Evaluation of the Efficacy of an Innovative Digital Therapeutic Medical Device, Lyv Endo, for the Management of Patients With Endometriosis

Overview

The main objective of this clinical study is to evaluate the clinical impact of using an innovative digital therapeutic device on the quality of life of patients with endometriosis. The working hypothesis is that the therapeutic digital medical device Lyv Endo may improve quality of life and reduce symptom intensity by enhancing patient engagement in the management of their condition. This justifies the need to evaluate the effect of Lyv Endo as a complement to standard medical care.

Endometriosis is a chronic, systemic, and inflammatory disease. Long considered a gynecological condition, endometriosis is now recognized as a systemic disease associated with symptoms and comorbidities that extend well beyond the reproductive system, affecting psychological well-being, social life, and professional activity. Endometriosis affects nearly 10% of women of reproductive age, corresponding to an estimated 1.5 to 2.5 million women in France. It is most commonly diagnosed in women aged 25 to 49 years, who represent 68.3% of cases, whereas women under 25 are rarely diagnosed (fewer than 4%). According to the French Haute Autorité de Santé (HAS), the prevalence of endometriosis may affect between 600,000 and 700,000 women aged 18 to 50 years in France. Endometriosis is characterized by the presence of endometrium-like tissue outside the uterus, which may lead to severe pain, particularly during menstruation, as well as infertility in approximately one-third of cases. On average, diagnosis is delayed by seven years, complicating the management of the disease. Common symptoms include severe menstrual pain (dysmenorrhea), chronic pelvic pain, deep dyspareunia, dyschezia during menstruation, cyclic urinary symptoms, and infertility. Diagnosis is primarily clinical, supported by imaging examinations such as transvaginal ultrasound and pelvic MRI to confirm the presence of lesions. In the absence of conclusive findings, empirical treatment may be initiated based on symptom relief, with a presumptive diagnosis. Laparoscopy, previously a routine diagnostic procedure, is now reserved for complex cases where imaging is inconclusive and treatments have failed. To date, there is no curative treatment for endometriosis. Current treatments are symptomatic and include hormonal therapies (progestins or combined oral contraceptives), hormonal intrauterine devices, and analgesics (e.g., tramadol, nefopam, paracetamol-codeine or paracetamol-tramadol combinations). Up to 83% of patients continue to experience persistent symptoms despite medical or surgical treatment. In cases of severe pain or infertility resistant to treatment, surgical intervention may be considered, although recurrence is possible. Given the chronic nature of the symptoms, endometriosis is a complex, multifactorial disease requiring multidisciplinary care. An integrative approach-including therapeutic education, regular physical activity, psychological support, and dietary measures-is essential to improve symptom management and patient quality of life. Supportive therapies such as physiotherapy and sophrology have shown benefits in endometriosis patients. These non-pharmacological therapies are increasingly recommended by pain specialists to address central sensitization and help raise pain thresholds, which are pathologically low in patients with chronic pelvic pain. This multimodal and multidisciplinary approach, as a complement to conventional pharmacological treatment, aligns with the HAS recommendations for managing chronic pain, which apply to endometriosis patients. However, most patients still lack access to such multidisciplinary care. This gap may be partly due to insufficient training in endometriosis among frontline healthcare professionals (e.g., general practitioners and community gynecologists), who are often unaware of the proven benefits of this type of approach and do not refer patients to relevant professionals (e.g., physiotherapists, psychologists, sex therapists). Additionally, the number of healthcare professionals specialized in endometriosis remains limited, especially in medically underserved areas. Finally, due to limited consultation time, healthcare providers may not be able to address all these aspects during routine visits. Over the past decade, the development of digital technologies and connected devices has opened new perspectives in patient care. These tools can play a crucial role by offering innovative solutions to relieve pain, enhance patient education, and foster greater autonomy in symptom self-management. In the field of endometriosis, there are currently very few digital medical devices specifically dedicated to supporting patients. The Lyv Endo device is a CE-marked Class I digital therapeutic medical device that stands out through its integrative, patient-centered approach to endometriosis management. Its innovation lies in its ability to deliver comprehensive and personalized content tailored to each patient's symptoms, addressing key limitations of traditional care (e.g., limited consultation time, low availability of trained professionals). This digital medical device offers individualized therapeutic support across five key modules: disease knowledge, mental well-being, adapted physical activity, nutrition, and sexual health. Lyv Endo is positioned at the forefront of digital medical technologies, with the goal of transforming endometriosis care. The main objective is to evaluate the clinical impact of using an innovative digital therapeutic device on the quality of life of patients with endometriosis. Secondary Objectives : * To evaluate the clinical impact of using the Lyv Endo digital therapeutic on the quality of life of patients with endometriosis * To evaluate the clinical impact on symptoms and complications associated with endometriosis * To evaluate the clinical impact on mental health * To assess the impact on lifestyle habits * To assess the organizational impact * To assess the health economic impact * To evaluate the usability of the full version of the therapeutic digital medical device