Menstrual and Dysmenorrhea Outcomes After Thermachoice III: A 2-Year Prospective Study
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Objective: The aim of this study was the evaluation of menstrual and dysmenorrhea outcomes 24 months after in office Thermachoice III endometrial ablations. Design: This was a prospective, single-arm cohort study. Materials and Methods: Patient recruitment was from November 2006 to November 2007, at the Women's Specialty Center, Dallas, TX. The Center is a community-based obstetrical and gynecologic medical clinic serving a largely lower socioeconomic patient population. Interventions included office-based diagnostic hysteroscopy, dilation and curettage, and Thermachoice III endometrial ablation under local analgesia. The primary outcome measure was menorrhagia resolution with categories of amenorrhea, hypomenorrhea, or failure. Failure was defined as subsequent menstrual flow similar to pretreatment state, need for further surgical/medical therapy, or any abnormal bleeding that was troublesome to the patient. Hemoglobin comparisons were included as an objective measure of therapy success. The secondary endpoint was impact on baseline dysmenorrhea. Statistical analysis was completed using the McNemar test for statistical significance for the primary endpoint; a paired t-test used for the secondary endpoint analysis (GraphPad Data Analysis and Biostatistics Software, La Jolla, CA, 2005). Statistical significance was set at 0.05. Results: Baseline N = 148. At 24 months, 122 (82%) patients made up the evaluable cohort. The largest resulting patient category was amenorrhea with 63% (77/122 evaluable), followed by hypomenorrhea at 33% (40/122 evaluable). Five (5) patients (4.1%) were clinical failures. Three (3) patients (2.4%) underwent subsequent hysterectomy. Dysmenorrhea reduction was statistically significant (p-value < 0.05) at 12 months and 24 months compared to baseline. Conclusions: Amenorrhea and dysmenorrhea reduction persisted 24 months after Thermachoice III ablation, with 96% of patients requiring no further therapy. Mary Ann Liebert, Inc. 2010.
