Symptom severity and quality of life in the management of vulvovaginal atrophy in postmenopausal women
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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Cited by (36)
Genitourinary syndrome of menopause: Should we treat symptoms or signs?
2022, Current Opinion in Endocrine and Metabolic ResearchCitation Excerpt :A recent post hoc analysis of a RCT of 10 mcg vaginal oestradiol found a lower cytological response in women older than 60 years compared to younger women, indicating reduced cellular responsiveness to treatment in older women [45]. This finding supports the clinical evidence that severe GSM, observed with increased age and time since menopause, may be more difficult to treat [46], and that initiation of treatment at the time of symptoms onset early in perimenopausal years may optimise long-term outcomes [47]. Several scales have been used in clinical trials to assess GSM signs as secondary outcomes, mainly focusing on vaginal epithelium characteristics, with an overall improvement observed for all prescription medications [28,48,49].
The role of hormone therapy in urogenital health after menopause
2021, Best Practice and Research: Clinical Endocrinology and MetabolismCitation Excerpt :Moreover, the notion that some urogenital symptoms associated with FSD were inevitable part of aging further contributed to overlooking the issue in spite many hormonal and non-hormonal options were available [25]. That being so, it was not surprising to observe that postmenopausal women with VVA receiving treatment complained of more severe symptoms than those untreated [26]. The main GSM signs and symptoms are reported in Fig. 1.
Efficacy and safety of a new vaginal gel for the treatment of symptoms associated with vulvovaginal atrophy in postmenopausal women: A double-blind randomized placebo-controlled study
2021, MaturitasCitation Excerpt :The chronic nature of VVA/GSM indicates that effective treatments should preferably be prescribed at the onset of the symptoms and signs of atrophic changes of the vagina, early before severe pictures of the condition occur, and should be continued over time in order to maintain their benefits. Recently, Panay et al. [14] showed that postmenopausal women with VVA receiving treatment complained of more severe symptoms than those untreated confirming that local treatment are used too late, when VVA symptoms are already severe. The therapeutic approach needs to be personalized and women’s preferences have to be taken into account because the level of comfort with a given therapy is strongly influenced by a multitude of individual and socio-environmental factors.
Viewing symptoms associated with Vulvovaginal Atrophy (VVA)/Genitourinary syndrome of menopause (GSM) through the estro-androgenic lens – Cluster analysis of a web-based Italian survey among women over 40
2020, MaturitasCitation Excerpt :However, several surveys showed that VVA/GSM is still an unmet need because of the uncomfortable dialogue on such an intimate topic [7] and also of the great confusion about therapies used for VVA, along with dissatisfaction with actual treatments leading to poor compliance [22]. It is also likely that women are too optimistic about resolving signs and symptoms when VVA/GSM is already severe [23] or is due to intrapersonal or interpersonal causes [24]. Therefore, to achieve the goal of a tailored effective prescription, clinicians should gain a better insight into attitudes and behaviour of women with VVA/GSM [25].