A pilot study of soft gel technology: a new vaginal device to improve the symptomatology of vulvovaginal atrophy in post-partum, menopause and in patients with recurrent vulvovaginitis.

Abstract

This is a pilot study to evaluate the effectiveness of the treatment with Vaginal Soft gels technology in the improvement of common signs and symptoms in postmenopausal, postpartum and with recurrent vulvovaginitis patients. These conditions may cause the onset of Vulvovaginal Atrophy (VVA) with effects on sexual activity, self-confidence and daily activities. The main symptoms are itching, irritation and dryness. Many therapies have been evaluated and almost all those without hormonal component have shown poor results. Women diagnosed with severe VVA from January to September 2018 were recruited. The study groups were composed of 25 postmenopausal women, 30 post-partum women and 30 women with recurrent vulvovaginitis. For each group, patients were randomized 1:1 among those who carried out the experimental treatment and those that did not perform it. The efficacy of treatment was evaluated with a clinical visit in which Vaginal Health Index (VHI) was estimated. The symptomatology was determined through the questionnaire Female Sexual Function Index (FSFI). A significant improvement has been shown with regard to the sexual function (orgasm, lubrification, pain) in patients who performed the treatment. A significant increase in VHI has been evaluated in postmenopausal patients (4 months p=0.054, 6 months p=0.005) and in recurrent vulvovaginitis but not in post-partum patients (4 months p=0.681, 6 months p=0.109). An improvement of lubrication, satisfaction, orgasm, pain, as well as dyspareunia, was observed in the three study groups. In this pilot study the treatment with soft gels seems to be effective in improving sexual health and atrophy being a treatment available for all types of patients thanks to the absence of systemic and local side effects. It is an excellent alternative especially for patients who cannot use hormones. These findings must be confirmed by larger and randomized further studies.