Immediate versus delayed treatment of perimenopausal bleeding due to benign causes by balloon thermal ablation

Study Objective. To compare the effectiveness and safety of thermal balloon ablation without pretreatment with endometrium-thinning agents compared wi th delayed ablation with pretreatment for women with perimenopausal menorrh agia. Design. Prospective, randomized, controlled trial (Canadian Task Force clas sification I). Setting. Hospital-based ambulatory medical center. Patients. Thirty women age 46 to 51 years with severe enough perimenopausal menorrhagia to make them candidates for either hysterectomy or endometrial ablation. Two patients with submucosal myomas and six who had undergone ce sarean section were included. interventions. Thirteen patients were randoml y assigned to be treated within 30 days and received a single intramuscular administration of gonadotropin releasing hormone (GnRH) analog; 17 women w ere allocated to be treated within 3 days of enrollment without uterine pre paration. A thermal balloon was inserted transcervically under general anes thesia, and after inflation in the endometrial cavity with 5% dextrose in w ater, was heated to 87 degrees C for 8 minutes. Measurements and Main Results. Immediate and long-term major and minor comp lications and success rates were analyzed. Bleeding patterns and mean durat ion of menstrual flow were compared between groups at 6-month follow-up. No major intraoperative or postoperative complications occurred in either gro up, including the women who had recently undergone hysteroscopic myomectomy or had a history of cesarean section. Minor side effects were similar in b oth groups, and did not exceed 5%. Overall, at 6-month follow-up, 7 women w ere amenorrheic, 20 hypomenorrheic, and 3 eumenorrheic. No significant diff erences were noted between women treated with immediate or delayed ablation in either the distribution of bleeding patterns or days of flow per cycle (mean +/- SEM 1.8 +/- 0.42 vs 2.1 +/- 0.75 days, respectively). Conclusion. This pilot study suggests that prompt treatment of perimenopaus al menorrhagia with thermal balloon endometrial ablation is as effective an d sale as deferred therapy combined with GnRH analog as an endometrium-thin ning agent. In light of our results, the theory that previous cesarean sect ion and presence of small submucosal myomas constitute relative contraindic ations for the procedure merits further consideration.