HYSTERECTOMY AND DYSFUNCTIONAL UTERINE BLEEDING

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DESCRIPTION: This study is a randomized clinical trial which will compare patient outcomes and relative costs of hysterectomy, endometrial ablation, and gonadotropin releasing hormone (GnRH) agonist therapy (3 months GnRH followed by oral contraceptives for 21 months) for women presenting with refractory dysfunctional uterine bleeding. The project will study 125 women in each of three trial arms. Subjects will be chosen from the clinic populations which presently use one of three clinical sites and/or referrals from the HMO and private practitioners. Study sites are the clinical centers at Minneapolis HealthPartners, University of Illinois, and Henry Ford Health System. Subject inclusion criteria are those with diagnosed dysfunctional uterine bleeding who are: premenopausal and have completed childbearing, and have failed prior attempts with oral contraceptives, progestins, or non-steroidal anti-inflammatory agents. The exclusion criteria are: contraindication to hysterectomy such as coexistent condition likely to cause similar symptoms (e.g., endometriosis, pelvic inflammatory disease, endometrial polyps, leiomyomata uteri, or presence of a significant medical problem such as severe coronary heart or chronic obstructive pulmonary disease, multiple prior abdominal surgeries with complications); contraindication to GnRH agonist, estrogen, or progestin therapy (e.g., severe preexistent osteoporosis, prior thromboembolism, chronic liver disease); smoking over 10 cigarettes per day; documented coronary artery disease; contraindication to endometrial ablation such as severe cervical stenosis, endometrial hyperplasia with atypia or neoplasia on endometrial biopsy; or likely inability to follow the study protocol for two years. Subjects will be randomized and stratified by clinical center and by age (less than 45 years, 45 years or older). To increase the likelihood that the intervention groups will be comparable on the characteristics in the protocol, stratification on physician will also be considered. The study duration is 5 years -- including 9 months for planning, training, and implementation; 18 months for recruitment; 24 months for follow-up beyond the end of recruitment; and 9 months for data analysis and manuscript preparation. Data collection and subject follow-up will occur at three-month intervals after initiation of treatment, according to the assigned arm. There will be an interval medical and brief physical examination (blood pressure, pulse, breast, abdominal, and pelvic examination), in addition to laboratory tests at 12 and 24 months. Information on health status outcomes, specific patient outcomes which concern women who have dysfunctional uterine bleeding, and costs to both the health system and the patient will be collected. Outcomes to be evaluated will include functional status and health-related quality of life, sexual function, morbidity/side effects, and cost. An additional important aim of the project is to detail clinical outcomes, including frequency and duration of symptoms, side effects, and rate of failure of GnRH agonist followed by long-term oral contraceptive therapy.