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Multicenter Observational Cohort Study on the Epidemiology of Therapeutic Strategies in Patients Affected by Adenomyosis
The primary objective of this multicenter observational cohort study is to evaluate the current medical approach to the management of adenomyosis in women, with particular focus on treatment selection and treatment persistence. The secondary objective is to identify the criteria guiding therapeutic choices in daily clinical practice within a multicenter setting. Adenomyosis is a benign gynecological condition characterized by the presence of endometrial-like epithelial and stromal tissue within the myometrium. It mainly affects women aged 41 to 45 years and typically presents with symptoms such as chronic pelvic pain, dysmenorrhea, and menorrhagia. The most commonly used treatments include GnRH agonists, progestins, and intrauterine devices (IUDs); however, there are no universally accepted guidelines for the management of this condition, and therapeutic options remain a matter of debate. This is a multicenter observational cohort study with both prospective and retrospective recruitment of women affected by adenomyosis. Italian clinical centers will be included and will recruit patients aged between 20 and 50 years, with a diagnosis of adenomyosis confirmed by ultrasound or magnetic resonance imaging (MRI) and/or histology, and presenting significant symptoms (VAS ≥ 4 for pelvic pain or bleeding \> 100 on the Pictorial Blood Assessment Chart - PBAC). Cases of concomitant endometriosis, pregnancy, and conditions preventing informed consent will be excluded. Each center will collect data regarding the prescribed treatment, its effectiveness, and treatment persistence over time. The study duration will be 12 months, with data collection at baseline (V0), 3 months (V1), 6 months (V2), and 12 months (V3). Approximately 200 patients will be enrolled across 20 centers, with an enrollment period of 12 months. The analysis will be conducted based on the frequency of treatment use and changes in treatment response in relation to age, symptoms, and other clinical factors.
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