Clinical and demographic profile of women diagnosed with vulvar lichen sclerosus in the region of Terres de l’Ebre: a multi-centric observational study

Abstract

Background: vulvar lichen sclerosus (VLS) is a chronic inflammatory, non-neoplastic and non- infectious vulvar dermatosis with a relapsing and evolutive course. It occurs in all ages, but

especially in post-menopausal women. Estimated prevalence is around 3%; otherwise, VLS incidence is reportedly rising. The aetiology of LS is still unknown, but data suggests a multifactorial origin including a genetic, autoimmune, hormonal, and local and systemic infectious backdrop. Symptoms include intense pruritus, pain, burning and dyspareunia. The typical lesions are white plaques and papules, often with areas of ecchymosis, excoriation and ulceration. VLS affects inter-labial sulci, labia minora, clitoral hood, clitoris, perineum and the perianal region. This cutaneous disorder can lead to destruction of the vulvar architecture, with scarring of the clitoral prepuce, resorption of the labia minora and narrowing of the introitus. Therefore, it can end up with a negative repercussion on the sexual function and quality of life of these women. In the vast majority of patients, it is a benign disease, but malignancy transformation can occur. It should be diagnosed as soon as possible, as early treatment is needed in order to prevent scarring and possible malignant change and it is essential for patients to be counselled that long-term treatment and follow-up is very important. Additional research is needed to identify the optimal potency, dosing, and duration of use. Objective: our main objective will be to determine the clinical and demographic profile of women diagnosed with vulvar lichen sclerosus (VLS) in the region of Terres de l’Ebre. Design: this is a multi-centric observational, descriptive, population and transversal study. It will be conducted in the different medical centres with gynaecological assistance in the region of Terres de l’Ebre belonging to Institut Català de la Salut (ICS), where the hospital of reference is Hospital de Tortosa Verge de la Cinta (HTVC) between March 2021 to March 2025. Participants: the study will include patients over 18 years old, clinically and pathologically diagnosed with vulvar lichen sclerosus. Methods: data will be obtained from patient’s medical records, a patients’ questionnaire and three different scores. A consecutive non-probabilistic sampling will be used to recruit the 282 patients required