Long-Term Bleeding Status And Hysteroscopic Cavity Access Results Following Water Vapor Endometrial Ablation for Heavy Menstrual Bleeding (HMB) In Subjects Who Have Large Cavities, Uterine Myoma and/or Intratubal Contraceptive Inserts

Abstract

Study Objective To assess long-term menstrual status and hysteroscopic uterine cavity access a mean 4 years after water vapor endometrial ablation in a subset of patients traditionally not indicated for endometrial ablation treatment. Design Prospective, multicenter, observational. Setting Eight private practice and outpatient locations in North and Central America. Patients or Participants 29 women with large uterine cavities (10-12 cm uterine cavity lengths), non-cavity obstructing myoma up to 4 cm in diameter and/or intratubal contraceptive inserts underwent water vapor endometrial ablation for HMB. Three women had both large cavities and myomas. These 29 women completed 3-year follow-up as part of the AEGEA Pivotal Clinical Trial (NCT01979861). All patients consented to a diagnostic hysteroscopy a mean 4 years from the ablation procedure. Self-reported menstrual status was captured prior to diagnostic hysteroscopy. The degree of hysteroscopic access was judged by an Independent Reviewer blinded to subject history and procedural details. Interventions Diagnostic hysteroscopy. Measurements and Main Results At a mean 4 years post ablation, 93% (27/29) of subjects reported a return to normal, light or no menstrual bleeding. Cavity access was achieved in in 90% (26/29) of subjects. Cornua / ostia were visualized in 88% (23/26) of subjects with cavity access. Conclusion Water vapor endometrial ablation provides enduring reduction in menses and permits long-term cavity access in subjects with longer cavities (up to 12cm), uterine myoma and/or intratubal contraceptive inserts, each of which has been traditionally excluded from endometrial ablation treatment.