Medical Devices: Evidence and Research (Dec 2020)
First Use of Thermal Stabilized Hyaluronic Acid Injection in One-Year Follow-Up Patients with Genitourinary Syndrome
Abstract
Elisabetta Garavaglia,1 Cinzia Sala,2 Manuela Busato,1 Gilberto Bellia,3 Nadia Tamburlin,1 Alberto Massirone1 1Agorà, Italian Scientific Society of Aesthetic Medicine, Milan, Italy; 2Private Practice, Milan, Italy; 3Medical Affair, IBSA Farmaceutici, Italia Srl, Lodi, ItalyCorrespondence: Elisabetta GaravagliaAgorà, Italian Scientific Society of Aesthetic Medicine, Piazza Caiazzo 1, Milan 20124, ItalyTel +39 3382731072Email [email protected]: Evaluation of the impact of hyaluronan hybrid cooperative complex (HCC) injections in premenopausal and postmenopausal Italian women affected by vulvar-vaginal atrophy (VVA), one of the symptoms of genitourinary syndrome (GS), on self-reported quality-of-life, vaginal symptoms, and sexual activity, as well as treatment side-effects.Methods: We surveyed a sample of 26 women affected by VVA with follow-up at 6 and 12 months. Deep intradermal injections of HCC were delivered at 1-month intervals. Evaluation of the treatment impacting the VVA patients was assessed by three international validated questionnaires (Visual Analogic Scale, VAS; health-related quality-of-life test, SF12; Female Sexual Function Index, FSFI). The statistically significant differences between pre- and after-treatment responses have been assessed by Wilcoxon signed-rank test and repeated measures ANOVA test.Results: At 6– 12-month follow-up, general quality-of-life (SF12) did not show any significant improvement. On the contrary, VVA patients showed significant improvements of genital symptoms (VAS) and sexual function (FSFI). Global FSFI score increased by 58% and evidenced important satisfaction (P≤ 0.05).Conclusion: Vestibular HCC injection is an office, safe, fast, not expensive, and reproducible procedure effective in vulvar-vaginal atrophy. This study can be used as a pilot for future trials.Keywords: hyaluronic acid, bio-stimulation, vulvovaginal atrophy, genito-urinary syndrome of menopause, hyaluronic acids injection, menopause, hyaluronan hybrid cooperative complexes
