Abstract
Objective
Compare amenorrhea rate, menstrual symptoms, patient satisfaction, and adverse events in women who underwent endometrial ablation with the NovaSure versus the Minerva radiofrequency ablation systems.
Methods
We surveyed 189 premenopausal women (mean 40.8±6.2 years old) who underwent endometrial ablation for abnormal uterine bleeding using the NovaSure (n=97) or Minerva (n=92) systems, at four private US gynecology clinics, and whose procedure date was after July 2015 with follow-up ≥3 months. Women were surveyed an average of 11.3±3.9 months (range 137–532 days) after ablation.
Results
The subject-reported amenorrhea rate was 52% higher in NovaSure subjects than Minerva subjects (64% and 42%, respectively; p=0.004). Age and bleeding cyclicity did not affect amenorrhea rate in either group. Normal-to-no bleeding was reported by >90% of subjects after either treatment. NovaSure was significantly more effective than Minerva at reducing pad/tampon use in women with any residual bleeding (2.4±5.2 items/day versus 4.7±5.5 items/day, p=0.049). NovaSure was significantly more effective than Minerva at reducing premenstrual syndrome (PMS) symptoms (p=0.019) and menstrual pain (p=0.003), and more NovaSure subjects (94%) than Minerva subjects (78%) were satisfied with clinical outcomes (p=0.003). Adverse events did not differ by treatment; three women in each group progressed to hysterectomy.
Conclusion
While overall bleeding reduction in premenopausal women with abnormal uterine bleeding was excellent with either endometrial ablation system, NovaSure treatment resulted in a higher patient-reported 1-year amenorrhea rate, and women with residual bleeding used fewer pads and tampons than Minerva-treated women. Additionally, NovaSure subjects reported better menstrual-related life quality and PMS symptom alleviation, and greater satisfaction with outcomes than Minerva-treated women.
Acknowledgments
This study was funded by Hologic Inc. The authors thank Matthew Silverman, MSci, PhD (Biomedical Publishing Solutions, Delray Beach, FL) for scientific, analytical, and editing services in preparing this manuscript, and Christine Martunas, CCRP, for rigorous data compilation, quality control, and analysis.
Disclosure
All authors were principal investigators in the current study and received compensation from Hologic for participation. Dr Scordalakes is a speaker for Shionogi & Co. Ltd., and a shareholder of The Women’s Hospital (Newburgh, IN). Dr delRosario is on the speakers’ bureau for Minerva Surgical, Inc. Dr Stankiewicz is a consultant for Ethicon and for Myriad Genetics. The authors report no other conflicts of interest in this work.