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Abstract

Study ObjectiveTo evaluate the safety and effectiveness of microwave endometrial ablation (MEA) in women with excessive menstrual bleeding.DesignA multi-center, prospective analysis of 318 subjects is underway with a 2:1 ratio of treatment (MEA) versus control, rollerball endometrial ablation (REA) with evaluation at 3, 6, 12, 24, and 36 months.SettingEight study sites consisting of private practice and academic centers.PatientsInclusion criteria were pre-menopausal women, 30 years or greater, with documented menorrhagia and pictorial blood loss assessment chart (PBLAC) score of 185 or higher, with uterine cavity size between 6–14 cm, and an absence of endometrial pathology. These women failed, were unable to tolerate, or refused medical therapy. Submucosal myomas were included unless they were greater than 3 cm in diameter or obstructed access to the endometrial cavity based on pre-operative diagnosis. Pre-treatment with GnRH was used for all subjects. Anesthesia included local, local combined with IV sedation, or general.InterventionMEA or REA based on randomization assignment.Measurements and Main Results64% MEA and 56% REA subjects are amenorrheic, with a preliminary analysis at 36 months post-op. Satisfaction rates are 95% and 90% respectively for MEA and REA. The clinical outcomes have been maintained across the 3 years and will be presented based on age, cavity size, and presence of fibroids.ConclusionMicrowave endometrial ablation is an effective, simple, safe, and rapid treatment for excessive menstrual bleeding, offering continued high amenorrhea rates 3 years after ablation. Study ObjectiveTo evaluate the safety and effectiveness of microwave endometrial ablation (MEA) in women with excessive menstrual bleeding. To evaluate the safety and effectiveness of microwave endometrial ablation (MEA) in women with excessive menstrual bleeding. DesignA multi-center, prospective analysis of 318 subjects is underway with a 2:1 ratio of treatment (MEA) versus control, rollerball endometrial ablation (REA) with evaluation at 3, 6, 12, 24, and 36 months. A multi-center, prospective analysis of 318 subjects is underway with a 2:1 ratio of treatment (MEA) versus control, rollerball endometrial ablation (REA) with evaluation at 3, 6, 12, 24, and 36 months. SettingEight study sites consisting of private practice and academic centers. Eight study sites consisting of private practice and academic centers. PatientsInclusion criteria were pre-menopausal women, 30 years or greater, with documented menorrhagia and pictorial blood loss assessment chart (PBLAC) score of 185 or higher, with uterine cavity size between 6–14 cm, and an absence of endometrial pathology. These women failed, were unable to tolerate, or refused medical therapy. Submucosal myomas were included unless they were greater than 3 cm in diameter or obstructed access to the endometrial cavity based on pre-operative diagnosis. Pre-treatment with GnRH was used for all subjects. Anesthesia included local, local combined with IV sedation, or general. Inclusion criteria were pre-menopausal women, 30 years or greater, with documented menorrhagia and pictorial blood loss assessment chart (PBLAC) score of 185 or higher, with uterine cavity size between 6–14 cm, and an absence of endometrial pathology. These women failed, were unable to tolerate, or refused medical therapy. Submucosal myomas were included unless they were greater than 3 cm in diameter or obstructed access to the endometrial cavity based on pre-operative diagnosis. Pre-treatment with GnRH was used for all subjects. Anesthesia included local, local combined with IV sedation, or general. InterventionMEA or REA based on randomization assignment. MEA or REA based on randomization assignment. Measurements and Main Results64% MEA and 56% REA subjects are amenorrheic, with a preliminary analysis at 36 months post-op. Satisfaction rates are 95% and 90% respectively for MEA and REA. The clinical outcomes have been maintained across the 3 years and will be presented based on age, cavity size, and presence of fibroids. 64% MEA and 56% REA subjects are amenorrheic, with a preliminary analysis at 36 months post-op. Satisfaction rates are 95% and 90% respectively for MEA and REA. The clinical outcomes have been maintained across the 3 years and will be presented based on age, cavity size, and presence of fibroids. ConclusionMicrowave endometrial ablation is an effective, simple, safe, and rapid treatment for excessive menstrual bleeding, offering continued high amenorrhea rates 3 years after ablation. Microwave endometrial ablation is an effective, simple, safe, and rapid treatment for excessive menstrual bleeding, offering continued high amenorrhea rates 3 years after ablation.