Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB)

Inclusion Criteria: Abnormal uterine bleeding in the absence of structural pathology, pharmacologic agents, IUD use, or systemic disorders of hemostasis that could explain the condition. Exclusion Criteria: Prescreen Age < 18 years Postmenopausal status (or bilateral oophorectomy) Bleeding not considered excessive by woman Desire to retain fertility Refusal to consider surgery Known myoma (from prior examination) Eligibility Screen Lack of willingness to have a gynecologic or ultrasound examination Lack of willingness to be interviewed about bleeding or consider study Pregnancy Prior endometrial resection or ablation Prior myomectomy, myolysis, or hysterectomy Medical History No tentative diagnosis of DUB History of malignancy of vagina, cervix, endometrium, or ovary History of complex endometrial hyperplasia or simple hyperplasia with atypia Current use of tamoxifen < 6 months since onset of excessive uterine bleeding < 9 months since stopping the use of IUD < 9 months since stopping the use of implantable hormone agent < 18 months since stopping use of Depo-Provera < 6 months of anovulatory DUB after reaching euthyroid status for woman with diagnosis of hypothyroidism < 3 months since pathology results indicate presence of endometrial polyp Baseline Gynecologic Examination Enlarged (>= 14 weeks gestational age) uterus Focal bleeding of genital, urinary, or gastrointestinal tract Ultrasound Examination Presence of any submucosal myoma Presence of any myoma >= 3 cm, any location Presence of > 3 myomas, any size or location Presence of endometrial polyp(s) Malignancy of the vagina, cervix, endometrium, or ovary Laboratory and Ancillary Tests FSH level in women ages > 45 years confirming postmenopausal status Abnormal urinary tract or gastrointestinal tract imaging related to uterine bleeding Evidence of cervical cancer (screened by Pap smear in last 12 months and confirmed by colposcopy) Evidence of complex endometrial hyperplasia or simple hyperplasia with atypia or endometrial cancer (endometrial biopsy in last 12 months) Any test value inconsistent with a diagnosis of DUB Any test values, unlikely to change, compromising patient safety for surgery Other Any existing medical condition, unlikely to change, putting patient at excessive risk for surgery Request for prophylactic bilateral oophorectomy by woman aged <45 years Lack of willingness to comply with study requirements Uncooperative behavior Any coexisting condition that may influence a patient's ability to comply with participation Refusal to allow evaluation or follow-up In process of scheduling surgery at time of baseline visit Provisional Eligibility Criteria Refusal of randomization < 3 months of medical management (excluding GnRH agonist therapy) within the past 2 years Ongoing evaluation or treatment for abnormal cervical cytology (including endocervical polyps) Gastrointestinal or urinary tract condition unrelated to uterine bleeding currently being treated Any temporary test value compromising patient safety Any temporary existing medical condition putting patient at excessive risk from surgery Any coexisting condition requiring surgery (except tubal occlusion for any woman or oophorectomy for women >= 45 years of age) Lack of willingness to proceed with surgery at this time Lack of willingness to proceed with surgery likely to result in infertility