Vulvovaginal Atrophy Symptoms Research Articles

Rehabilitation of patients with vulvovaginal atrophy

Background. Genitourinary syndrome of menopause (GSM) is characterized by a number of pathological changes, in particular urological disorders, vulvovaginal atrophy (VVA) and sexual dysfunction. They are commonly accompanied by decreased quality of life (QoL) and often require medical intervention. At the same time, the steps taken to effectively solve this problem are not enough. Thus, it seems relevant to search for rehabilitation methods for VVA patients.Objective: to determine the effectiveness of current rehabilitation methods for VVA patients.Material and methods. The search of publications in international scientific databases PubMed/MEDLINE, ScienceDirect, search engines and eLibrary revealed 4,330 publications, of them 44 sources were selected for the analysis after the screening procedure according to PRISMA scheme.Results. VVA is based on decreased serum estrogen level and estrogen receptors quantity. Estrogen is a vasoactive hormone that promotes blood supply to the genitals and is involved in maintaining the normal genitourinary microflora. This may occur in women for age-related reasons or as a result of ongoing therapy or radical surgical intervention. At the same time, GSM is often formed, where VVA is one of the key elements. These changes are accompanied by sexual dysfunction, distress and decreased overall QoL in women. It is advisable to carry out complex personalized rehabilitation and QoL monitoring for such patients. The effectiveness of estrogen-containing therapy for topical use as well as adjunctive therapy with non-hormonal lubricants and moisturizing gels or creams was shown for VVA patients.Conclusion. It was determined that VVA symptoms, in general, significantly affect the patients’ QoL, regardless of age. The necessity of developing specialized rehabilitation programs conducted by specialists of various profiles was noted. The effectiveness of these programs will be higher with timely diagnosis, which also requires significant attention.

Multifaceted Impact of CO2 Laser Therapy on Genitourinary Syndrome of Menopause, Vulvovaginal Atrophy and Sexual Function.

Genitourinary syndrome of menopause (GSM) encompasses a range of distressing symptoms in the vulvovaginal and/or bladder-urethral regions related to menopause changes, negatively influencing woman's quality of life and sexual activity. Fractional micro-ablative CO2 laser therapy has shown the potential to reinstate the vaginal epithelium to a condition akin to the premenopausal state, thereby ameliorating the subjective symptoms associated with GSM. We conducted a prospective, pilot study in 73 sexually active postmenopausal women treated with CO2 laser for their GSM symptoms, while assessing Vaginal Health Index Score (VHIS) and sexual function through the Female Sexual Function Index (FSFI) Questionnaire. The laser treatment resulted in a decrease in VHIS and patient-reported vulvovaginal atrophy (VVA) symptoms, with a significantly lower prevalence of vaginal itching, dryness, and burning (p < 0.001), as well as dyspareunia (p = 0.002). The occurrence of urinary incontinence, urgency, and vaginal heaviness significantly reduced, with an improvement in the staging of cystocele, either to Stage 1 or complete resolution (p < 0.001). FSFI total and domain scores were significantly higher after the treatment, indicating better sexual function, with a post-treatment score median of 25 (p < 0.001). Therefore, using a three-cycle fractional CO2 laser was an effective choice for reducing urogenital discomfort related to GSM in postmenopausal women.

Understanding the Benefits of CO2 Laser Treatment for Vulvovaginal Atrophy.

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.

Photothermal tissue reconstruction and the use of phytoestrogens in the treatment of genitourinary menopausal syndrome

Introduction. Genitourinary syndrome of menopause (GSM) is a complex of symptoms resulting from changes to the vulvovaginal region, urethra and bladder due to estrogen and other sex steroid deficiency. Vulvovaginal atrophy is one of its manifestations, and vaginal dryness, dyspareunia, burning and itching are the most common symptoms.Aim. To analyse 20 clinical cases of the use of innovative laser procedures combined with phytoestrogens in patients with vulvovaginal atrophy as a symptom of GSM vs the standard systemic protocol for menopausal hormone therapy.Materials and methods. A clinical case-control study was conducted among 20 postmenopausal women. The age of the subjects ranged from 50 to 65 years with amenorrhea for at least 1 year, a follicle-stimulating hormone level of &gt;30 IU/L and various presentations of GSM. The women were divided into two groups: group 1 (n = 10) received laser therapy combined with phytoestrogens, group 2 (n = 10) received systemic menopausal hormonal therapy. To evaluate the results, a survey with a specialized international vulvovaginal symptom questionnaire (VSQ) was carried out to determine the vaginal health index scores before and after treatment.Results. After treatment, both groups showed significant improvement in the form of the reduction or disappearance of symptoms of vulvovaginal atrophy. The prescription of phytoestrogens provided an additional positive effect after 3 sessions of carbon dioxide laser treatment.Conclusion. The carbon dioxide laser exposure resulted in the reduction or disappearance of the local symptoms of climacteric syndrome in the form of GSM, and the use of phytoestrogens as part of Mense BAA supplemented the treatment of psychoemotional and neurovegetative changes, which allowed us to make a conclusion about the feasibility, high efficiency and safety of the complex treatment for women, who do not wish to take menopausal hormone therapy and (or) have absolute contraindications. However, further research on the laser technologies and other non-hormonal techniques to treat GSM is required to carry out a more complete and accurate assessment of the effectiveness and safety of these treatments.

Vulvovaginal atrophy: current methods of diagnosis and treatment

Aim. To review modern methods of diagnosis and treatment of vulvovaginal atrophy (VVA), which is one of the manifestations of genitourinary syndrome of menopause in periand postmenopausal women.Materials and methods. A review of domestic and foreign literature on the prevalence and modern methods of diagnosis and treatment of VVA was carried out.Results. Unlike vasomotor symptoms, VVA progresses with age, causing a significant impairment in women’s quality of life. Symptoms usually begin to bother perimenopausal patients, but their frequency and severity increase significantly in postmenopausal women. Diagnosis of VVA can present some difficulties, as many women perceive their condition as a natural manifestation of aging and do not seek medical care. Currently, drug and non-drug therapies for VVA have been proposed, each of which has its own characteristics, indications, and contraindications. However, the safety and effectiveness of some of them have not been fully proven.Conclusion. VVA is common in periand postmenopausal women. Modern aspects of the diagnosis and treatment of this pathology can significantly improve the quality of life of patients with VVA symptoms. However, further research is needed to confirm safety of the proposed treatment methods, and search for new techniques is required.

The Use of Carbon Dioxide (Co2) Lasers in the Treatment of Vulvovaginal Atrophy Symptoms in Perimenopausal and Postmenopausal Women

This study explores the efficacy of pixelated carbon dioxide (CO2) laser treatment in mitigating vulvovaginal atrophy symptoms among perimenopausal and postmenopausal women. This study examines the effectiveness of CO2 laser treatment in reducing vaginal discomfort for women experiencing menopause. With a cohort of 127 participants (mean age 47 ± 5 years), the researchers administered three sessions of vaginal CO2 laser treatment over three months. The primary evaluation metric was patient-reported satisfaction levels, aiming to assess the treatment's impact on alleviating symptoms associated with vulvovaginal atrophy, such as dryness, burning, and discomfort during intercourse. The findings revealed that 98% of the patients experienced significant symptom improvement three months post-treatment. Notably, 89% reported a resolution of sexual dysfunction due to vaginal dryness, and 96% indicated an end to discomfort and burning sensations. The satisfaction of the patients is extremely high, with 98% of the participants being satisfied with the results, and this satisfaction has persisted even after some time following the treatment. Furthermore, 95% of the women encountered no discomfort during the procedure, and any post-treatment complaints were mild and temporary, with a watery discharge being the most common. The study concludes that pixel CO2 laser treatment is a practical, painless, and efficient approach for addressing vulvovaginal atrophy symptoms, yielding high patient satisfaction rates. The study finds that using pixel CO2 laser treatment is a practical and painless way to help with symptoms of vaginal discomfort, and most patients are satisfied with the results.

The effects of a real-time temperature monitoring non-ablative monopolar radiofrequency technology on vulvovaginal atrophy symptoms in postmenopausal Chinese women.

Vulvovaginal atrophy (VVA) includes a wide range of conditions affecting the reproductive and urinary systems, often requiring careful evaluation and management for optimal health. 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. 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. 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. 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.

Prescriber perceptions of boxed warnings: A qualitative study.

To explore how boxed warning (BW) information fits within the context of prescribers' overall treatment decision-making and communication with patients. In-depth interviews (N = 52) were conducted with primary care providers and specialists. Participants were presented with one of two prescribing scenarios: (1) estrogen vaginal inserts to treat vulvovaginal atrophy (VVA) associated with menopause; or (2) direct-acting antivirals (DAA) to treat chronic hepatitis C virus infection (HCV). The semi-structured interviews explored participants' treatment decision-making within the scenario, reactions to current prescribing information for a product within the FDA-approved drug class, as well as their perceptions of BWs generally. Across scenarios, providers described that the BW is only one of several factors that influence treatment decision-making. In the VVA scenario, symptom severity, family history, and experience with nonprescription drugs were raised as common factors that influence prescribing considerations; compared to comorbid infections, viral load, and HCV genotype in the HCV scenario. Perceptions of the DAA BW were generally positive or neutral, as many participants found the information important and appropriate. The VVA BW was viewed less favorably, with many participants stating the BW overstates the risk for this drug. Findings suggest that BWs are one of several factors that influence providers' treatment decisions, and BW influence largely depends on context. Providers across scenarios expressed notable differences in their perceptions of the risk information provided in the presented BWs; however, across scenarios participants expressed consideration of how patients may perceive the BW.

(124) An Open-Label, Vulvoscopic Pilot Study of Intravaginal Prasterone in Menopausal Women with Dyspareunia Examining Vestibular Tissue Changes

Abstract Introduction Prasterone (DHEA), a daily 6.5 mg intravaginal insert, is approved in the US and Canada for moderate to severe dyspareunia, a symptom of vulvovaginal atrophy from menopause. Prasterone converts intracellularly in vaginal epithelial cells into active androgens and estrogens without affecting systemic hormone blood levels. Although prasterone is a vaginal insert, the significant reduction of pain in the phase 3 registration trials suggests improvement of the vestibular endodermal genital tissue health associated with dyspareunia in androgen and estrogen deficient states like menopause. To the best of our knowledge, there have not been previous prospective studies documenting visible changes to the vestibule with daily administration of 6.5 mg prasterone in menopausal women with vulvovaginal atrophy and moderate to severe dyspareunia. Objective It is the aim of this study to investigate whether an intravaginal therapy, prasterone, could affect the vestibular tissue, assessing for changes in visual appearance, pain, and responses on sexual event diaries over the 20-week administration of intravaginal 6.5 mg prasterone. Methods This 20-week, open-label, prospective, pilot study included 11 menopausal women (median age = 56 y) treated daily with 6.5 mg prasterone intravaginal inserts and assessed every 4 weeks. During vulvoscopy, vestibular pain was assessed by cotton-tipped swab testing and vestibular and vaginal health were independently assessed using the Visual Scale (VS). In addition, vulvoscopic photographs were obtained and assessed using the Vulvoscopic Genital Tissue Appearance (VGTA) scale to evaluate overall genital tissue health. Mean changes from baseline for genital tissue health and pain assessments were analyzed by repeated measures one-way analysis of variance, followed by Dunnett’s post-hoc test. Sexual event diaries were completed, and adverse events recorded. Results Eleven participants completed the study, with a total of 1607 vulvoscopic photographs, showing reduction in vestibular erythema and pallor at end of study. Total VGTA scores at week 20 showed improvement from baseline (mean change = -7.9, p = 0.0016). Changes in VS scores were significantly reduced from baseline after active treatment by week 4 and maintained through week 20 for the vestibule (3.00, p = 0.004) and vagina (4.00, p = 0.002) respectively), suggesting improved vestibular and vaginal tissue health. Cotton-tipped swab test scores were significantly reduced from baseline after week 8 through week 20 (mean change = (-7.27, p = 0.019), suggesting decreased pain. Diary results showed decrease in pain from 81.3% during the first month to 8.3% during the last month of the study, with sexual activities discontinued due to discomfort reduced from 45.8% to 6.3% respectively. No prasterone related adverse events were reported. Conclusions This is the first prospective vulvoscopic study showing that intravaginal hormone therapy significantly improves total VGTA, VS and cotton-tipped swab test scores. This observation may explain the robust effect of prasterone in lowering dyspareunia in menopausal women with moderate to severe dyspareunia. Our findings suggest that intravaginal prasterone exerts biologic activity on the androgenic endodermal vestibule, as the medication passes from vagina to vestibule, resulting in amelioration of pain associated with sexual activity. Disclosure Yes, this is sponsored by industry/sponsor: AMAG Pharmaceuticals, Inc. Clarification: Industry funding only - investigator initiated and executed study.

Lower Urinary Tract Symptoms in Greek Women After Menopause: The LADY Study.

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. 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). 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). 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.

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.

Efficacy of a Diode Vaginal Laser in the Treatment of the Genitourinary Syndrome of Menopause.

Genitourinary syndrome of menopause (GSM) and vulvovaginal atrophy (VVA) are the most frequent menopause-related clinical entities and are consistently included in the definition of pelvic floor disorders (PFDs). Nonhormonal therapies, such as lubricants and moisturizers, are indicated as first-line treatments, while the "gold standard'' is represented by topical estrogen products; however, in cancer survivors hormonal treatment is not indicated. For this reason, energy-based therapeutic approaches-for instance, through laser technologies-may be employed as alternative options in this kind of patient; however, there are no studies evaluating the efficacy of a pure diode vaginal laser in the treatment of GSM. As a consequence, with our study, we aimed to evaluate outpatient nonablative diode laser treatment in sexually active women, with contraindications, no response, or refusal of local estrogenic therapy. This prospective study included patients with GSM, aged ≥ 18 years old, with contraindications, or refusal of local estrogen therapies. Women were evaluated via the use of their Vaginal Health Index (VHI) scores, which consists of five measures: elasticity, fluid volume, pH, epithelial integrity, and moisture. Moreover, the intensity of VVA symptoms (vaginal burning, vaginal itching, vaginal dryness, dyspareunia, and dysuria) was measured using a 10 cm visual analog scale (VAS), where the left extreme of the scale (score = 0) indicated "absence of symptom" and the right indicated "symptom as bad as it could be" (score = 100). Sexual function was evaluated with the Female Sexual Function Index (FSFI-19) questionnaire. The treatment was performed using a Leonardo Dual diode laser (Biolitec Italia Srl, Milano, Italy). The laser treatment consisted of three sessions, one per month. One month after the third session, the VHI, symptom VAS, and FSFI-19 were re-evaluated. In addition, the Patient Global Impression of Improvement (PGI-I) questionnaire was collected. Our study enrolled a total of 26 consecutive patients. All patients were either in menopause or under treatment with gonadotropin-releasing hormone (GnRH). None of the patients reported adverse effects after laser treatment. In total, 19 (73.1%) patients referred improvements of their symptoms according to PGI-I scores. All domains of the FSFI-19 questionnaire, significantly improved after the diode laser treatment. The mean VHI score increased by 3.2 points, from 12.2 to 15.4 (p < 0.001). Additionally, we documented a significant improvement in symptoms affecting the VAS score, from 69.2 to 43.5 points (p < 0.001). A diode vaginal laser is an effective and easily tolerated ambulatory procedure for vaginal functional restoration in the treatment of GSM and VVA.

Vaginal Laser Treatment for the Genitourinary Syndrome of Menopause in Breast Cancer Survivors: A Narrative Review.

Vulvovaginal atrophy (VVA) is a chronic condition resulting from reduced estrogen levels during menopause. The North American Menopause Society and the International Society for the Study of Women's Sexual Health suggested the term "genitourinary syndrome of menopause" (GSM) to indicate the broader aspects of VVA. Breast cancer treatments, such as chemotherapy and endocrine therapy, can induce early and abrupt menopausal symptoms, including GSM, which negatively affects sexual function and the quality of life of the survivors. Vaginal laser therapy has emerged as a safe and effective option for the management of GSM in breast cancer survivors (BCSs). Two main types of lasers, the non-ablative erbium:YAG laser and fractional microablative CO2 vaginal laser, have been evaluated for GSM treatment. While there are few randomized controlled trials (RCTs) on the subject of BCSs, a wealth of prospective and retrospective studies have highlighted the beneficial effects of vaginal laser therapy on the symptoms of VVA, vaginal health, sexual function, and overall quality of life. More comprehensive research is essential to confirm its enduring effectiveness and safety, with a focus on conducting standardized and meticulously controlled investigations. This study is a narrative review that summarizes clinical trials ranging from the earliest to the most recent ones on laser treatment for GSM in BCSs.

Treatments and Management of Menopausal Symptoms: Current Status and Future Challenges

In the United States (US), menopause occurs at an average age of 52. Menopausal symptoms tend to be maximal during the few years before and the year after menopause (during perimenopause), except for symptomatic vulvovaginal atrophy, which may worsen over time. Up to 20% of bone density loss occurs during the first 5 years after menopause, followed by an age-related bone loss rate similar to that in men. Menopause should be considered confirmed if an age-appropriate woman who is not pregnant has not had a menstrual period for 12 months. Regarding treatment, for vaginal dryness or dyspareunia due to menopause, vaginal stimulation and vaginal lubricants and moisturizers are recommended, and if these are ineffective, low-dose vaginal estrogen, in the form of creams, tablets, suppositories, or rings should be considered; other options include oral ospemifene or intravaginal dehydroepiandrosterone (DEHA) suppositories. Before prescribing hormone replacement therapy (HRT) and periodically while therapy continues, women should be informed of risks (e.g., deep vein thrombosis [DVT], pulmonary embolism [PE], stroke, breast cancer, gallbladder disease, and urinary incontinence); potential harms are greatest for women who start HRT after 60 years of age or who are 10-20 years past menopause onset. If women choose HRT to relieve hot flushes, estrogen plus, a progestin or conjugated estrogen/bazedoxifene could be prescribed for women who still have the uterus. Treatment with HRT should be tailored to maximize benefits and minimize harms, and periodically benefits and harms should be reassessed; low-dose transdermal HRT may lead to a lower risk of DVT and stroke. Selective serotonin reuptakereuptake inhibitors (SSRIs), selective serotonin-nor-epinephrine reuptake inhibitors (SNRIs), and gabapentin could be considered as less effective alternatives to HRT for relieving hot flushes; paroxetine 7.5 milligrams (mg) is the only non-hormonal drug approved in the US for the relief of hot flushes. Effective non-drug options include cognitive behavioral therapy and hypnosis.

Effects of Non-Ablative Solid-State Vaginal Laser (SSVL) for the Treatment of Vulvovaginal Atrophy in Breast Cancer Survivors after Adjuvant Aromatase Inhibitor Therapy: Preliminary Results.

One of the side effects of anti-estrogen treatments in breast cancer survivors (BCSs), especially with aromatase inhibitor (AI) treatment, is the frequent appearance of vulvo-vaginal atrophy (VVA). We aim to evaluate the efficacy, safety and feasibility of a new type of non-ablative Solid-State Vaginal Laser (SSVL) treatment in BCSs with VVA. A total of 30 BCSs with a history of AI use and symptoms of VVA were treated with a non-ablative SSVL (LASEmaR 1500™-EUFOTON)in this non-randomized pilot study. The effects of the laser have been evaluated at baseline, 10 wk and 24 wk using a visual analogue scale (VAS), the Vaginal Health Index (VHI), the Vulvar Health Index (VuHI), the Female Sexual Function Index (FSFI), the EORTC QLQ-BR23, the Vaginal Maturation Index (VMI) and vaginal pH. At 10-week follow-up vs. baseline there were no statistically significant differences in FSFI, lubrication and EORTC QLQ-BR23. In all the subjective (dyspareunia, VHI, VuHI, FSFI, QLQ) and objective parameters (VMI and pH) there was a statistically significant improvement at the 6-month follow-up. Satisfaction was very high (4.7 out of 5), with 95.7% of patients being satisfied, more than or very satisfied. Preliminary results of SSVL treatment of VVA and dyspareunia in BCSs after AI treatment suggest clinical improvement, without relevant side effects and with a high degree of satisfaction.

The Impact of Systemic Sclerosis on Sexual Health: An Italian Survey.

To evaluate the impact of systemic sclerosis (SSc) on vulvovaginal atrophy (VVA) and sexual health in an Italian population. An Italian survey about the prevalence and severity of VVA (on a 0 to 10 scale) and sexual dysfunction (using the Female Sexual Function Index-FSFI) through an anonymous online questionnaire. We investigated couple relationships and intimacy with partners, the predisposition of patients to talk about their sexual problems, physicians' receptivity, and treatment scenarios. Risk factors for VVA symptoms and sexual dysfunction were assessed. A total of 107 women affected by SSc were enrolled. Of these, 83.2% of women (89/107) complained about VVA symptoms and 89.7% (among sexually active women; 87/97) about sexual dysfunction. Menopausal status did not affect VVA symptoms, while age was the only independent risk factor for sexual dysfunction. About 70% (74/107) of women reported a negative impact of disturbances on intimacy with their partner. A total of 63 women (58.9%) had never discussed their sexual problems and VVA condition with a physician. Lubricants were the only treatment prescribed, and 75% of women would welcome new therapies, even if experimental (62.9%). In women with SSc, VVA symptoms and sexual dysfunction are highly prevalent, independently from menopause. In more than half of the investigated women with SSc, we found reluctance to talk about their sexual problems, despite being symptomatic. This should encourage physicians to investigate vulvovaginal and sexual health. SSc patients would welcome the advent of new treatment possibilities for their VVA and sexual complaints.

A Prospective Study to Investigate the 12-week Efficacy of Soy Isoflavone Vaginal Gel (0.5%) in Postmenopausal Women with Symptoms of Vulvovaginal Atrophy

A Prospective Study to Investigate the 12-week Efficacy of Soy Isoflavone Vaginal Gel (0.5%) in Postmenopausal Women with Symptoms of Vulvovaginal Atrophy

Comparison of the effect of vaginal vitamin E cream with conjugated estrogen vaginal cream on vulvovaginal atrophy and overactive bladder syndrome: a randomized controlled trial

ObjectivesThe present study aimed to investigate the effect of vitamin E on vulvovaginal atrophy (VVA) and overactive bladder syndrome (OABS).Materials and methodsThis trial was conducted on 72 postmenopausal women referring to health centers. Participants were randomly divided into the intervention (vitamin E, vaginal cream) and control (conjugated estrogen, vaginal cream) groups. The duration of the intervention was eight weeks, as they took medicine every day in the first week and then, twice a week. The primary outcome is to compare the symptoms of VVA in the intervention and control groups, and the secondary outcome includes the comparison of the mean score of OABS, pH, vaginal health index (VHI), and side effects eight weeks after treatment.ResultsThe mean score of VVA in both groups improved significantly during eight-week, and the difference between the groups was not statistically significant [Adjusted mean difference (AMD): 0.63, 95% Confidence interval (CI) − 1.03–2.28, p = 0.449]. The mean score of OABS decreased significantly in both groups, and the difference between the groups was not statistically significant [AMD: 0.261, 95% CI − 1.278–1.799, p = 0.736]. The mean score of VHI increased significantly in both groups, and the difference between the groups was not significant [AMD: 0.64, 95% CI − 0.13–1.42, p = 0.101].ConclusionVaginal vitamin E cream may be an alternative to vaginal estrogen in the symptom relief of vaginal atrophy and OABS among postmenopausal women, especially those who cannot use hormone therapy.

(012) Vulvovaginal Atrophy (VVA) Treatment Compliance Correlates with Improved Outcome

Abstract Introduction To effectively manage chronic conditions such as VVA, daily or semi-daily patient compliance to a treatment regimen is essential. Despite the fact that risk of cancer or cancer recurrence prevents many women from treating their VVA with hormone therapy, patient compliance to over-the-counter moisturizers and lubricants is relatively low: 40% of women find them completely unsatisfactory due to difficulty of use and lack of desired treatment outcome. As an alternative to current therapies, an at-home, easy-use therapeutic ultrasound device was developed with the potential to increase treatment compliance and help women successfully manage their VVA. This study aimed to optimize patient compliance by increasing ease of device use, minimizing therapy side effects, and tracking self-reported patient data electronically. Objectives To assess the correlation between patient-reported and objectively tracked actual compliance to therapy, as well as the association between treatment compliance and improvement in patient condition. Methods This randomized (1:1), double-blind, sham-controlled trial assessed the effectiveness of a daily, at-home ultrasound therapy, applied to the vaginal introitus for 8 min/day over the course of 12 weeks, on menopausal vaginal dryness in an ambulatory setting (Clinicaltrials.gov NCT00583-1). In 30 post- menopausal women (ages 48-70), device use compliance was collected via a self-reported electronic diary completed daily on a mobile phone. Objective compliance data were obtained from a logger installed in all devices, which recorded the duration and time the device was used every day. Participants self- assessed change (from baseline to 12 weeks) in VVA symptoms (vaginal dryness, soreness, irritation, dyspareunia) measured by the Vaginal Assessment Scale (VAS) with a 4-level response score ranging from none, mild, moderate, to severe. Healthcare providers evaluated change in vaginal tissue response (tissue elasticity, vaginal fluid, pH, mucosa, and vaginal moisture) assessed by the Vaginal Health Index (VHI) giving a numerical score (1-5) for each of the 5 parameters. Results After week-12 follow-up, participants in the operating group self-reported compliance (mean ± SE%) of 85.4 ± 5.4% and the device log objectively tracked compliance of 80.7 ± 7.2% (paired t-test, P=0.17). The sham group had self-reported compliance of 89.5 ± 2.1% and the device log compliance of 82.5 ± 5.2% (P=0.14). There was no significant difference (ANOVA) between operating and sham groups compliance for self-reported (P =0.46) or objective log data (P =0.83). With both operating and sham groups combined, there was a significant strong correlation (r=0.76, P&amp;lt;0.0001) between self-reported and device log compliance. Linear regression showed a significant positive dose-response between treatment and change in VHI score from baseline to week 12 (r=0.51, P=0.04). A smaller positive correlation was observed between treatment compliance and participants’ self-assessed change in VAS score (r=0.40, P=0.28). Conclusions Objective device use compliance was high (80.7-82.5%) across both groups assessed, indicating general participant desire to receive the therapy. In addition, participants with higher treatment rates had better scores in VHI, which indicated decreased VVA severity. For post-menopausal women, high adherence to the daily at-home ultrasound therapy proved efficacious in improving their condition of VVA and could offer a new therapeutic option. Disclosure Yes - Madorra. Industry funding only - investigator initiated and executed study – Yes.

Efficacy, tolerability, and endometrial safety of ospemifene compared with current therapies for the treatment of vulvovaginal atrophy: a systematic literature review and network meta-analysis.

Ospemifene is a novel selective estrogen receptor modulator developed for the treatment of moderate to severe postmenopausal vulvovaginal atrophy (VVA). The aim of the study is to perform a systematic literature review (SLR) and network meta-analysis (NMA) to assess the efficacy and safety of ospemifene compared with other therapies used in the treatment of VVA in North America and Europe. Electronic database searches were conducted in November 2021 in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Randomized or nonrandomized controlled trials targeting postmenopausal women with moderate to severe dyspareunia and/or vaginal dryness and involving ospemifene or at least one VVA local treatment were considered. Efficacy data included changes from baseline in superficial and parabasal cells, vaginal pH, and the most bothersome symptom of vaginal dryness or dyspareunia, as required for regulatory approval. Endometrial outcomes were endometrial thickness and histologic classifications, including endometrial polyp, hyperplasia, and cancer. For efficacy and safety outcomes, a Bayesian NMA was performed. Endometrial outcomes were compared in descriptive analyses. A total of 44 controlled trials met the eligibility criteria (N = 12,637 participants). Network meta-analysis results showed that ospemifene was not statistically different from other active therapies in most efficacy and safety results. For all treatments, including ospemifene, the posttreatment endometrial thickness values (up to 52 wk of treatment) were under the recognized clinical threshold value of 4 mm for significant risk of endometrial pathology. Specifically, for women treated with ospemifene, endometrial thickness ranged between 2.1 and 2.3 mm at baseline and 2.5 and 3.2 mm after treatment. No cases of endometrial carcinoma or hyperplasia were observed in ospemifene trials, nor polyps with atypical hyperplasia or cancer after up to 52 weeks of treatment. Ospemifene is an efficacious, well-tolerated, and safe therapeutic option for postmenopausal women with moderate to severe symptoms of VVA. Efficacy and safety outcomes with ospemifene are similar to other VVA therapies in North America and Europe.