Sage Journals: Discover world-class research

Abstract

Background

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.

Aim

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).

Methods

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.

Results

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).

Conclusion

The preliminary results of this study suggest that VNOD is a safe and effective treatment for VA in postmenopausal women, and improves sexual function.

Keywords

VNOD vaginal atrophy female sexual function vaginal health index hyaluronic acid oxygen

Get full access to this article

View all access options for this article.

References

Portman

Gass

MLS

on behalf of the Vulvovaginal Atrophy Terminology Consensus Conference Panel . Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the international society for the study of women’s sexual health and the North American menopause society. Climacteric 2014; 17: 557–563.

Mili

Paschou

Armeni

, et al. Genitourinary syndrome of menopause: a systematic review on prevalence and treatment. Menopause 2021; 28: 706–716.

Palacios

Nappi

Bruyniks

, et al. The European vulvovaginal epidemiological survey (EVES): prevalence, symptoms and impact of vulvovaginal atrophy of menopause. Climacteric J Int Menopause Soc 2018; 21: 286–291.

Meriggiola

Villa

Maffei

, et al. Vulvovaginal atrophy in women with and without a history of breast cancer: baseline data from the PatiEnt satisfactiON studY (PEONY) in Italy. Maturitas 2024; 183: 107950.

Nappi

Baber

. What is in a name? A decade after changing from VVA to GSM have we come any closer to ending the ‘silent suffering’ of postmenopausal women with genitourinary symptoms? Climacteric J Int Menopause Soc 2023; 26: 289–291.

Management of symptomatic vulvovaginal atrophy . 2013 position statement of the North American menopause society. Menopause 2013; 20: 888–902.

The 2020 genitourinary syndrome of menopause position statement of the North American menopause society. Menopause 2020; 27: 976–992.

Santen

Stuenkel

Davis

, et al. Managing menopausal symptoms and associated clinical issues in breast cancer survivors. J Clin Endocrinol Metab 2017; 102: 3647–3661.

Alvisi

Ceccarani

Foschi

, et al. Effect of ospemifene on vaginal microbiome in postmenopausal women with vulvovaginal atrophy. Menopause 2023; 30: 361–369.

10.

Alvisi

Baldassarre

Martelli

, et al. Effects of ospemifene on vaginal epithelium of post-menopausal women. Gynecol Endocrinol Off J Int Soc Gynecol Endocrinol 2017; 33: 946–950.

11.

Alvisi

Baldassarre

Gava

, et al. Structure of epithelial and stromal compartments of vulvar and vaginal tissue from women with vulvo-vaginal atrophy taking ospemifene. J Sex Med 2018; 15: 1776–1784.

12.

Lami

Alvisi

Baldassarre

, et al. Safety and efficacy of non-ablative CO2 laser treatment of vulvo-vaginal atrophy in women with history of breast cancer. Arch Gynecol Obstet 2024; 309: 1575–1583.

13.

Quick

Zvinovski

Hudson

, et al. Fractional CO2 laser therapy for genitourinary syndrome of menopause for breast cancer survivors. Support Care Cancer Off J Multinatl Assoc Support Care Cancer 2020; 28: 3669–3677.

14.

Cox

Panay

. Vulvovaginal atrophy in women after cancer. Climacteric J Int Menopause Soc 2019; 22: 565–571.

15.

Sassarini

Perera

Spowart

, et al. Managing vulvovaginal atrophy after breast cancer. Post Reprod Health 2018; 24: 163–165.

16.

Gordon

Gonzales

Krychman

. Rethinking the techno vagina: a case series of patient complications following vaginal laser treatment for atrophy. Menopause 2019; 26: 423–427.

17.

Di Donato

D’Oria

Scudo

, et al. Safety evaluation of fractional CO2 laser treatment in post-menopausal women with vaginal atrophy: a prospective observational study. Maturitas 2020; 135: 34–39.

18.

Condemi

Di Giuseppe

Delli Carpini

, et al. Vaginal natural oxygenation device (VNOD) for concomitant administration of hyaluronic acid and topical hyperbaric oxygen to treat vulvo-vaginal atrophy: a pilot study. Eur Rev Med Pharmacol Sci 2018; 22: 8480–8486.

19.

Barbero

Villasco

Villa

, et al. Conjugate treatment with high concentration normobaric oxygen and hyaluronic acid for vaginal atrophy: a prospective study. Eur Rev Med Pharmacol Sci 2023; 27: 2011–2017.

20.

Massarotti

Asinaro

Schiaffino

, et al. Vaginal oxygen plus hyaluronic acid on genito-urinary symptoms of breast cancer survivors. Climacteric J Int Menopause Soc 2023; 26: 129–134.

21.

Weber

Limpens

Roovers

JPWR

. Assessment of vaginal atrophy: a review. Int Urogynecology J 2015; 26: 15–28.

22.

Svalestad

Thorsen

Vaagbø

, et al. Effect of hyperbaric oxygen treatment on oxygen tension and vascular capacity in irradiated skin and mucosa. Int J Oral Maxillofac Surg 2014; 43: 107–112.

23.

Dos Santos

CCM

Uggioni

MLR

Colonetti

, et al. Hyaluronic acid in postmenopause vaginal atrophy: a systematic review. J Sex Med 2021; 18: 156–166.

24.

Buzzaccarini

Marin

Noventa

, et al. Hyaluronic acid in vulvar and vaginal administration: evidence from a literature systematic review. Climacteric J Int Menopause Soc 2021; 24: 560–571.

25.

Nappi

Martella

Albani

, et al.

Hyaluronic acid: a valid therapeutic option for early management of genitourinary syndrome of menopause in cancer survivors?

Healthc. Basel Switz 2022; 10: 1528.

26.

Litwiniuk

Krejner

Speyrer

, et al. Hyaluronic acid in inflammation and tissue regeneration. Wounds Compend. Clin Res Pract 2016; 28: 78–88.

27.

Cyphert

Trempus

Garantziotis

. Size matters: molecular weight specificity of hyaluronan effects in cell biology. Int. J. Cell Biol 2015; 2015: 563818.

28.

Santoro

Roeca

Peters

, et al. The menopause transition: signs, symptoms, and management options. J Clin Endocrinol Metab 2021; 106: 1–15.

29.

Bachmann

. Urogenital ageing: an old problem newly recognized. Maturitas 1995; 22: S1–S5.

30.

Rosen

Brown

Heiman

, et al. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther 2000; 26: 191–208.

31.

Derogatis

Rosen

Leiblum

, et al. The female sexual distress scale (FSDS): initial validation of a standardized scale for assessment of sexually related personal distress in women. J Sex Marital Ther 2002; 28: 317–330.

32.

Wiegel

Meston

Rosen

. The female sexual function index (FSFI): cross-validation and development of clinical cutoff scores. J Sex Marital Ther 2005; 31: 1–20.

33.

DeRogatis

Clayton

Lewis-D’Agostino

, et al. Validation of the female sexual distress scale-revised for assessing distress in women with hypoactive sexual desire disorder. J Sex Med 2008; 5: 357–364.

34.

Hilditch

Lewis

Peter

, et al. A menopause-specific quality of life questionnaire: development and psychometric properties. Maturitas 1996; 24: 161–175.

35.

Sydora

Fast

Campbell

, et al. Use of the menopause-specific quality of life (MENQOL) questionnaire in research and clinical practice: a comprehensive scoping review. Menopause N. Y. N 2016; 23: 1038–1051.

36.

Alvisi

Lami

Baldassarre

, et al. Short-term efficacy and safety of non-ablative laser treatment alone or with estriol or moisturizers in postmenopausal women with vulvovaginal atrophy. J Sex Med 2022; 19: 761–770.

37.

Home - caressflow oxygen for vulvo-vaginal treatments. Caressflow. https://www.caressflow.com/.

38.

La terapia. Caressflow. https://www.caressflow.com/site/la-terapia/.

39.

Hyalo Gyn idratante vaginale in gel - Secchezza vaginale. https://hyalogyn.it/prodotti/gel-idratante/ (2022).

40.

Merlino

D’Ovidio

Matys

, et al. Therapeutic choices for genitourinary syndrome of menopause (GSM) in breast cancer survivors: a systematic review and update. Pharm. Basel Switz 2023; 16: 550.

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.00 MB

0.64 MB

1.91 MB

Topical high concentration oxygen with hyaluronic acid: A safe and effective treatment for vaginal atrophy and sexual function improvement

Abstract

Background

Aim

Methods

Results

Conclusion

Keywords

Get full access to this article

References

Supplementary Material