Search Results (216)

Background: Uterine fibroids are the most common benign tumors in women of reproductive age, and their coexistence with pregnancy is becoming increasingly frequent as maternal age at first pregnancy rises. Objective: The objective of this study was to evaluate the impact of uterine fibroids on obstetric and neonatal outcomes and, secondarily, the effect of pregnancy on fibroid growth. Study Design: This retrospective observational study included 1512 pregnant women, 136 of whom had uterine fibroids, who were followed at a university hospital. Ultrasound examinations were performed before pregnancy (T0) and during the first (T1), second (T2), and third (T3) trimesters. Fibroid number, size, location, and ultrasound characteristics according to FIGO classification were recorded. Obstetric complications, mode of delivery, and neonatal outcomes were analyzed according to fibroid type and size. Fibroid growth throughout pregnancy was also evaluated. Results: Among 1512 pregnant women followed between 1 January 2024 and 30 November 2025, 136 patients (9.0%) had uterine fibroids. A positive family history of fibroids was identified in 36% of cases. Gestational complications were infrequent overall, although gestational hypothyroidism was significantly more common among women with fibroids, whereas preeclampsia and postpartum hemorrhage were significantly less frequent in univariable analysis. Vaginal delivery was less frequent in the fibroid group, while operative vaginal delivery and cesarean section were significantly more common. Fetal growth restriction (FGR) and umbilical venous pH also differed significantly between groups. In multivariable analysis adjusted for maternal age, BMI, parity, ART, smoking, chronic hypertension, and diabetes, the association with cesarean section was attenuated (aOR 1.47, 95% CI 0.93–2.32), whereas lower PPH rates persisted (aOR 0.34, 95% CI 0.14–0.84) and a slight inverse association with umbilical venous pH remained detectable (β −0.01, p = 0.01). Exploratory stratification according to FIGO classification (3–4 vs. 5–7) showed significant differences in PPH, cesarean section, FGR, and LGA. Repeated-measure analysis demonstrated progressive fibroid growth in maximum diameter during pregnancy compared with preconceptional measurements (T0) (p < 0.001), with substantial enlargement already observed by the second trimester and fibroids ≤5 cm exhibiting greater relative growth at T2 compared with T0 than larger lesions (+18% vs. +7%; p = 0.03). Conclusions: Uterine fibroids were not consistently associated with adverse obstetric or neonatal outcomes, although careful obstetric surveillance remains warranted. Pregnancy was associated with progressive fibroid growth, particularly in smaller lesions and during early gestation. Full article

Background/Objectives: The vaginal and urinary tracts form an interconnected urogenital ecosystem. Oral probiotics have shown benefit in pregnancy for selected outcomes, including bacterial vaginosis and Group B Streptococcus agalactiae (GBS) colonization. However, their effects on vaginal Lactobacillus composition appear to be strain-specific. This prospective exploratory single-arm study evaluated whether vaginal Lactobacillus detection and routine urinary parameters changed during 60 days of oral multi-strain synbiotic supplementation in pregnant women with abnormal urinalysis. Methods: Twenty pregnant women at 28–32 weeks of gestation with abnormal routine urinalysis (leukocyturia, hematuria, and/or reported bacterial flora) received a multi-strain synbiotic containing seven probiotic strains and inulin twice daily for 60 days. Vaginal detection of L. crispatus, L. reuteri, L. rhamnosus, L. gasseri (supplement species), and L. jensenii (comparator) was assessed by species-specific real-time PCR at baseline (T0) and after 60 days (T1). Routine urinalysis was recorded at both times, and GBS colonization status at T1. Paired comparisons used McNemar’s exact and Wilcoxon tests; all analyses were exploratory. Results: Bacterial flora on urinalysis decreased from 20/20 (100%) to 8/20 (40%) (p < 0.001). Urinary pH, leukocyte and epithelial cell counts did not change significantly. Vaginal L. reuteri detection increased (2/20 to 10/20; p = 0.008). Four women (20%) were GBS-positive at T1. Conclusions: During 60 days of oral multi-strain synbiotic supplementation, temporal changes were observed in reported urinary bacterial flora and vaginal detection of selected Lactobacillus species. These exploratory findings require confirmation in larger controlled studies. Full article

Background/Objectives: Vaginal natural orifice transluminal endoscopic surgery lateral suspension (vNOTES-LS) may reduce the perioperative burden of conventional laparoscopic lateral suspension (LLS), but comparative evidence remains limited. We compared perioperative, anatomical, safety, and patient-reported outcomes. Methods: This single-center retrospective cohort included 97 women with stage III–IV pelvic organ prolapse who underwent vNOTES-LS (n = 33) or LLS (n = 64) and completed 12-month follow-up. The primary outcome was anatomical success at 12 months. Results: Operating time was shorter with vNOTES-LS (78.0 ± 16.6 vs. 110.0 ± 14.2 min; p < 0.001), as were estimated blood loss, hospitalization, and 24-h pain scores. After adjustment, vNOTES-LS was associated with a 31.7-min shorter operating time (95% CI, −38.7 to −24.6; p < 0.001). Anatomical success was 87.9% versus 89.1% (p = 1.000; RR, 0.99; 95% CI, 0.85–1.15), with an absolute risk difference of −1.2 percentage points (95% CI, −14.7 to 12.3). Cumulative mesh exposure within 12 months was 9.1% and 9.4%, respectively. No statistically significant between-group differences were detected in recurrence, measured safety outcomes, or longitudinal changes in the Pelvic Floor Distress Inventory-20 (PFDI-20), Pelvic Floor Impact Questionnaire-7 (PFIQ-7), and 12-item Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Conclusions: vNOTES-LS was associated with shorter operating time and favorable early perioperative outcomes. Observed 12-month anatomical success rates were not statistically significantly different; however, equivalence or non-inferiority cannot be concluded. Full article

Background: Genitourinary syndrome of menopause (GSM) is a common consequence of hypoestrogenism that negatively affects vulvovaginal health, sexual function, and quality of life. Evidence comparing non-hormonal treatment options in women with hormone-dependent malignancies remains limited. This study evaluated patient-reported outcomes following non-ablative Er:YAG laser therapy or hyaluronic acid vaginal gel in women with hormone-dependent cancer and GSM. Methods: In this prospective randomized pilot study, 65 women with hormone-dependent malignancies and GSM were randomized to receive either three sessions of non-ablative Er:YAG vaginal laser therapy (n = 34) or 0.2% hyaluronic acid vaginal gel applied intravaginally every 72 h for two months (n = 31). The primary outcome was change in the total Vulvovaginal Symptom Questionnaire (VSQ) score; change in the total Female Sexual Function Index (FSFI) score was a secondary outcome, and domain-level analyses were exploratory. Outcomes were assessed at baseline and one month after treatment. Wilcoxon signed-rank and Mann–Whitney U tests were used for the principal analyses; adjusted analyses were performed using ANCOVA. The study was retrospectively registered at ClinicalTrials.gov (Identifier: NCT07420647; first posted on 19 February 2026). Results: Within-group improvements were observed under both active interventions. The primary between-group comparison showed no difference in total VSQ change (p = 0.398). Total FSFI change favored laser therapy in the unadjusted between-group comparison (p = 0.034), and the exploratory baseline-adjusted difference was 2.72 points (95% CI, 0.19–5.25; p = 0.036). Domain-level analyses were exploratory and were not adjusted for multiplicity. Conclusions: In this active-comparator pilot study, total VSQ change was comparable between groups and the adjusted total FSFI estimate favored laser therapy. Without a sham or untreated control, within-group changes cannot establish intervention-specific efficacy; these comparative findings require confirmation in larger controlled trials. Full article

Background/Objectives: Cervical cancer cells evade chemotherapy by upregulating antioxidant defenses (e.g., glutathione (GSH)). A platform that simultaneously amplifies ROS and suppresses antioxidant defense is a low toxicity strategy. This study presents a local nanoplatform that combines chemodynamic therapy (CDT) with chemotherapy for the localized treatment of cervical cancer. Methods: Diallyl trisulfide (DATS) was loaded into the echinacoside (ECH)-copper metal–phenolic networks (MPNs) nanoparticles (ECD NPs) through a one-step coordination assembly method. The nanoparticles were incorporated into a poloxamer/HPMC thermosensitive hydrogel for vaginal delivery. The formulation was characterized for size, drug loading, sol–gel transition, and pH-responsive release. Antitumor activity was evaluated in SiHa and HeLa cells via Cu²⁺ uptake, GSH depletion, ROS accumulation, apoptosis markers, and viability. In vivo efficacy and biosafety were assessed in an orthotopic cervical cancer model. Results: ECD NPs showed uniform size (~135 nm), high DATS loading (~27.6%). The ECD NPs-loaded hydrogel exhibited a sol–gel transition at 36.7 °C. The ECD NPs-loaded hydrogel released 16.4% of DATS at pH 7.4, 32.4% at pH 4.5, 64.8% at pH 6.5, and 80.9% at pH 5.6 over 24 h. Release was minimal at vaginal pH, clearly triggered at tumor pH, and fastest at lysosomal pH, confirming pH-responsive behavior. The ECD NPs-loaded hydrogel enhanced Cu²⁺ uptake, depleted GSH, elevated ROS, and reduced cell viability to <50% at 80 μg/mL. In the orthotopic model, the ECD NPs hydrogel achieved a tumor inhibition rate of 87.81%, significantly outperforming free DATS (65.3%) and blank MPN (55.62%) hydrogels, with no evident systemic toxicity. Conclusions: The ECD NPs hydrogel triggers a Cu²⁺-driven ROS/GSH cascade that combines copper-mediated oxidative stress with DATS-induced apoptosis for enhanced antitumor activity. Its vaginal localization, pH-responsive release, and biosafety profile support further evaluation for cervical cancer therapy. Full article

Amniotic oxidative stress in women with vaginal infection but no documented intra-amniotic infection has received little attention. In this prospective cohort study of 90 women undergoing elective cesarean delivery, 45 had symptomatic, culture- or Nugent-confirmed vaginal infection and 45 were asymptomatic controls. Amniotic fluid advanced oxidation protein products (AOPP) and malondialdehyde (MDA) were measured by commercial ELISA. Both were higher in the infection group (median 7.96 versus 5.77 ng/mL and 12.49 versus 7.73 nmol/mL, both p < 0.001), with lower cord blood pH (p = 0.003) and more frequent neonatal intensive care unit (NICU) admission (26.7% versus 4.4%, p = 0.007). AOPP was associated with NICU admission (area under the curve 0.917, 95% CI 0.777 to 0.999), although this rests on 14 events with thresholds derived and evaluated in the same sample. Elevations were largest in the bacterial vaginosis and aerobic bacterial subgroups, but the etiologies did not differ. Both kits were designed for serum and are not validated for amniotic fluid, and 16.7% of MDA measurements fell outside the calibration range, so the MDA results are semi-quantitative. Vaginal infection at cesarean delivery is associated with higher amniotic oxidative stress markers; these findings are exploratory and require external validation. Full article

Background/Objectives: Certain strains of Lactobacillus acidophilus are widely used as probiotics. However, their functional potential for female reproductive tract health remains insufficiently characterized. While most studies have focused on individual strains, the distribution of putative probiotic-associated genes across the species remains unclear. This study aimed to evaluate the vaginal probiotic potential of Lb. acidophilus using population genomic analysis and comparative phenotypic characterization. Methods: Pan-genomic analysis was performed on 109 Lb. acidophilus genomes (107 public genomes and 2 vaginal isolates). Putative probiotic-associated gene clusters were identified by functional annotation, categorized into functional modules, and compared among ecological-origin groups. Two vaginal isolates (strains A2 and A3) were characterized in vitro for growth under different pH conditions, cell surface hydrophobicity, lactic acid and hydrogen peroxide production, antimicrobial activity, hemolysis, and antimicrobial susceptibility. Results: The Lb. acidophilus pan-genome was closed, with 1782 of 1902 gene clusters (93.69%) classified as core. Thirty-six putative probiotic-associated gene clusters were identified and grouped into four modules: environmental tolerance, adhesion/colonization, exopolysaccharide/biofilm synthesis, and nutrient metabolism/microbial competition. Thirty-four of the 36 gene clusters were present in all 109 genomes, and no general ecological origin-specific distribution pattern was observed. Three bacteriocin-related gene clusters were conserved across all genomes. A2 and A3 exhibited similar lactic acid production and growth patterns at pH 4–6. Both produced relatively low amounts of hydrogen peroxide compared with the reference strains. A3 showed higher cell surface hydrophobicity and moderate inhibition against Gardnerella vaginalis, while A2 showed no inhibition of this organism. Both isolates were non-hemolytic, and were susceptible to vancomycin and linezolid, resistant to clindamycin, and non-susceptible to daptomycin. No acquired antibiotic resistance genes were detected. Conclusions: Most putative probiotic-associated gene clusters were conserved across the Lb. acidophilus population, whereas A2 and A3 showed strain-dependent phenotypic differences. These findings support combining population genomic analysis with strain-level phenotypic testing when selecting Lb. acidophilus candidates for bacterial vaginal infections. Full article

Objective: Conventional progesterone (P4) formulations suffer from low bioavailability, severe local irritation, and poor patient adherence due to P4’s poor aqueous solubility. This work aimed to develop and screen a biodegradable PLGA/NMP (Poly(lactic-co-glycolic acid)/N-methyl-2-pyrrolidone) injectable in situ gel for sustained P4 delivery to overcome these clinical limitations. Significance: Commercial oral, vaginal, and oil-based intramuscular P4 preparations cannot maintain stable long-term drug exposure, and they cause injection-site pain/inflammation. The screened in situ depot system reduces administration frequency and local tissue irritation, supporting convenient luteal phase support and pregnancy maintenance. Methods: Nine formulations with variable P4 loading (10–50% w/w) and PLGA concentration (15–55% w/w) were fabricated. Formulations were screened via three core endpoints: injectability (injection force and discharge rate), in vitro sustained release in 10% Hydroxypropyl-β-cyclodextrin (HP-β-CD)-Phosphate-buffered saline (PBS) sink medium, and 7-day subcutaneous histocompatibility in rats. high-performance liquid chromatography (HPLC) was validated for progesterone quantification; Hematoxylin and eosin (H&E) staining assessed local inflammatory responses. Results: Formulations with progesterone ≤ 30% w/w and PLGA ≤ 35% w/w exhibited acceptable injectability (injection force < 50 N; discharge rate > 79%). Higher PLGA concentrations suppressed initial burst release (16.74% at 8 h for 35% PLGA vs. 29.8% for 20% PLGA). All formulations formed stable ellipsoidal subcutaneous depots and completed progesterone release within 4 days. Histopathology revealed only mild local inflammation (histological score = 1) without severe necrosis, superior to highly irritating oil injections in formulation control groups. Conclusions: The screened PLGA-based progesterone in situ gel resolves critical drawbacks of traditional progesterone dosage forms. This low-irritation, sustained-release injectable platform provides a scalable industrial formulation candidate for long-acting hormone therapy. Full article

The earliest gut and nasal bacterial community profiles after birth remain incompletely characterized, particularly when both sites are examined in parallel. We aimed to characterize these profiles according to delivery mode within the first 48 h of life in a Mexican cohort. Meconium and nasal wash samples from 60 neonates (30 vaginal and 30 cesarean deliveries) were analyzed by V3–V4 16S rRNA gene amplicon sequencing on an Illumina MiSeq platform, followed by QIIME 2 processing. All 60 meconium samples yielded analyzable 16S rRNA profiles. Nasal washes yielded analyzable profiles in 10/30 vaginally delivered and 12/30 cesarean-delivered neonates (p = 0.79). No statistically significant differences in alpha diversity were detected by delivery mode in gut samples (observed ASVs, p = 0.842; Shannon index, p = 0.183; Pielou’s evenness, p = 0.121; Faith’s phylogenetic diversity, p = 0.574) or nasal samples (p = 0.356, 0.947, 0.644, and 0.114, respectively). In unadjusted PERMANOVA comparisons, gut community structure differed by delivery mode for Bray–Curtis (p = 0.001), weighted UniFrac (p = 0.021), and unweighted UniFrac (p = 0.013) distances, whereas nasal comparisons were not statistically significant. Traditional ANCOM identified Staphylococcus as the feature with the highest W statistic in cesarean-delivered neonates (W = 65). Descriptive phylum-level profiles were examined across maternal urinary tract infection, premature rupture of membranes, maternal comorbidities, maternal BMI, hours since birth, and recorded antibiotic exposure; these comparisons were not multivariable and cannot exclude residual confounding. Delivery mode was associated with differences in early gut bacterial community structure in this cohort. Nasal findings were inconclusive because only 22 washes yielded analyzable 16S rRNA profiles and the workflow was not optimized to quantify ultra-low-biomass bacterial DNA. These cross-sectional data do not establish persistence, causality, or the timing at which nasal communities become stable. Full article

Background: Genitourinary syndrome is a common, chronic condition associated with estrogen deficiency that negatively impacts vaginal health, sexual function, and quality of life in peri- and postmenopausal women. Non-hormonal vaginal moisturizers represent an important therapeutic option for women who cannot or do not wish to use estrogen therapy. Objective: The aim of this study was to evaluate the safety and efficacy of Provagin^®, a hyaluronic acid–based non-hormonal vaginal moisturizer, in postmenopausal women with mild to moderate vaginal dryness. Methods: This was a prospective, single-center, open-label, before-and-after clinical study with sexually active postmenopausal women. Participants applied 3 g of Provagin^® intravaginally every three days for 22 ± 2 days. Clinical assessments were conducted at baseline, 24 and 72 h after first application, and after 6 and 22 days of use. Outcomes included vaginal pH, vaginal microbiota, epithelial integrity, participant-reported symptoms (vaginal dryness, dyspareunia, and pruritus), and adverse events. Results: A total of 45 participants completed the study. Vaginal pH remained stable throughout the study period. No clinically relevant changes were observed in vaginal microbiota, except for a significant increase in Lactobacillus spp. counts. Epithelial integrity was preserved at all time points. Significant improvements in participant-reported symptoms were observed as early as 24 h after first use and continued through the study, with mean vaginal dryness scores decreasing by 69.3%. Conclusions: Provagin^® demonstrated a safety profile and was associated with improvements of genitourinary syndrome of menopause (GSM), without affecting vaginal pH, microbiota composition, or vaginal epithelial integrity. These findings support the use of Provagin^® as a safe, non-hormonal therapeutic option for postmenopausal women with GSM. Full article

Genitourinary syndrome of menopause (GSM) is a common chronic condition in postmenopausal women, yet biomarkers predicting response to local estrogen therapy remain insufficiently defined. In this prospective study, 216 postmenopausal women with GSM received local estradiol vaginal tablet therapy for 12 weeks. Baseline assessments included symptom evaluation, vaginal pH, vaginal maturation index (VMI), and quantitative real-time PCR measurement of six target microorganisms. Treatment response was defined as an improvement of at least 2 points in the most bothersome symptom (MBS) score. After 12 weeks, MBS score, vaginal pH, and VMI improved significantly, with increased abundance of L. crispatus, L. jensenii, and L. gasseri and decreased abundance of L. iners, Gardnerella, and Candida. Overall, 128 of 216 women responded (59.3%; 95% CI, 52.6–65.6%). Higher baseline L. iners abundance was independently associated with a lower probability of response (adjusted RR per log10-unit increase, 0.82; 95% CI, 0.70–0.95), with the highest tertile showing a lower response likelihood than the lowest (RR, 0.71; 95% CI, 0.54–0.93). These findings suggest that L. iners may be a promising candidate microbial marker for pretreatment risk stratification, although external validation is needed before clinical application. Full article

Background: Vulvovaginal candidiasis, bacterial vaginosis, and mixed vaginal infection are among the most common infectious conditions encountered in gynecological practice. Although intravaginal dequalinium chloride exhibits broad antimicrobial activity, real-world longitudinal data describing treatment-associated clinical and microscopic changes remain limited, particularly in Latin American populations. Objective: We aimed to characterize the short-term longitudinal evolution of clinical manifestations, vaginal pH, and fresh wet-mount microscopic findings in women with vulvovaginal candidiasis, bacterial vaginosis, and mixed vaginal infection treated with intravaginal dequalinium chloride during routine outpatient gynecological care. Methods: This retrospective longitudinal study included non-pregnant women with vulvovaginal candidiasis, bacterial vaginosis, or mixed vaginal infection who received intravaginal dequalinium chloride as the sole anti-infective therapy. Patients were evaluated at baseline, treatment completion (Day 7), and post-treatment follow-up (Day 14). Longitudinal assessment included patient-reported symptoms, physician-assessed clinical findings, vaginal pH, and fresh wet-mount microscopic examination. To ensure consistent evaluation across study visits, predefined protocol-based standardized assessment criteria were applied uniformly to all patients. Repeated-measures non-parametric analyses were performed to compare longitudinal changes over time. Results: Sixty-nine women were included, comprising those with vulvovaginal candidiasis (n = 24), bacterial vaginosis (n = 31), and mixed vaginal infection (n = 14). Significant longitudinal improvement was observed in clinical manifestations, vaginal pH, and fresh microscopic findings across all diagnostic groups (all p < 0.0001). Median composite assessment scores decreased from 8 (IQR 6–10) at baseline to 3 (IQR 1–5) at treatment completion and to 1 (IQR 0–3) at post-treatment follow-up. Improvements in vaginal pH were accompanied by reductions in inflammatory and infection-associated microscopic findings and by increased predominance of Döderlein bacilli during follow-up. Intravaginal dequalinium chloride was generally well tolerated, with only mild transient adverse events documented. Conclusions: In this retrospective longitudinal study, intravaginal dequalinium chloride treatment was associated with short-term changes in clinical manifestations, vaginal pH, and fresh microscopic findings among women with vulvovaginal candidiasis, bacterial vaginosis, and mixed vaginal infection. These findings describe short-term treatment-associated changes observed in routine clinical practice but do not establish comparative efficacy, causality, or microbiological cure. Prospective controlled studies incorporating standardized microbiological endpoints and longer follow-up are warranted to confirm these observations. Full article

Conventional synthetic meshes for pelvic organ prolapse (POP) frequently cause severe complications, such as tissue erosion, due to a profound mechanical mismatch with native tissue. This study proposes a novel biphasic composite scaffold combining a load-bearing melt electrowritten (MEW) polycaprolactone (PCL) framework with a compliant alginate–gelatin (Alg-Gel) hydrogel matrix. PCL meshes (1.5 and 2.0 mm pores) were infiltrated with varying Alg-Gel ratios (4:3 and 5:2) and structurally evaluated through mechanical testing, swelling/degradation assays in a simulated acidic vaginal environment (pH 4.3), and finite element analysis (FEA). Results demonstrated that the 1.5 mm PCL architecture provides a robust baseline to withstand physiological loads. Notably, the hydrogel matrix provides a viscoelastic damping effect that synergistically improves the overall mechanical stability of the composite. Furthermore, FEA accurately predicted the non-linear macroscopic response of the composite constructs. Modulating the Alg-Gel ratio also enabled precise tuning of swelling capacity (up to 1400%) and degradation kinetics. Ultimately, this biomimetic system offers a highly adaptable, tissue-like protective cushion with enhanced dynamic stability, presenting a versatile platform for future in vivovalidation. Full article

Background/Objectives: Recurrent urinary tract infection (rUTI) is common after menopause, but estrogen deficiency alone does not explain variation in recurrence, symptoms, and microbial profiles. This study aimed to synthesize evidence on the interactions among estrogen deficiency, urogenital microbial ecology, diabetes, obesity, microbial reservoirs, and anatomical, neurological, and functional modifiers of postmenopausal rUTI susceptibility. Methods: PubMed and Scopus were searched for original studies published from 1 January 2021 to 15 June 2026. A structured narrative synthesis included 62 original reports comprising clinical interventions, observational cohorts, microbiome and multi-omic studies, and cellular and animal experiments. Evidence was interpreted according to study design, population relevance, and biological directness. Results: Menopause was associated with reduced Lactobacillus dominance, higher vaginal pH, and altered vaginal or urinary communities, although findings were heterogeneous. Vaginal estrogen reduced recurrence and improved the local urogenital environment, but microbiome restoration is not established as its sole mechanism. Gut, rectal, vaginal, urinary, and bladder-wall reservoirs may contribute to persistence or repeated exposure. Diabetes was linked to dysbiosis and impaired urothelial defence, whereas obesity evidence remained less direct. Pelvic organ prolapse with incomplete emptying, elevated postvoid residual urine, age-related detrusor dysfunction, stroke, immobility, functional dependence, incontinence, and catheter exposure may further modify susceptibility. Conclusions: Postmenopausal rUTI is multifactorial. The urogenital microbiome–metabolic interface is a useful integrative framework, but not a validated causal or diagnostic model. Vaginal estrogen, urine culture, metabolic and bladder-function assessment, and antimicrobial stewardship remain the clinical foundation; microbiome-directed strategies require prospective validation. Full article

Background/Objectives: Genitourinary Syndrome of Menopause (GSM) negatively affects quality of life in postmenopausal women, causing sexual dysfunction, vaginal atrophy, and pelvic discomfort. Personalized medicine highlights the need for individualized, non-hormonal therapeutic options for women with contraindications to or preferences against hormonal treatment. Non-hormonal therapies, such as laser treatments, have emerged as potential alternatives, but evidence comparing intravaginal and extravaginal K-Laser therapy remains limited. This study aimed to evaluate the efficacy of intravaginal and extravaginal K-Laser therapy on the symptoms of Genitourinary Syndrome of Menopause (GSM) in postmenopausal women. Methods: In this single-center, randomized, single-blind, placebo-controlled trial, 57 postmenopausal women were randomly assigned to receive either intravaginal and extravaginal K-Laser Cube Plus 30 therapy (n = 36) or a simulated control treatment (n = 21). The primary outcome was sexual function, measured by the Female Sexual Function Index (FSFI). Secondary outcomes included vaginal pH and pelvic floor muscle function assessed via the PERFECT protocol. Outcomes were assessed at baseline and after 6 weeks. Results: Sixty-seven women were enrolled, and ten were lost to follow-up. The treatment group showed significant improvements over the control group in FSFI (mean difference = 6.38; p < 0.001), PERFECT protocol scores (mean difference = 0.78; p = 0.004), CPPQ-Mohedo (mean difference = 5.44; p < 0.001), and Menopause Rating Scale (mean difference = 6.50; p = 0.017). Significant reductions were also observed in vaginal dryness, vulvar dystrophy, and atrophy (p < 0.001). Conclusions: Intravaginal and extravaginal K-Laser therapy appears to be a safe and effective non-hormonal treatment for GSM and may support personalized management strategies. However, further well-designed randomized clinical trials with larger samples, longer follow-up of both laser-treated and control groups, and objective outcome measures are needed to provide higher-quality evidence regarding efficacy and identify the patients most likely to benefit. Full article