New medical device containing verbascoside, carrageenan and glycerophosphoinositol for the treatment of dyspareunia in reproductive age women. A prospective observational study

Introduction: Dyspareunia, especially in reproductive age, often has a negative impact on women's sexual life, with great psychological impact. Our aim was to assess the effect of a device containing verbascoside, glycerophosphoinositol (GPI), hyaluronic acid sodium salt (HANa) and carrageenan (CG) for the treatment of idiopathic dyspareunia and its impact on sexual function in reproductive age women. Methods: We recruited 43 sexually active women of reproductive age who had been suffering from superficial idiopathic dyspareunia in the last 6 months. The therapy with a device containing verbascoside, GPI, HANa and CG was applied in the vulvar and vaginal area twice a day for 12 weeks. Quality of Life (QoL) and the sexual function were assessed with Female Sexual Function Index (FSFI) and Female Sexual Distress Scale (FSDS) questionnaires before and after 12 weeks of treatment. Results: After treatment, the mean FSFI total score was 27.87 ± 1.86, significantly higher than before treatment (p < 0.0001). Improvement in distress about sex life was shown after treatment. The mean FSDS total score decreased significantly after 12 weeks (p < 0.0001). A reduction in dyspareunia measured with a VAS scale was observed. Conclusions: Local application of a combination of verbascoside, GPI, HANa and CG effectively reduced dyspareunia and pain without any important adverse effects.