ABSTRACT
Background and Objectives: Vulvovaginal atrophy (VVA) is a condition that affects a large number of women and can significantly impact their quality of life. While several treatments are currently available for VVA, there are potential risks associated with their use. Non-hormonal medical devices have been developed to treat VVA, offering a potential alternative to traditional hormone-based therapies. This study aimed to evaluate the safety and efficacy of the combined treatment with two medical devices, Plurigin Ovules and Plurigin Solution, used as an adjuvant in the treatment of VVA. Materials and Methods: This is a retrospective, observational study. Data were collected from medical records of all patients who received the combination treatment of both medical devices as part of normal clinical practice for the treatment of VVA. The performance of the medical devices was analyzed using the THIN Prep. A comprehensive physical examination and gynecological evaluation were conducted before the initiation of treatment (day 0), as well as at follow-up 1 (day 90), follow-up 2 (day 180), and follow-up 3 (day 270). Data analysis included descriptive analysis and statistical tests. Results: The study included 76 women (mean age: 59 years). At follow-up 3, 61% of the respondents demonstrated improved THIN Prep results and symptom resolution (p < 0.001; CI [0.5003, 0.7197]). Moreover, the percentage of patients reporting dyspareunia, burning, and irritation decreased over the course of the study, with the majority of patients reporting no symptoms at follow-up 3. Conclusions: The use of Plurigin Ovules plus Plurigin Solution may be an effective treatment option for VVA, improving vaginal health, alleviating symptoms, and improving sexual function, leading to improved quality of life for women suffering from this condition. However, the study has limitations, such as its retrospective nature, and further studies are needed to confirm the efficacy and safety of these devices.