OBJECTIVE: This is a pilot study to evaluate the effectiveness of concomitant administration of hyaluronic acid and topical hyperbaric oxygen therapy (THOT) by a specifically designed medical device (vaginal natural oxygenation device, VNOD) in improving the symptomatology of postmenopausal patients with vulvo-vaginal atrophy (VVA).PATIENTS AND METHODS: Women with diagnosis of severe VVA from September 2017 to May 2018 were included. Five biweekly administration of THOT and concomitant of hyaluronic acid were performed with a specifically designed medical device. In each occasion, the intensity of patient's symptoms (well-being such as absence of dyspareunia, vaginal dryness, vulvar and/or vaginal itching; vaginal burning; presence of fluid) was determined with a graduated scale from 1 to 6 and the vaginal elasticity and the vaginal wall epithelium appearance were also determined with a graduated scale from 1 to 5. The change in all parameters from baseline to end of therapy was evaluated.RESULTS: Twenty-five patients were considered for the final analysis. A significant improvement in well-being (0.3 vs. 5.1, p < 0.001). vaginal burning (0.2 vs. 5.1, p < 0.001), presence of fluid (0.6 vs. 4.9, p < 0.001), vaginal epithelium appearance (1.8 vs. 4.7, p < 0.001), and vaginal elasticity (1.1 vs. 3.8, p < 0.001) was observed between the first and the last therapy session. All the patients reported a recovery of their sexuality at the end of the five treatment sessions.CONCLUSIONS: In this pilot study, the use of VNOD seems to be a valid treatment of VVA, resulting in a completely natural type of therapy well accepted by patients with immediate therapeutic effects and without side effects: these findings must be confirmed in a well-designed randomized controlled trial.

Vaginal natural oxygenation device (VNOD) for concomitant administration of hyaluronic acid and topical hyperbaric oxygen to treat vulvo-vaginal atrophy: a pilot study / Condemi, L; Di Guseppe, J; Delli Carpini, G; Garoia, F; Frega, A; Ciavattini, A. - In: EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES. - ISSN 1128-3602. - 22:23(2018), pp. 8480-8486.

Vaginal natural oxygenation device (VNOD) for concomitant administration of hyaluronic acid and topical hyperbaric oxygen to treat vulvo-vaginal atrophy: a pilot study

Di Guseppe, J;Delli Carpini, G;Ciavattini, A
2018-01-01

Abstract

OBJECTIVE: This is a pilot study to evaluate the effectiveness of concomitant administration of hyaluronic acid and topical hyperbaric oxygen therapy (THOT) by a specifically designed medical device (vaginal natural oxygenation device, VNOD) in improving the symptomatology of postmenopausal patients with vulvo-vaginal atrophy (VVA).PATIENTS AND METHODS: Women with diagnosis of severe VVA from September 2017 to May 2018 were included. Five biweekly administration of THOT and concomitant of hyaluronic acid were performed with a specifically designed medical device. In each occasion, the intensity of patient's symptoms (well-being such as absence of dyspareunia, vaginal dryness, vulvar and/or vaginal itching; vaginal burning; presence of fluid) was determined with a graduated scale from 1 to 6 and the vaginal elasticity and the vaginal wall epithelium appearance were also determined with a graduated scale from 1 to 5. The change in all parameters from baseline to end of therapy was evaluated.RESULTS: Twenty-five patients were considered for the final analysis. A significant improvement in well-being (0.3 vs. 5.1, p < 0.001). vaginal burning (0.2 vs. 5.1, p < 0.001), presence of fluid (0.6 vs. 4.9, p < 0.001), vaginal epithelium appearance (1.8 vs. 4.7, p < 0.001), and vaginal elasticity (1.1 vs. 3.8, p < 0.001) was observed between the first and the last therapy session. All the patients reported a recovery of their sexuality at the end of the five treatment sessions.CONCLUSIONS: In this pilot study, the use of VNOD seems to be a valid treatment of VVA, resulting in a completely natural type of therapy well accepted by patients with immediate therapeutic effects and without side effects: these findings must be confirmed in a well-designed randomized controlled trial.
2018
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11566/283598
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