Abstract
Genitourinary syndrome of menopause (GSM) is a condition affecting many postmenopausal women. Among the available treatments, the vaginal natural oxygenation device (VNOD) is a new promising option. To evaluate the safety and the effectiveness of vaginal high concentration (HC) oxygen (O2) and hyaluronic acid (HA) in postmenopausal women with vaginal atrophy (VA). Study 1: Ten subjects received HA and O2 at a concentration of 21% (sham group) and ten at 95% (treatment group). All subjects completed five sessions of VNOD. Evaluations and questionnaires were completed at baseline, before each session and at one-month follow-up: Visual Analogue Scale, Vaginal Health Index (VHI), Vaginal Maturation Value (VMV), Menopause Quality Of Life (MeNQoL), Female sexual function index (FSFI) and Female sexual distress scale (FSDS). Study 2: 52 postmenopausal women with VA completed the same protocol of study 1 with HC O2 and HA. Treatment was well-tolerated. In study 1, in the treatment group we recorded significant improvements in VHI score (p-value 0.001), VMV (p-value 0.005) and in the psychosocial, physical and sexual domains of the MeNQoL compared to sham group. In study 2, all women experienced a significant improvement in VHI (p-value <0.001), FSFI total score (p-value 0.007), desire (p-value 0.004), lubrication (p-value 0.006), satisfaction (p-value 0.042), pain (p-value 0.001) domains, FSDS score (p-value 0.003) and MeNQoL sexual domain (p-value <0.001). The preliminary results of this study suggest that VNOD is a safe and effective treatment for VA in postmenopausal women, and improves sexual function.
Published Version
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