Uterine fibroids (UF) are the most common benign pelvic tumors among women in the United States.1,2 The prevalence of UF increases with age until menopause, with >60% of cases occurring in women aged 30–44 years.3,4 Although UF can be asymptomatic, ∼25% of women are symptomatic,2 with heavy menstrual bleeding (HMB) being the most frequently reported symptom.5–8 Although HMB commonly drives the need for treatment in patients with UF, it is not the only factor; other symptoms, such as pain and fatigue, can severely impair multiple aspects of women’s health-related quality of life and lead patients to seek medical attention.3,8,9
No clear consensus currently exists regarding appropriate treatment protocols for patients with symptomatic UF,10 although it is acknowledged that shared decision-making should be used in treatment selection, and that quality of life should be a central consideration.11 Recently published guidelines from the American College of Obstetricians and Gynecologists (ACOG) regarding the management of symptomatic UF suggest that treatment decisions should be guided by individual patient symptoms and long- and short-term treatment goals.12 However, very few drugs are indicated for UF,13–16 and only limited evidence is available for many commonly used pharmacologic options.17 Medical treatments used for UF or its symptoms include nonsteroidal anti-inflammatory drugs, tranexamic acid, hormonal therapy, aromatase inhibitors, gonadotropin-releasing hormone (GnRH) analogs, and progesterone modulators.7 These typically provide only short-term symptom control, and the long-term use of some of these drugs can lead to adverse effects such as reduced bone density or dyslipidemia.12
Inpatient and outpatient surgical options include hysterectomy, myomectomy, uterine artery embolization, and endometrial ablation. These treatments are effective but may lead to complications and may not preserve fertility or the uterus.18,19 Based on a 2020 retrospective database analysis, hysterectomy was the most common surgery in the United States for symptomatic UF management between 2010 and 2015, accounting for 68%–76% of initial UF-related surgeries.18
The 2012 multinational Uterine Bleeding and Pain Women’s Research Study surveyed reproductive-aged women with and without UF (n = 1,533 and n = 20,213, respectively) and found that women with UF consistently experienced a significantly higher frequency and severity of pain symptoms than women without UF.8 Although most women with symptomatic UF choose nonsurgical first-line management,10 current evidence indicates that medical therapy use is limited in the year following UF diagnosis.18,20 There is a need to better understand the real-world clinical characteristics and treatment patterns of women with UF who are symptomatic due to HMB or for other reasons, such as pain.
The objective of this retrospective database analysis was to describe the clinical characteristics and treatment patterns (hormonal therapy, pain management, and surgery) of US women with medical claims for UF who did and did not have medical claims for HMB (UF-HMB and UF-only, respectively). The deidentified records of these women were followed for a minimum of 2 years after their index diagnosis of UF. Patients were identified at incident diagnosis and followed for a minimum of 2 years after their index claim.