Post-Ablation Cavity Evaluation: A Prospective Multicenter Observational Clinical Study to Evaluate Hysteroscopic Access to the Uterine Cavity 4 Years After Water Vapor Endometrial Ablation for the Treatment of Heavy Menstrual Bleeding

ABSTRACT Study Objective Patients who have undergone endometrial ablation may present a diagnostic challenge when they subsequently develop vaginal bleeding, pelvic pain, or postmenopausal bleeding. Extensive scarring of the uterine cavity often precludes evaluation and/or conservative treatment. For further research on this topic, we performed hysteroscopic examination in study subjects mean duration 4 years after had water vapor ablation. Design Prospective, multicenter, observational clinical study. Setting Eight private practice outpatient sites United States and Mexico. Seventy completed their 36-month follow-up AEGEA Pivotal Trial. Interventions Diagnostic hysteroscopy. Measurements Main Results The were screened for general health infection underwent Menstrual bleeding status was recorded. video analyzed by an independent reviewer, assessed access visualization cornua tubal ostia as well characterized adhesions basis criteria March et al. An reviewer also subjectively whether Pipelle biopsy intrauterine device placement would be feasible. Uterine achieved 90% (63/70) subjects. Among with access, visualized 79% (50/63) absent 75% (47/63), only 2 women having severe (3%, 2/63). Biopsy projected to feasible 86% (62/70) 60% (42/70) all subjects’ statuses not correlated access. results consistent large cavities International Federation Gynecologic Obstetrics type II VI myomas ≤4 cm. Conclusion Water preserved accessible most subjects, minimal incidence adhesions, procedure.