Hyaluronic acid for vaginal health and quality of life in postmenopausal women: A systematic review and meta-analysis of randomized controlled trials.

Effectiveness of radiofrequency therapy combined with pelvic floor muscle training in breast cancer survivors with genitourinary syndrome of menopause: a study protocol.

The interplay between the local microbiome and inflammatory environment is crucial in modulating the immune response. This research addresses the paucity of studies in the Indian context by mapping the cervical microbiome and associated inflammatory milieu in 43 apparently healthy women and evaluating its perturbations with various asymptomatic vaginal infections. Cervical microbiome was mapped for forty three participants, aged 18-45, who were enrolled from a community clinic as a part of longitudinal contraceptive study from October 2021 to September 2023. Sociodemographic data, clinical history, and cervical and cervicovaginal lavage specimens were collected. Microbiome analysis involved nanopore sequencing of the entire 16S rRNA region amplicon, while cytokine assessment in cervicovaginal lavage specimens utilized multiplex immunoassays. Firmicutes, Bacteroidetes, Actinobacteria, Proteobacteria, and Fusobacteria appeared as dominant phyla with 32.55% having asymptomatic bacterial vaginosis (BV),16.27% asymptomatic Candida, and 13.95% coinfections. The cervical microbiome was dominated by Lactobacillus iners (45.69%), followed by Lactobacillus helveticus (6.53%) and Lactobacillus reuteri (5.86%). Women with BV exhibited an increased abundance of Prevotella and Streptococcus, while Candida infections were associated with elevated Atopobium and Collinsella species. Pro-inflammatory cytokines (IL-1β, IL-6, TNF-α, IL-8) showed variable levels, with Lactobacillus positively correlating with the regulatory cytokine TNF-α in in Candida infections. In BV Lactobacillus species such as L. agilus, L.iners and L. salivarius showed positive correlation with TNF-α. Additionally, Lactobacillus manihotivoranswas negatively associated with IL-1β, while Lactobacillus brevis and Lactobacilluszeae showed negative correlations with IL-8. This study maps the cervical microbiome and cytokine profile of healthy Indian women and demonstrates that asymptomatic bacterial vaginosis and Candida infections induces variations, highlighting the complex host-microbe interactions that govern vaginal health.

Lactobacillus crispatus is a dominant member of the healthy vaginal microbiota, yet the mechanisms by which it modulates host immunity remain poorly defined, in part due to the lack of tractable in vivo models. Here, we integrate bacterial genetics, in vitro epithelial systems, human-derived data and proteomic approach (Olink®) to uncover a critical role for L. crispatus exopolysaccharides (EPS) in shaping the bacteria-vagina interactions. Comparative genomics identified a conserved EPS biosynthetic locus, with the priming glycosyltransferase gene epsE emerging as a regulatory node, in line with its distinct expression in human vaginal samples. Functional disruption of epsE abrogated L. crispatus EPS production and revealed its role for immune modulation. In human vaginal epithelial monolayers, EPS presence enhanced immune-regulatory (LAP TGF-beta-1) and anti-inflammatory (CST5) responses, whereas its absence triggered elevated pro-inflammatory cytokines (IL1β, IL6, IL8) and matrix metalloproteinase (MMP10). In a 3D vaginal organotypic model, EPS increased chemokines (CXCL5, CXCL6) linked to immune surveillance and the presence of the markers was validated in vaginal samples of healthy volunteers. These findings position EPS as a key immunomodulatory structure of L. crispatus, advancing our mechanistic understanding of host-commensal interactions and informing microbiome-based strategies to promote vaginal health.

A Systematic Review of Patient-Reported Outcomes on the Impact of Radiotherapy on Sexual Health in Gynecologic Cancer Patients.

Abstract Background: Most patients with estrogen receptor-positive (ER+), metastatic breast cancer (mBC) treated with endocrine therapy (ET) will ultimately develop resistance. A large unmet need exists especially when resistance occurs following treatment with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i), which is potentially driven by a mutation in the ERα-coding gene, ESR1. Lasofoxifene (LAS), an oral, next-generation ET and ER breast antagonist, was evaluated in two phase 2 studies of women with ER+/HER2- mBC and an ESR1 mutation who had disease progression on previous ET and CDK4/6i. In the ELAINE 1 trial, LAS monotherapy provided numerically greater progression-free survival (PFS, median 5.6 mos vs 3.7 mos; HR: 0.669 [95% CI, 0.445‒1.125], P=0.138), objective response rate (ORR, 13% vs 3%; P=0.124), and clinical benefit rate (CBR, 37% vs 22%; P=0.117) compared with the ER degrader fulvestrant (fulv), with a favorable safety profile (Goetz MP et al. Ann Oncol 2023;34:1141‒51). The single-arm, ELAINE 2 trial showed that LAS combined with abemaciclib (Abema) was well tolerated with a median PFS of ∼13 mos, ORR of 56%, and CBR of 66% (Damodaran S et al. Ann Oncol 2023;34:1131‒40). The phase 3, registrational, ELAINE 3 trial was initiated based on these promising earlier-phase data. Recent results from postMONARCH confirmed superior efficacy of fulv/Abema over fulv/placebo (mPFS 6.0 mos vs 5.3 mos, HR 0.73 [0.57‒0.95], nominal P-value 0.017) in non-biomarker‒selected, mBC patients after progression on a prior CDK4/6i and aromatase inhibitor (AI), with similar HR in an ESR1-mutated cohort (Kalinsky K et al. J Clin Oncol 2025;43:1101‒12). Additionally, recent data from EMBER-3 demonstrated meaningful PFS with a novel ET combined with abemaciclib after progression on AI/CDK4/6i (Jhaveri KL et al. N Engl J Med 2025;392:1189‒202). The ELAINE 3, global trial will compare LAS/Abema with fulv/Abema in a post-CDK4/6i, ESR1-mutation‒selected, mBC population. Methods: ELAINE 3 (NCT05696626) is an open-label, phase 3, multicenter study evaluating the efficacy, safety, and tolerability of LAS plus Abema versus fulv plus Abema. Patients are being enrolled at approximately 152 sites in 13 countries (Australia, Belgium, Canada, China, France, Italy, Israel, Poland, Romania, Spain, Taiwan, United Kingdom, United States). Key inclusion criteria are pre- and postmenopausal women and men aged ≥18 yrs; ER+/HER2-, locally advanced and/or mBC (measurable and/or non-measurable disease); ≥1 acquired ESR1 mutation; progression on an AI plus palbociclib or ribociclib as their first hormonal treatment for advanced/mBC; and ≤1 line of chemotherapy in the advanced/metastatic setting. Patients will be randomized 1:1 to receive LAS 5 mg/day plus Abema 150 mg BID, or fulv 500 mg IM (days 1, 15, and 29, then once monthly) plus Abema 150 mg BID. Treatment will continue until progression, death, unacceptable toxicity, or withdrawal from the study. The primary endpoint is PFS per RESIST 1.1 by blinded independent central review (BICR); key secondary endpoints are ORR, overall survival, CBR, duration of response, and time to response. Safety, time to cytotoxic chemotherapy, and quality of life (including vaginal health) will also be evaluated. Blood samples for circulating tumor DNA (ctDNA) will be collected for genomic analyses at screening, at weeks 4 and 8 and every 8 weeks thereafter, and at the final visit. Outcomes with LAS/Abema and fulv/Abema will be compared using a stratified Cox proportional hazards model and stratified logrank test with an expected PFS hazard ratio of 0.68 at final analysis. Enrollment is currently ongoing to meet the target sample size of 500 patients. Citation Format: M. P. Goetz, S. A. Wander, T. Bachelot, G. Curigliano, A. de Nonneville, E. N. Gal-Yam, K. Jhaveri, S. L. Sammons, S. Shen, C. J. Twelves, G. Gasper, P. V. Plourde, D. J. Portman, S. Damodaran. Open-label, randomized, multicenter, phase 3, ELAINE 3 study of the efficacy and safety of lasofoxifene plus abemaciclib for treating ER+/HER2-, locally advanced or metastatic breast cancer with an ESR1 mutation [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS5-07-30.

Abstract Introduction: Genitourinary syndrome of menopause (GSM) is a common yet underrecognized effect of endocrine therapy leading to sexual dysfunction in breast cancer survivors. Vaginal hormones are the most effective treatment but are infrequently prescribed due to concerns regarding systemic absorption. Platelet-rich plasma (PRP) is derived from a patient’s blood and centrifuged to remove erythrocytes, and the concentrated growth factors promote tissue repair, angiogenesis, and collagen synthesis. It is unknown whether PRP, created and applied in a standardized approach, could improve vulvovaginal symptoms in patients on estrogen suppressive therapies. This phase II trial sought to determine whether 2 vulvovaginal PRP treatments could constitute a novel GSM therapeutic for breast cancer patients with GSM. Methods: A prospective phase II pilot trial included female breast cancer patients with GSM treated with two sessions of PRP one month apart. 4cc of PRP was created from 30cc of whole blood collected by venipuncture using the Magellan Autologous Platelet Separator System (Isto Biologics, Hopkinton, MA). PRP was injected into the posterior vagina, vestibule, and posterior fourchette. The primary outcome was a change in patient-reported GSM symptoms using the validated Vulvovaginal Symptom Questionnaire (VSQ), compared at baseline (T0) and one month after the treatment #2 (T1). Secondary outcomes included vaginal health index (VHI) collected on exam, as well as patient-reported sexual function (Female Sexual Function Index: FSFI) and sexual distress (Female Sexual Distress Scale-Revised: FSDS-R). Lower VSQ and FSDS correspond to less GSM symptoms and lower sexual distress, respectively, whereas higher VHI and FSFI correspond to less atrophy and greater sexual function. Exploratory analyses included outcome assessment at 6 months (T2). Paired t-tests compared mean score differences between timepoints. Results: 18 breast cancer patients were enrolled (2023-2025), 17 received 2 treatments. Median age was 51.5 years (38-66), 89% received chemotherapy, and all patients were on endocrine therapy during the trial. Mean VSQ, FSDS-R, and VHI significantly improved from T0 to T1 (Table 1), and remained significantly improved at T2 (n=11). Of 7 sexually inactive patients at enrollment, 5 resumed sexual activity during the study. Post-treatment pain scores were low, and one patient developed post-treatment itching requiring an antihistamine and fluconazole. Conclusion: Two treatments of vulvovaginal PRP improved breast cancer patient-reported vulvar symptoms and lowered sexual distress when applied in a standard application, and the improvements appear to be durable for 6 months after completing treatment. Funding: SCCC Cancer Survivorship Research Pilot Award (CC-CSRP-2023) Citation Format: M. Curran, T. Wolde, J. Firdman Moore, G. Sierra, N. Paez, L. Pla, A. Van Mossel, K. Rojas. A phase II trial of platelet-rich plasma for breast cancer patients with genitourinary syndrome of menopause [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS5-04-25.

Background/Objectives: Genitourinary syndrome of menopause (GSM) is a common and under-diagnosed condition that significantly affects the quality of life of post-menopausal women. Conventional treatments, especially those based on estrogens, have limitations, which has prompted the search for alternative therapies in the field of regenerative medicine. In this context, intradermal injectable collagen, with regenerative and analgesic properties, could represent an innovative option. This study aims to evaluate the efficacy and safety of multipoint intradermal injections of collagen (MD-Tissue) in the treatment of GSM refractory to conventional first-line therapy. Methods: A retrospective study was conducted in 20 patients diagnosed with GSM. Intradermal injections of collagen were administered in the vulvovaginal region. Clinical outcome was assessed using the Visual Analog Scale (VAS) for baseline pain and dyspareunia, the Vaginal Health Index (VHI), the Vulvar Health Index (vHI), the Vulvovaginal Symptoms Questionnaire (VSQ) and the Clinical Global Impression scale (CGI). Results: Three months after end of injections, baseline pain measured using the VAS was significantly reduced from a mean of 5.9 to 0.8 (p < 0.001), and pain during intercourse decreased from 8.7 to 2.0 (p < 0.001). Significant improvements were also observed in the tissue parameters of VHI and vHI. In the VSQ, 100% of patients reported improvement in at least one domain, including itching, dryness, burning, and social and sexual impact. According to the CGI scale, 80% reported feeling 'much better' and 20% 'moderately better'. No relevant adverse effects were reported. Conclusions: Intradermal vulvovaginal collagen injections appear to be a safe and potentially effective intervention in improving pain and other symptoms of GSM, within the regenerative medicine approach. These preliminary results justify prospective studies, with larger sample sizes and long-term follow-up, to confirm and consolidate clinical utility.

To evaluate the efficacy of nonablative capacitive-resistive monopolar radiofrequency on sexual function and vaginal health in postmenopausal women with genitourinary syndrome of menopause. This was a single-blind, randomized, controlled clinical trial. The participants were randomly assigned to receive six weekly sessions of capacitive-resistive monopolar radiofrequency (n=32) or sham treatment (n=30). Sexual function was assessed using the Female Sexual Function Index (FSFI) and vaginal health was assessed using the Vaginal Health Index (VHI). The estrogenic status was determined by vaginal cytology, which involves calculating the proportions of basal, intermediate, and superficial cells. Assessments were conducted at baseline, post-treatment, and 12-week follow-up. Compared with the control group, the intervention group showed significantly greater improvements in the Female Sexual Function Index and Vaginal Health Index at post-treatment and at the 12-week follow-up. FSFI mean changes were 5.86 versus 1.33 at posttreatment (P<0.001) and 4.41 versus -0.41 at 12-week follow-up (P=0.011). VHI mean changes were 4.75 versus -0.03 at post-treatment (P<0.001) and 6.90 versus -0.66 at follow-up (P<0.001). The effect sizes were moderate to large for the FSFI (Cohen's d >0.77, 95% CI, 0.25-1.29) and large for the VHI (d >3.49, 95% CI, 2.68-4.28). No significant changes were observed in estrogenic status, and no adverse events were reported. Capacitive-resistive monopolar radiofrequency significantly improved sexual function and vaginal health in women with genitourinary syndrome of menopause, thereby supporting its use as a safe, nonhormone treatment option.

Introduction: The vaginal microbiome is a critical modulator of vaginal immunology and undergoes constant changes throughout life. While the vaginal microbiota of premenopausal women is extensively studied, its composition and implications on vaginal health in peri-menopausal and postmenopausal women remains unclear. Notably, differences in vaginal microbiome composition may influence susceptibility to mucosal infections, including bacterial vaginosis (BV), sexually transmitted infections (STIs), and human immunodeficiency virus (HIV). Methods: With no time restrictions, a systematic search of Ovid EMBASE and Ovid Medline was conducted from inception to May 2024. Three independent reviewers screened titles, abstracts, and full texts and extracted data on population demographics, sequencing methods, BV diagnostic criteria, and vaginal microbiome composition. The inclusion criteria were studies comparing premenopausal and postmenopausal women with outcomes reporting vaginal bacterial composition. Secondary outcomes include hormone or estrogen levels and glycogen content. Results: Five studies met the inclusion criteria. These studies span two countries, with participants aged 18 to 61 years. Four studies used 16S rRNA gene sequencing; one used bacteria-specific qPCR. Premenopausal women predominantly exhibited Lactobacillus-dominated community state types (CSTs) I and III, with higher glycogen levels and lower vaginal pH compared to postmenopausal women. The vaginal microbiomes of postmenopausal women are largely presented as CST-IV, characterized by reduced Lactobacillus spp. and increased diversity of other anaerobes. Estrogen therapy partially restored Lactobacillus dominance, improving microbial stability. Transition rates between CSTs were more frequent in premenopausal women, typically between Lactobacillus crispatus-dominant (CST I) and high-diversity anaerobic-dominant (CST IV). Discussion: Age-related changes in the vaginal microbiome underscore the impact of hormonal decline and glycogen availability on microbial dynamics. The differences in vaginal microbiome composition access life stages may reflect age-related susceptibility to urogenital conditions. Estrogen therapy emerges as a potential intervention to restore microbial balance and improve vaginal health outcomes in postmenopausal women. Conclusion: Further research is needed to explore targeted interventions supporting microbial resilience across life stages. Such interventions could inform strategies to prevent urogenital conditions and enhance overall vaginal health for women as they age.

The vaginal microbiome plays an important role for women's health. Changes in its composition have been associated with several sexually transmitted infections, including human papillomavirus (HPV) or parasitic infections such as Schistosoma haematobium (Sh). In Madagascar, gynaecological conditions such as chronic manifestations of Sh infections (female genital schistosomiasis, FGS), HPV infections, and cervical cancer are highly prevalent; however, data on the interplay between these conditions and the vaginal microbiota (VM) is still scarce. Additionally, the majority of data originates from the Global North, generating a biased understanding of "healthy" VM across different geographical and social contexts. The objective of our study was to characterize for the first time the VM of adult women of reproductive age in Madagascar and to describe the variability of the vaginal environment in presence of three conditions affecting the urogenital tract. We characterized the VM of 443 participants, identifying the five community state types (CSTs I - V) with CST IV (57.1 %, diverse) and CST III (34.1 %, Lactobacillus iners-dominated) as the most prevalent. CSTs were associated with previous antibiotics usage, while variability in the alpha and beta diversity was associated with dietary behaviour and previous antibiotics usage. Differential abundance analysis showed variations among specific taxa in HPV- and FGS-positive participants. With this first study of the VM in Madagascar we contribute to a broader understanding of vaginal health as well as narrowing the gap of VM research in sub-Saharan Africa by enriching microbiota databases.

Effect of a non-hormonal vaginal moisturizer on vaginal and vulvar health in postmenopausal women with breast cancer: A randomized clinical trial.

Platelet-Rich Plasma in the Management of Genital Lichen Sclerosus: A Review of Mechanisms, Evidence, and Future Directions.

Non-hormonal vaginal gel improves vaginal and sexual health in menopausal women: results from a 6-month prospective study.

This study explores the development of electrospun nanofibrous materials as delivery systems for the probiotic strain Lactobacillus paragasseri K7 (LK7) and the bioactive glycoprotein lactoferrin (LF) with applications targeting vaginal health. Electrospinning was used to encapsulate LK7 and LF into poly-(ethylene oxide) (PEO)-based nanofibers supported on polypropylene fabric. Three formulationsPEO/LF, PEO/lactobacilli (LB) (with LK7), and PEO/LF/LBwere characterized for their physicochemical properties, fiber morphology (SEM), chemical composition (FTIR, XPS), and antioxidant activity (2,2'-azino-bis-(3-ethylbenz-thiazoline-6-sulfonic acid) (ABTS) assay). SEM analysis confirmed successful nanofiber formation, though LK7 remained on the fiber surface due to its size. FTIR and XPS analyses verified the incorporation of functional groups and elements associated with LF and LK7. The antioxidant assays showed that both LF and LK7 exhibited strong radical scavenging activity in formulations and it decreased slightly after electrospinning. Among the electrospun samples, the PEO/LF/LB formulation demonstrated the highest antioxidant potential. The viability and release studies revealed that 0.38-0.45% of LK7 survived during the electrospinning process and that the bacterial cells were released rapidly within 1 min of PBS exposure. Storage at 8 or 20 °C under 65% humidity reduced the viability (cfu) further, likely due to a transition to a viable but nonculturable (VBNC) state. Despite the low survival rates, the immediate release profile and antimicrobial potential of the materials support their suitability for short-term therapeutic applications such as vaginal tampons or wound dressings. This study highlights the potential of nozzle-free electrospinning for developing delivery systems for live biotherapeutics and postbiotics and suggests future work to optimize viability or expand into postbiotic applications.

Vaginal health is crucial to a woman's overall well-being. Bacterial vaginosis, a common gynecological condition resulting from dysbiosis, remains a significant clinical challenge. This study aims to investigate whether postbiotics derived from vaginal Lactobacillus strains exhibit therapeutic effects against bacterial vaginitis. Postbiotics, consisting of inanimate microorganisms and/or their components, were analyzed and found to contain lactic acid and acetic acid as the primary acidic constituents. In a model of Gardnerella vaginalis-induced bacterial vaginosis, postbiotics demonstrated enhanced antibacterial and antioxidant activities. They significantly alleviated clinical symptoms, modulated the composition of the vaginal microbiota, and increased microbial diversity. Specifically, postbiotics reduced the abundance of endotoxin-producing Escherichia-Shigella and Enterobacteriaceae, while promoting beneficial bacteria such as Muribaculaceae, Lachnospiraceae, and Streptococcus. Additionally, postbiotic treatment restored the balance between Th17 and Treg cells and regulated associated inflammatory factors. These findings indicate that postbiotics improve bacterial vaginitis through multiple mechanisms, including antibacterial and antioxidant effects, immune regulation, and restoration of vaginal flora structure and metabolic balance. This study highlights the potential clinical value of postbiotics in the treatment of bacterial vaginosis.

BackgroundVaginal microecology can reveal the health of the female reproductive tract directly. Female vaginal microecology reflects the state of female reproductive tract health. This study aimed to utilize a variety of female vaginal microecological indicators to comprehensively assess the relationship between the level of vaginal microecological health and Ureaplasma urealyticum (UU) infection in women.MethodsA total of 408 participants were included in this study, including 144 UU-positive and 264 UU-negative individuals. Clinical information of the participants was collected, and vaginal microecological indicators (cleanliness, hydrogen peroxide (H2O2), leukocyte esterase (LEU), sialidase (SNA), N-acetyl glucosidase (NAG), and β-glucuronidase (GUS)) were tested. The measurement data were expressed as mean ± standard deviation (x ± s), and the comparison of data between groups was performed using a t-test; count data were expressed as the number of cases (percentage) (n[%]), and the data between groups were compared using the chi-square test. Univariate and multivariate logistic regression model analyses explored the factors modifying infection with UU.ResultsUU-positive patients exhibited higher rates of cleanliness positivity, H2O2 positivity, LEU positivity, SNA positivity, NAG positivity, and GUS compared to UU negative patients (P < 0.05) . The univariate logistic regression model found that cleanliness, H2O2, LEU, SNA, NAG, and GUS were risk factors for UU infection in women (Cleanliness: odds ratio [OR] = 4.30, 95% confidence interval [CI] [2.79–6.63]); H2O2: OR = 9.01, 95% CI [5.33–15.23]; LEU: OR = 1.88, 95% CI [1.22–2.91]; s SNA: OR = 5.53, 95% CI [2.73–11.19]; NAG: OR = 2.41, 95% CI [1.35–4.30]; and GUS: OR = 1.95, 95% CI [1.21–3.15]) . The multivariate logistic regression model found that the independent risk factors for UU infection in patients were cleanliness (OR = 3.00, 95% CI [1.66–5.43]) and H2O2 (OR = 7.24, 95% CI [4.19–12.51]).ConclusionsVaginal cleanliness and H2O2 abnormalities are risk factors for UU infections in women. Therefore, female UU infections can be prevented by maintaining vaginal microecology.

Efficacy of pelvic floor muscle training combined with promestriene in improving pelvic floor dysfunction in middle-aged and elderly women: a retrospective study.

Vaginal symptoms and sexual function in climacteric women experiencing stress urinary incontinence: a secondary analysis from a six-month follow-up of a randomised trial comparing microablative radiofrequency, pelvic floor muscle training, and combination treatments.

The field of female genital aesthetic, reconstructive, and functional surgery has rapidly expanded due to advances in laser and regenerative technology, but its fragmented terminology currently limits academic cohesion and standardization. This narrative review proposes gynecoplastic surgery as a unified term that integrates the aesthetic, reconstructive, and functional domains of female genital surgery. The review was structured using PubMed, Scopus, and Web of Science to consolidate knowledge on terminology, anatomical classification, and objective evaluation tools, including validated indices, such as the Vaginal Health Index and Vulvar Health Index, and imaging modalities, such as high-frequency ultrasound. The literature confirms a convergence of restorative, aesthetic, and functional procedural goals, supported by emerging objective metrics for vulvovaginal evaluation. Gynecoplastic surgery offers an encompassing framework, connecting the historical evolution of reconstructive gynecology with advances in imaging and regenerative therapies. Standardizing terminology under this framework will promote academic clarity, facilitate multidisciplinary collaboration, and align clinical practice with modern evidence-based assessment, supporting its future adoption in research, training, and patient communication.