Vaginal Atrophy Research Articles

(002) An Update to The Safety of VE Therapy for Genitourinary Syndrome of Menopause in Women with a History of Breast Cancer – A Claims Database Analysis

Abstract Introduction Systemic therapies for breast cancer (BC) may result in genitourinary syndrome of menopause (GSM) in up to 70% of postmenopausal breast cancer survivors. Though systemic estrogen therapy is usually avoided in these patients, vaginal estrogen (VE) therapy may be prescribed to treat GSM symptoms. However, we recently demonstrated, few eligible patients with GSM and a history of breast cancer are prescribed VE. Objective To assess the recurrence rates of breast cancer in women diagnosed with GSM with a history of breast cancer by VE therapy status using a large US claims database. Methods A US health research network was queried. Our cohort consisted of females diagnosed with BC within five years prior to the initial GSM diagnosis. Patients with active disease within three months prior to diagnosis of GSM were excluded. Recurrence was defined as mastectomy, radiation, chemotherapy, or secondary malignancy within three months to five years after initiating VE therapy for GSM. The study cohort included those with ≥3 VE prescriptions. The control cohort included women with BC without any VE prescriptions after GSM diagnosis. Propensity matching was performed. A sub-analysis evaluating the effect of concurrent aromatase inhibitor (AI) use with VE was also conducted with concurrent AI use defined as ≥3 AI prescriptions. Results We identified 42,113 females with a diagnosis of GSM following BC diagnosis with any ER status; 5.0% received VE. Of the initial cohort, 10,584 patients had ER+ BC; 3.9% of this group received VE. Risk of BC recurrence was comparable between those who received VE and those who did not in both the any-ER (RR 1.03, 95% CI [0.91-1.18]) and ER+ status (RR 0.94, 95% CI [0.77-1.15]) analyses. BC recurrence-free survival was comparable between those who received VE and those who did not in both the any-ER (HR 0.98, 95% CI [0.85 – 1.14]) and ER+ status (HR 0.88, 95% CI [0.69 – 1.12]) analysis. A sub-analysis comparing concurrent VE and AI prescriptions to those with VE-only was performed. Risk of BC recurrence was significantly higher among those who received AI+VE versus VE-only in both the any-ER (RR 5, 95% CI [3.05 – 8.19]) and ER+ status (RR 2.64, 95% CI [1.55 – 4.47]) analysis (Table 1). Significant differences in BC recurrence-free survival were observed between the AI+VE and VE-only groups in both the any-ER (HR 9.88, 95% CI [5.50 – 17.73]) and ER+ status (HR 4.82, 95% CI [2.36 – 9.84]) analysis. (Figure 1). No mortality event was observed at five- or ten-year follow-up in either analysis. Conclusions We found similar BC recurrence risk between BC survivors with and without prescriptions of VE. An increased risk of BC recurrence was seen with concurrent AI and VE use. These results suggest that VE therapy in select patients with GSM is safe. Disclosure No.

(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.

Management of stress urinary incontinence associated with perimenopause

Pelvic health physiotherapy is recommended as first-line treatment for those with lower urinary tract symptoms and pelvic floor dysfunction. Pelvic health physiotherapists treat a number of genitourinary conditions conservatively, including stress urinary incontinence, overactive bladder, pelvic organ prolapse and vaginal atrophy. When physiotherapy management alone does not fully resolve symptoms, medication may be required. Independent prescribing enables the physiotherapist to maintain continuity of care, allowing a smoother, more effective patient journey. This offers quicker access to medicines and helps avoid delays in commencing appropriate treatment, reducing waiting times across other services. In this article, the role of the pelvic health physiotherapy independent prescriber is detailed in a case study of a patient referred with symptoms of stress urinary incontinence associated with impaired pelvic floor function and episodic constipation, in addition to perimenopausal vaginal dryness causing dyspareunia.

Safety and efficacy of a class II medical device based on highly purified and standardized plant extracts in the management of post-menopausal patients with vulvar and vaginal atrophy: a single-center prospective observational study.

Despite the gold standard treatment for genitourinary syndrome of menopause (GSM) is based on the use of local or systemic estrogen-containing products, the typical long-term side effects of hormonal treatments and, most importantly, the contraindications in patients with history of breast and endometrial neoplasms do limit in some extent its use. As hyaluronic acid and some highly purified botanicals have clearly demonstrated their anti-inflammatory and mucosa-protecting properties, we have tested, in women with GSM, a class II vaginal medical device containing hyaluronate gel and a mucoadhesive active enriched with purified alkylamides from Zanthoxylum bungeanum, triterpenes from Centella asiatica and high molecular weight polysaccharides from Tamarindus indica. Our single-center, open-label, prospective and observational study was conducted on 50 menopausal women enrolled at the Department of Maternal-Fetal Medicine at Umberto I Polyclinic Hospital in Rome, Italy. Gel administration lasted 150 days and was performed daily for the first 12 days and every 48 hours for the remaining 138 days. Clinical evaluations were performed at baseline and after 12, 57 and 150 days. Besides product safety, main outcomes of our study were: 1) vaginal health (by Vaginal Health Index score [VHI]); 2) sexual quality of life (by Female Sexual Distress Scale [FSDS]); and 3) percentage of women declaring regular sexual activity. The product was safe with no specific adverse events reported. It significantly improved VHI (about 5% after 57 days and 8% after 150 days), FSDS (about 7% after 57 days and 10% after 150 days), and sexual activity (about 20% after 150 days). It also reduced dryness, dyspareunia, burning, itching, and dysuria incidence, respectively by about 18%, 14%, 14%, 27% and 11% after 150 days. In women with GSM, the intravaginal administration of a hyaluronate-based gel enriched with purified botanical actives endowed with anti-inflammatory and mucosal-protecting properties, reduced painful sensation during sexual acts and increased regular sexual activity.

The Effect of Pelvic Floor Muscle Training on Health-Related Quality of Life in Postmenopausal Women With Genitourinary Syndrome: A Systematic Review and Meta-Analysis.

Genitourinary syndrome is commonly reported in postmenopausal women. Kegel's exercise is a noninvasive therapy that improves pelvic floor muscle parameters. However, the effect of Kegel's exercise on health-related quality of life (HRQoL) in postmenopausal women with genitourinary syndrome has not been synthesized or shown. This study was designed to systematically review and analyze the previous literature to determine whether Kegel's exercise enhances HRQoL in postmenopausal women with genitourinary syndrome of menopause. A systematic review and meta-analysis of randomized controlled trials was conducted, and six databases were searched, including Embase, MEDLINE, Cochrane, CINAHL, Web of Science, and Scopus, from their dates of inception to November 2021. Eligible studies evaluated the effects of Kegel's exercise on HRQoL in postmenopausal women with urinary, sexual, or genital symptoms. Review Manager software was used to perform the meta-analysis using a random-effects model. Chi-square and I2 tests were used to evaluate heterogeneity among the studies. Meta-analysis was performed based on the symptoms (i.e., urinary, sexual, and genital) identified in the quality-of-life questionnaires. This systematic review covered five studies with 268 participants. The research appraisal found most of these studies had a low risk of bias. The intervention periods ranged from 4 to 12 weeks. Compared with non-Kegel's exercise or regular activity, Kegel's exercise was found to significantly improve HRQoL-related urinary symptoms (three studies, standardized mean difference = -0.95, 95% CI [-1.35, -0.54], I2 = 0%). However, the effect of this exercise on HRQoL-related sexual symptoms did not differ from non-Kegel's exercise or regular activity (two studies, standardized mean difference = 1.11, 95% CI [-0.25, 2.47], I2 = 94%). None of the covered studies examined the effect of Kegel's exercise on HRQoL-related genital symptoms. Kegel's exercise is an effective intervention for improving HRQoL-related urinary symptoms in postmenopausal women. However, there remains insufficient evidence to assess the effectiveness of Kegel's exercise on HRQoL-related genital symptoms in this population. The results support using Kegel's exercise as a useful intervention to manage urinary symptoms in postmenopausal women.

Role of Platelet-Rich Plasma in Genitourinary Syndrome of Menopause.

The genitourinary syndrome of menopause (GSM) encompasses a range of symptoms linked to the genitourinary tract stemming from the reduction in estrogen levels following menopause. These symptoms may endure throughout a woman's lifetime. Platelet-rich plasma (PRP), known for its capacity to induce angiogenesis and the restoration effects of growth factors, has been widely employed in various disorders, including GSM. This article aims to comprehensively review the existing literature on the utilization of PRP for managing GSM. The search was executed in electronic databases, specifically PubMed, Scopus, and Google Scholar, up until April 2023. Eligible studies were meticulously chosen for inclusion in this systematic review. PRP emerges as a viable alternative for addressing vaginal atrophy, exhibiting favorable outcomes. Notably, it can be considered for patients with contraindications to hormonal therapy. However, the available body of evidence supporting the use of PRP for GSM remains limited. PRP presents itself as a promising agent, offering a patient-friendly, cost-effective alternative modality. To establish the efficacy of PRP in treating GSM definitively, future randomized trials are imperative.

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.

Contributors: Genitourinary Syndrome of Menopause.

Contributors: Genitourinary Syndrome of Menopause.

Safety and efficacy of non-ablative CO2 laser treatment of vulvo-vaginal atrophy in women with history of breast cancer.

Breast cancer survivors (BCS) suffer severe vulvo-vaginal atrophy (VVA) and some of the most effective therapies are contraindicated. In literature we have no data about the non-ablative CO2 laser on these women. The aim of this study was to examine its efficacy, safety and acceptability in BCS. The enrolled women underwent 3 sessions of laser therapy (t0, t1, t2) and a one-month follow up examination (t3). At each time point we measured objective signs of VVA via VHI (Vaginal Health Index) and VuHI (Vulvar Health Index) and subjective parameters (Dryness, Burning, Itching, Dysuria) via visual analog scales (VAS). In sexually active women we evaluated the sexual function with FSFI (Female Sexual Function Index), FSDS (Female Sexual Distress Score) scores and MENQOL (menopause quality of life questionnaire). We enrolled 26 BCS. The mean VHI, VuVHI, dryness and burning VAS scores improved significantly and this improvement was not influenced by the initial VVA grade. MENQOL sexual domain, Lubrication, Orgasm and Pain domains and FSFI total score improved significantly, while Desire, Arousal and Satisfaction domains of FSFI and FSDS did not. At t0 women using Aromatase Inhibitors suffered more severe vaginal dryness than women using Tamoxifen or no therapy, but the three subgroups improved without differences. No adverse event and minimum discomfortwere reported. The non-ablative CO2 laser is a safe and effective treatment of VVA and has positive effects on sexual function in BCS regardless the use of adjuvant therapies and the initial grade of VVA.

Randomized trial: treatment of genitourinary syndrome of menopause using radiofrequency

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

Efficacy of Traditional Kegels Versus Reverse Kegels on Vaginal Atrophy among Post Menopausal Women

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

Changes in vaginal secretion lipidom as a result of therapy in patients with vulvovaginal atrophy

Introduction. Vulvovaginal atrophy is a chronic progressive disease that includes physiological and anatomical changes as a result of a decrease in the level of sex hormones. VVA affects approximately 50% of middle-aged and older women and has a detrimental effect on interpersonal relationships, sexual health, and overall quality of life. Dynamic quadripolar radiofrequency (DRF) is a non-invasive procedure that may be a potential treatment for vulvar diseases.Aim. To study the metabolites of vaginal swabs in postmenopausal women treated with DRF.Materials and methods. The study included 180 women divided into 3 groups: treatment with DRF; treatment with a combination of DRF and estradiol, and estradiol treatment. In all patients, vaginal swabs were taken before the start of treatment and a month after treatment, and clinical parameters were assessed at 6 time points. Lipids were extracted from the cervico-vaginal fluid by the Folch method followed by liquid chromatography-mass spectrometric analysis. A comparative analysis of the clinical data of each of the groups and lipid profiles after treatment with a zero time point and their changes and a correlation analysis of changes in lipid levels and changes in clinical parameters before treatment and after 1 month was carried out.Results. There was a statistically significant reduction in the severity of VVA symptoms one month after treatment in all groups. The most pronounced effect of the therapy was observed in groups with the use of DRF with the preservation of the effect up to 12 months. In the first and second groups, a statistically significant difference was found in the levels of 2 lipids, in the third – in 4. In the first group, a correlation was found with lipids related with pain and lubrication, in the second – with vaginal pH, in the third – with the index of vaginal health, orgasm, satisfaction and pain.Conclusions. VVA therapy by DRF and local hormonal treatment triggers an inflammatory cascade in tissues. The use of the strategy of treatment with physical methods of influence has a mechanism of influence similar to the local application of estrogen in VVA. DRF therapy leads to the normalization of the vaginal microbiota and can compete with the use of estrogen in this therapeutic effect.

Urologic perspective of genitourinary syndrome of menopause

AbstractBackgroundExperts define the Genitourinary Syndrome of Menopause (GSM) as a collection of signs and symptoms associated with decreased oestrogen levels. Its prevalence ranges between 13% and 87% in postmenopausal women.ObjectiveWe aimed to describe the main pathophysiology mechanisms of GSM affecting the lower urinary tract and the manifestations and treatment options for lower urinary tract dysfunction in GSM.ResultsSeveral treatments and recommendations have been proposed to enhance patients' ability to manage their symptoms, such as regular sexual activity or masturbation, to increase this physiological response and reduce the severity of GSM.ConclusionGSM is a multifactorial and complex syndrome that affects postmenopausal women. Impairment of urogenital structures implies diverse manifestations of genital atrophy and lower urinary tract symptoms.

The Concept behind the Suitability of Menstrual Blood-Derived Stem Cells for the Management of Vaginal Atrophy among BRCA Mutation Carriers after RRSO.

Risk-reducing bilateral salpingo-oophorectomy (RRSO) is recommended for breast cancer gene 1 (BRCA1) and 2 (BRCA2) mutation carriers. A major consequence of RRSO is surgical menopause associated with severe menopausal symptoms, mostly genitourinary complaints. Due to the inherent breast cancer risk, estrogen-based therapies are generally avoided in these patients. So far, the non-hormonal approaches available are not efficient to successfully treat the disabling vaginal atrophy-related symptoms. In regenerative medicine, mesenchymal stem cells (MSC) are the most frequently used cell type due to their remarkable and regenerative characteristics. Therapies based on MSC have revealed positive outcomes regarding symptoms and signs associated with vaginal atrophy by promoting angiogenesis, vaginal restoration, and the proliferation of vaginal mucosa cells. Menstrual blood-derived stem cells (MenSC) are a novel source of MSC, with promising therapeutic potential directly linked to their high proliferative rates; low immunogenicity; non-invasive, easy, and periodic acquisition; and almost no associated ethical issues. In this review, we update the current knowledge and research regarding the potential value of previously preserved MenSC in the therapy of vaginal atrophy among BRCA mutation carriers subjected to RRSO.

Diffuse reflectance spectroscopy and imaging for non-invasive objective assessment of genitourinary syndrome of menopause: a pilot study

The genitourinary symptom of menopause (GSM) affects up to 65% of women, resulting in symptoms such as vulvovaginal dryness, discomfort, and dysuria, which significantly impacts quality of life. The current assessment methods rely on subjective questionnaires that can be influenced by individual differences, as well as invasive measurements that are time-consuming and not easily accessible. In this study, we explore the potential of a non-invasive and objective assessment tool called diffuse reflectance spectroscopy and imaging (DRSI) to evaluate tissue chromophores, including water, lipid, oxyhemoglobin, and deoxyhemoglobin. These measurements provide information about moisture content, lipid levels, oxygen saturation, and blood fraction, which can serve as surrogate markers for genital estrogen levels. Our findings reveal distinct differences in these chromophores among pre, peri, and postmenopausal subjects. By using lipid and blood fraction tissue chromophores in a K-Nearest Neighbour classifier model, we achieved a prediction accuracy of 65% compared to vaginal maturation index (VMI) that is clinically used to assess estrogen-related hormonal changes. When age was included as the third feature, the accuracy increased to 78%. We believe that by refining the study protocol and configuring the fiber probe to examine tissue chromophores both in the superficial vulva skin for epidermal water content and the deeper layers, DRSI has the potential to provide objective diagnosis and aid in monitoring the treatment outcome of GSM.

Surgery for female urethral stricture.

Female urethral stricture (FUS) is a rare entity that causes great morbidity and suffering in those affected. As the available scientific data is sparce, there are no formal guidelines or standard of care for this disease. This is a narrative review of the surgical management for female urethral stricture. The literature review was performed on PubMed. Articles were limited to English, but there was no limitation in terms of date. Management of FUS is divided between endoscopic and open surgical repair. Urethral dilation with or without urethrectomy can be offered as a first-line treatment. However, the rate of success of this procedure remains inferior to open surgical repair, and its efficacy decreases with the number of previous dilations. For distal urethral strictures, distal urethrectomy and advancement meatoplasty may be considered. Vaginal flaps are readily available, easy to harvest, well-vascularized, and allow for a dorsal or ventral orientation urethroplasty. The results of this procedure are promising, but most studies are small and retrospective. Labia flaps are easily accessible, wet, hairless, and elastic. The main limitations with the use of vaginal or labial tissues are co-existing conditions such as lichen sclerosis or vaginal atrophy, which may affect future results. Vaginal and labial graft urethroplasty can be used when it is not possible to mobilize an adequate flap. Stricture-free rates of this technique are variable. In cases of more severe stricture, an augmentation urethroplasty using buccal mucosa graft may be necessary. The techniques used in FUS replicate those for male urethral strictures, where both ventral and dorsal approaches can be utilized. Although there is growing interest in the field, the optimal management of FUS remains to be determined.

Real‑world performance and safety of vaginal ovules in reducing the vaginal symptoms associated with vulvovaginal atrophy and postmenopausal sexual dysfunction.

Decreasing estrogen levels during the postmenopausal period results in tissue atrophy and physiological changes, such as thinning of the vaginal epithelium, prolapse and decreased pelvic floor strength and control. Sexual dysfunction associated with vaginal dryness occurs in postmenopausal patients. The present study (trial no. NCT05654610) was designed as an observational, multicenter, real-world clinical investigation to evaluate the performance and safety of the medical device Halova® ovules in decreasing vaginal symptoms associated with vulvovaginal atrophy and sexual dysfunction. A total of 249 female participants were treated with Halova ovules, both in monotherapy and in combination with vaginal lubricants. The primary objective was to evaluate the tolerability of Halova ovules in the management of symptoms associated with perimenopause or genitourinary syndrome of menopause. The evolution of clinical manifestations such as vaginal dryness, dysuria, dyspareunia and endometrial thickness was defined a secondary objective. Halova ovules were rated with 'excellent' clinical performance by 92.74% of participants as a standalone treatment and 95.71% of the study participants when used in association with vaginal lubricants. Sexual dysfunction-associated parameters, such as vaginal dryness and dyspareunia, were reduced by similar percentages in each arm, 82% (monotherapy) and 80% (polytherapy) for vaginal dryness and 72% in monotherapy vs. 48% polytherapy reducing dyspareunia. No adverse reactions associated with treatment with Halova were reported. The medical device demonstrated anti-atrophic activity in the genitourinary tract, resulting in significantly improved symptoms associated with normal sexual functioning.

Different effects of CO2 laser and estrogen treatment on vaginal mucosa microbiota and function in genitourinary syndrome of menopause patients.

To characterize the effects of CO2 laser treatment and estrogen treatment on vaginal microbiota in patients with genitourinary syndrome of menopause (GSM). Sixty-four patients with genitourinary syndrome were divided into the estrogen group, the CO2 laser group, and the control group. The control group did not receive any treatment. Vaginal mucosa was collected after 3 and 12 months of treatment. The former was used for 16S rRNA sequencing, and the latter was used for pathological evaluation. Vaginal health and voiding function were assessed using the vaginal health index (VHI) scale and the UDI-6 scale at 3 and 12 months after treatment. The results showed that both treatments reduced alpha diversity in the vaginal flora. Additionally, the abundance of 65 genera differed significantly between the treatment and control groups, with an increase in potentially beneficial bacteria such as Lactobacillus, IheB3_7, Mycoplasma urealyticum, and Streptococcus. In addition, the VHI and UDI-6 scores improved in both treatment groups compared to the control group after 3 months. Whereas VHI and UDI-6 scores were close to baseline in the estrogen group, and remained significantly improved in the CO2 laser group after 12 months. Pathological results showed that both methods improved the vaginal health status of patients with GSM after 12 months of treatment. However, the CO2 group exhibited a more significant increase in type III collagen. Both CO2 laser and estrogen therapies can regulate the vaginal flora imbalance of GSM and improve the corresponding symptoms. However, the long-term efficacy of CO2 laser therapy is superior compared to estrogen therapy.

The effect of fractional microablative carbon dioxide laser therapy on vaginal atrophy in menopause women: A review

Vaginal atrophy is one of Genitourinary Syndrome of menopause. This condition occurs due to decreased estrogen levels during menopause. Epidemiological data obtained from several countries estimated that up to 50% of post-menopausal women experience symptoms of vaginal atrophy. This paper aims to conduct a systematic review, and this meta-analysis is to analyze the effect of micro ablative fractional CO2 laser therapy on vaginal atrophy in postmenopausal women. Data was collected online from Pubmed-MEDLINE, Scopus, EBSCO, Cambridge Core, ProQuest, Springer Link, Cochrane Library, and ClinicalTrials.gov databases. Tracking will be carried out in May-July 2023. The population of this study is the result of clinical trial research on the effect of microablative fractional CO2 laser therapy on vaginal atrophy in postmenopausal women. Meta-analysis showed that the VHI score was higher after therapy in the group that received micro ablative fractional CO2 laser compared to the group that received sham laser for vaginal atrophy in menopausal women. VAS scores were lower after administration in the group that received microablative fractional CO2 laser compared to the group that received sham laser for vaginal atrophy in menopausal women. The incidence of side effects in the CO2 laser group did not differ from the sham laser group. This study recommends an RCT study was conducted comparing micro ablative fractional CO2 laser compared to other energy-based devices such as erbium laser and radiofrequency on vaginal atrophy in postmenopausal women so that it can be used as a basis for further systematic review research and meta-analysis.

Современные лазерные технологии в гинекологической практике: возможности инновационного неодимового лазера

Aim. To summarize a review of modern literature and present a clinical observation of the use of the Magic Gyno Nd:YAG laser for the treatment of vulvovaginal atrophy in postmenopausal patients. Key points. One of the most significant problems of the menopausal period is genitourinary syndrome of menopause (GSM), the symptoms of which have a significant impact on the quality of life and sexual health of most women during menopause and occur in more than 50% of patients. The search and study of new effective and safe methods for treating the symptoms of GSM is an extremely urgent task, the importance of which, taking into account existing demographic and social trends, will only increase in the coming years. In addition to the objective risks associated with hormonal therapy, which is the "gold standard" in the treatment of GSM, it should be noted that for some patients it is contraindicated for medical reasons, and sometimes women themselves do not want to use hormone-containing drugs. Thus, there is a need to select other methods of therapy that will provide long-term symptomatic effect. Based on the available data, treatment of GSM using laser devices may be comparable in effectiveness to local hormonal therapy, and superior in safety. One of the most promising instruments of this class is the Nd:YAG laser, successfully used in cosmetology, ophthalmology, dentistry, surgery, urology, as well as in gynecology. After therapy with a neodymium laser, an improvement in lubrication and elasticity of the tissues of the vulva and vagina, normalization of the pH of the vaginal discharge was shown, as well as a significant reduction in the manifestations of sexual dysfunction and an increase in the quality of sexual life noted by patients. Conclusion. The neodymium laser method in gynecological practice is a new promising method of treatment. Although further randomized controlled trials are required, it has now been successfully used in the treatment of GSM and for patients who are contraindicated for hormonal therapy, or those who do not want to use even topical estrogens due to obsessive stereotypes and unreasonable fears. may become an alternative to local estrogen therapy. Key words: vulvovaginal atrophy, neodymium laser, Nd:YAG laser, genitourinary syndrome of menopause, hormone replacement therapy, estriol, vaginal wall prolapse.