D A Grainger1, B L Tjaden, C Rowland, W R Meyer. 1. Division of Reproductive Endocrinology, University of Kansas School of Medicine Wichita, 2903 East Central, Wichita, KS 67214, USA.
Abstract
STUDY OBJECTIVE: To evaluate 2-year follow-up results in patients participating in a randomized, clinical trial comparing uterine balloon therapy with rollerball endometrial ablation. STUDY DESIGN: Prospective, randomized, clinical trial (Canadian Task Force classification I). SETTING:Fourteen university-affiliated and private practice sites. PATIENTS: Two hundred fifty-five women with menorrhagia. INTERVENTIONS: Patients were randomized to rollerball or uterine balloon endometrial ablation. MEASUREMENTS AND MAIN RESULTS:Patient satisfaction with both treatments was consistently high. Only 15 hysterectomies had been performed (6 for menorrhagia) at the end of 2 years, 11 in the rollerball group, 4 in the balloon therapy group. CONCLUSION: Endometrial ablation by both procedures was highly successful in avoiding hysterectomy and relieving symptoms of menorrhagia. Additional benefits were reduction in dysmenorrhea and premenstrual syndrome.
RCT Entities:
STUDY OBJECTIVE: To evaluate 2-year follow-up results in patients participating in a randomized, clinical trial comparing uterine balloon therapy with rollerball endometrial ablation. STUDY DESIGN: Prospective, randomized, clinical trial (Canadian Task Force classification I). SETTING: Fourteen university-affiliated and private practice sites. PATIENTS: Two hundred fifty-five women with menorrhagia. INTERVENTIONS:Patients were randomized to rollerball or uterine balloon endometrial ablation. MEASUREMENTS AND MAIN RESULTS:Patient satisfaction with both treatments was consistently high. Only 15 hysterectomies had been performed (6 for menorrhagia) at the end of 2 years, 11 in the rollerball group, 4 in the balloon therapy group. CONCLUSION: Endometrial ablation by both procedures was highly successful in avoiding hysterectomy and relieving symptoms of menorrhagia. Additional benefits were reduction in dysmenorrhea and premenstrual syndrome.