子宫肌瘤症状和生活质量”问卷的生活质量，以及对该手术的满意度的访谈。记录并分析再干预和并发症发生率。
结果：干预后36个月，肌瘤体积和直径显着减少-90.2％/-55.7％（p<0.001），症状严重程度评分降低-71.8％UMP-bRA后三年（p<0.001）。生活质量的总体改善在第三次随访时表现为生活质量评分增加+26.0%(p<0.001)。如果回到过去，接受采访的患者中有88.5％会再次进行手术。再干预率为10/61(16.4%):3次子宫切除术,3个子宫肌瘤切除术,3次宫腔镜手术和1次VU-RFA再次手术。在这组不成功的手术中，发现显性肌瘤的平均直径大于成功肌瘤的平均直径（5.3对4.4cm。).在61个案例中，无重大并发症发生,观察到的2个次要并发症是自限性的。
结论：基于位置的子宫肌瘤射频消融是一种安全的，有效,和微创解决方案用于治疗有症状的肌瘤。的确,这些36个月时的临床结局数据显示了UMP-bRFA如何治疗子宫纤维瘤病的症状.在80％以上的平均直径小于5厘米的肌瘤患者中，成功避免了子宫切除术或子宫肌瘤切除术。
