The overall objective of the Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding Follow-up Study (STOP-DUB/FS) is to assess the long-term effectiveness of hysterectomy versus endometrial ablation (EA) in women with dysfunctional uterine bleeding (DUB). The primary outcomes of STOP-DUB/FS are bleeding, pain, fatigue, and whether the problem that led the women to seek care is solved at 4 years post-surgery. Additional outcomes include health related quality of life, sexual function, urinary incontinence, adverse events, re-operation rate and costs. STOP-DUB will continue to involve Clinical Centers in the US and Canada, as well as the American College of Obstetricians and Gynecologists. STOP-DUB is the only US-based randomized clinical trial that compares surgical alternatives to hysterectomy for patient-based outcomes and costs associated with treatment. STOP-DUB was funded in 1996 under a Request For Applications that proposed patient follow-up for 2 years. Extension of STOP-DUB follow-up to at least 4 years is essential to confirm recent results from a UK randomized trial. The UK trial found that while hysterectomy and EA both result in similar short term patient satisfaction, EA is associated with re-operation rates of nearly 40 percent by 4 years post-surgery. Thus, EA may not be a cost effective alternative. STOP-DUB randomized and collected baseline data on 237 patients recruited at 25 Clinical Centers. As of June 7, 2002, 213/237 (90 percent) patients re-consented to extended follow-up, 206/213 (97 percent) remain enrolled, and the median length of follow-up is 24 months. By 1 year post-surgery, 16.5 percent of STOP-DUB randomized patients who received EA had reported additional surgery for DUB. This re-operation rate is considerably less than that of 29 percent rate at 1 year post-surgery reported by the UK trial. Data collected in STOP-DUB/FS will involve telephone interviews every 6 months and notification by Clinical Centers of re-operation, intercurrent visits, and adverse events. Hospital bills will continue to be requested and abstracted every 6 months. Our efforts in all years will focus on patient follow-up, data processing and analysis, and publication.
| Munro, Malcolm G; Dickersin, Kay; Clark, Melissa A et al. (2011) 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. Menopause 18:445-52 |
| Frick, Kevin D; Clark, Melissa A; Steinwachs, Donald M et al. (2009) Financial and quality-of-life burden of dysfunctional uterine bleeding among women agreeing to obtain surgical treatment. Womens Health Issues 19:70-8 |
