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The Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding: summary of an Agency for Health Research and Quality-sponsored randomized trial of endometrial ablation versus hysterectomy for women with heavy menstrual bleeding

Munro, Malcolm G. MD, FACOG, FRCS(c)1; Dickersin, Kay MA, PhD2; Clark, Melissa A. PhD3; Langenberg, Patricia PhD4; Scherer, Roberta W. PhD2; Frick, Kevin D. PhD5; for the Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding Group

doi: 10.1097/gme.0b013e31820786f1
Special Section: Causality, Diagnosis & Management of Abnormal Uterine Bleeding

Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding is an agency for the Healthcare Research and Quality project built around a multicenter randomized clinical trial comparing hysterectomy and endometrial ablation (EA) for the treatment of heavy menstrual bleeding unrelated to structural causes. For inclusion, women self-defined their complaint, and the endometrial cavity was evaluated to exclude structural lesions. The primary outcomes were bleeding and major problem "solved" at 24 months, with length of institutional stay, surgical complications, quality of life, and reoperation included as secondary outcomes. Also measured was the baseline economic impact of heavy menstrual bleeding. The randomized controlled trial enrolled 237 women. Institutional stay was longer, and perioperative adverse events were more common and severe for those randomized to hysterectomy. At 24 months, 94.4% and 84.9% of women randomized to hysterectomy and EA, respectively, considered their major problem to be solved; at 48 months, the numbers were similar at 98.0% and 85.1%. Postprocedure quality-of-life measures (SF-36, EuroQOL) improved similarly in both groups, but reoperation was more common for women undergoing EA (34, or 30.9%, at 60 mo), with most (32 of 34) selecting hysterectomy.

At baseline, women reported missed work as well as activity and leisure limitations. Excess monetary costs were $306 per patient-year (95% CI, $30-$1,872). Excess work and home management loss costs were $2,152 (95% CI, $1,862-$2,479). It was estimated that successful treatment, regardless of the type of intervention, could result in a gain of 1.8 quality-adjusted life years. Future studies will examine and compare the impact of the study interventions on economic outcomes.

From the 1Departments of Obstetrics and Gynecology, David Geffen School of Medicine at UCLA and Kaiser Permanente Southern California, Los Angeles Medical Center, Los Angeles, CA; 2Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; 3Departments of Community Health and Obstetrics and Gynecology, Brown University Medical School, Providence, RI; 4Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore, MD; and 5Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.

Received September 14, 2010; revised and accepted November 18, 2010.

Presented at the Premeeting Symposium: "Abnormal Uterine Bleeding: Causality, Diagnosis & Management"; October 6, 2010.

Funding/support: This work was supported by Agency for Health Research and Quality Grant R01 HS 009 506-06A1.

Financial disclosure/conflicts of interest: Malcolm G. Munro is a consultant to Boston Scientific Inc, Bayer Women's Health, Conceptus Inc, Ethicon Women's Health and Urology, and Karl Storz Endoscopy Americas. Grant support was awarded to him by Karl Storz Endoscopy Americas.

Address correspondence to: Malcolm G. Munro, MD, FACOG, FRCS(c), Department of Obstetrics and Gynecology, 4900 Sunset Boulevard, Station 3-B, Los Angeles, CA 90027. E-mail: mmunro@ucla.edu

©2011The North American Menopause Society