Vaginal Atrophy Research Articles

Exploring community pharmacists’ views around HRT and the menopause

Abstract Introduction The number of women in England prescribed HRT has increased dramatically in the last seven years.1 Meanwhile, from 2018, HRT product shortages have resulted in the release of Serious Shortage Protocols allowing community pharmacists to supply alternative HRT products where appropriate.2 Furthermore, in 2022, the first over-the-counter medication for vaginal atrophy in menopause was licensed.3 With so many recent changes, it seemed an opportune time to determine community pharmacists’ views on the topic. Aim The aim of this study was to explore community pharmacists’ views around HRT and the menopause. Methods A qualitative approach using semi-structured interviews was chosen to allow for exploration of views. A list of community pharmacies from Stoke-on-Trent and Staffordshire was obtained from the NHS website. They were grouped into independent and multiple pharmacies in both urban and rural areas. Twenty pharmacies were then randomly selected from across the lists, emailed and invited to participate in the study; a participant information sheet and consent form was attached. This was followed up with a telephone call one week later, and a day and time for interview was agreed. Telephone interviews were undertaken, with consent obtained verbally, and the interview digitally recorded. The interview guide was developed based on the literature review and aim of the study. The guide addressed experiences of patient queries regarding HRT and the menopause, views of the OTC vaginal tablet and their confidence in discussing menopause with patients. Interviews were transcribed verbatim and thematically analysed. Ethical approval was obtained from Keele School of Pharmacy and Bioengineering Ethics Committee. Results Nine interviews were undertaken in October 2022, lasting 10 to 15 minutes. Five interviewees were male, five from urban areas, all from different companies and experience ranged from 3 months to 45 years. Four themes emerged from the transcripts, namely: increase in queries; managing shortages; lack of knowledge on Gina®; and limited professional interest in the topic. Patients were found to rarely ask about menopausal symptoms, with most queries related to risks associated with HRT or advice on various formulations. All pharmacists found dealing with shortages to be time-consuming and potentially stressful. Many of the pharmacists had not heard of the new vaginal tablet and did not stock it. Those who did, felt it was expensive and unlikely to sell. All stated they would like further training on the menopause but only one would consider specialising as a future area of prescribing. Discussion/Conclusion This was a small study with relatively short interviews, due to the time constraints facing working pharmacists. Despite this, similarity in responses suggest that data saturation may have been reached. This study confirms previous reports of increasing queries relating to HRT, particularly around shortages, and the stress associated with dealing with them. The pharmacists stated they would like further training on the topic, although CPPE packages on menopause are available. Despite the increased attention and prescribing of HRT, there was little desire to specialise and prescribe in this area; this should be explored further.

Community pharmacists' perceptions of the POM to P reclassification of medicines for sexual and reproductive health – A survey study

Abstract Introduction In the UK, medicines reclassification is the process of changing the legal classification of a medication, such as from a prescription-only medicine (POM) to a pharmacy (P) or general sales list (GSL) medicine.1 It is overseen by the Medicines and Healthcare products Regulatory Agency (MHRA). and improves patient access to certain medications while ensuring safeguards are in place for their safe and responsible use.2 A number of the most recent POM to P reclassifications have been for medications used in sexual and reproductive healthcare. Aim To investigate community pharmacists' (CPs’) perceptions of POM to P medicine reclassifications for sexual and reproductive health: sildenafil citrate (Viagra Connect, for erectile dysfunction), desogestrel (Hana/Lovima, for contraception), and estradiol hemihydrate (Gina, for vaginal atrophy). Methods The study population was all CPs in Greater London. The survey consisted of 59-questions in five sections. The first section was for general perceptions about the reclassification of medicines, while the other sections were specific to the medicines studied. The final section was demographics. Question types included multiple-choice, 5-point Likert scale, and free text. The recommended sample size was 340 (95% CI), therefore, 398 CPs, in 210 pharmacies, were approached. Ethical approval was obtained from the university ethics committee. Participants were posted a participant information sheet (PIS) one week before distribution of the survey as a hard copy. The survey was also available on Microsoft Forms. Data were analysed in Microsoft Excel and Statistical Package for Social Sciences (SPSS). Descriptive statistics were given in numbers and percentages. Results The response rate was 37.7% (N=150/398). Most CPs (88%) perceived that medication reclassification increased their role and provided greater access to medicines for the public. However, less than half (44%) had a good understanding of the reclassification process. Sildenafil was available to purchase in all of the visited pharmacies, however, desogestrel was only sold in 50% of them, and estradiol was sold in only 28%. Reasons cited for not selling desogestrel and/or estradiol included lack of public awareness about the availability of these products, and a lack of public interest in purchasing them. While the availability of sildenafil as a P medicine was seen as a positive for improving safe access, many CPs (86%) expressed concerns about the high risk of its misuse. In terms of training, the available training for sildenafil received higher ratings compared to that for desogestrel or estradiol. Most CPs (67%) indicated that having case studies incorporated into the training for POM to P switches helped them understand which patients could safely purchase these medications. Discussion/Conclusion CPs are positive about the availability of sexual and reproductive health medications over the counter. They do have concerns, however, about the potential of some of these medications to be misused, and also feel that more awareness of the availability of these products needs to be raised. Those producing training materials for reclassified medications should incorporate case studies as these support CP decision making. A limitation of this study was that the recommended sample size was not achieved.

Vaginal CO2 laser therapy for genitourinary syndrome in breast cancer survivors—VagLaser study protocol: a randomized blinded, placebo-controlled trial

BackgroundVaginal CO2 laser therapy is a new treatment option for genitourinary syndrome of menopause. Its potential is particularly interesting in breast cancer survivors, where existing treatment options often are insufficient as hormonal treatment is problematic in these women. The objective of this study is to investigate the effectiveness of vaginal laser treatment for alleviation of genitourinary syndrome of menopause in breast cancer survivors treated with adjuvant endocrine therapy. The secondary objective is to explore the importance of repeated vaginal laser treatment and the long-term effects in this patient population.MethodsVagLaser consist of three sub-studies; a dose response study, a randomized, participant blinded, placebo-controlled study and a follow-up study. All studies include breast cancer survivors in adjuvant endocrine therapy, and are conducted at the Department of Obstetrics and Gynecology, Randers Regional Hospital, Denmark. The first participant was recruited on 16th of February 2023. Primary outcome is vaginal dryness. Secondary subjective outcomes are vaginal pain, itching, soreness, urinary symptoms and sexual function. Secondary objective outcomes are change in vaginal histology (punch biopsy), change in vaginal and urine microbiota, and change in vaginal pH.DiscussionMore randomized controlled trials, with longer follow-up to explore the optimal treatment regimen and the number of repeat vaginal laser treatments for alleviation the symptoms of genitourinary syndrome of menopause in breast cancer survivors treated with endocrine adjuvant therapy, are needed. This study will be the first to investigate change in vaginal and urine microbiota during vaginal laser therapy in breast cancer survivors.Trial registrationClinicalTrials.gov: NCT06007027 (registered 22 August, 2023).Protocol version: Version 1, Date 13.11.2023.

Foreword: Genitourinary Syndrome of Menopause.

Foreword: Genitourinary Syndrome of Menopause.

Hormonal Medications for Genitourinary Syndrome of Menopause.

Genitourinary syndrome of menopause is a common, under-reported, and undertreated chronic progressive condition requiring long-term treatment. Hypoestrogenism in the urogenital tissues is associated with bothersome dyspareunia, vulvovaginal symptoms, overactive bladder, and frequent urinary tract infections. Vaginal hormone therapies, including vaginal estrogen and intravaginal dehydroepiandrostenedione, are safe and effective and improve symptoms and clinical findings. Systemic hormone therapy treats vulvovaginal atrophy less effectively than vaginal hormone therapies with increased stress and urge urinary incontinence. Oral ospemifene effectively treats vaginal dryness and dyspareunia. Clinicians need to ask about symptoms of genitourinary syndrome of menopause, confirm the diagnosis, and suggest appropriate treatment options.

Genitourinary Syndrome of Menopause: Does Everyone Have It?

In 2014, the North American Menopause Society and the International Society for the Study of Women's Sexual Health recommended using the term genitourinary syndrome of menopause (GSM) to cover a range of genital and urinary symptoms that might be experienced during and after menopause. The term as currently defined, however, includes symptoms that may not be menopausal symptoms. The term GSM also includes "objective" measures such as vaginal pH that do not relate to symptom severity and are not priorities for clinicians or patients. We question the validity of GSM as a new syndrome and recommend the definition of the syndrome be revised to ensure it more closely reflects the symptoms attributable to menopause and the experience, difficulties, and response to treatment of those affected.

GSM and Quality of Life Measures.

The impact of bothersome vulvovaginal symptoms related to hypoestrogenism on quality of life (QOL) has been evaluated in large international surveys and qualitative studies of vulvovaginal atrophy, most of which were completed before the introduction of the term genitourinary syndrome of menopause (GSM) and focus primarily on vulvovaginal atrophy. The QOL domain most affected in these studies is sexual function, although women also report impacts on self-confidence, self-esteem, sleep, and general enjoyment of life. Health-related QOL measures are available that evaluate the impact of some symptoms associated with GSM on QOL; new measures are in development that assess the full range of symptoms associated with GSM.

Carbon dioxide laser therapy for the management of genitourinary syndrome of menopause: A meta‑analysis of randomized controlled trials.

Genitourinary symptoms of menopause (GSM) affect ~50% of women after menopause. Recently, CO2 laser therapy has been used for managing GSM but without high quality evidence. The present review assessed the effectiveness of CO2 laser therapy in the management of GSM. PubMed, Embase, Web of Science, CENTRAL and Scopus databases were searched for randomized controlled trials (RCTs), published up to June 30, 2023, comparing CO2 laser and sham laser treatments for GSM management. The outcomes of interest included Female Sexual Function Index (FSFI), Vaginal Health Index (VHI) and visual analog scale (VAS) for dyspareunia, dryness, burning, itching and dysuria. A total of seven RCTs were included in the review and meta-analysis, with 6/7 studies using three sessions of laser therapy, 4-8 weeks apart. Meta-analysis demonstrated no statistically significant difference in FSFI [mean difference (MD), -1.48; 95% CI, -5.85, 2.89; I2=45%] and VHI scores (MD, -0.18; 95% CI, -1.66, 1.31; I2 =72%) between laser and control groups. Meta-analysis also demonstrated no statistically significant difference in VAS scores for dyspareunia (MD, -1.63; 95% CI; -4.06, 0.80; I2=91%), dryness (MD, -1.30; 95% CI, -3.14, 0.53; I2=75%), burning (MD, -0.76; 95% CI, -2.03; 0.51 I2=56%), itching (MD, -0.28; 95% CI, -0.95, 0.38; I2=0%) and dysuria (MD, 0.15; 95% CI, -0.37, 0.67; I2=23%) between the groups. The included RCTs had low risk of bias. In conclusion, meta-analyses of high-quality sham-controlled RCTs indicated that CO2 may not have any beneficial effect on GSM. Limited data and high heterogeneity in meta-analyses in this area of research are important limitations that need to be addressed by future RCTs.

OCT angiography in the monitoring of vaginal health.

Fractional-pixel CO2 laser therapy shows promise for treating the genitourinary syndrome of menopause (GSM). Nevertheless, it remains controversial in the field of female pelvic medicine. This is due to the inherent difficulties in obtaining noninvasive biopsies to evaluate the treatment's efficacy and safety objectively. To address this challenge, we developed a noninvasive intravaginal optical coherence tomography (OCT)/OCT angiography (OCTA) endoscopic system, whose probe features a shape identical to the laser treatment probe. This system can provide high-resolution OCT images to identify the microstructure of vaginal tissue and visualize the vasculature network in vivo. We conducted clinical research on 25 post-menopausal patients with GSM. OCT/OCTA scans were acquired at four different locations of the vagina (distal anterior, distal posterior, proximal anterior, and proximal posterior) during the whole laser treatment session. A U-Net deep learning model was applied to segment the vaginal epithelium for assessing vaginal epithelial thickness (VET). Blood vessel density and VET were quantified to monitor the efficacy of fractional-pixel CO2 laser therapy. Statistical correlation analyses between these metrics and other clinical scores were conducted, validating the utility of our system. This OCT/OCTA endoscopic system has great potential to serve as a noninvasive biopsy tool in gynecological studies to screen, evaluate, and guide laser treatment for GSM.

Structure of pathology in vulva area

This article describes the structure of morbidity in the vulvar area in women 45–72 years old, and analyzes the frequency of discrepancies in diagnoses among dermatovenerologists and gynecologists. It has been established that nonspecific vulvitis / vulvovaginitis (23%), lichen sclerosus (20%), genitourinary menopausal syndrome (20%), contact dermatitis (12%), lichen planus (7%), atopic dermatitis (6%), vulvar itching (5%), psoriasis (2%) predominate in the structure of vulvar pathology in women.

Sea buckthorn, its bioactive constituents, and mechanism of action: potential application in female reproduction.

Sea buckthorn (Hippophae rhamnoides L.) is a flowering shrub, and its berries have been utilized for decades as a raw ingredient in cuisines and herbal remedies. This evidence-based study focuses on its key bioactive constituents, and mechanism of protective effects with a focus on female reproductive processes. Parts of the plant contain phenols, carotenoids (lycopene, carotene, lutein, and zeaxanthin), flavonoids (isorhamnetin, quercetin, glycosides, and kaempferol), tocopherols, sterols, polyunsaturated fatty acids, minerals, vitamins, omega 3, 6, 9 and rare omega 7 fatty acids etc. Key polyphenolic flavonoids such as isorhamnetin and quercetin are believed to be mainly responsible behind its health benefits (against cardiovascular diseases, metabolic syndrome, obesity etc.) through properties including anti-cancer, antioxidant, and anti-inflammatory activities. These sea buckthorn constituents appear to mediate healthy ovarian cell proliferation, death, and hormone release, as well as decrease ovarian cancer possibly through apoptosis, and hormonal (estrogen) release. Thus, sea buckthorn and its bioactive ingredients may have potential in the management of gynecological problems such as uterine inflammation, endometriosis, and easing symptoms of vulvovaginal atrophy in postmenopausal women (by targeting inflammatory cytokines and vascular endothelial growth factor - VEGF). Apigenin, myricetin, and luteolin have also been recommended as prospective ovarian cancer preventative and adjuvant therapy options as they can inhibit ovarian cancerogenesis by triggering apoptosis and halting the cell cycle in ovarian tumors. Furthermore, its oil (containing carotenoid, sterol, and hypericin) has been speculated as an alternative to estrogen replacement therapy for postmenopausal women particularly to improve vaginal epithelial integrity. However, it is uncertain whether steroid hormone receptors, reactive oxygen species (ROS), and inflammatory regulators are actually behind sea buckhorn's actions. Sea buckthorn, and its compounds' health promoting potential warrants further validation not just in vitro and in animal research, but also in clinical trials to identify and/or standardize optimal methods of delivery of biologically active molecules.

Genitourinary syndrome of menopause in patients with breast cancer treated by hormonotherapy: women's perception in ITAC, a French web-based survey

To describe frequency, intensity and impact of genito-urinary syndrome of menopause (GUSM) in breast cancer (BC) survivors receiving hormonotherapy (HT). Web-based survey hosted on the Seintinelles website (database of patients and caregivers). Specific questionnaire of 43 questions, including sociodemographic characteristics, history of BC, characteristics of HT, side effects other than GUSM, symptoms of GUSM (frequency, intensity, treatment, and impact) and overall expectations regarding treatment. Among 1157 participants, 96.4% had at least one GUSM symptom. Percentages with at least one urinary, gynecological, or sexual symptom were 56.0%, 85.6% and 86.1% respectively while 70.3% and 10% declared at least 5 and 10 symptoms respectively. Mean (SD) and median (range) numbers of symptoms were 5.9 (2.8) and 6 (0-14) respectively. Most frequently reported symptoms were decreased desire (77.8%), decreased arousal (71.4%), and vaginal dryness 68.4%). On a scale from 0 (no impact) to 10 (maximal impact), the most important impact was reported for sexual life (mean: 6.6±3.5) followed by psychological condition/self-image (mean 5.4±3.1), and relations with partners (mean: 5.1±3.4). Only 13.6% of participants had received information on GUSM prior to the survey. GUSM remains underdiagnosed and underestimated in BC survivors who receive HT, although it is among most frequent and disabling side effects of HT. Awareness should be increased among physicians, along with information to women. Early detection and treatment of symptoms and prophylaxis of GUSM in at-risk women should be implemented.

Genitourinary Syndrome of Menopause: A Narrative Review Focusing on Its Effects on the Sexual Health and Quality of Life of Women.

Genitourinary syndrome of menopause (GSM) is a progressive condition due to a hypoestrogenic state affecting perimenopausal and menopausal women. GSM was previously known as urogenital syndrome, vulvovaginal atrophy, or atrophic vaginitis. The term vulvovaginal atrophy did not encompass the symptoms of the urinary tract like incontinence, urgency, and discomfort, or allude that it is due to a hypoestrogenic state. Although a significant segment of the population is affected by GSM, it is very sparsely studied, detected, and treated. GSM affects the quality of life and sexual health of most menopausal women suffering from it. Only a few healthcare providers ask about the symptoms of GSM and a tiny percentage of women seek consultation for it. This may be because they are either embarrassed or believe it to be a part of the natural process of aging. As the life expectancy of women has increased in general, the prevalence of GSM has also risen, while it still remains underdiagnosed and untreated. Properly educating women so that they can seek consultation regarding symptoms of GSM, and training healthcare professionals about communicating with the patient, as well as correctly identifying, diagnosing, and managing the patient are all important to overcome this communication barrier.Once we cross the barrier of diagnosing patients with GSM, we still have to manage the patients with tailor-made prescriptions according to the severity of the symptoms and their preferences. While there are various treatment options, the most effective one is low-dose topical estrogen therapy. In this review, we intend to explore the existing knowledge about GSM and its effect on the quality of life and sexual health of women along with the treatment options for managing and reversing the effects of GSM.

Laser and radiofrequency for treating genitourinary syndrome of menopause in breast cancer survivors: a systematic review and meta-analysis protocol

IntroductionBreast cancer survivors (BCSs) experience more severe symptoms of genitourinary syndrome of menopause (GSM) than healthy postmenopausal women. As hormonal therapy with oestrogen should be avoided in BCSs, finding an...

Comparison of Low-Energy Radiofrequency Thermal Vaginal Therapy with Sham Treatment for Stress Urinary Incontinence in Postmenopausal Women: A Randomized Controlled Trial.

Low-energy radiofrequency (RF) thermal vaginal therapy for vaginal laxity and the genitourinary syndrome of menopause denatures collagen fibrils in the endopelvic fascia; fiber tightening during healing may stabilize the urethra and bladder neck, thereby resolving female stress urinary incontinence (SUI), especially in postmenopausal women. This study compared RF vaginal therapy with sham treatment for mild to moderate SUI. This double-blinded, randomized controlled trial, conducted at a tertiary center from September 2018 to April 2021, recruited postmenopausal women with mild to moderate degree of SUI who had never undergone surgery, energy-based therapy, or vaginal estrogen treatment. The intervention group received vaginal RF laser treatment; the sham group did not. The primary outcome was the 1-hour pad-weight test (PWT) result. Secondary outcomes were Incontinence Quality of Life (I-QOL), Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ-7), Patient Global Impression of Improvement (PGI-I), percentage of improvement among all participants, and adverse events. Data were analyzed using STATA 17.0. Forty-nine participants randomized to RF (n = 23) and sham (n = 26) groups were eligible for analysis. PWT decreased during follow-up in the RF group but remained stable in the sham group; PWT did not significantly differ between groups. The 1-year post-treatment success rate was higher in the RF group (69.6%) than in the sham group (38.5%). At 1 year post-treatment, there were no statistically significant differences in any secondary outcomes. Low-energy RF vaginal therapy is an alternative treatment for mild to moderate SUI in postmenopausal women without serious adverse events. Larger randomized controlled trials should be conducted.

Menopausal transition. Is it possible to delay the prescription of menopausal hormone therapy?

After the end of the reproductive period, women spend a third of their lives in menopause. During this period, they experience a range of predictable symptoms and conditions associated with changing levels of sex hormones and aging of the body. The menopausal transition precedes menopause by several years and is usually characterized by irregular menstrual cycles, hot flashes and night sweats. After menopause, genitourinary symptoms predominate, including vulvovaginal atrophy and dryness and complaints associated with urinary disturbances: increased urinary frequency, urgency, and nocturia. Menopausal hormone therapy is effective for vasomotor and genitourinary symptoms, but it is associated with the development of cardiovascular risks, cognitive impairment, depression, and a number of side effects. An alternative in the therapy of menopausal symptoms can be the prescription of biologically active supplement Happyclim®. The complex composition of the drug effectively fills the lack of its own estrogen in the female body. The preparation Happyclim® contains phytoestrogens (soy isoflavones, flavonoids) and auxiliary components (magnesium and B vitamins, vitamin C, extract of medicinal melissa), which with high efficiency affect the woman’s body during menopausal transition, alleviating the symptoms of menopause and improving the quality of life. This article presents a cross-section of the literature on the use of phytoestrogens and the dietary supplement Happyclim® during the perimenopausal transition to delay the administration of menopausal hormone therapy.

Current trends in the prevention and treatment of genitourinary menopausal syndrome

Genitourinary menopausal syndrome is still a widespread problem that significantly affects the quality of life in postmenopause. The cause of this state is hypoestrogenism that is associated with menopause and the following change in the vaginal microflora due to the elimination of lactobacilli. The disturbance of the vulval and vaginal microflora provides risks for the invasion of pathogenic microorganisms, and the deficiency of sex hormones is associated with atrophy of the epithelium of the urogenital tract. An analysis of published clinical studies using a combination of L. acidophilus and 0.03 mg estriol (Gynoflor® E) in postmenopausal women with vulvovaginal atrophy, breast cancer survivors, in postmenopausal women with breast cancer on aromatase inhibitors was performed. Treatment with a combination of L. acidophilus and 0.03 mg of estriol (Gynoflor® E) can be evaluated as safe without risk of endometrial effects or other systemic effects. Local estrogen therapy in postmenopausal women can restore the vaginal epithelium, and a useful lactobacillus flora is needed to prevent urogenital infections. Local application of estriol is preferable, as it causes a local proliferative response and has no stimulating effect on the endometrium. This method of therapy may also be considered for hormone-sensitive women with breast cancer on aromatase inhibitors. However, today, there are not enough clinically validated studies proving the absolute safety of this treatment method among breast cancer women. The effect of this therapy is achieved due to the synergistic action of estriol and lactobacilli.

Vaginal atrophy and genital pain in women on depot medroxyprogesterone acetate contraceptive injection.

Depot medroxyprogesterone acetate causes a hypo-estrogenic state in over half of users although clinical vaginal atrophy causing superficial dyspareunia is thought rarely to occur. This is a case series of ten women using depot medroxyprogesterone acetate who presented with superficial dyspareunia and clinical vaginal atrophy. The women were treated with vaginal estriol cream and their contraception was discontinued or changed. All patients had either a complete resolution of symptoms or a substantial improvement at follow-up, and the clinical and laboratory findings of vaginal atrophy had resolved. This case series demonstrates that vaginal atrophy may occur more frequently than previously thought.

Vulvovaginal atrophy in the CRETA study: the healthcare professionals’ perception

Objectives The objective is to assess the perception of gynecologists regarding patients’ adherence to vulvovaginal atrophy (VVA) treatments, to evaluate the gynecologists’ opinions on what their patients think about treatment adherence, and to compare the gynecologists’ opinions with the patients’ own perceptions within the CRETA study. Methods Spanish gynecologists who participated in the CRETA study were asked to fill out an online 41-item questionnaire to evaluate their views on VVA management. Results From 29 centers across Spain, 44 gynecologists completed the survey. Their mean age was 47.2 years old, two-thirds of them were women, and the average professional experience was over 20 years. According to the gynecologists, the therapy most frequently used by VVA-diagnosed women was vaginal moisturizers (45.5%), followed by local estrogen therapy (36.4%) and ospemifene (18.2%). Nevertheless, ospemifene was viewed as the therapeutic option with the most efficacy, easiest route of administration, shorter time to symptom improvement, lower percentage of dropouts, and higher treatment adherence. Conclusions Spanish gynecologists are in general agreement with their patients regarding VVA treatment preferences and the main issues for adherence and effectiveness. However, there is an opportunity for doctor–patient communication improvement. Among the three therapeutic options evaluated, ospemifene is regarded as offering some competitive advantages.

Management of patients with vulvovaginal atrophy and cytological abnormalities

The data on managing patients with vulvovaginal atrophy and abnormal cytological results are provided for obstetrician-gynecologists.