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Summary

In a recent article published in Climacteric by Nappi et colleagues [1], the efficacy and safety of hyaluronic acid-based vaginal pessaries were studied for the treatment of vulvovaginal atrophy (VVA) in postmenopausal women. In an open-label, non-comparative, non-controlled, prospective, multicenter clinical trial, 40 postmenopausal women lamenting VVA received a hyaluronate-based pessary, a non-sterile, glyceride-based, solid preparation, containing 0.2% Hydeal-D, every 3 days for 3 months. The treatment was effective in improving VVA signs, patient perception of VVA-associated symptoms, and other related parameters such as Vaginal Health Index (VHI) score, vaginal pH, vaginal maturation index. Female Sexual Function Index and Female Sexual Distress Scale-Revised scores bettered as well. Improvement at 3 months exceeded threshold values of VVA diagnosis, sexual dysfunction, and distress, indicating a clinically relevant amelioration of VVA symptoms. Finally, overall patient satisfaction was very high and persisted through follow-up.

Commentary

VVA is a troublesome condition affecting the quality of life. VVA occurs in more than half of postmenopausal women as well as in women suffering from other hypoestrogenic states, such as postpartum, premature ovarian insufficiency, and antiestrogen treatment (2). The most common complaints are dyspareunia and vaginal dryness, but some women also lament burning, itching, discharge, urinary discomfort, or bleeding with intercourse. Although this condition is highly prevalent, the use of effective treatment is still unsatisfactory [3]. Health-care providers should be proactive, given the plethora of options, including lifestyle modifications and hormonal treatments, as well as non-hormonal approaches, such as lubricants and moisturizers, and non-pharmacological therapies (2). Lubricants and moisturizers are the first options in international guidelines [4]. Among these, vaginal moisturizers containing hyaluronic acid (HA) have been suggested as one of the most effective non-hormonal strategies to treat VVA symptoms [5]. Efficacy of HA formulations depend on physical and chemical characteristics such as osmolality, molecular weight, concentration, density, permeability, and mechanical properties, pH. Hydeal-D is a HA ester characterized by strong hydrating properties [6,7]. Despite the open-labelled and non-comparative design and small sample size, the present study by Nappi and colleagues [1] does provide encouraging data on the efficacy of this new medical device containing Hydeal-D. Moreover, this vaginal pessary seems a safe, well-tolerated non-hormonal option for the treatment of VVA. Future randomized controlled studies however, are needed to confirm these preliminary results.

Camil Castelo-Branco MD MSc PhD
Clinical Institute of Gynecology, Obstetrics & Neonatology. Hospital Clínic Barcelona. University of Barcelona
Professor of Obstetrics & Gynecology. Head of Obstetrics & Gynecology Unit at the Department of Surgery – Faculty of Medicine. Director of the Master of Clinical Sexology and Sexual Health. University of Barcelona

References

  1. Nappi RE, Kotek M, Brešt’anský A, Giordan N, Tramentozzi E. Effectiveness of hyaluronate-based pessaries in the treatment of vulvovaginal atrophy in postmenopausal women. Climacteric. 2020 May 12:1-6.
    https://pubmed.ncbi.nlm.nih.gov/32396754/
  2. Naumova I, Castelo-Branco C. Current treatment options for postmenopausal vaginal atrophy. Int J Womens Health. 2018 Jul 31; 10:387-395.
    https://pubmed.ncbi.nlm.nih.gov/30104904/
  3. Castelo-Branco C, Biglia N, Nappi RE, Schwenkhagen A, Palacios S. Characteristics of postmenopausal women with genitourinary syndrome of menopause: Implications for vulvovaginal atrophy diagnosis and treatment selection. Maturitas. 2015 Aug;81(4):462-9.
    https://pubmed.ncbi.nlm.nih.gov/26071816/
  4. Sturdee DW, Panay N. Recommendations for the management of postmenopausal vaginal atrophy. Climacteric. 2010 Dec;13(6):509-22.
    https://pubmed.ncbi.nlm.nih.gov/20883118/
  5. Donders GGG, Ruban K, Bellen G, Grinceviciene S. Pharmacotherapy for the treatment of vaginal atrophy. Expert Opin Pharmacother 2019; 20:821–35
    https://pubmed.ncbi.nlm.nih.gov/30897020/
  6. Chen J, Geng L, Song X, Li H, Giordan N, Liao Q. Evaluation of the efficacy and safety of hyaluronic acid vaginal gel to ease vaginal dryness: a multicenter, randomized, controlled, open-label, parallel-group, clinical trial. J Sex Med 2013;10:1575–84.
    https://pubmed.ncbi.nlm.nih.gov/23574713/
  7. Advani P, Brewster AM, Baum GP, Schover LR. A pilot randomized trial to prevent sexual dysfunction in postmenopausal breast cancer survivors starting adjuvant aromatase inhibitor therapy. J Cancer Surviv 2017; 11:477–85.
    https://pubmed.ncbi.nlm.nih.gov/28229275/
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