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Introduction: The demand for effective and safe treatments of genitourinary syndrome (GSM) in post-menopausal women (PMW) is growing. Published data on the efficacy and safety of ospemifene (OSP) prompt an updated literature review to enlighten possible improvements in the GSM treatment. Area covered: We searched articles published in English from 2010 to 2023 through Medline (PubMed) and Embase databases with Boolean terms: OSP, PMW, GSM, endometrium, breast cancer, cardiometabolic syndrome, bone metabolism, adherence to treatment, and patient satisfaction. We selected randomized controlled trials (RCTs) and observational and cross-sectional studies and completed the search manually. Expert opinion: Of the 157 retrieved records, 25 primary studies met the inclusion criteria (15 regarding efficacy and safety, two for additional effects, and four for adherence and satisfaction with the OSP treatment). Seven RCTs involved nearly 5,000 patients, 10 out of 18 prospective observational studies 563, and six retrospective analyses 356,439. Evidence of OSP treatment in PMW with GSM relies on RCTs and remarkable real-world data. The 25 primary studies showcased the high clinical response to symptoms, the favorable safety profile of OSP with very few adverse events, a neutral impact on the endometrium, breast, bone, and thrombosis, and the possible improvement of cardiovascular risk factors. [ABSTRACT FROM AUTHOR]

Giulia Marchetti,1 Annika Taithongchai,2 Dudley Robinson2 1Urogynaecology Department, Irmandade de Misericórdia da Santa Casa de São Paulo, Sao Paulo, Brazil; 2Urogynaecology Department, King’s College Hospital, London, UKCorrespondence: Dudley Robinson, Email Dudley.robinson@nhs.netAbstract: Vulvar vaginal atrophy is a common condition affecting postmenopausal women, significantly impacting their quality of life. Fortunately, various treatment options are available, ranging from hormonal to non-hormonal therapies. Ospemifene has emerged as a promising non-hormonal alternative for managing vulvar vaginal atrophy. Its targeted approach, unique mechanism of action, favorable safety profile particularly for breast tissue, and efficacy make it a valuable option for women seeking relief from symptoms such as vaginal pain, dryness and dyspareunia and cannot receive estrogen supplementations. This is particularly the case for breast cancer survivors or women with a significant family history of estrogen-dependent cancers. Hence, tailored treatment plans, considering individual preferences and health circumstances, are essential in optimizing outcomes and improving the overall well-being of affected individuals.Keywords: ospemifene, vulvovaginal atrophy, genitourinary syndrome of menopause, breast cancer, detrusor overactivity

Objective: The study aimed to investigate the feasibility of a newly available topical gel in improving the symptoms of various vulvovaginal skin conditions (NCT05396261). Methods: Fifty-two women with diagnosed lichen sclerosus, lichen simplex chronicus, or genitourinary syndrome of menopause participated in this prospective single-arm feasibility study. Consented patients applied the product daily internally and externally to the genital area for approximately 6 months (short-term) and optionally up to 2 years (long-term). Outcome measures included patient-rated symptoms, investigator-assessed clinical signs, and visual severity of pathology of these vulvovaginal conditions. Clinical outcomes, patient adherence to the treatment, and adverse events were assessed, and the statistical analysis was split according to short-term and long-term treatment. Results: The majority of patients enrolled in the study suffered from an uncontrolled disease (90.4%). All patients showed significant improvement in all patient-rated symptoms (p < 0.001), overall clinical signs (p < 0.001), and visual severity of pathology (p < 0.001) short-term. These favorable results were maintained from month 6 up to 2 years. Patient compliance was high, and no adverse events were reported with use of the investigational product. Conclusions: This topical medical device could be an effective symptomatic management option for women suffering from various vulvovaginal conditions.

Background and Objectives: Postmenopausal vaginal discomfort is often attributed to vulvovaginal atrophy (VVA). Women with VVA experience symptoms such as vaginal dryness, itching, burning, irritation, and dyspareunia. Materials and Methods: This pilot study was conducted to assess the effects of a micro-ablative fractional CO2 laser on the clinical symptoms of VVA, as well as concordant sexual function. The severity of VVA symptoms was evaluated by a visual analogue scale (VAS), while the condition of the vaginal mucosa was evaluated using the Vaginal Health Index Score (VHSI). Sexual function was evaluated using the Female Sexual Function Index (FSFI) Questionnaire. Results: Our cohort included 84 sexually active postmenopausal women with bothersome VVA, leading to sexual health complaints. The mean age of the participants in our study was 55.2 ± 5.4 years, with an average postmenopausal period of 6 ± 4.8 years. The age of our patients and the length of their postmenopausal period exhibited a significant negative correlation with VHSI scores, while a longer postmenopausal period was associated with increased severity of vaginal dryness and dyspareunia. Baseline VHSI values showed that 65% of patients had atrophic vaginitis with pronounced VVA symptoms (70.2% experienced vaginal itching, 73.8% reported vaginal burning, 95.3% had vaginal dryness, and 86.1% suffered from dyspareunia). Lower VHSI values significantly correlated with lower FSFI scores, while more severe VVA symptoms scores correlated with lower FSFI scores. VVA symptoms were significantly less severe after treatment. VHIS regained high non-atrophic values in 98.8% of patients post-treatment (p < 0.001). FSFI total and domain scores were significantly higher after treatment (p < 0.001). Conclusions: Our study revealed that fractional CO2 laser is a useful treatment option to alleviate VVA symptoms and improve vaginal health and sexual functioning in postmenopausal women. [ABSTRACT FROM AUTHOR]

The issue of vaginal dryness in genitourinary syndrome of menopause (GSM) and its pervasive impact on women's quality of life is often overlooked. Extensive surveys conducted worldwide reveal limited understanding of vaginal dryness among public and health-care providers. Physician knowledge on menopause medicine varies globally, highlighting the need for standardized training. Effective communication between physicians and patients plays a crucial role in diagnosing and treating GSM symptoms. There are multiple treatment options to improve vaginal lubrication, including hormonal and non-hormonal therapies, along with lifestyle modifications. Tailoring treatments to individual patient preferences is crucial for compliance. Overall, GSM is multifaceted, from the prevalence of vaginal dryness to the nuances of treatment preferences. The urgency of widespread education and awareness of this matter must be underscored to meet the aim of enhancing the well-being and quality of life for women. [ABSTRACT FROM AUTHOR]

Background: Vulvovaginal atrophy (VVA) includes a wide range of conditions affecting the reproductive and urinary systems, often requiring careful evaluation and management for optimal health. Aims: This study aims to evaluate the symptom management effects of a real time temperature‐monitored non‐ablative RF device for the treatment of postmenopausal Chinese women with VVA symptoms. Methods: This pilot study involved 24 postmenopausal Chinese women with one or more VVA symptoms, who wished to remain sexually active. VHIS, VAS, and FSFI were used to track and evaluate various aspects of the patient's condition. Analyses were conducted at the end of the study to verify the statistical significance of the treatment's results. Results: All patients reported substantial, statistically significant, improvements on every VVA symptom tracked. Approximately 80% of the patients reported total symptom reversal at 12‐week post‐treatment follow‐up. Conclusion: This pilot study demonstrated that non‐ablative, monopolar RF technology equipped with real time temperature monitoring is feasible and safe in the treatment of postmenopausal women with VVA symptoms, and efficacious at up to 12 weeks post‐treatment. [ABSTRACT FROM AUTHOR]

Background and Objectives: Genitourinary syndrome, previously defined as vulvovaginal atrophy, manifests with signs and symptoms deriving from estrogen diminution in the female genitourinary tract. Stable ozonides are derivatives of artemisinin found to be stable against strong basic and acidic conditions. Vitamin E is an important antioxidant diminishing the output of reactive oxygen species in the oxidation of fats and the emanation of free radicals, reducing cellular injury and aging. The primary aim of the present study was to assess the positive effects of an ozonide plus a vitamin E acetate-based compound (Ozoile) on genitourinary syndrome symptom relief after a maximum of 20 days of treatment. Materials and Methods: The inclusion criteria for patients' enrollment were women of child-bearing age or in menopause reporting genitourinary syndrome's related symptoms, such as pain, burning, a bad smell, dyspareunia, dryness, itching, bleeding, and nervousness. The exclusion criteria were Sjogren's syndrome and patients administered retinoic acid, an agent that causes mucosal dryness. Participants completed a questionnaire before and after 20 days of treatment. Results: The incidence of pain decreased from 16.7% to 11.8% (p-value < 0.0001). In addition, the mean symptom intensity decreased from 2.10 to 0.87 (p-value < 0.0001). Dryness was the most frequent pre-treatment symptom and decreased from 85.5% to 53.8% (p-value < 0.0001) (mean: 2.21 vs. 0.90; p-value < 0.0001). Conclusions: Ozoile was effective in reducing most gynecologic symptoms related to genitourinary syndrome. However, further studies are needed to compare its effect with other standards of care. [ABSTRACT FROM AUTHOR]

A randomized controlled study was conducted to evaluate the safety and efficacy of radiofrequency treatment in postmenopausal women not willing to use or presenting a contraindication for menopause hormone therapy (MHT) and suffering from genitourinary syndrome of menopause (GSM). A prospective randomized open study evaluated the effect of radiofrequency treatment versus a gel (control group) in postmenopausal women suffering from GSM. Patients were assessed at baseline and after 10–12 weeks of treatment for severity of vulvovaginal atrophy, dyspareunia, pH, vaginal smear maturation index, Vaginal Health Index and Female Sexual Function Index. The difference at baseline and after 10–12 weeks of treatment and the difference in improvement were tested between groups by a two-sample t-test and the Mann–Whitney test. Due to the COVID-19 pandemic, we were only able to treat 48 patients (24 patients using radiofrequency and 24 patients using a gel). Globally, at the end of the study, there were no differences in changes of the measured outcomes between the group of women treated with radiofrequency and the control group. Radiofrequency treatment was found to be safe, but was not superior to a gel, although the study lacked power. The study was registered at ClinicalTrials.gov (NCT03857893). [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: The genitourinary syndrome of menopause (GSM), apart from symptoms related to vulvovaginal atrophy (VVA), also consists of lower urinary tract symptoms (LUTS). Based on the common embryological origin of the genital and lower urinary system, the presence of estrogen receptors, and the high prevalence of VVA and LUTS in the menopausal population, the two conditions can coexist. This study is aimed at investigating the prevalence and risk factors of LUTS in a sample of Greek peri- and postmenopausal women. Methods: Four hundred and fifty (450) women, aged 40–70 years, attending three outpatient gynecology clinics for routine examination, completed a structured interview and responded to a validated questionnaire (International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms, ICIQ-FLUTS). Results: Urinary urgency or frequency affected 51.6% and dysuria 43.6% of the participants. Mild urgency or frequency was described by 25.6%, moderate by 14.4%, and severe by 11.6% of the women. Mild dysuria was reported by 26.26%, moderate by 5.8%, and severe by 11.6%. Age, weight, BMI, and number of pregnancies and abortions correlated with a higher ICIQ-FLUTS score. Women with moderate/severe symptoms of VVA, such as irritation, a burning sensation, and pruritus of the vulva or vagina, had a higher ICIQ-FLUTS score than women without such symptoms (beta coefficient 2.42, CI 1.204, 3.635, p < 0.001). Conclusions: Lower urinary tract symptoms are very common among peri- and postmenopausal women and are linked to symptoms of VVA. Our data support the need for prompt evaluation of women transitioning to menopause, as these symptoms compromise the quality of life. [ABSTRACT FROM AUTHOR]

Background: Vulvovaginal atrophy (VVA) negatively affects the sexual well-being and quality of life of postmenopausal women, yet it is underreported and undertreated. Aim: The study sought to investigate the efficacy and safety of a nonablative, noncoagulative multipolar radiofrequency (RF) and pulsed electromagnetic field–based device (PEMF) in treatment of symptoms related to VVA. Methods: Seventy-six women ≥19 years of age with symptoms associated with VVA were enrolled into this prospective, randomized, sham-controlled, multicenter clinical study. Subjects were randomized to receive 3 RF + PEMF treatments (active group) or sham treatments (sham group) delivered to vaginal tissue at monthly intervals. The Vaginal Health Index (VHI), along with the Female Sexual Function Index (FSFI), subject sexual satisfaction and vaginal laxity (VL) score, treatment-associated pain, and adverse events were assessed at 4 follow-up (FU) visits between 1 and 12 months after treatment. Outcomes: Changes from baseline VHI, pH, FSFI, VL, and sexual satisfaction scores between the active and sham groups were compared before and after treatment. Results: Mean VHI scores in the active group were significantly better compared with the sham group after treatment at all but the last FU visit (P <.001). A greater decrease in pH (active over sham) was seen at 1 and 4 months after treatment (P <.05). FSFI improvement was shown in the active group; however, it was not significantly better than sham improvement at all FU visits. Subject sexual satisfaction in the active group showed better improvement over sham at all FU visits (P <.05), while VL evaluations saw greater improvement in the active group at 4, 6, and 12 months posttreatment (P <.05). Treatment satisfaction was greater in the active group and pain was minimal in both groups. No serious adverse effects were reported. Clinical Implications: As a noninvasive alternative to traditional surgical and topical procedures, 3 sessions of noninvasive combination RF/PEMF safely demonstrated improvement in symptoms related to VVA. Strengths and Limitations: This study was strengthened by the randomized, sham-controlled design; large sample size; and extended FU period. The study assessments were decreased at later FU visits due to the global COVID pandemic, and this was a key limitation to the study. Conclusion: Nonablative, noncoagulative multipolar RF/PEMF therapy was safe, improved symptoms associated with VVA, and improved female sexual function while yielding high subject satisfaction. [ABSTRACT FROM AUTHOR]

Genitourinary syndrome of menopause encompasses the group of urogenital signs and symptoms resultant from hypoestrogenism, including genital dryness, burning or irritation, sexual discomfort, pain or dysfunction, and urinary urgency, dysuria, and recurrent urinary tract infections. Genitourinary syndrome of menopause can have a profound impact on well-being, functioning, and quality of life in postmenopausal women. Treatment includes vaginal moisturizers and lubricants geared towards providing symptomatic relief; hormonal treatments which promote epithelial thickening and production of vaginal secretions; and pelvic floor physical therapy along with behavioral therapies that address pelvic floor hypertonicity and psychosocial factors. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

This review summarizes our current understanding of associations of the postmenopausal vaginal microbiome with genitourinary syndrome of menopause. We review the normal postmenopausal microbiota, examine the association of the microbiome with vulvovaginal symptoms, describe microbial communities associated with physical and laboratory findings, and report the impact of different treatments for genitourinary syndrome of menopause on microbiota and symptom improvement. Postmenopausal vaginal symptoms have an underlying pathophysiology that has not been fully elucidated. Estrogen treatment may not be sufficient to relieve symptoms of vaginal discomfort in all postmenopausal individuals. In addition, other interventions targeted at changing the microbiota or pH do not consistently improve symptom severity. [ABSTRACT FROM AUTHOR]

Scientific information is incomplete regarding the genitourinary syndrome of menopause. Both the lower genital and urinary tracts are rich in receptors for reproductive hormones and are highly susceptible to waning ovarian hormones at menopause. Symptoms of dryness and pain emerge in late perimenopause, but they can also result earlier from cancer therapies or bilateral oophorectomy. Lower urinary tract symptoms rise in prevalence at midlife and increase further with advancing age. Because ovarian senescence is typically followed by years of aging, some postmenopausal complaints may be attributable to increasing longevity. [ABSTRACT FROM AUTHOR]

OBJECTIVE: This study aims to compare the effects of vaginal estrogen and hyaluronic acid on vulvovaginal atrophy. PATIENTS AND METHODS: This randomized controlled study included a total of 300 patients, with 150 patients in each group (Group E and Group H). The VHI score was determined based on a pre-treatment evaluation conducted by a gynecologist. After one month of receiving vaginal estrogen in Group E and vaginal hyaluronic acid in Group H, the patients were re-evaluated by their physicians. RESULTS: A statistically significant difference was found between the pre- and post-treatment VHI scores in Group E and Group H (p = 0.000; p = 0.000). No statistical difference was found between Group E and Group H in terms of treatment efficacy (p = 0.712). The pre- and post-treatment complaints of dryness, itching, dyspareunia, burning, and dysuria were found to be statistically signifi- cant in Group E and Group H (p = 0.000; p = 0.000; p = 0.000; p = 0.000; p = 0.000 in Group E, respectively) (p = 0.000; p = 0.000; p = 0.000; p = 0.000; p = 0.000 in Group H, respectively). No statistical difference was observed regarding dyspareunia, dysuria, and burning complaints (p = 0.632; p = 0.106; p = 0.128, respectively). However, hyaluronic acid was found to be significantly more effective for itching complaints (p = 0.002), while estrogen was found to be significantly more effective for dryness complaints (p = 0.012). CONCLUSIONS: Hyaluronic acid and estrogen were equally effective in vaginal treatment. Hyaluronic acid may be preferred for patients in whom hormonal therapy is contraindicated or for those who prefer non-hormonal therapy. [ABSTRACT FROM AUTHOR]

Background: Menopause leads to a dramatic drop in ovarian function which lower the oestrogen in the circulating blood may cause atrophy of vaginal epithelium. Traditionally the atrophy of vaginal epithelium was managed by Kegels exercise but not attempted using reverse Kegels exercise. Purpose: This present study attempted the reverse Kegels exercise and compares the effectiveness with traditional Kegels exercise on vaginal atrophy and vaginal pH among postmenopausal women. Materials and Methods: 32 postmenopausal women in the age group between 40 to 60 years with vaginal atrophy were recruited and randomly assigned to one of the two groups: Traditional Kegels group (n=16) and Reverse Kegels group (n=16). The vulvovaginal symptom questionnaire (VSQ) and vaginal pH test kit were used as outcome measures to assess the vulvovaginal symptoms and vaginal pH level before and after the intervention. Results: The t-test analysis was used to analyse the comparison within and between the groups. The p value of the Vulvovaginal symptom questionnaire in post-test values between the groups was 0.0256 (p value < 0.05) which was statistically significant. Conclusion: Based on the outcome measures the participants in the traditional Kegels exercise found to be better in reliving the vulvovaginal symptoms. However, the vaginal pH level in both the groups after intervention does not show any changes. [ABSTRACT FROM AUTHOR]

Stem cell transplant proved its efficacy in increasing the survival rate among young patients diagnosed with hematological malignancies. A transplant conditioning regimen is particularly destructive on the genital system, often determining premature ovarian failure, accompanied by vulvovaginal atrophy and sexual dysfunctions. The aims of the present study were, first, to evaluate sexual dysfunctions among transplanted women, using clinical examination and the female sexual function index (FSFI), and second, to determine their impact on a couple's relationship. A prospective observational comparative study was performed and included 38 patients who underwent allogenic stem cell transplant (SCT) procedures for different hematological malignancies and 38 healthy patients (control group). This study included baseline evaluation, one-year, and three-year follow-up visits. In addition to anamnesis and medically obtained information, FSFI was evaluated to determine the impact of gynecological damage in a subjective manner. In the study group, vulvovaginal atrophy was diagnosed in 76.32%, with subsequent sexual dysfunctions in 92.10% of patients, based on FSFI scoring. Even though the results improved throughout the study, at the last visit, mild vulvovaginal atrophy was diagnosed in 81.58% of patients, and the FSFI score was abnormal for 21.05%. When compared to the control group, both sexual dysfunctions and FSFI results were considerably impaired, with statistical significance. There is a confirmed negative impact of sexual dysfunctions and self-declared FSFI on couple/marital status and couple relationships, with statistical significance, at the last visit. In conclusion, anatomical, functional, and psychological difficulties are a reality of long-term survivors after a stem cell transplant. They should be addressed and assessed equally to other medical conditions, as they may determine serious consequences and impact the sexual quality of life and the couple's relationship. [ABSTRACT FROM AUTHOR]

This study aimed to examine the impact of fractional CO2 laser treatment of pelvic symptoms in women who have undergone perineal trauma from vaginal delivery. It was a retrospective, monocentric analysis that encompassed all women assessed for pelvic discomfort or signs of vulvovaginal atrophy following vaginal delivery between 2013 and 2018. The severity of symptoms was assessed using the Visual Analogue Scale (VAS). Twenty-seven patients met the inclusion criteria and were sorted into two groups: (1) women who had undergone episiotomies during labor (n = 11); and (2) women who had experienced spontaneous tears during vaginal delivery (n = 16). For women with episiotomies, each treatment and subsequent evaluation consistently showed a significant reduction in dyspareunia intensity. A similar positive trend was observed regarding pain at the introitus (7.5 vs. 6.5 after the first treatment, p = 0.03; 6.5 vs. 3 after the second treatment, p = 0.01; 3 vs. 1 after the third treatment, p = 0.01). Among women experiencing spontaneous perineal tears during delivery, there was a notable decrease in dyspareunia following all treatments (8 vs. 7 after the first treatment, p = 0.01; 8 vs. 4 after the second treatment, p = 0.02; 3 vs. 1 after the third treatment, p = 0.03). The impact of laser treatment did not exhibit significant differences between women who underwent episiotomies and those who experienced spontaneous perineal tears. In conclusion, fractional CO2 laser can be regarded as a non-pharmacological option for managing pelvic floor symptoms in women who encountered perineal trauma during delivery, independently from the nature, spontaneity, or iatrogenesis of the perineal laceration. [ABSTRACT FROM AUTHOR]

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. 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. 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. 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. [ABSTRACT FROM AUTHOR]

To develop a model to identify women likely to be severely impacted by vulvovaginal atrophy (VVA), based on their experience of symptoms and non-clinical factors. Multivariate statistics and machine-learning algorithms were used to develop models using data from a cross-sectional, observational, multinational European survey. A set of independent variables were chosen to assess subjective VVA severity and its impact on daily activities. A final composite model was selected that included three categories of variables: clinical severity, patient demographics/clinical characteristics and Day-to-Day Impact of Vaginal Aging (DIVA) variables related to emotion/mood, impact on lifestyle and frequency of sex. The model accurately classified 71% of women. Three DIVA variables (feeling bad about yourself, desire/interest in sex, physical comfort related to sitting) explained much of the variation in the dependent variable of the model. Over 90% of the impact of VVA relates to certain psychosocial and behavioral aspects that can be identified without the need to consider physical signs/symptoms. Non-clinical factors can contribute significantly to the overall VVA burden. Questions used in developing the composite model could form the basis of an instrument to help screen women prior to clinical consultation and improve VVA management. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficacy of daily vaginal gel containing hyaluronic acid (HA) and Biosaccharide Gum-1 (BG-1) on vulvovaginal atrophy (VVA) and on sexual function and quality of life (QoL). Materials and methods: One hundred-four postmenopausal women with VVA were enrolled in the nonrandomized comparison cohort study. Of them, 50 women on HA/BG-1 participated in the study group and 54 women on lubricants/moisturizers on-demand as a control group.The primary endpoint was the efficacy of the vaginal gel on VVA evaluated by the Vaginal Health Index (VHI) score. Secondary endpoints included sexual behavior by the self-administered female sexual function index (FSFI) questionnaire, and quality of life (QoL), by the Short Form-36 questionnaire (SF-36). Results: All symptoms of AVV improved after 12 weeks of treatment in women on HA/BG-1. The VMI, although improved at the 12-week follow-up compared to baseline, it connoted a low estrogenic stimulation value. Sexual function improved significantly in women on HA/BG-1. Moreover, women reported a significant improvement in the somatic aspects of QoL. No benefits were obtained by the women in the control group. Conclusions: Treatment with HA/BG-1 could have used in postmenopausal women who complain of vaginal dryness. The amelioration of VVA-related signs could improve sexual function and QoL.

Laura Cucinella,1,2 Lara Tiranini,1,2 Chiara Cassani,1,3 Silvia Martella,4 Rossella E Nappi1,2 1Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy; 2Research Centre for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS San Matteo Foundation, Pavia, Italy; 3Unit of Obstetrics and Gynecology, IRCCS San Matteo Foundation, Pavia, Italy; 4Unit of Preventive Gynecology, IRCCS European Institute of Oncology, Milan, ItalyCorrespondence: Rossella E Nappi, Research Centre for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS San Matteo Foundation, Piazzale Golgi 2, Pavia, 27100, Italy, Tel +390382501561, Fax +390382516176, Email nappi@rossellanappi.comAbstract: Genitourinary syndrome of menopause (GSM) is a frequent consequence of iatrogenic menopause or anti-estrogenic adjuvant therapies in breast cancer survivors (BCSs). GSM may profoundly affect sexual health and quality of life, and a multidimensional unique model of care is needed to address the burden of this chronic heterogeneous condition. Severe symptoms may be insufficiently managed with non-hormonal traditional treatments, such as moisturizers and lubricants, recommended as the first-line approach by current guidelines, because concerns exist around the use of vaginal estrogens, particularly in women on aromatase inhibitors (AIs). Vaginal laser therapy has emerged as a promising alternative in women with GSM who are not suitable or do not respond to hormonal management, or are not willing to use pharmacological strategies. We aim to systematically review current evidence about vaginal laser efficacy and safety in BCSs and to highlight gaps in the literature. We analyzed results from 20 studies, including over 700 BCSs treated with either CO2 or erbium laser, with quite heterogeneous primary outcomes and duration of follow up (4 weeks– 24 months). Although evidence for laser efficacy in BCSs comes mostly from single-arm prospective studies, with only one randomized double-blind sham-controlled trial for CO2 laser and one randomized comparative trial of erbium laser and hyaluronic acid, available data are reassuring in the short term and indicate effectiveness of both CO2 and erbium lasers on the most common GSM symptoms. However, further studies are mandatory to establish long-term efficacy and safety in menopausal women, including BCSs.Keywords: genitourinary syndrome of menopause, GSM, vaginal laser, breast cancer, vulvovaginal atrophy, VVA

Obliterative surgical procedures have been classically used as a method to reduce pelvic organ prolapse in elderly women who do not wish to preserve the vagina for sexual intercourse. The aim of this video is to demonstrate a surgical technique of repairing complete labia majora fusion in a woman who had previously undergone one of these procedures. We present the case of an 80 year-old woman with a history of progressive difficulty on voiding onset and sensation of incomplete bladder emptying. She reported an obliterative procedure to correct her pelvic organ prolapse (POP) 10 years earlier. On physical examination, complete fusion of labia majora was observed, causing abnormal urinary drainage. Perineal reconstructive surgery was performed without complications and the application of topical Promestriene was prescribed. Optimal genital re-epithelization was observed during follow-up. As observed, patients undergoing obliterative surgery who present with genital atrophy are at increased risk of developing vulvar adherences. Applying vaginal moisturizers or local topical estrogens can prevent this condition. In severe vulvar fusions, early surgical treatment is recommended to prevent potentially serious complications. [ABSTRACT FROM AUTHOR]

Background and Objectives: Postmenopausal vaginal discomfort is often attributed to vulvovaginal atrophy (VVA). Women with VVA experience symptoms such as vaginal dryness, itching, burning, irritation, and dyspareunia. Materials and Methods: This pilot study was conducted to assess the effects of a micro-ablative fractional CO2 laser on the clinical symptoms of VVA, as well as concordant sexual function. The severity of VVA symptoms was evaluated by a visual analogue scale (VAS), while the condition of the vaginal mucosa was evaluated using the Vaginal Health Index Score (VHSI). Sexual function was evaluated using the Female Sexual Function Index (FSFI) Questionnaire. Results: Our cohort included 84 sexually active postmenopausal women with bothersome VVA, leading to sexual health complaints. The mean age of the participants in our study was 55.2 ± 5.4 years, with an average postmenopausal period of 6 ± 4.8 years. The age of our patients and the length of their postmenopausal period exhibited a significant negative correlation with VHSI scores, while a longer postmenopausal period was associated with increased severity of vaginal dryness and dyspareunia. Baseline VHSI values showed that 65% of patients had atrophic vaginitis with pronounced VVA symptoms (70.2% experienced vaginal itching, 73.8% reported vaginal burning, 95.3% had vaginal dryness, and 86.1% suffered from dyspareunia). Lower VHSI values significantly correlated with lower FSFI scores, while more severe VVA symptoms scores correlated with lower FSFI scores. VVA symptoms were significantly less severe after treatment. VHIS regained high non-atrophic values in 98.8% of patients post-treatment (p < 0.001). FSFI total and domain scores were significantly higher after treatment (p < 0.001). Conclusions: Our study revealed that fractional CO2 laser is a useful treatment option to alleviate VVA symptoms and improve vaginal health and sexual functioning in postmenopausal women.

Background and Objectives: Genitourinary syndrome, previously defined as vulvovaginal atrophy, manifests with signs and symptoms deriving from estrogen diminution in the female genitourinary tract. Stable ozonides are derivatives of artemisinin found to be stable against strong basic and acidic conditions. Vitamin E is an important antioxidant diminishing the output of reactive oxygen species in the oxidation of fats and the emanation of free radicals, reducing cellular injury and aging. The primary aim of the present study was to assess the positive effects of an ozonide plus a vitamin E acetate-based compound (Ozoile) on genitourinary syndrome symptom relief after a maximum of 20 days of treatment. Materials and Methods: The inclusion criteria for patients’ enrollment were women of child-bearing age or in menopause reporting genitourinary syndrome’s related symptoms, such as pain, burning, a bad smell, dyspareunia, dryness, itching, bleeding, and nervousness. The exclusion criteria were Sjogren’s syndrome and patients administered retinoic acid, an agent that causes mucosal dryness. Participants completed a questionnaire before and after 20 days of treatment. Results: The incidence of pain decreased from 16.7% to 11.8% (p-value < 0.0001). In addition, the mean symptom intensity decreased from 2.10 to 0.87 (p-value < 0.0001). Dryness was the most frequent pre-treatment symptom and decreased from 85.5% to 53.8% (p-value < 0.0001) (mean: 2.21 vs. 0.90; p-value < 0.0001). Conclusions: Ozoile was effective in reducing most gynecologic symptoms related to genitourinary syndrome. However, further studies are needed to compare its effect with other standards of care.

Abstract Background This study aimed to explore the current situation and existing issues regarding the management of vulvovaginal atrophy (VVA) or the genitourinary syndrome of menopause (GSM). A nationwide web-based questionnaire survey was conducted among 1,031 Japanese women aged 40 years or older. Materials and methods Eligible women were asked to complete a questionnaire about how they dealt with their symptoms and how satisfied they were with their coping methods. Results Of those highly conscious of their GSM symptoms (n = 208; 20.2%), 158 had sought medical consultation (15.3%), with only 15 currently continuing to seek consultation (11.5%). Of the specialties consulted, gynecology was the most frequently consulted (55%). Furthermore, those unwilling to seek medical consultation despite their symptoms accounted for the greatest proportion (n = 359; 34.8%), with 42 (23.9%) having never sought consultation. Topical agents, e.g., steroid hormone ointments/creams, were the most frequent treatments provided by the clinics (n = 71; 40.3%), followed by oral and vaginal estrogens (n = 27; 15.5%), suggesting that estrogen therapy was not the first choice of treatment at the clinics. While 65% of patients treated at the clinics reported satisfaction with the treatments, this was inconsistent with the fact that many were reported to have remained untreated and very few continued with treatment. Conclusions Survey results suggest that GSM, including VVA, remains underdiagnosed and undertreated in Japan. Medical professionals should deepen their understanding of GSM and raise their level of care to select the appropriate treatment for the condition.

Objective To develop a model to identify women likely to be severely impacted by vulvovaginal atrophy (VVA), based on their experience of symptoms and non-clinical factors.Methods Multivariate statistics and machine-learning algorithms were used to develop models using data from a cross-sectional, observational, multinational European survey. A set of independent variables were chosen to assess subjective VVA severity and its impact on daily activities.Results A final composite model was selected that included three categories of variables: clinical severity, patient demographics/clinical characteristics and Day-to-Day Impact of Vaginal Aging (DIVA) variables related to emotion/mood, impact on lifestyle and frequency of sex. The model accurately classified 71% of women. Three DIVA variables (feeling bad about yourself, desire/interest in sex, physical comfort related to sitting) explained much of the variation in the dependent variable of the model. Over 90% of the impact of VVA relates to certain psychosocial and behavioral aspects that can be identified without the need to consider physical signs/symptoms.Conclusion Non-clinical factors can contribute significantly to the overall VVA burden.Questions used in developing the composite model could form the basis of an instrument to help screen women prior to clinical consultation and improve VVA management.

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.

This study aimed to measure safety, systemic pharmacokinetics and preliminary efficacy of a vaginal tamoxifen capsule (DARE-VVA1) among postmenopausal women with moderate-to-severe vulvovaginal atrophy. This was a randomized, placebo-controlled, double-blind, phase 1/2 study of DARE-VVA1, in four doses (1, 5, 10 and 20 mg). Seventeen women were enrolled and 14 completed the 8-week treatment. DARE-VVA1 was safe. All adverse events were of mild or moderate severity and distributed similarly among active and placebo groups. Plasma tamoxifen concentrations were highest among women using DARE-VVA1 20 mg, but the maximum mean (standard deviation) plasma tamoxifen concentrations on day 1 (2.66 ± 0.85 ng/ml) and day 56 (5.69 ± 1.87 ng/ml) were <14% of those measured after one oral tamoxifen dose. Active study product users had significant decreases from pre-treatment baseline in vaginal pH and proportion of vaginal parabasal cells (p = 0.04 for both endpoints), with women randomized to the 10 mg or 20 mg dose experiencing the largest treatment impact. The severity of vaginal dryness and dyspareunia decreased significantly from baseline with active study product use (p = 0.02 for both endpoints). DARE-VVA1 is safe and results in minimal systemic exposure to tamoxifen. Preliminary efficacy data support further development of this product. [ABSTRACT FROM AUTHOR]

This study aimed to evaluate the self-reported satisfaction of Spanish postmenopausal women currently treated for vulvovaginal atrophy (VVA) symptoms. The CRETA (CRoss sectional European sTudy on Adherence) is a multicenter cross-sectional study conducted in 29 public and private hospitals in Spain, which enrolled postmenopausal women receiving treatment with ospemifene, local hormone therapy (HT) or vaginal moisturizers for VVA. After the prior informed consent of the patients, sociodemographic and treatment perception data were collected using a structured questionnaire. Among 752 women who completed the survey, the satisfaction score was significantly higher for the group treated with ospemifene (mean 8.3 ± 1.4) compared with the local HT group (7.2 ± 1.7) and the vaginal moisturizer group (6.5 ± 2.1) according to a 10-point Likert scale (p < 0.0001). Compared to vaginal moisturizers and local HT, participants treated with ospemifene reported the highest adherence (96.7% vs. 70.2% and 78.6%, respectively) and the lowest number of missed doses in the last month (0.6 ± 1.3 standard deviation [SD] vs. 3.5 ± 4.3 SD and 2.0 ± 2.8 SD, respectively) (p < 0.0001). Ospemifene was significantly perceived as easy to use (83.9% vs. 44.9% and 58.6%, respectively; p < 0.0001), efficacious in reducing the time to relieve symptoms (17.1% vs. 7.0% and 6.7%, p = 0.0005 and p = 0.0006, respectively) and convenient for sexual life (53.1% vs. 25.6% and 42.3%, p < 0.0001 and p = 0.0234, respectively). Among postmenopausal women with VVA, treatment with ospemifene has the most positive perceptions and the highest overall satisfaction level and could be an optimal therapeutic approach, maximizing patient adherence. [ABSTRACT FROM AUTHOR]