https://orcid.org/0000-0003-3437-0723
Abstract
Study Objective
To report 36-month follow-up of a pivotal trial that evaluated the safety and effectiveness of the AEGEA Water Vapor System for the treatment of heavy menstrual bleeding (HMB) secondary to Abnormal Uterine Bleeding due to Endometrial disorders or Leiomyomata (AUB-E and AUB-L).
Methods
A prospective, multicenter, single-arm clinical trial at 14 sites in the US, Canada, Mexico, and the Netherlands. Inclusion criteria included a Pictorial Blood Loss Assessment (PBLAC, Higham) score ≥150 and allowed treatment of subjects with leiomyomata classified by the International Federation of Gynecology and Obstetrics (FIGO) Types 2–6 up to 4 cm in diameter, a uterine cavity up to 12 cm in length (uterine sound), Essure® contraceptive inserts and/or prior cesarean section. Follow-up assessments were conducted annually up to 36 months after endometrial ablation. The following outcomes were evaluated for 125/155 women: gynecological adverse events, qualitative assessment of menstrual flow, quality of life using the Menorrhagia Impact Questionnaire (MIQ), patient satisfaction, and medical or surgical reintervention for AUB.
Results
One hundred and fifty-five premenopausal women aged 30 to 50 years were enrolled from September 2014 through May 2015. Water vapor endometrial ablation was performed under varying anesthesia/sedation regimens in offices, surgical centers and operating rooms. There were 6 procedure-related adverse events that occurred between 12- and 36-month follow-up, 1 of which was deemed serious (hematometra managed successfully hysteroscopically). Seventy-two percent reported amenorrhea or light menstrual flow. The mean quality of life (MIQ) score improved from 14.7 at baseline to 6.4. Ninety-three percent reported “Satisfied” or “Very Satisfied.” Post-ablation hysterectomy for any indication was performed in 6.5% of patients, and the total rate of re-intervention for bleeding was 7.1%.
Conclusion
Outcomes 36-months after water vapor endometrial ablation for HMB are consistent with 12- and 24-month follow-up results in all subgroups evaluated. The AEGEA Water Vapor System increases the population of patients amenable to efficacious and acceptable treatment of Heavy Menstrual Bleeding (HMB) due to Abnormal Uterine Bleeding (AUB-E,-L). CinicalTrials.gov NCT01979861 registered November 8, 2013.
Keywords:
Data Sharing Statement
Will individual participant data be available (including data dictionaries)? NO. What data in particular will be shared? N/A. What other documents will be available? N/A. When will data be available (start and end dates)? N/A. By what access criteria will data be shared (including with whom, for what types of analyses, and by what mechanism)? N/A.
Acknowledgments
The AEGEA Investigator Group Jeffrey Baker M.D., Clinical Research Prime, Idaho Falls, ID. Cindy Basinski M.D., CMB Research, Newburgh, IN. Jose G Garza-Leal M.D., Hospital Universitario Dr. Jose E Gonzalez Universidad Autónoma de Nuevo León, Monterrey, MX. Seth Herbst M.D., Institute for Women’s Health and Body, Wellington, FL. D. Alan Johns M.D., Baylor, Scott and White Research Institute Fort Worth, TX. Mark Levie, M.D., Montefiore Medical Center, Bronx, NY. David Levine M.D., Mercy Hospital, St. Louis, MO. Andrea Lukes M.D. Carolina Women’s Research and Wellness, Durham, NC. Charles Miller M.D., The Advanced Gynecologic Surgery Inst., Naperville, IL. James Presthus M.D., Fairview Center for Women, Edina, MN. Christopher Walker M.D., Clinical Associates of Orlando, Orlando, FL. Hugo van Eijndhoven, M.D. Isala Hospital, Zwolle, The Netherlands. Kirk Brody M.D., Chattanooga Medical Research LLC, Chattanooga, TN. Statistician Peter Shabe Advance Research Associates, 2350 Mission College Boulevard, Suite 825, Santa Clara, CA 95054. Portions of this manuscript were presented at the 47th AAGL Global Conference In Las Vegas, NV in November 11–15, 2018.
Disclosures
The authors received research-related support for the conduct of this study. Dr. Harris is Medical Director of AEGEA Medical. Dr Harris reports being a clinical trial investigator for Sebela Pharmaceuticals, Medicines360, Bayer, Inovio Pharmaceuticals, and Myovant, outside the submitted work. Dr Nicholas Leyland reports a research grant from and advisory board and speaker’s bureau for AbbVie, outside the submitted work. The authors report no other potential conflicts of interest for this work.