Three-Year Prospective Menstrual and Dysmenorrhea Outcomes after ThermachoiceIII (R) in-Office Therapy

Objective: The purpose of this study was the evaluation of menstrual and dysmenorrhea outcomes 36 months after in-office ThermachoiceIII (R) endometrial ablations. Design: The study was a prospective, single-arm cohort study. Methods: Patient recruitment was from November 2006 to November 2007, at Women's Specialty Center Dallas, a community-based obstetric and gynecologic clinic serving a predominately lower socioeconomic population. Intervention included simultaneous office-based diagnostic hysteroscopy, dilation and curettage, and ThermachoiceIII endometrial ablation with the patient 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 troublesome to the patient. Hemoglobin comparisons were included as an objective outcomes measure. The secondary endpoint was impact on pre-existing dysmenorrhea. Statistical analysis was completed via McNemar test for statistical significance for the primary endpoint; 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: The baseline number of patients was 148. At 36 months, 120 (81%) patients made up the evaluable cohort. Menstrual patterns were: amenorrhea 58% (69/120 evaluable), followed by hypomenorrhea 31% (37/120 evaluable). Eight patients (6.7%) were considered clinical failures, of whom six (5%) underwent subsequent hysterectomy. Dysmenorrhea reduction remained significant (p value < 0.05) at 36 months compared with baseline. Conclusions: Amenorrhea and dysmenorrhea reduction persisted 36 months after ThermachoiceIII ablation; 93% of the evaluable cohort required no further therapy.