Surgical treatments outcomes project for dysfunctional uterine bleeding (STOP-DUB): Design and methods

The Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB) was a multicenter, randomized clinical trial that assessed the efficacy and effectiveness of hysterectomy versus endometrial ablation (EA) for dysfunctional uterine bleeding (DUB) in women for whom medical management has not provided relief. Resource centers included a coordinating center, a chair's office, the American College of Obstetricians and Gynecologists, the Agency for Healthcare Research and Quality Project Office and 33 clinical centers in the United States and Canada. STOP-DUB enrolled: (1) eligible patients for whom medical treatment had not been successful and who were randomized to either hysterectomy or EA and (2) an observational cohort of patients who were "provisionally ineligible" or who were eligible but did not wish to be randomized. Enrollment began in October 1997 and ended in June 2001. The primary outcome addressed by the randomized trial was the impact of surgery on bleeding, pain, fatigue, and the major problem (symptom) that led the woman to seek treatment for her condition, measured 1 year following surgery. Additional outcomes included the impact of surgery at time points after 1 year; changes in quality of life, activity limitation, sexual functioning, and urinary incontinence; surgical complications; additional surgery; and resource utilization. The costs and the relative cost-effectiveness of the two surgeries were calculated. The main scientific objective for the observational study was to examine changes over time in terms of treatment selected, DUB-related symptoms, and quality of life.