Stamford Hospital, Stamford, Connecticut; Magee-Women's Hospital, Pittsburgh, Pennsylvania; Arizona Gynecology Consultants, Phoenix, Arizona; Mercy Hospital, St. Louis, Missouri; Virginia Mason Medical Center, Seattle, Washington; and Hospital Universitario "Dr. José Eleuterio González" de Universidad Autónoma de Nuevo León, Monterrey, NL, Mexico.
Obstet Gynecol. 2019 Jan;133(1):13-22. doi: 10.1097/AOG.0000000000003032.
To evaluate the 12-month safety and effectiveness of transcervical ablation for the treatment of symptomatic uterine leiomyomas.
In this prospective, multicenter, single-arm interventional trial, transcervical ablation was performed on 1-10 leiomyomas per patient with leiomyoma diameters ranging from 1 to 5 cm. Treated leiomyomas included all nonpedunculated types. Coprimary endpoints assessed at 12 months were reduction in menstrual blood loss and absence of surgical reintervention. Additional assessments included symptom severity, quality of life, patient satisfaction, reductions in uterine and leiomyoma volumes, and safety.
One hundred forty-seven patients were enrolled and treated in the United States and Mexico. The study met its coprimary endpoints at 12 months (N=143; full analysis set), because 64.8% of patients (95% CI 56.3-72.6%) experienced 50% or greater reduction in menstrual bleeding and 99.3% of patients (95% CI 95.1-99.9%) were free from surgical reintervention. The mean pictorial blood loss assessment chart score decreased by 38.9%, 48.4%, and 51.1% at 3, 6, and 12 months, respectively (P<.001), and 95.1% of patients experienced a reduction in menstrual bleeding at 12 months. There were significant mean improvements in symptom severity and health-related quality of life of 32.1 points and 43.7 points, respectively, at 12 months (all P<.001). Mean maximal leiomyoma volume reduction per patient was 62.4% (P<.001). More than half of patients returned to normal activity within 1 day, 96.3% of patients reported symptom improvement at 12 months, and 97% expressed satisfaction with the treatment at 12 months. There were no device-related adverse events.
Transcervical ablation was associated with a significant reduction in leiomyoma symptoms with no device-related adverse events and a low surgical reintervention rate through 12 months, demonstrating its potential to safely and effectively treat all nonpedunculated leiomyoma types through a uterus-conserving, incisionless approach.
ClinicalTrials.gov, NCT02228174.
Supported by Gynesonics, Inc.
评估经宫颈消融术治疗有症状子宫平滑肌瘤的 12 个月安全性和有效性。
在这项前瞻性、多中心、单臂干预性临床试验中，对每位患者的 1-10 个直径为 1-5 厘米的平滑肌瘤进行经宫颈消融术。治疗的平滑肌瘤包括所有非有蒂类型。12 个月时评估的主要终点为月经失血量减少和无手术再次干预。其他评估包括症状严重程度、生活质量、患者满意度、子宫和肌瘤体积减少以及安全性。
在美国和墨西哥共纳入并治疗了 147 名患者。该研究在 12 个月时达到了主要终点（N=143；全分析集），因为 64.8%的患者（95%CI 56.3-72.6%）经历了 50%或更大程度的月经出血减少，并且 99.3%的患者（95%CI 95.1-99.9%）无需手术再次干预。在 3、6 和 12 个月时，画片出血评估图表评分分别平均下降 38.9%、48.4%和 51.1%（P<.001），95.1%的患者在 12 个月时月经出血减少。在 12 个月时，症状严重程度和健康相关生活质量分别平均改善 32.1 点和 43.7 点（均 P<.001）。每位患者的最大肌瘤体积平均减少 62.4%（P<.001）。超过一半的患者在 1 天内恢复正常活动，96.3%的患者在 12 个月时报告症状改善，97%的患者在 12 个月时对治疗表示满意。无与器械相关的不良事件。
经宫颈消融术与肌瘤症状显著减少相关，无与器械相关的不良事件，手术再次干预率低，在 12 个月时显示出通过子宫保留、无切口的方法安全有效地治疗所有非有蒂肌瘤类型的潜力。
ClinicalTrials.gov，NCT02228174。
由 Gynesonics，Inc. 提供支持。
