LAUSR

Study Objective Determine the ability to perform a diagnostic hysteroscopic exam more than 3 years after a water vapor endometrial ablation procedure. Design Prospective, observational, multicenter, pooled analysis of the Post-Ablation Cavity Evaluation (PACE) Trial Series. Setting Office and outpatient centers in the U.S. (7) and Mexico (1). Patients or Participants 70 women who had undergone water vapor endometrial ablation a mean of 3.9 years earlier as part of the AEGEA Pivotal Clinical Trial (NCT01979861). The mean age of subjects at time of diagnostic hysteroscopy was 44 years. None of the subjects had undergone any gynecologic intervention involving the uterine cavity since their participation in the AEGEA Pivotal Clinical Trial. Interventions Diagnostic hysteroscopy. Measurements and Main Results Hysteroscopic examinations were recorded and all analyses were made by an Independent Reviewer blinded to subject history and ablation procedure results.Hysteroscopic access to the uterine cavity was achieved in 90% (63/70) of subjects. One or both cornua and ostia were visualized in 79% (50/63) of subjects with cavity access. Intracavity adhesions were absent in 75% (47/63) with only two findings of severe adhesions (3%, 2/63) of subjects with cavity access. Biopsy was projected to be feasible in 89% (62/70) and IUD placement in 60% (42/70) of all subjects. A selection bias analysis demonstrated comparability of the subjects enrolled in this study to the remaining eligible subjects who completed three-year follow-up in the Pivotal Trial. Conclusion Water vapor endometrial ablation preserved an accessible and evaluable uterine cavity and visualization of the ostia in the majority of the subjects studied with minimal findings of severe adhesions.