Elsevier

Maturitas

Volume 124, June 2019, Pages 55-61
Maturitas

Symptom severity and quality of life in the management of vulvovaginal atrophy in postmenopausal women

https://doi.org/10.1016/j.maturitas.2019.03.013Get rights and content

Highlights

  • Despite the available treatments, relief of symptoms of vulvovaginal atrophy in postmenopausal women remains unsatisfactory.

  • A better knowledge of the association between treatments, quality of life and symptoms may help disease management.

  • Postmenopausal women with vulvovaginal atrophy receiving treatment complained of higher number and more severe symptoms.

  • Women on systemic treatment had fewer and milder symptoms and presented with better vaginal and vulvar health.

  • The treatment of vulvovaginal atrophy should be initiated at early stages of the disease to prevent irreversible changes.

Abstract

Objectives

To evaluate the association between treatments for vulvovaginal atrophy (VVA) and symptom frequency and severity, quality of life (QoL) and sexual functioning in postmenopausal women.

Study design

Cross-sectional survey conducted in postmenopausal women aged 45–75 years. Data on demographic and clinical variables, as well as vaginal, vulvar and urinary symptoms were collected. The EuroQoL questionnaire (EQ5D3L), the Day-to-Day Impact of Vaginal Aging (DIVA), the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale - revised (FSDS-R) were filled out.

Main outcome measures

Association between treatments for VVA and symptom frequency.

Results

Women on VVA treatment presented with more severe symptoms. The sexual function score was higher in the treated women (FSFI: 15.6 vs 16.7; p = 0.010), as was the score for sexual distress (FSDS-R: 9.2 vs 12.3, p < 0.0005). The systemic hormone group presented with fewer VVA symptoms, lower vaginal impact (DIVA), and better sexual function (FSFI and FSDS-R) and vaginal health. The rates of sexual distress and vulvar atrophy were higher in the non-hormonal treatment group. No significant differences were found according to treatment duration.

Conclusions

Postmenopausal women with VVA receiving treatment complained of more severe symptoms than those untreated. Women on systemic treatment had fewer and milder VVA symptoms and presented with better vaginal and vulvar health than women on other treatments. Many women request effective local treatment too late, when VVA symptoms are already severe. Our data suggest that VVA treatments should ideally be initiated when symptoms commence and cause distress, rather than later, when symptoms may have become more severe and even a cause of intolerable distress for the woman.

Introduction

Vulvovaginal atrophy (VVA) is a common condition of menopause which leads to symptoms in approximately 50% of postmenopausal women [1,2]. Symptoms of VVA include vaginal dryness, dyspareunia, vulvar and vaginal irritation and/or itching, dysuria and post-coital bleeding [3]. Women often do not report the symptoms of VVA because they feel it is a natural part of ageing or due to embarrassment. Also, women’s perceptions seem to vary across countries attending the possibilities of the healthcare systems, especially in relation to communication with professionals [4]. This leads to underreporting by women, underdiagnosing and often undertreatment by healthcare providers, despite a significant impact of VVA symptoms on interpersonal relationships, daily activities and sexual function [5] and on quality of life (QoL) of postmenopausal women [6,7].

The main therapeutic goal of treatment is the relief of symptoms [8,9] as well as to restore the vaginal physiology [8]. Non-hormonal treatments, like vaginal moisturizers and lubricants, and vaginal estrogens are considered the standard of care. Systemic estrogens are only recommended if other postmenopausal symptoms are present, requiring systemic estrogen treatment (e.g. vasomotor symptoms) [3,10]. Recent, evidence-based therapies for VVA include ospemifene, a selective estrogen receptor modulator [[11], [12], [13]], and prasterone, a DHEA (dehydroepiandrosterone) based vaginal insert [14]; even more recently, the vaginal application of energy based devices like laser or radiofrequency, although there is still a lack of robust data regarding the efficacy and (long term) safety of these devices [15].

Insufficient symptom relief, poor compliance and inconvenience have been cited as major limitations of some vaginal treatments [5]. An appropriate management of VVA in postmenopausal women appears essential to minimize its impact in patients and partners.

The European Vulvovaginal Epidemiology Survey (EVES) study is a large cross-sectional survey of women visiting a gynecologic or menopause clinic in two European countries (Spain and Italy). Apart from evaluating VVA symptomatology, QoL, lifestyle and therapies, this study has unique characteristics as there was a physical examination to confirm VVA [16]. In that study, a 67% of women with confirmed VVA showed a very low to moderate satisfaction with treatment for VVA. Up to 61% reported no relief to moderate relief of treatment. Reasons for not being satisfied were mainly that they considered treatment not effective enough (41.3%) or messy (18.5%) [16]. Despite the available therapeutic options, the relief of symptoms of VVA in postmenopausal women and satisfaction with current treatments can be improved by development of both healthcare provider- and patient-based educational programs as previously suggested [17]. A better knowledge of the association between different management options and symptom/QoL outcomes will help to improve VVA-related healthcare [16,18].

This analysis of the EVES study evaluates the association of treatment vs no treatment, including differences between treatment options and duration of treatment, and symptom frequency and severity, menopause-specific QoL and sexual function in postmenopausal women with VVA.

Section snippets

Design and patients

The EVES study is a cross-sectional survey among postmenopausal women (>12 months after the last menstrual period) aged 45–75 years old attending menopausal centres or gynaecological clinics in Italy and Spain. The study was conducted in accordance with the Declaration of Helsinki and was approved by the Institutional Review Board of the participant centres. All patients provided written informed consent before study entry. From a total population of 2412 women initially enrolled, 2160 were

Demographics and treatments used

Table 1 compares main demographic characteristics between untreated and treated women for VVA. The most relevant finding was the time since menopause, which was significantly higher in women treated for VVA (mean ± SD of 10.3 ± 7.0 vs 9.5 ± 7.1, p = 0.009). Supplementary Table 1 shows the main demographic characteristics by type of treatment (local non-hormonal, local and systemic hormonal). Women on systemic hormonal treatment were younger and had a shorter period since menopause than the

Discussion

The current cohort analysis of the EVES study shows that in a Southern European population of postmenopausal women with at least one symptom of VVA, up to 57.5% were not using any form of treatment. Spanish and Italian women were similar in terms of baseline demographics and time since menopause. However, VVA symptoms were more prevalent in the Spanish population as was the use of concurrent VVA treatments. Overall, the most common treatment was local non-hormonal therapy (31.8%), followed by

Conclusions

Vulvovaginal atrophy, a common but underreported condition, occurs in women who experience a reduction in estrogen levels. We found that postmenopausal women with VVA already using a treatment have more and worse symptoms than those not using treatment. The most plausible interpretation of these results might be that women only seek or commence treatment when symptoms have already become so distressing that they cannot tolerate them any longer.

Early treatment of VVA may prevent further

Contributors

Nick Panay participated in the study design, and wrote the manuscript with writing and editorial support from a third party.

Santiago Palacios participated in the study design and critically revised the manuscript.

Nico Bruyniks critically revised the manuscript.

Martire Particco critically revised the manuscript.

Rossella E. Nappi participated in the study design and critically revised the manuscript.

All authors developed the methodology, supervised the collection of data managed by a third party,

Conflict of interest

Nick Panay has received honoraria for lecturing and acting in an advisory capacity for a number of pharma companies, including Abbott, Bayer, Besins, Mithra, MSD, Mylan, Novo Nordisk, Pfizer, SeCur and Shionogi.

Santiago Palacios has financial relationships (as a lecturer, member of advisory boards and/or consultant) with Pfizer, Servier, Amgen, MSD, Preglem, Gynea, Sandoz, Procare Health, Bayer, MSD, Serelys and Shionogi. He has also been a symposium speaker or advisory board member and has

Funding

This research did not receive a specific grant from funding agencies in the public or not-for-profit sectors. Sponsorship and article processing charges for this study were funded by Shionogi Ltd.

Ethical approval

The study received the approval of the pertinent ethics committee at all participating centres, centralised by the University of Pavia (Italy) and the Palacios Institute of Women’s Health (Spain).

Provenance and peer review

This article has undergone peer review.

Research data (data sharing and collaboration)The authors have no authorization to share data, mainly because the sharing of the database would involve patient data protection issues.

The complete list of the EVES Study investigators is as follows

C. Argudo Prieto (Gijón, Spain), L. Baquedano Mainar (Zaragoza, Spain), A. M. Becorpi (Firenze, Italy), P. Benedetti Panici (Roma, Italy), C. Benedetto (Torino, Italy), N. Biglia (Torino, Italy), M. Busacca (Milano, Italy), A. Cagnacci (Modena, Italy), J. Calleja Abu-Amshah (Madrid, Spain), M. J. Cancelo Hidalgo (Guadalajara, Spain), C. Castelo Branco i Flores (Barcelona, Spain), A. Cianci (Catania, Italy), E. Cicinelli (Bari, Italy), P. Coronado Martin (Madrid, Spain), M. Correa Rancel (Santa

Acknowledgements

Manuscript writing and editorial support was provided by Mónica Giménez, PhD, and Emili González-Pérez, PhD, from TFS, S.L., with financial support provided by Shionogi Ltd. The study was sponsored by Shionogi Ltd.

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