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Objective: We aimed to evaluate real-world data for the use of fractional CO2 laser therapy for treating symptoms of vulvovaginal atrophy (VVA). Background: VVA is widespread and can reduce the pat...

To assess vaginal health, endometrial thickness, and changes in bone markers in postmenopausal women with vulvovaginal atrophy (VVA) treated with 60 mg/day of ospemifene under routine clinical practice.The AYSEX study is a Spanish observational and prospective study performed in one center in which 5 gynecologists recruited postmenopausal women with VVA in routine clinical practice treated continuously with ospemifene 60 mg/day for 12 months as an appropriate therapeutic option. This article refers to the 3- and 6-months analysis. Vaginal health was assessed by pH and using Vaginal Health Index (VHI) at baseline and 3 months later. Endometrial thickness, measured by vaginal ultrasonography, and bone resorption marker (CTx) were assessed at baseline and 6 months later.A total of 100 postmenopausal women cytologically and clinically diagnosed with VVA were included in the study. After 3 months of treatment with ospemifene, pH improved from 6.1 to 4.5 (Up to date, this is the only prospective and observational study with ospemifene in routine clinical practice conditions and confirms the results previously reported from randomized controlled clinical trials, improving VVA, not increasing endometrial thickness, and decreasing CTx levels by exerting an anti-resorptive function.

Physiological loss of ovarian function during the menopausal transition often leads to the development of unfavorable symptoms associated with vulvovaginal atrophy, recurrent urinary tract infections and dyspareunia. Currently, the scientific community is actively discussing the risks and benefits of prescribing menopausal hormone therapy to relieve the consequences of estrogen deficiency. The study of vaginal microbiota in dynamics made it possible to take a deeper look at the development of genitourinary menopausal syndrome and associate several microorganisms with specific undesirable manifestations. The link between recurrent urinary tract infections during menopause and physiological replacement of microbiota by opportunistic flora with the development of unpleasant symptoms resolves doctors to resort to irrational courses of antibiotic therapy. The review is devoted to the generalization of information on microbiological changes in the vagina during perimenopause, the possibilities of choosing the optimal hormone therapy for the correction of symptoms, the use of new promising methods, including management by modulating the vaginal microbiota.

Introduction: Vulvovaginal atrophy (VVA) is a chronic condition caused by estrogen deficiency. It affects around 50% of postmenopausal women, reducing their general and sexual quality of life as well as the quality of their personal relationships. Aim: The aim of this clinical guide is to set out an individualized approach to the management of VVA with topical estrogens and non-hormonal preparations. Materials and methods: Literature review and consensus of expert opinion. Summary recommendations: An individualized approach is required for the management of VVA. Topical low-dose estrogens are effective and also alleviate urinary incontinence and prevent recurrent urinary tract infections. Women should not be denied long-term use of topical estrogens as long as they feel that this treatment is of benefit to them, because the safety data are reassuring. Non-hormonal preparations (lubricants and moisturizers) should be the first-line treatment for VVA in women taking adjuvant endocrine therapies for cancers considered to be hormone-dependent. They can be used over the long term. Sistema de Investigacion y Desarrollo (SINDE) ; Vice-Rectorado de Investigacion & Postgrado (VRIP) of the Universidad Catolica de Santiago de Guayaquil, Guayaquil, Ecuador

Objective: Symptoms, such as vaginal laxity, dryness, dyspareunia, itching, burning, and urine leakage, associated with vulvovaginal atrophy (VVA) with hypo-osteogenesis etiology, are frequently seen in postmenopausal females, and they diminish quality of life. This study aimed to evaluate the efficacy of CO2 laser treatment in these cases and to evaluate the potential side-effects related to this type of treatment. Materials and Methods: A retrospective examination was made of the clinical examination and treatment records of 30 patients, aged 48–72 years, who presented with VVA complaints and underwent CO2 laser treatment for a total of three sessions at intervals of 4–6 weeks. The VVA symptoms of all the patients were evaluated using a Visual Analog Scale (VAS) before the first laser session and 4 weeks after the final session. Results: The VVA symptoms of dryness, painful sexual relations, vaginal burning, itching, and vaginal introitus pain were evaluated with VAS scores; a statistically significant reduction was determined in all five symptoms after CO2 laser treatment. Conclusion: A significant reduction was obtained in the VVA complaints with no significant side-effects following the application of CO2 laser treatment for VVA cases in the postmenopausal females. Thus, this treatment can be considered to a reliable alternative for patients who do not wish to use local estrogen creams long-term, those with a history of breast or gynecological cancer, and those with contra-indications for the use of local estrogen.

Vulvovaginal atrophy (VVA) is a common menopause-related symptom affecting more than 50% of midlife and older women and cancer patients whose ovarian function are lost or damaged. Regardless of estrogen deficiency, whether other factors such as the gut microbiota play role in VVA have not been thoroughly investigated. To this end, we performed ovariectomy on 12-weeks' old mice and follow-up at 4 weeks after ovariectomy, and observed atrophied vagina and an altered gut microbiota in ovariectomized mice.. We further performed fecal microbiota transplantation with feces from another cohort of ovary-intact fecund female mice to the ovariectomized ones, and found that the vaginal epithelial atrophy was significantly alleviated as well as the gut microbiota was pointedly changed. All these results suggest that ovarian activity has some influence on the gut microbiota, and the latter from the ovary-intact female mice can somehow make the vagina of mice deficient in ovarian function healthier maybe by up-expressing ESR1 in vaginal cells and enhancing regeneration in vagina. This kind of association between gut microbiota and vaginal health need further exploration such that it may provide an alternative treatment by modulating gut microbiota in patients suffering from VVA but may be reluctant to hormone therapy.

The aim of current study was to estimate the impact of vulvovaginal atrophy (VVA) on sexual function in a clinical population of Italian postmenopausal women. Women aged 45-75 years with at least one VVA symptom completed three questionnaires: Day-to-Day Impact of Vaginal Aging (DIVA), Female Sexual Function Index (FSFI) and Female Sexual Distress Scale revised (FSDS-R). A gynaecological examination was performed for VVA confirmation. Among the 1,066 evaluable patients, VVA was confirmed in around 90% of the sample. Sexual function impairment was significantly higher in patients with confirmed VVA as observed by significant differences in the sexual function component of the DIVA questionnaire (

Urogenital aging is a common process affecting all women in the post-menopausal period of their life, and it is substantially due to oestrogen deprivation after ovarian function cessation. These changes can lead to a progressive, chronic, and complex association of symptoms identified as the genitourinary syndrome of menopause, which has a significant impact on quality of life. Genitourinary syndrome and urogenital aging do not resolve spontaneously and usually recur when treatment is stopped. Therefore, appropriate long-term management is of paramount importance, and local oestrogen is the most effective treatment to reverse urogenital aging and to improve symptoms of genitourinary syndrome as replacement therapy. In some women, topical oestrogen may be inconvenient, it may not achieve complete response, or it may be contra-indicated. Several non-hormonal therapies have been investigated, but few treatments have been reported as potentially able to reverse the urogenital aging process similarly to exogenous oestrogens. Laser seems the most promising, although further studies to define its safety and efficacy are mandatory. Vitamin D and E, and phytotherapy have returned conflicting results and require further confirmation. Lifestyle modifications, physiotherapy, and electrical stimulation represent inexpensive and applicable treatments that might slow urogenital aging. Among the hormonal non-oestrogenic therapies, the use of vaginal oxytocin and dehydroepiandrosterone have been found to be effective compared to placebo, as well as the use of oral ospemifene, which partially relieves vulvovaginal atrophy.

Zusammenfassung Die menopausale Hormontherapie (MHT) begann 1942 in den USA und wurde weltweit in den 1960er-Jahren wegen der sehr erfolgreichen Behandlung vegetativer und vasomotorischer Beschwerden sehr populär. Diese manifestieren sich in vielen Fällen schon prämenopausal und können über ca. 10 Jahre andauern und die Lebensqualität erheblich einschränken. Viele Frauen stellen sich in dieser perimenopausalen Lebensphase nicht primär beim Gynäkologen, sondern beim Hausarzt oder Kardiologen vor, da Blutdruckschwankungen und insbesondere die typischen nächtlichen Palpitationen Angst machen. Eine fachübergreifende Betrachtung kann unnötige diagnostische Maßnahmen bis zur invasiven Herzkatheteruntersuchung und inadäquate Therapien mit Betablockern, Antidepressiva und Sedativa vermeiden.Daneben ist es auch in der hausärztlich-internistischen Praxis wichtig, die Auswirkungen sowohl eines Hormonmangels als auch einer Hormontherapie auf innere Organerkrankungen zu kennen. Die Hormontherapie kann vorbestehende Erkrankungen positiv, negativ oder gar nicht beeinflussen. Betroffene Patientinnen erwarten zurecht eine enge Kooperation der Spezialisten – Gynäkologen, Endokrinologen und Internisten –, wenn es um die Entscheidung für oder gegen eine menopausale Hormontherapie (MHT) geht, insbesondere nach den Unsicherheiten, welche die mittlerweile revidierten Ergebnisse der WHI (women’s health initiative) -Studie hervorgerufen hatten.

Background and Objectives Genitourinary syndrome of menopause (GSM) is a common condition affecting of most postmenopausal women, which greatly impacks the quality of life,and need to treat. This prospective multicenter cohort study aimed to compare the efficacy and safety of the fractional carbon dioxide (CO2) laser with that of topical estrogen for vaginal treatment and relieving symptoms of genitourinary syndrome of menopause (GSM). Study Design/Materials and Methods This study included 162 postmenopausal patients who received vaginal laser or topical Estriol cream therapy between January 2017 and May 2019 at eight study centers in China. The degree of GSM‐related symptoms (vaginal burning, dryness, and dyspareunia) was evaluated using the Vaginal Health Index score (VHIS) and Visual Analog Scale (VAS) at baseline, 1, 3, 6, and 12 months posttreatment. The primary endpoint was the improvement in vaginal burning, dryness, and dyspareunia at 6 months after treatment. Multivariate logistic regression was used to compare the rate of improvement in the two groups. Results At baseline, the laser and control groups showed no significant difference in the mean age, time after menopause, and the VHIS (all P > 0.05). In the laser group, compared with baseline, significant differences were seen in the VHIS after the first or second treatment session and at 1, 3, 6, and 12 months posttreatment (P 0.05). The VHIS scores were significantly higher after 1 month (16.63 ± 2.79 vs. 15.57 ± 2.43) and 12 months (15.72 ± 2.59 vs. 12.12 ± 4.08) of treatment in both the groups (P 0.05). The VAS findings at 6 months posttreatment were significantly different when compared with the pretreatment findings (P

Purpose: This study aimed to clarify the efficacy of intravaginal CO2-laser treatment in postmenopausal women with genitourinary syndrome of menopause (GSM). Materials and methods: This double-blind, randomized, sham-controlled trial included postmenopausal women diagnosed with GSM and bothersome dryness and dyspareunia. Treatment consisted of three sessions. Active CO2-laser treatments (active group) were compared to sham treatments (sham group) with the primary endpoints being changes in dryness and dyspareunia intensity, as assessed by the 10-cm visual analog scale. Secondary endpoints were as follows: changes in Female Sexual Function Index (FSFI; total score and all domains), itching, burning, dysuria, and Urogenital Distress Inventory (UDI-6); incidence of symptoms; and presence of adverse events. All outcomes were evaluated at baseline and 4 months post baseline. Results: Fifty-eight women (28 in the active group and 30 in the sham group) were eligible for inclusion. In the active group, dryness, dyspareunia, FSFI (total score), itching, burning, dysuria, and UDI-6 were significantly improved (mean [standard deviation] –5.6 [2.8], −6 [2.6], 12.3 [8.9], −2.9 [2.8], −2.3 [2.8], −0.9 [2.1], and −8.0 [15.3], respectively). In the sham group, dryness, itching, and burning were significantly improved (–1.9 [2], −1.4 [1.9], and −1 [1.9], respectively). All changes were in favor of the active group. After completion of the protocol, the proportion of participants with dryness, dyspareunia, and sexual dysfunction was significantly lower in the active group compared to those in the sham group (all p < 0.005). Conclusions: CO2 laser could be proposed as an effective alternative treatment for the management of GSM as it is superior to sham treatments.

Vaginal dryness is common during and after menopause due to declining estrogen. It is one of the symptoms of vulvovaginal atrophy (VVA), which is part of the genitourinary syndrome of menopause. This can be distressing for women and cause pain, discomfort, and dyspareunia. Vaginal dryness affects over 50% of postmenopausal women but is under-reported and thus under-treated due to barriers to seeking help. Estrogen replacement can resolve symptoms, but may be contraindicated or not desired by all women. Over-the-counter vaginal moisturizers and lubricants can ease the symptoms of VVA. However, their chemical composition varies enormously and some are known to cause detrimental effects due to unphysiological pH, osmolality, and additives. The primary purpose of this review is to assess both their efficacy and safety. Women should be directed toward products that are as 'body-similar' as possible to vaginal secretions in terms of pH and osmolality. Products with potentially harmful ingredients should be avoided. Lubricants can be trialed for sexual activity and moisturizers for symptom control, even if topical or systemic menopause hormone therapy is being used.

Background : Vulvovaginal atrophy is a condition that often occurs in menopausal women due to Estrogen decreased. Prasterone (DHEA) is a steroid hormone that can be converted into Estrogen in the target tissue. Objective : This paper aims to evaluate the effectiveness of administering Prasterone as Vulvovaginal Atrophy therapy in menopausal women. Methods : A systematic data search was performed on a medical database (PUBMED, Google scholar, Cochrane). Inclusion criteria: (1) randomized study of Prasterone as Vulvovaginal Atrophy therapy in postmenopausal women, (2) all-inclusive papers can be accessed completely, and (3) the data obtained can be accurately analysed. Results: Three RCTs with a total of 696 patients were analysed. The average number of Superficial Cells (mean difference [MD] 7.63, and 95% [CI] 7.57 to 7.70 (P

OBJECTIVE Breastfeeding-related hypoestrogenic state has been reported as a possible risk factor for postpartum dyspareunia. This study aimed to evaluate the prevalence and characteristics of postpartum vulvovaginal atrophy according to 3 different diagnostic methods and to estimate its association with postpartum dyspareunia and daily vulvovaginal symptoms. METHODS This is a prospective cohort study of puerperal women attending a routine postpartum checkup. Participants completed a questionnaire and underwent a gynecological examination. Atrophy was diagnosed separately according to gynecologist impression, vaginal pH measurement (≥5.1), and cytologic vaginal maturation index. Patients were followed up with a telephone survey 2-3 months later, inquiring about symptoms possibly associated with atrophy. RESULTS Of 117 participants, vaginal atrophy was diagnosed in 48% by gynecological examination, 62% by a pH level of 5.1 or greater, and 40.2% had cytological atrophy. Of the 35.9% of women who had resumed sexual intercourse (42/117), 69% reported dyspareunia. No significant association was found between dyspareunia and atrophy parameters. There was no difference in the rates of dyspareunia among women who were exclusively breastfeeding (21/27 = 78%), partially breastfeeding (4/7 = 57%), or not breastfeeding (4/8, 50%). Atrophy was more common in breastfeeding women according to the 3 criteria (gynecological examination: 57.6% vs 16.7%, p = .006; pH: 70% vs 22%, p < .001; vaginal maturation index: 51.1% vs 0%, p < .001). Of the 117 participants, 47% reported daily vulvovaginal symptoms. Those with daily symptoms reported more dyspareunia as compared with those without daily symptoms (85% vs 52%, p = .025). CONCLUSIONS A high prevalence of atrophy was observed in puerperal women in association with breastfeeding. There was no significant association between atrophy and dyspareunia or daily vulvovaginal symptoms.

Local oestrogens, the current treatment for vulvar and vaginal atrophy (VVA), are not suitable for all women. Standard of care (SoC) consists of over-the-counter lubricants and moisturisers. Senshio® (ospemifene) provides a treatment option for postmenopausal women who are not candidates for local vaginal oestrogen therapy who would otherwise have an unmet clinical need. The aim of this study was to estimate the cost-effectiveness of ospemifene, a selective oestrogen receptor modulator, for the treatment of moderate to severe symptomatic VVA in postmenopausal women who are not candidates for local vaginal oestrogen therapy. The Scottish Medicines Consortium (SMC) recently evaluated the clinical and cost-effectiveness evidence of ospemifene plus SoC compared with SoC alone. A cost-effectiveness study, from a National Health Service (NHS) Scotland perspective over a lifetime time horizon, was submitted to the SMC. The cohort-based Markov model used robust clinical evidence from two large pivotal phase III randomised controlled studies and included four health states classified by dyspareunia symptom severity: none, mild, moderate and severe. The movement of women between health states was dependent on the effectiveness of treatment in reducing dyspareunia. Extensive sensitivity analyses were undertaken to assess the level of confidence associated with the base-case results. Treatment with ospemifene was associated with an additional cost of £847 per patient and an increase in quality-adjusted life-years (QALY) of 0.06 per patient. Ospemifene had an incremental cost-effectiveness ratio of £14,138 per QALY. In the probabilistic sensitivity analysis, there was a probability of 89% that ospemifene was cost-effective at a threshold of £20,000 per QALY gained. Ospemifene remained cost-effective under all scenario analyses. The SMC reviewed the clinical and economic evidence and judged that the evidence demonstrated a robust case to support prescribing ospemifene in NHS Scotland. Ospemifene is a cost-effective intervention that has recently been accepted by the SMC for the treatment of postmenopausal women with moderate to severe VVA who are not candidates for local oestrogen.

Objectives To evaluate the safety of and patient satisfaction with fractional CO2 laser for the treatment of vulvo-vaginal atrophy (VVA) in postmenopausal patients. Study design Patients affected by VVA were considered for the study. All women were treated using a Lumenis AcuPulse DUO (Lumenis, Yokneam, Israel) in fractionated mode with a 28 mm probe, FemTouch™. Pain during different steps of the procedure (introduction, rotation and extraction of probe and laser impulse transmission) was evaluated on a 7-point Likert scale. The occurrence of side-effects was evaluated at the end of the procedure, and in the three-month follow-up (after the last treatment) complications were classified as ‘early’ (occurring within 30 days) or late (after 30 days). Participant satisfaction was measured on a 7-point Likert scale (1= strongly disagree, 7= strongly agree). The institutional review board approved the study protocol. Results Fifty-three women were enrolled in the study. No severe complications occurred after a median follow-up of six months. One patient (1.9 %) reported dizziness immediately after treatment, which completely resolved within 15 min. A minor bleeding occurred related to tip introduction and rotation. One patient (1.9 %) aborted the procedure because of discomfort on probe introduction but decided to repeat the procedure after two weeks. Two patients (3.7 %) reported symptoms of dysuria within 7 days of the procedure. The mean overall pain score at first treatment, evaluated on the 7-point Likert scale, was 3.57 ± 1.50. The mean pain scores related to probe introduction and rotation were 3.13 ± 1.37 and 2.32 ± 1.08, whereas pain scores for extraction and laser impulse transmission were 1.23 ± 0.27 and 1.13 ± 0.37 respectively. Mean overall pain score (1.27; CI 95 % 0.83–1.71, p Overall, patient satisfaction with the procedure was high: 89.7 % of patients would highly (value 5–7) recommend the procedure and 94.9 % would be ready to repeat the procedure to maintain results. Discomfort related to treatment was lower than expected for 41 % of patients (value 5–7) and as expected for 48.7 % (value 3–4). Conclusion Fractional CO2 laser for treatment of VVA seems a safe therapeutic option. No severe complications occurred. A minority of patients reported mild complications, but these resolved without the need for treatment. Most discomfort was related to probe introduction and rotation. Overall, patients were highly satisfied, and they would repeat laser treatment.

Background and objectives More studies are needed to assess the long-term safety profile and clinical outcomes of lasers and energy-based devices to treat the symptoms associated with vulvovaginal atrophy. This study evaluated a series of three fractional CO2 laser treatments to the vulva and vagina with a 1-year follow-up in a postmenopausal population. Study design/materials and methods In this prospective, self-controlled, open-label clinical study, 18 postmenopausal females with atrophic vaginitis received 3 monthly treatments to the vulva and vagina with a fractional CO2 laser system and 1-, 3-, 6-, and 12-month follow-up. Investigators used the Vaginal Health Index (VHI) to assess changes in vaginal elasticity, fluid volume, vaginal pH, epithelial integrity, and moisture. Sexual function at each timepoint was subject-reported, using the validated Female Sexual Function Index (FSFI). Results Treatment of the vulva and vagina in postmenopausal women with fractional CO2 laser resurfacing resulted in statistically significant improvements as compared with baseline at all post-treatment and follow-up intervals to 12 months in VHI and FSFI (P ≤ 0.003 and P ≤ 0.03, respectively). Mean total VHI score increased from a baseline of 11.8-22.8 (93.2% improved) at 6-month follow-up (P = 0.0002) slightly decreasing to 21.4 (81.4% improved) at 12-month follow-up post-treatment (P = 0.0003). Mean FSFI Scores increased from a baseline of 17.9-26.3 (46.9% improvement) at 12-month follow-up post-treatment (P ≤ 0.0048). Cohort analysis revealed restoration of normal or near-normal (23-25) VHI following laser treatment in the recently menopausal (1-3 years) greatly exceeded that of the >3 years postmenopausal population and the difference was statistically significant (P ≤ 0.05). Normal/near-normal VHI at 3-, 6-, and 12-month post-treatment was 88%, 88%, and 63% in the recently postmenopausal cohort, as compared with 30%, 40%, and 10% of the >3 years postmenopausal group (P ≤ 0.05). Patient satisfaction following treatment was rated as high at 94% at 12-month follow-up. Safety findings demonstrated no-to-slight discomfort in the majority of subjects and transient erythema and edema, with no adverse events associated with treatment. Conclusion Fractional CO2 laser treatment of the vulva and vagina resulted in statistically significant improvements in VHI and FSFI compared with baseline in postmenopausal population that were sustained to 12-month follow-up. Restoration of normal VHI was observed in a statistically significant greater percentage in the recently postmenopausal cohort (1-3 years) as compared with postmenopausal cohort of >3 years, suggesting that early intervention is correlated with improved outcomes. Lasers Surg. Med. © 2020 Wiley Periodicals, Inc.

Abstract Purpose VVA is a common disease, with approximately 50% of all postmenopausal women having related symptoms. VVA has a significant impact on the personal and sexual lives and on many aspects of women’s self-esteem and emotional well-being. It is particularly frequent and severe in patients treated for BC, where it originates significant economic and social costs. Given the lack of published evidence on this subject, a Delphi Panel was carried out to evaluate:The epidemiology of VVA and of its risk-factors/comorbidities in ItalyThe present standard of care and unmet medical needsThe comparison between recent US epidemiological data and the Italian situationThe health resources used in VVA BC The burden of illnessDespite the considerable negative impact on quality of life, a disparity between the high prevalence of this condition and the infrequent clinical diagnosis is documented in medical practice and in surveys. This inaccuracy is thought to be primarily a consequence of patients’ unwillingness and/or reluctance to report symptoms in the clinical setting and of health-care professional’s difficulty in approaching this sensitive topic during routine consultations. Methods A Delphi Panel methodology was used: a first round of written questionnaires, followed by a plenary meeting with a facilitator and by two additional rounds of telephone interviews. Results The prevalence of the condition in Italy can be estimated in 115,000 cases out of 380,000 BC survivors. The Panel confirmed that the epidemiological findings of a recent pharmacoeconomic analysis of a US claims database can be applied to Italian patient population. The Panel confirmed also an estimate of 4.25 additional cases/100/yr of UTI (urinary tract infection) in VVA BC patients (vs. a non-VVA-matched population), of 3.68 additional cases of vulvovaginitis, of 6.97 cases of climacteric symptoms, and of 3.64 cases of bone and joint disorders. As far as the resource use is concerned, in the VVA BC populations, 33.4 additional gynecological visits/100/year can be expected, along with 22.8 additional cancer screenings, 7.07 additional outpatient visits and 5.04 screenings for HPV. Conclusions Even in Italy, a diagnosis of VVA, especially in a BC population, is associated with a relevant increase in the burden of illness and social costs, compared to a control population matched for age without VVA. This is due essentially to an increase in comorbidities and resource utilization with the consequence that an adequate treatment could reduce the impact of the condition.

During the menopause, a fall in estrogen levels often leads to many unfavorable symptoms, including changes in the vascular and urogenital systems, in mood, and sleep. The symptoms of vulvovaginal atrophy are especially troublesome for menopausal women. These symptoms not only disturb the sexual sphere, but also functioning at work and in the family. Based on the literature, a review of contemporary methods of management in the case of symptoms of vulvar atrophy in menopausal women has been performed. The current methods of treating vulvovaginal atrophy in menopausal women are described. The pharmacology of the available dehydroepiandrosterone (DHEA) preparations, both oral and vaginal, was briefly analyzed. Own experiences of using DHEA are presented. Vaginal DHEA has been found to be an effective and safe treatment in menopausal women with symptoms of vaginal atrophy.

Genitourinary syndrome of menopause (GSM) is a term used to define a compilation of signs and symptoms arising from decreased estrogenic stimulation of the vulvovaginal and lower urinary tract. Among 27-84% of women in postmenopausal are affected for symptoms of GSM, and these can unquestionably impair health, sexual function, consequently the quality of life of these women. The main signs and symptoms of GSM include, among others, burning, irritation, vulvovaginal dryness, dyspareunia, urinary symptoms of urgency, dysuria, or recurrent urinary tract infection. The diagnosis can be made through anamnesis, questionnaires, physical exams, and, sometimes, complementary exams. Objective vaginal assessment is essential and can be complemented by using the Vaginal Health Index (VHI), Vaginal Maturation Index (VMI), or vaginal pH measurement. The acknowledgment of this condition by health professionals is crucial for its identification and proper management and exclusion of other conditions that make a differential diagnosis with it. info:eu-repo/semantics/publishedVersion

Ovarian function can start to decline a few years before the eventual cessation of the menstrual cycle. The average age of Menopause in the UK is 51, and it is a restrospective diagnosis after 12 months of amenorrhoea. Women can experience many symptoms such as vasomotor and vulvovaginal symptoms that can impact them physically, psychologically, sexually and impact their overall wellbeing. Women may have medical contraindications to hormonal therapy or may prefer non-hormonal or alternative treatments. This review looks at the evidence, efficacy and safety of a range of complementary or alternative treatments and non-hormonal pharmacological treatments for the treatment of vasomotor symptoms and vulvovaginal atrophy of menoopause.

Aino Fianu Jonasson,1 Mikael Åstrom2 1Department of Clinical Sciences, Intervention, and Technology, Division of Obstetrics and Gynaecology, Karolinska Institute, Stockholm, Sweden; 2StatCons, Malmö, SwedenCorrespondence: Aino Fianu JonassonDepartment of Clinical Science, Intervention and Technology Division of Obstetrics and Gynecology, Karolinska Institute, Stockholm, 171 77, SwedenTel +46-70-483-6028Email aino.fianu.jonasson@ki.sePurpose: This pilot study assessed the efficacy of 12 weeks of daily treatment with a vaginal gel based on a water-based cellulose gel in reducing the severity of moderate–severe symptoms of vulvovaginal atrophy (VVA) and followed adverse events in female breast cancer patients undergoing treatment with adjuvant aromatase- inhibitor therapy.Methods: In this open, uncontrolled pilot study, the efficacy and safety of the gel during a treatment period of 12 weeks (daily 1× 1 mL) were evaluated (n=28). The gel is made of water and hypromellose, a hydropropylmetyl cellulose, which works by coating the vagina, and was developed to treat moderate–severe symptoms of VVA. The primary efficacy variable was the most bothersome symptom (MBS; among vulvovaginal irritation and itching, vaginal dryness, dysuria, or dyspareunia) self-identified at baseline on a four-point scale.Results: A total of 28 patients fulfilled all entry criteria and had data available after the start of treatment. Treatment with the gel reduced MBS scores from baseline (n=28, mean 2.71) to week 12 (n=27, mean 1.33, mean reduction 1.37; p=0), and reduced the overall total scores for VVA symptoms from a mean of 5.39 at baseline to 2.25 at week 12 (p=0). Eleven subjects (39%) reported 19 AEs.Conclusion: A 12-week treatment with the gel significantly reduced the severity of MBSs and VVA symptoms, improved quality of life, and was safe to use in women with breast cancer undergoing adjuvant aromatase-inhibitor therapy. In view of the beneficial effects of nonhormonal treatments, for cancer patients in particular, the water-based cellulose gel VagiVital is a suitable candidate for first-choice treatment of VVA symptoms in breast cancer patients and in women predisposed to cancer.Keywords: vulvovaginal atrophy, MBS, nonhormonal therapy, dyspareunia, vaginal dryness, adjuvant AI therapy, breast cancer

Genitourinary syndrome of menopause (GSM) causes significant symptomatic aggravation that affects the quality of life (QoL). Vulvovaginal atrophy (VVA), the hallmark of GSM, is managed with topical non-hormonal therapy, including moisturizers and lubricants, and topical estrogen application. Patients not responding/being unsatisfied with previous local estrogen therapies are candidates for a noninvasive modality. Carbon dioxide (CO2) laser therapy, especially the fractionated type (FrCO2), has drawn considerable attention over the past two decades as a non-invasive treatment for GSM. This systematic review describes the accumulated evidence from 40 FrCO2 laser studies (3466 participants) in GSM/VVA. MEDLINE, Scopus and Cochrane databases were searched through April 2021. We analyze the effects of FrCO2 laser therapy on symptoms, sexual function, and QoL of patients with GSM/VVA. As shown in this review, FrCO2 laser therapy for GSM shows good efficacy and safety. This modality has the potential to advance female sexual wellness. Patient satisfaction was high in the studies included in this systematic review. However, there is a lack of level I evidence, and more randomized sham-controlled trials are required. Furthermore, several clinical questions, such as the number of sessions required that determine cost-effectiveness, should be addressed. Also, whether FrCO2 laser therapy may exert a synergistic effect with systemic and/or local hormonal/non-hormonal treatments, energy-based devices, and other modalities to treat GMS requires further investigation. Lastly, studies are required to compare FrCO2 laser therapy with other energy-based devices such as erbium:YAG laser and radiofrequency.

It is estimated that 50% of women will suffer a severe form of vulvovaginal atrophy (VVA) related to menopause. Equally, young women may temporarily present this clinical problem while receiving various pharmacological or endocrine treatments or radiotherapy.To determine clinical and diagnostic exams required to confirm the presence of VVA (also referred to as atrophic vaginitis, urogenital atrophy, or genitourinary syndrome of menopause) and rule out other genital or pelvic clinical conditions.Literature review searches were carried out on the main scientific article search engines (PubMed, SciELO, Cochrane) using different clinical terms, treatments or interventions and comorbidity related to VVA.The development and severity of VVA depend mainly on the duration of hypoestrogenism. Hypoestrogenism causes changes in the urogenital tissue, generating signs and symptoms, such as dryness, burning, soreness, itching, and irritation of the genital skin. The diagnosis can be made through anamnesis (patient history), questionnaires, physical exam, and, sometimes, complementary exams. Objective vaginal assessment is essential and can be completed with the Vaginal Health Index, the Vaginal Maturation Index, or vaginal pH in the absence of infection or semen. The exclusion of other vulvovaginal organic pathology is essential to reach an accurate diagnosis and provide adequate treatment.The specialist should be able to identify VVA, rule out other pathologies that make a differential diagnosis and conduct proper management.

Objectives: The aim of the study was to evaluate the effectiveness of CO 2 fractional laser therapy on perimenopausal urogenital symptoms. Material and methods: This prospective, open-label study included 205 patients who received three CO 2 laser treatments. Clinical assessment was checked at baseline as well as at six weeks and 12 months post-treatment. The following scores were measured Vaginal Health Index Score (VHIS), International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and assessment of the severity of selected urogenital symptoms. Results: Significant improvements in dryness, dyspareunia, burning, vaginal laxity, urinary incontinence, as were the results on the VHIS and ICIQ-UI SF at six weeks post-treatment (p < 0.05 for all scores), which were maintained through the follow-up visit at 12 months. No complications were observed either during or after laser therapy. Conclusions: CO 2 ablative laser treatment can be effective in reducing vulvovaginal atrophy symptoms such as vaginal laxity, dryness, painful sexual intercourse, burning, and decreases the severity of stress urinary incontinence and urge incontinence symptoms. Positive results were maintained at 12 months after the laser treatment.

Vulvovaginal atrophy (VVA) resulting from estrogen deprivation at menopause often results in distressing vaginal dryness and dyspareunia. Fewer than 25% of affected women seek help for this condition citing embarrassment, cultural values, an aging or unavailable partner and concerns about use of estrogens following the Women's Health Initiative. Available non-hormonal treatments, such as moisturizers, while affording some relief can be messy to apply and do not prevent disease progression. A new oral selective estrogen receptor modulator, ospemifene, has been found to have strong estrogenic activity in vaginal tissues without adverse estrogenic effects at other sites.

Aim: Presentation of basic clinical scientific data based on modern evidence of anatomical and physiological changes in the urogenital tract in periand postmenopause and the principles of management of women with genitourinary menopausal syndrome.Material and methods: The review of domestic and foreign sources devoted to prevalence, modern diagnostics and methods of vaginal atrophy treatment was carried out.Results: the present article contains modern terminology, data on etiopathogenesis, clinic, diagnostics and treatment methods of VVA, clinical examples.

Due to the increase in life expectancy, today, most women live in a state of estrogen deficiency for more than a third of their life time. According to the recent document on the stages of aging of the female reproductive system (the STRAW+10 working group), there are three main stages that include the reproductive period, the menopausal transition, and postmenopause. One of the most common manifestations of postmenopause is vulvovaginal atrophy or genitourinary syndrome, which leads to a dramatic decrease in the woman’s quality of life. Up to 45 % of postmenopausal women suffer from this disorder, and 80 % of them experience a negative impact on their quality of life. The main symptoms of vulvovaginal atrophy are dryness, itching, burning, and dyspareunia. Caution must be exercised in relation to “silent” atrophy, which is not manifested by subjective complaints of vaginal mucosa atrophy, and can only be visualized by colposcopy. According to the recommendations of the International Menopause Society (IMS), updated in 2016, therapy should be started before the atrophic changes become irreversible; the treatment should continue for a long time to maintain the achieved therapeutic effect. If no symptoms other than vulvovaginal atrophy are noted, local estrogen therapy is indicated. Estriol has advantages over other medications due to its lower affinity for estrogen receptors. In earlier studies as well as those updated here (2014–2018), estriol applied topically as a vaginal cream or vaginal suppositories, has a selective effect on the urogenital tract and practically does not interfere with the proliferation of the uterine endometrium. The confirmed efficacy and safety of estriol allow for its permanent use, beginning with the starting dose and then switching to the maintenance one.

Introduction Hormonal contraception is available worldwide in many different forms. Fear of side effects and health concerns are among the main reasons for not using contraceptives or discontinuing their use. Although the safety and efficacy of contraceptives have been extensively examined, little is known about their impact on female sexual function, and the evidence on the topic is controversial. Aim To review the available evidence about the effects of hormonal contraceptives on female sexuality in order to provide a position statement and clinical practice recommendations on behalf of the European Society of Sexual Medicine. Methods A comprehensive review of the literature was performed. Main Outcome Measure Several aspects of female sexuality have been investigated, including desire, orgasmic function, lubrication and vulvovaginal symptoms, pelvic floor and urological symptoms, partner preference, and relationship and sexual satisfaction. For each topic, data were analyzed according to the different types of hormonal contraceptives (combined estrogen-progestin methods, progestin-only methods, and oral or non-oral options). Results Recommendations according to the Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence criteria and specific statements on this topic, summarizing the European Society of Sexual Medicine position, were developed. Clinical Implications There is not enough evidence to draw a clear algorithm for the management of hormonal contraception-induced sexual dysfunction, and further studies are warranted before conclusions can be drawn. A careful baseline psychological, sexual, and relational assessment is necessary for the health care provider to evaluate eventual effects of hormonal contraceptives at follow-up. Strengths & Limitations All studies have been evaluated by a panel of experts who have provided recommendations for clinical practice. Conclusion The effects of hormonal contraceptives on sexual function have not been well studied and remain controversial. Available evidence indicates that a minority of women experience a change in sexual functioning with regard to general sexual response, desire, lubrication, orgasm, and relationship satisfaction. The pathophysiological mechanisms leading to reported sexual difficulties such as reduced desire and vulvovaginal atrophy remain unclear. Insufficient evidence is available on the correlation between hormonal contraceptives and pelvic floor function and urological symptoms.

Objective: To prospectively evaluate the effects of ospemifene on the vulva and vagina in postmenopausal women using vulvar-vestibular photography and direct visual assessments. Methods: Postmenopausal women (aged 40-80 years) with moderate to severe vaginal dryness as their most bothersome symptom (MBS) were randomized to daily ospemifene 60 mg or placebo in this 12-week, multicenter, double-blind, phase 3 study. Vulvar-vestibular photographic images were captured at baseline and week 12 and were independently assessed with the Vulvar Imaging Assessment Scale (VIAS). Changes from baseline in Vaginal and Vulvar Health Indices (VHI and VuHI) with ospemifene versus placebo were analyzed at weeks 4, 8, and 12. Correlations between VIAS, VHI, and VuHI, with vaginal dryness severity and the Female Sexual Function Index (FSFI) scores were also assessed. Results: In all, 631 eligible participants were randomized (ospemifene 316, placebo 315) and included in the intention-to-treat population. Compared with placebo, ospemifene significantly improved total scores for VIAS (P = 0.0154), VHI (P

The number of women surviving longer after a cancer diagnosis is increasing. This means that more awareness regarding their health is required. This review will focus on vulvovaginal atrophy (VVA)/genitourinary syndrome of menopause, one of the most distressing adverse iatrogenic effects of the menopause, secondary to cancer therapies. The cancer therapies themselves, such as radiotherapy, chemotherapy, and surgery, have a direct impact on the lower genital tract which interplays with the ensuing hypoestrogenic state of the menopause. Symptoms of VVA are still under-reported and undertreated as neither clinicians nor patients are forthcoming in discussing the problem, despite its profound negative impact on quality of life. In terms of treatment of VVA, this review will look at the use of various options, including estrogen post cancer diagnosis, as well as considering newer emerging therapies such as dehydroepiandrosterone, ospemifene, and laser. The care of a woman post cancer diagnosis should be a multidisciplinary responsibility. However, further research is required into emerging treatment options as well as long-term safety data, to ensure all health-care providers and women are fully informed and confident to effectively address the impact of VVA post cancer diagnosis.

Purpose Vulvovaginal atrophy (VVA) is a commonly reported issue among breast cancer patients, and its aetiology is multifactorial. Treatment is difficult in these women, particularly because the use of oestrogens has traditionally been discouraged. Vaginal laser treatment has been reported to improve symptoms. We aimed to assess the impact on symptoms and sexual function of vaginal laser in women with early breast cancer (EBC). Methods We performed a single-arm investigator initiated pilot study of female EBC patients with symptomatic VVA. A total of 3 vaginal laser treatments were administered 4 weeks apart. Questionnaires were completed at baseline, 4, 8 and 12 weeks. Our primary endpoint was symptomatic improvement of VVA at 12 weeks on 10 cm visual analogue scales. Our secondary endpoints were improvement in sexual function using the Female Sexual Function Index (FSFI) and patient-reported improvements in symptoms, sexual function and quality of life. Statistical analysis was performed with a Wilcoxon Signed Rank test. Results 26 patients were enrolled between February 2016 and August 2017. All patients were post-menopausal, 25 of whom had received anti-oestrogen therapy for their breast cancer. Questionnaire compliance was high (98%) and all patients received the three pre-planned treatments. There was significant improvement in each of the VVA symptoms: dryness (p Conclusions Patients receiving vaginal laser had improvement in VVA symptoms and sexual function. Further randomised sham-controlled trials are needed to further assess this treatment.

During the course of their lives, almost all women face pathological changes in the vulvovaginal area caused by various causes: dysplasia of connective tissue, excessive physical activity, childbirth, reduction of sex hormones, etc. Vulvovaginal symptoms have no significant impact on life expectancy and have a significant impact on the quality of life. In this regard, the modern possibilities of correction of these conditions, especially the minimally invasive ones, become especially important. The article discusses the methods of treatment and prophylaxis of age-associated pathological changes in the vulvovaginal area using a CO2-laser. Mechanisms of laser radiation influence on tissues are considered when using different modes. The advantages of microablative CO2-fraction laser photothermolysis in vaginal and vulva tissue rejuvenation programs are shown. The analysis of clinical studies on the use of lasers in the treatment of vulvovaginal diseases has been carried out, and tasks have been set for the development and implementation of highly effective and safe technologies in the practice of gynaecologists that affect the mucous membranes of the vagina and vulva, as well as a reliable assessment of their effectiveness.

Introduction The prevalence of menopausal women with confirmed vulvovaginal atrophy (VVA) oscillates between 67–98%. Aim To assess the prevalence of postmenopausal women with VVA confirmed by gynecologic clinical assessment among all women attending menopause centers in Spain, as well as to describe the impact of VVA on quality of life and sexual functioning. Methods Women aged 45–75 years old with the last menstrual period >12 months before were included in a cross-sectional study. Main Outcome Measures Women with ≥1 VVA symptoms filled out a number of questionnaires, including EuroQoL, Day-to-Day Impact of Vaginal Aging, Female Sexual Function Index, and Female Sexual Distress Scale-revised. A gynecologic examination was performed to confirm diagnosis. Results 1,177 evaluable patients were included. VVA was confirmed in 87.3% of the patients. Almost 80% of women who acknowledged being sexually active (n = 717) presented pain during intercourse. As compared with patients without confirmed VVA (n = 66), patients with confirmed VVA (n = 1,028) were significantly older (P < .0001), had lower rates of sexual activity (P < .05), and used more VVA treatments (P < .05). Severe vaginal atrophy and severe vulvar atrophy were more prevalent in VVA-confirmed women (P < .0001, in both cases). No differences regarding the confirmation of VVA were observed for EuroQoL and Day-to-Day Impact of Vaginal Aging quality-of-life questionnaires. Sexual function measured through the Female Sexual Function Index score was significantly reduced in sexually-active patients with confirmed VVA (P < .05). Conclusion VVA signs and symptoms are highly prevalent in Spanish postmenopausal women. Confirmation of VVA diagnosis was associated with impaired sexual function. The early recognition of VVA symptoms should be actively promoted in medical practice, instead of waiting until signs appear to exclude other reasons for VVA and to manage treatment effectively.

Objective Vulvovaginal atrophy is a common, but under-recognized condition affecting postmenopausal women. To guide development of an intervention to boost its detection and treatment, we surveyed primary care and gynecology clinicians practicing in an integrated healthcare system. Methods We constructed a three-part survey that contained (1) eight multiple-choice knowledge questions; (2) three Likert-scale questions regarding clinicians' likelihood of assessing for vulvovaginal atrophy symptoms at a routine (well) visit, confidence in advising patients about symptoms and counseling about therapy; and (3) a 12-item check list of potential barriers to diagnosis and treatment. Analyses were performed using multiple regression. Results Of the 360 clinicians who were sent an e-mail request, 119 (90 primary care, 29 gynecology) completed the survey (33%). Responders and nonresponders did not differ by age, specialty, or clinician type. The proportion with correct responses to knowledge questions differed between primary care (63%) and gynecology (77%) (adjusted mean difference [AMD] =16, 95% CI [10-22]). Primary care clinicians were less likely than gynecology clinicians to assess for symptoms (AMD = 1.04, 95% CI [0.55-1.52]), and were less confident about their ability to advise on symptoms (AMD = 0.66, 95% CI [0.33-0.99]) and to counsel patients about treatment (AMD = 0.76, 95% CI [0.42-1.10]). Lack of time (71%) and educational materials (44%) were the most common barriers to diagnosis and treatment. Conclusions Primary care and gynecology clinicians differ in their knowledge and confidence in managing vulvovaginal atrophy but report similar practice barriers. Addressing identified knowledge deficits and practice barriers may lead to improved management of vulvovaginal atrophy.

Vulvovaginal atrophy accompanied by lower urinary tract dysfunction related to low levels of estrogen and androgens is labeled as genitourinary syndrome of menopause (GSM). Although this condition affects most postmenopausal women worldwide, it seems to be underdiagnosed and undertreated. Women should be properly advised to choose an adequate treatment modality to improve their quality of life, sexual relationships and social activity. The aim of this article to is increase knowledge of GSM. The current treatment options, both hormonal and non-hormonal, are reviewed. Topical estrogen therapy still remains the gold standard, but the demand for individually tailored therapy is growing. New treatment modalities are continuously included in clinical practice. They should consider the whole personality of a woman as well as cultural and social factors. Further studies on GSM and on the effectiveness of various treatment options are necessary to achieve this purpose.

Perimenopausal changes caused by oestrogen deficiency are accompanied by a decrease in the content of collagen and elastin in the tissues, leading to thinning of the epithelium and the resultant disappearance of the superficial layer, which leads to smooth muscle dysfunction as well as connective tissue degradation. This aetiopathogenetic chain results in a set of symptoms experienced by approximately 50% of women in the peri- and postmenopausal period. Symptoms of dryness, burning, dyspareunia and urgency contribute to a significant reduction in the quality of sexual function and general comfort of life due to recurrent infections of the vagina, vulva and urinary tract. Different therapeutic methods may benefit genitourinary syndrome of menopause (GSM), while innovative methods such as lasers or radiofrequency deserve further study in this area.

Purpose Women with breast cancer (BC) often suffer from severe vulvovaginal atrophy (VVA) which ultimately leads to poor sexual and urinary quality of life. We conducted a prospective study among women with BC and VVA, in order to evaluate the long-term effect of laser therapy on VVA. Methods Women with BC and VVA were proposed to have fractional microablative CO2 laser therapy (MonaLisaTouch®, DEKA) once per month for 3 months. Efficacy of laser therapy was assessed at baseline, 6 months and 18 months after treatment, using Female Sexual Function Index (FSFI) score, Ditrovie score and vaginal pH. A pap smear was also performed and the epithelial maturation pattern was noted. Paired statistical tests were used to compare results between baseline, 6 months and 18 months. Results 46 women with BC (median age [interquartile range] 56.5 years [47.0 – 59.4]) were included between May and October 2018. PH level slightly decreased over time (mean Δ at 18 months −0.3, SD = 0.7, p = 0.02) whereas maturation pattern on pap smear did not change. Sexual quality of life was significantly improved at 6 months and 18 months (mean Δ at 6 months 8.3, SD = 6.2 (p

Genitourinary syndrome of menopause (GSM) may affect up to 90% of menopausal women, including vulvovaginal atrophy (VVA), burning, pain, bleeding, irritation, dyspareunia, anorgasmia, and urinary symptoms. Vaginal symptoms from lack of estrogens can have a significant impact on the sexual health and quality of life (QoL) in as many as 50% of postmenopausal women. Several therapeutic alternatives, both hormonal and non- hormonal, have been proposed. Microablative COinf2/inflaser is one of the three non-surgical energy-based therapies, with Erbium:YAG laser and temperature-controlled radiofrequency (RF). Microablative COinf2/inflaser induces morphological changes in vaginal tissues and results of several clinical trials suggest that this type of laser improves symptoms of GSM. Moreover, this treatment seems to be safe. Given the increasingly widespread use of laser COinf2/infas a non-hormonal alternative treatment for GSM, the authors reviewed the current published literature evaluating this therapy, to compare efficacy and safety of different protocols.

The aim of this study was to evaluate the impact of vaginally prasterone administration on postmenopausal women with genitourinary syndrome of menopause (GSM) affected by overactive bladder syndrome (OAB). A secondary aim of this study was to assess the efficacy of prasterone on VVA and quality of life (QoL).Thirty-two postmenopausal women with GSM and referred OAB symptoms received treatment with daily intravaginal prasterone 6.5 mg. We assessed urinary symptoms through approved ICIQ-OAB and ICIQ-UI questionnaires on incontinence. Women were also screened by the Vaginal Health Index (VHI) to investigate the vulvovaginal atrophy (VVA). Quality of life (QoL) was assessed by the SF-12 Health Survey. Each questionnaire was administrated at baseline (T0) and after a 12-week treatment (T1).Incontinence questionnaires showed improvement at T1 (from 7.8 ± 2.7 to 2.7 ± 2.2, p 0.001). Even if women referred an improvement of daily urine although the women reported improvement in daily urine leaks, their urine leak amount did not improve statistically significant [T0 (28.6%) Vs T1 (14.3%), p 0.16]. Prasterone therapy improved significantly the VHI [T1(21 ± 3.7) Vs T0 (10.8 ± 4.1), p 0.001]. Finally, women had a statistically significant improvement both in Mental [T1(49.9 ± 11.2) Vs T0 (42 ± 9.2), p 0.009],) and Physical Health [T1(47.1 ± 9.1) Vs T0 (38.6 ± 8.4), p 0.006], domains of the SF-12 questionnaire. No women referred side effects.Prasterone is an inactive precursor converted into estrogens and androgens into vaginal tissue. It leads to positive effects on VVA through the activation of the vaginal androgen and estrogen receptors. Empirical evidence in this study suggests that intravaginal 6.5 mg prasterone administration could be an effective treatment for postmenopausal women with GMS affected by OAB.

Objective: The aim of the present randomized placebo-controlled single-center study was to assess the efficacy and safety of a new vaginal gel (Meclon Idra - Alfasigma) in the treatment of vulvovaginal atrophy (VVA). The gel is composed of sea buckthorn (Hippophaë rhamnoides) oil, aloe vera, 18β-glycyrrhetic acid, hyaluronic acid and glycogen. The study assessed whether the gel can reduce VVA symptoms (vaginal dryness, itching, burning sensation) and improve sexual function in postmenopausal women over 12 weeks. Study Design: Postmenopausal women (n° = 60) reporting VVA symptoms were recruited and randomized in a 1:1 ratio to the gel or placebo. Active vaginal gel or placebo was applied for 14 days and then twice a week for 90 consecutive days. Main outcome measure: The Vaginal Health Index (VHI), including vaginal pH, was used to assess changes in objective signs, whereas the self-reported Female Sexual Function Index (FSFI) was used to investigate sexual function. Results: Meclon Idra was effective in reducing vaginal pain, dyspareunia and vaginal pH, with the VHI showing significant improvement at day 90 (P

OBJECTIVE Vulvovaginal atrophy is frequent, can be bothersome and can impair quality of life in postmenopausal women. The main objective of this prospective, randomized study was to compare the acceptability of low-dose vaginal 17β-estradiol (estradiol) tablets and vaginal promestriene cream in postmenopausal women with moderate-to-severe symptomatic vulvovaginal atrophy. METHODS Overall, 120 patients were randomized to receive estradiol or promestriene (n = 60 per group). Acceptability was assessed with a specific questionnaire. Symptom intensity, the Vaginal Health Index (VHI), vaginal pH and the Vaginal Maturation Index were also evaluated. RESULTS Acceptability was higher for estradiol tablets. Compared to promestriene cream, hygiene and ease of use were greater after 4 weeks (p = 0.011 and p = 0.001, respectively) and after 12 weeks (p = 0.009 and p = 0.011, respectively). Reduction of symptom intensity was greater with estradiol. Both treatments improved the VHI and decreased vaginal pH. However, superficial cell percentages increased significantly (p

To assess the effect of ospemifene 60 mg/day in vulvovaginal atrophy (VVA) in postmenopausal women under conditions of routine clinical practice after 3 months of follow-up.The AYSEX study is a Spanish observational, prospective, and unicentric study in which 5 gynecologists recruited postmenopausal women with VVA in routine clinical practice treated with ospemifene 60 mg/day as an appropriate therapeutic option. Vaginal health, sexual health, dryness, dyspareunia, quality of life, and satisfaction with treatment were assessed at baseline and after three months using validated scales.A total of 100 postmenopausal women cytologically and clinically diagnosed with VVA were included in the study. After 3 months of treatment with ospemifene, vaginal health index increased and vaginal pH, dryness, and dyspareunia decreased significantly (This study in routine clinical practice conditions confirms the results previously reported by randomized controlled trials, including a significant improvement in VVA, sexual function, quality of life, and satisfaction with the treatment.

Introduction/Background Women with breast cancer (BC) often suffer from severe vulvovaginal atrophy (VVA) linked to endocrine deprivation, which is worsened by BC treatments and ultimately leads to urinary symptoms, dyspareunia and poor sexual quality of life. Treatment side effects, including gynaecological side effects, could affect adherence to treatment, such as endocrine therapy. We conducted a prospective study on women with BC to evaluate the effect of fractional microablative CO2 laser therapy on VVA in the long term. Methodology Women with a history of BC, without contra-indication to laser therapy and suffering from VVA were proposed to have fractional microablative CO2 laser therapy (MonaLisaTouch®, DEKA) once per month for 3 months. Vaginal health was objectively determined with pH level and trophicity on pap smear. Sexual and urinary quality of life status were assessed using the Female Sexual Function Index (FSFI) score and the Ditrovie score. Measurements were performed at baseline and 6 months. Quality life scores were also assessed about 18 months after the last laser session. Paired statistical tests between baseline and 6 months and between baseline and end of study were computed using R software (version 4.0.2). Results 46 women with BC (median age [interquartile range] = 56.5 [47.0 – 59.4]) were treated between May and December 2018, of whom 36 were taking endocrine therapy (tamoxifen n=6, aromatase inhibitors ± LHRH agonist n=30). pH level slightly decreased over time (mean = 6.5 (SD 0.9) at baseline versus 6.4 (SD 0.9) at 6 months, p=0.02) whereas trophicity on pap smear did not change. Sexual quality of life was significantly improved at 6 months and at the end of study (mean = 11.3 (SD 7.5) at baseline versus 19.4 (SD 6.7) (p Conclusion Our data show that fractional microablative CO2 laser is effective for women with BC on VVA’s symptoms and gynaecological quality of life. Effects are long-lasting but decrease after a certain time suggesting that maintenance sessions might be necessary. More research has yet to be done on treatment schedule for women with BC, such as number of laser sessions at initiation (3 or 4) and duration before maintenance sessions. Disclosures he microablative laser was provided by DEKA. There was no financial support from DEKA.

Transvaginal laser therapies are being increasingly used for a variety of indications, particularly genitourinary syndrome of the menopause and stress urinary incontinence. This article reviews the current data pertaining to the place of these devices in current clinical practice. Whilst there has been a rapid increase in the number of publications over the last few years, many of the studies are of small numbers, short duration, and poor quality and are device-sponsored. The evidence suggests that vaginal laser therapy with either the erbium-doped yttrium aluminum garnet laser (FotonaSmooth