Search Results (28)

Background and Objectives: Genitourinary syndrome of menopause (GSM) is a prevalent and distressing condition in postmenopausal women, often leading to sexual dysfunction characterized by vaginal dryness, pain, and reduced libido. While local estrogen therapy remains the standard treatment, due to safety concerns and contraindications, there is growing interest in the exploration of alternative interventions. This study aimed to compare the effectiveness and safety of intravaginal platelet-rich plasma (PRP) therapy versus local hormonal treatment in improving sexual function and vaginal health in postmenopausal women. Materials and Methods: A prospective, controlled clinical trial was conducted between January 2023 and December 2024 across three private gynecology clinics in Timișoara, Romania. Ninety postmenopausal women aged between 50 and 65 years with FSFI scores ≤ 23 were randomized into two groups: one receiving three monthly sessions of autologous PRP and the other undergoing 12 weeks of vaginal estriol therapy. Outcomes were assessed using validated tools—the Female Sexual Function Index (FSFI), the Vaginal Health Index (VHI), the Patient Global Impression of Improvement (PGI-I), and patient satisfaction scores—at baseline, week 6, and week 12. Results: Both of the treatment groups demonstrated significant improvements in FSFI and VHI scores at 12 weeks, with the PRP group showing a slightly higher, though not statistically significant, mean increase in the total FSFI (+10.1 vs. +9.3 points). Clinical gains were also observed in lubrication, elasticity, and dyspareunia. Patient satisfaction was high in both groups (93.3% PRP vs. 88.9% hormonal), and there were no reports of serious adverse events during the study period. The PRP group exhibited fewer side effects, without systemic symptoms, supporting its favorable safety profile. Conclusions: PRP therapy is a well-tolerated, hormone-free treatment that offers clinically meaningful improvements in sexual function and vaginal health, comparable to estrogen therapy. It may be particularly beneficial for women with contraindications to hormones or in advanced postmenopause. Further long-term studies are needed to confirm these findings and optimize treatment protocols. Full article

Background/Objectives: Genitourinary syndrome of menopause (GSM) encompasses a variety of symptoms associated with estrogen deficiency, affecting the genitourinary tract. Effective management often requires a multifaceted approach. Although radiofrequency (RF) treatment has been explored as a non-hormonal intervention for GSM, evidence remains limited and inconclusive. Oral collagen peptides have demonstrated systemic tissue benefits in dermatological studies, but with effects that are not yet well understood in the context of GSM. This pilot study investigated whether combining RF with an oral supplementation containing specific bioactive collagen peptides and ultra-low-molecular-weight hyaluronic acid would provide superior symptom relief compared to RF alone in women with GSM. Methods: Twenty menopausal women were randomized into two groups: Group 1 (n = 10) received vulvovaginal RF treatment every two weeks for two months; Group 2 (n = 10) received the same RF treatment alongside daily oral supplementation for four months. Subjective symptoms, objective signs, and vaginal pH were assessed at baseline (T0), post-RF treatment (T1), and three months post-RF treatment (T2), employing a two-way repeated-measures ANOVA to assess differences between groups over time. Results: Both groups showed substantial improvements in all the clinical parameters evaluated at T1 and T2 compared to T0. However, the magnitude of such improvements was higher among patients from Group 2, who achieved better outcomes at T2 compared to patients from Group 1, with differences being statistically significant regarding subjective symptoms (p < 0.001), objective signs (p < 0.001), and vaginal pH (p = 0.015), thus demonstrating the sustained benefits of the combination therapy over RF treatment alone during the follow-up time. Conclusions: Combined treatment with vulvovaginal RF and food supplements improved the signs and symptoms of GSM, and compared to RF treatment alone, it enhanced and maintained the benefits in a three-month follow-up period. Full article

Objectives: We aimed to study the efficacy of fractional CO₂ laser for genitourinary syndrome of menopause (GSM) symptoms in breast cancer (BC) survivors through a randomized, sham-controlled study, followed by an open-phase study assessing the impact of additional treatments. Methods: BC survivors with GSM were randomized to receive either three sessions of intravaginal CO₂ laser or sham treatment every 3–4 weeks. The laser’s energy was 45–60 mJ/pixel. Outcomes were compared one month following the last session. Participants initially receiving laser treatment were offered three more sessions, while those receiving sham had six laser sessions in an open-label study. Results: Thirty-four BC survivors were randomized to laser (n = 19) or sham (n = 15) treatments. Dyspareunia and intercourse dryness scores improved in both groups one month post-treatment, without a significant advantage of laser over sham. The laser treatment resulted in a reduction in daily dryness (−1.30 ± 0.55, p = 0.017), an increase in vaginal hydration (3.24 ± 1.13, p = 0.004), and an increase in Vaginal Health Index (VHI) (2.26 ± 0.50, p < 0.001). Most participants (18/19 and 9/15, respectively) opted to continue laser treatments after unblinding, resulting in 27 patients receiving six laser treatments. Increasing the number of laser treatments was associated with a constant improvement in Visual Analogue Score (VAS) scores for dyspareunia, intercourse dryness, daily dryness, burning, discomfort, itch, and average VAS, as well as pH, VHI, and hydration. Conclusions Three fractional CO₂ laser treatments for BC survivors reduced daily dryness but did not improve dyspareunia and sexual dryness when compared to sham in this randomized trial. Increasing the number of treatment sessions seemed to improve outcomes; however, it remained clinically insufficient, even after six treatments. Full article

The genitourinary syndrome of menopause (GSM) is a prevalent condition impacting a substantial number of women globally. Presently, the management of GSM typically entails the administration of estrogen via oral, dermal, or vaginal routes for a prolonged period of time. This study involves the development of a polymer-based hollow cylindrical delivery system loaded with estradiol hemihydrate (E2) for prolonged delivery to the uterine cavity (EPHCD) combined with a norethindrone acetate (NETA)-loaded polymeric matrix (NLPM), with both units placed onto an intra-uterine device to form a multi-component drug delivery system for the management of GSM (MCDDS). In developing EPHCD, a central composite design (CCD) was employed to evaluate and optimize the impact of formulation factors on EPHCD release and unit weight loss. The optimized EPHCD was further assessed for its chemical integrity, surface morphology, hydration characteristics, release behavior, ex vivo permeation and cytocompatibility. The optimized EPHCD, which featured a high drug load (10%) and low ethyl cellulose-to-polycaprolactone ratio (EC-to-PCL, 10%), demonstrated favorable attributes with a cumulative drug release and weight loss of 23.78 ± 0.84% and 2.09 ± 0.21%, respectively, over a 4-week testing period. The release kinetics were further noted to obey the Peppas–Sahlin model. Evaluation of MCDDS revealed an in vitro drug release comparable to the individual units, with permeation studies displaying an initial increase in the rate of flux for both drugs during the first 2 h, followed by a subsequent decrease. Moreover, the MCDDS components showed good cytocompatibility against NIH/3T3 cells, with cell viability of more than 70%. Upon evaluation of the MCDDS system, the results of this study highlight its potential as a viable sustained-release intrauterine platform for the treatment of GSM. Full article

Background/Objectives: Vaginal laser therapy is a promising treatment for menopausal vulvovaginal atrophy (VVA). This study evaluates the efficacy of a dual-wavelength diode laser (980 + 1470 nm) in treating VVA. Methods: Thirty postmenopausal patients with moderate-to-severe VVA were recruited, and twenty-nine completed the study. Patients underwent a screening visit (T0); three laser sessions at 4-week intervals (T1, T2, and T3); and a follow-up visit 4 weeks after the last treatment (T4). At T0 and T4, the Schiller test and Vaginal Maturation Index (VMI) were performed; sexual function was assessed through the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale-Revised (FSDS-R). At each visit, the Vaginal Health Index (VHI) and the Visual Analog Scale (VAS) for dyspareunia were administered. Potential side effects were investigated, and the VAS for the pain associated with the procedure was assessed. Data analysis included the overall group and two subgroups: women with (group A) and without (group B) a history of breast cancer (BC). Results: Significant improvements in the VHI and reduced dyspareunia were observed at T4 compared to T0 in all groups. The improvement was already seen after the first procedure, with further improvement after the other procedures, being persistent at the 1-month follow-up. The Schiller test showed significant improvements from T0 to T4 in all groups. The VMI showed a significant improvement from T0 to T4 in the overall group and group B. The FSFI questionnaires showed a significant improvement in all areas for the whole population, whereas the FDSF-R questionnaire showed an improvement only in the overall group. Procedural pain was low (mean VAS 1.6), and no side effects were reported. Conclusions: The dual-wavelength diode laser is an effective and safe option for the treatment of VVA in patients with and without a history of BC. Full article

Background: Genitourinary Syndrome of Menopause (GSM) is a prevalent condition in postmenopausal women characterized by symptoms such as vaginal dryness, itching, and urinary tract issues due to declining estrogen levels. Despite its widespread impact on quality of life, GSM often remains underdiagnosed and without effective treatment. Methods: This study assessed the long-term efficacy of fractional CO₂ laser treatment in alleviating GSM symptoms in perimenopausal women. The study involved 125 participants, with clinical evaluations conducted using vaginal pH, the Vaginal Health Index Score (VHIS), the Vaginal Maturation Index (VMI), and the Female Sexual Function Index (FSFI). Results: Results indicated significant improvements in these parameters, with pH levels decreasing, VHIS scores rising, and notable gains in VMI and FSFI observed up to 12 months post-treatment. This improvement has been validated through both subjective and objective assessments of GSM. Conclusions: The findings indicate that this method is effective and safe, with no significant side effects reported. However, conducting a long-term observational study on eventual longer protocol for maintaining the positive effect of this therapy should be conducted. Full article

Genitourinary syndrome of menopause (GSM) affects a significant percentage of postmenopausal women and manifests as vaginal dryness, irritation, and urinary discomfort, typically treated with vaginal estrogens. Hydrogels are preferred over creams due to their superior comfort and mucoadhesive properties. This study introduces a novel vaginal gel formulation containing hydroxyethyl cellulose (HEC) and estriol-hydroxypropyl-β-cyclodextrin complex (E3-HPBCD) for the treatment of GSM. The estriol (E3) release profile of the gel was evaluated using a Franz diffusion cell system, and its permeability was tested on reconstructed human vaginal epithelium. Biocompatibility was assessed using (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide) (MTT), lactate dehydrogenase (LDH) assays, and real-time cell analysis (RTCA) on human skin keratinocyte (HaCaT) cells, which showed increased cell viability and no obvious cytotoxicity. The results indicated that efficient E3 release and satisfactory epithelial permeability with HPBCD provide the bioavailability of E3. These results suggest the potential of the gel as a biocompatible and effective alternative for the treatment of GSM. Further studies are required to assess the long-term safety and clinical efficacy. Full article

This scoping review explores the therapeutic strategies available for managing genitourinary syndrome of menopause (GSM), a condition often underdiagnosed and undertreated despite significantly affecting women’s quality of life. GSM results from decreased estrogen levels during menopause, leading to a range of symptoms including vulvovaginal atrophy and urinary tract issues. Material and Methods: we screened the literature for original studies with “menopause”, “hormonal therapy”, “vulvovaginal atrophy”, “urinary incontinence”, “urinary infections”, “genitourinary syndrome”. Results: A total of 451 relevant articles were retrieved. After screening, 19 articles were included in this scoping review. Discussion: First-line treatments typically include lubricants and moisturizers for short-term symptom relief, while unresolved or severe cases may warrant hormonal treatment. Topical hormonal treatments often have fewer side effects than systemic alternatives. Special attention is given to selective estrogen receptor modulators like ospemifene and steroid hormones like dehydroepiandrosterone (DHEA), which have shown beneficial effects on GSM symptoms. Moreover, innovative therapeutic approaches, such as laser treatment, are discussed in the context of their efficacy and accessibility. The safety of GSM hormonal therapy in women with a history or risk of cancer is also addressed, noting the need for more definitive research in this area. While there is a growing demand for tailored therapy, this scoping review emphasizes the importance of effective communication and counseling to allow women to make informed decisions about their treatment. Overall, this review underscores the need for increased awareness and further research into effective treatment options for GSM. Full article

Background: Menopause, a natural phase in a woman’s life, often adversely affects physical, mental, sexual, and emotional well-being due to low estrogen levels. This study examines the impact of vaginal ovules with tocopherol acetate (Filme Gyno-V^® ovules, manufactured by Panin Srl and distributed by Hulka Srl, Italy), 500 mg per ovule, on vaginal health in pre- and menopausal women. Methods: Fifty women aged 50–70 were divided into menopausal (28) and premenopausal (22) cohorts and treated with the ovules for two weeks, with assessments before and after treatment. Results: The findings showed that distressing symptoms of vaginal atrophy, such as dryness, itching, and pain during intercourse, were resolved post-treatment. A molecular analysis revealed a reduction in Escherichia coli in both cohorts and an increase in three species of Lactobacillus in premenopausal patients. Conclusions: This study concludes that Filme Gyno-V ovules may benefit vaginal health by alleviating atrophy symptoms and promoting healthy vaginal microbiota. Full article

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

The genitourinary syndrome of menopause (GSM) is a widely occurring condition affecting millions of women worldwide. The current treatment of GSM involves the use of orally or vaginally administered estrogens, often with the risk of endometrial hyperplasia. The utilization of progestogens offers a means to counteract the effects of estrogen on the endometrial tissue, decreasing unwanted side effects and improving therapeutic outcomes. In this study, a norethindrone acetate (NETA)-loaded, hollow, cylindrical, and sustained release platform has been designed, fabricated, and optimized for implantation in the uterine cavity as a counter-estrogenic intervention in the treatment of GSM. The developed system, which comprises ethyl cellulose (EC) and polycaprolactone (PCL), has been statistically optimized using a two-factor, two-level factorial design, with the mechanical properties, degradation, swelling, and in vitro drug release of NETA from the device evaluated. The morphological characteristics of the platform were further investigated through scanning electron microscopy in addition to cytocompatibility studies using NIH/3T3 cells. Results from the statistical design highlighted the platform with the highest NETA load and the EC-to-PCL ratio that exhibited favorable release and weight loss profiles. The drug release data for the optimal formulation were best fitted with the Peppas–Sahlin model, implicating both diffusion and polymer relaxation in the release mechanism, with cell viability results noting that the prepared platform demonstrated favorable cytocompatibility. The significant findings of this study firmly establish the developed platform as a promising candidate for the sustained release of NETA within the uterine cavity. This functionality serves as a counter-estrogenic intervention in the treatment of GSM, with the platform holding potential for further advanced biomedical applications. Full article

Background and Objectives: Genitourinary syndrome of menopause (GSM) affects more than half of postmenopausal women. This study aimed to evaluate the clinical and histological aspects of microablative fractionated CO₂ laser (CO₂L), microablative fractionated radiofrequency (RF) and intravaginal estrogen (ET) therapy as GSM treatments for the vulvar vestibule. Materials and Methods: This study included postmenopausal women with at least one moderate-to-severe complaint of GSM. Women in the CO₂L and RF groups received three monthly sessions of outpatient vulvovaginal therapy. The procedures were performed 30 min after applying 4% lidocaine gel to the vulva and vaginal introitus. Vulvar vestibular pain was assessed after each application using a 10-point VAS. A follow-up evaluation was performed 120 days after beginning each treatment. Digital images of the vulva were obtained and a 5-point Likert scale (1 = much worse, 2 = worse, 3 = neutral, 4 = better, 5 = much better) was used to assess the global post-treatment women’s impression of improvement regarding GSM. Results: A significant change in clinical aspects of the vulva was observed after all treatments with a reduction in the atrophic global vulvar aspect and an enhancement of the trophic aspect. High satisfaction was also reported after treatment according to the Likert scale evaluation: CO₂L (4.55 ± 0.97), RF (4.54 ± 0.95), CT (4 ± 1.41), p = 0.066. Histological evaluation revealed enhanced dermal papillae before pre-treatment, significantly reducing post-treatment in all groups (p = 0.002). No unintended effects were reported. Conclusions: CO₂L, RF, and ET significantly improved GSM concerning the vulvar vestibule at the 4 months follow-up. Full article

In the context of the menopausal transition, genitourinary syndrome of menopause (GSM) refers to a range of genitourinary symptoms, from vaginal dryness to dysuria and urinary urgency. While hormonal treatments are standard, their associated side effects have driven the exploration of alternatives like vaginal CO₂ laser. We aimed to evaluate the randomized controlled trials (RCTs) comparing vaginal CO₂ laser treatment for GSM to sham controls. This systematic review sourced four electronic databases until June 2023. The analysis incorporated seven RCTs with 407 women. The CO₂ laser and sham control were comparable for most parameters, including the female sexual function index (FSFI) and visual analogue scale (VAS) for dyspareunia, vaginal health index, pH, and patient satisfaction. However, the CO₂ laser group showed significant improvement in the vaginal assessment scale for GSM symptoms. Sensitivity analyses revealed that parameters like FSFI showed significant differences in favor of CO₂ laser group upon the exclusion of specific studies. In conclusion, vaginal CO₂ laser therapy emerges as a promising alternative for GSM management, especially for most bothersome GSM symptoms; however, the need for further well-designed RCTs remains to validate its broad safety and efficacy. Full article

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

Recent years have witnessed the emergence of growing evidence concerning vitamin D’s potential role in women’s health, specifically in postmenopausal women. This evidence also includes its connection to various genitourinary disorders and symptoms. Numerous clinical studies have observed improvements in vulvovaginal symptoms linked to the genitourinary syndrome of menopause (GSM) with vitamin D supplementation. These studies have reported positive effects on various aspects, such as vaginal pH, dryness, sexual functioning, reduced libido, and decreased urinary tract infections. Many mechanisms underlying these pharmacological effects have since been proposed. Vitamin D receptors (VDRs) have been identified as a major contributor to its effects. It is now well known that VDRs are expressed in the superficial layers of the urogenital organs. Additionally, vitamin D plays a crucial role in supporting immune function and modulating the body’s defense mechanisms. However, the characterization of these effects requires more investigation. Reviewing existing evidence regarding vitamin D’s impact on postmenopausal women’s vaginal, sexual, and urological health is the purpose of this article. As research in this area continues, there is a potential for vitamin D to support women’s urogenital and sexual health during the menopausal transition and postmenopausal periods. Full article