Dysfunctional uterine bleeding (DUB) refers to bleeding that is both irregular in cycle and increased in volume affecting women of reproductive age. Consequences of DUB include discomfort, fatigue, limitation of activity, impaired sexual function, depression, and anemia. Estimates of prevalence for menorrhagia range from 9-20% of women, and metrorrhagia occurs in 53 women per 1,000. The underlying etiology of DUB can be divided into two groups, including those with anovulatory bleeding and those with idiopathic ovulatory DUB. In many cases, it is not possible to determine the etiology. Current treatment of DUB generally begins with diagnostic evaluation to rule out other causes of bleeding (e.g., pregnancy, fibroids, neoplasm) followed by medical treatment using either hormonal or non-hormonal medications. If symptoms persist, surgery is often recommended. The traditional surgical approach for treatment of DUB refractory to medical treatment is hysterectomy, accounting for up to 40% of the 590,000 hysterectomies performed annually in the U.S. Bleeding problems are solved by hysterectomy in 98.2% of cases, but postoperative morbidity and complications are common (43% total, 9.6% moderately severe, and 0.6% severe). The cost of hysterectomies is estimated to exceed $5 billion annually. Hysteroscopic endometrial ablation is a minimally invasive technique designed to stop DUB without resorting to hysterectomy. Bleeding problems are reduced or solved in 90% of cases, but 23% may experience deterioration over time requiring repeat treatment. Surgical complications occur following 1-2% of these procedures. The cost per procedure is lower than for hysterectomy. Very little prospectively acquired data are available to compare the efficacy, safety, and costs of hysterectomy versus endometrial ablation. The primary aim of this study is to compare effectiveness of hysterectomy and endometrial ablation for treatment of DUB. The primary measure of success is resolution of bleeding problems as reported by patient questionnaires. Secondary measures of outcome include quality of life (QOL) issues. In addition, this study is designed to describe the natural history and demographics of DUB in a population of women who do not undergo surgery. Finally, a pilot cost analysis is planned to compare both direct treatment-related costs of surgery and indirect costs as related to recovery and productivity of the patient. The application proposes a prospective, randomized, non-blinded, multi-institution study. Twenty participating institutions were chosen to represent diverse geographic distribution and patient demographics, as well as both academic and community health care centers. Eligible patients include premenopausal women aged r 18 with DUB of r 6 months duration, who have not responded to r 3 months of medical therapy. Patients must be willing and able to give consent and have no further reproductive desires. If r 40 years old, the patient must have an endometrial biopsy within 12 months showing no hyperplasia or neoplasia, and if r 45 years old, she must have a serum FSH to rule out menopause. Exclusion criteria include a large or irregular uterus, focal bleeding from other sites, past or present gynecologic malignancy, pregnancy hemoglobin r 7g/dL, coagulopathy, prior endometrial ablation or hysterectomy. Patients presenting with DUB will be asked for informed consent to undergo a baseline examination and screening for the protocol. The baseline exam will include physical exam and either ultrasound or hysteroscopic evaluation of the endometrium. A log of patients refusing consent will be maintained for comparison with those who proceed with the study. Eligible patients will be interviewed. Patients who choose to proceed will be randomized to undergo either hysterectomy or endometrial ablation. Clinic follow up visits are scheduled for 1 and 6 weeks after surgery, after which hospital and clinic records, operative notes, and pathology reports will be abstracted. Telephone interviews of patients are scheduled for 3, 6, 12, 18, and 24 months after surgery, at which time a standardized questionnaire evaluating recovery, resolution of bleeding, performance status, sexual function, quality of life, and psychological functioning will be administered. The instruments used in the questionnaires have been previously validated by the investigators in published studies with the exception of standardized quality of life and psychological mood instruments which are in widespread use. Patients who are not eligible for randomization or who elect medical treatment will be followed using the same questionnaires to provide information about the natural history of DUB. If a patient in the medical group later becomes eligible for randomization, she will be allowed to do so. Patients electing to undergo surgery without randomization will be monitored only for demographic data but not for outcomes data. The primary statistical endpoint is to test the equivalence of hysterectomy and endometrial ablation. Pilot data from the Maryland Women's Health Study and citation of 6 small prospective studies of endometrial ablation provide standard deviations on primary outcome, side effects, and complications allowing calculation of sample size. Using a 4-point outcome scale on the questionnaire, a desired alpha error of 0.01 (two sided test) and power of 0.95 could be obtained if 400 patients are randomized to each treatment arm. In addition, 300 patients in the medical treatment arm and 200 patients in the non-randomized surgical arm will be followed for comparison data. A pilot project to evaluate direct and indirect cost of the two treatment methods is planned but is, as yet, undefined. The instruments and evaluations for this portion of the study are scheduled to be evaluated in Phase I of the project. Evaluation of costs for all patients may or may not be evaluable or within budget for this project, according to the research plan.
|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|