Treatment Of Vulvovaginal Atrophy Research Articles

Vulvovaginal atrophy: current methods of diagnosis and treatment

Aim. To review modern methods of diagnosis and treatment of vulvovaginal atrophy (VVA), which is one of the manifestations of genitourinary syndrome of menopause in periand postmenopausal women.Materials and methods. A review of domestic and foreign literature on the prevalence and modern methods of diagnosis and treatment of VVA was carried out.Results. Unlike vasomotor symptoms, VVA progresses with age, causing a significant impairment in women’s quality of life. Symptoms usually begin to bother perimenopausal patients, but their frequency and severity increase significantly in postmenopausal women. Diagnosis of VVA can present some difficulties, as many women perceive their condition as a natural manifestation of aging and do not seek medical care. Currently, drug and non-drug therapies for VVA have been proposed, each of which has its own characteristics, indications, and contraindications. However, the safety and effectiveness of some of them have not been fully proven.Conclusion. VVA is common in periand postmenopausal women. Modern aspects of the diagnosis and treatment of this pathology can significantly improve the quality of life of patients with VVA symptoms. However, further research is needed to confirm safety of the proposed treatment methods, and search for new techniques is required.

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.

Vulvovaginal atrophy in the CRETA study: the healthcare professionals’ perception

Objectives The objective is to assess the perception of gynecologists regarding patients’ adherence to vulvovaginal atrophy (VVA) treatments, to evaluate the gynecologists’ opinions on what their patients think about treatment adherence, and to compare the gynecologists’ opinions with the patients’ own perceptions within the CRETA study. Methods Spanish gynecologists who participated in the CRETA study were asked to fill out an online 41-item questionnaire to evaluate their views on VVA management. Results From 29 centers across Spain, 44 gynecologists completed the survey. Their mean age was 47.2 years old, two-thirds of them were women, and the average professional experience was over 20 years. According to the gynecologists, the therapy most frequently used by VVA-diagnosed women was vaginal moisturizers (45.5%), followed by local estrogen therapy (36.4%) and ospemifene (18.2%). Nevertheless, ospemifene was viewed as the therapeutic option with the most efficacy, easiest route of administration, shorter time to symptom improvement, lower percentage of dropouts, and higher treatment adherence. Conclusions Spanish gynecologists are in general agreement with their patients regarding VVA treatment preferences and the main issues for adherence and effectiveness. However, there is an opportunity for doctor–patient communication improvement. Among the three therapeutic options evaluated, ospemifene is regarded as offering some competitive advantages.

Effects of Non-Ablative Solid-State Vaginal Laser (SSVL) for the Treatment of Vulvovaginal Atrophy in Breast Cancer Survivors after Adjuvant Aromatase Inhibitor Therapy: Preliminary Results.

One of the side effects of anti-estrogen treatments in breast cancer survivors (BCSs), especially with aromatase inhibitor (AI) treatment, is the frequent appearance of vulvo-vaginal atrophy (VVA). We aim to evaluate the efficacy, safety and feasibility of a new type of non-ablative Solid-State Vaginal Laser (SSVL) treatment in BCSs with VVA. A total of 30 BCSs with a history of AI use and symptoms of VVA were treated with a non-ablative SSVL (LASEmaR 1500™-EUFOTON)in this non-randomized pilot study. The effects of the laser have been evaluated at baseline, 10 wk and 24 wk using a visual analogue scale (VAS), the Vaginal Health Index (VHI), the Vulvar Health Index (VuHI), the Female Sexual Function Index (FSFI), the EORTC QLQ-BR23, the Vaginal Maturation Index (VMI) and vaginal pH. At 10-week follow-up vs. baseline there were no statistically significant differences in FSFI, lubrication and EORTC QLQ-BR23. In all the subjective (dyspareunia, VHI, VuHI, FSFI, QLQ) and objective parameters (VMI and pH) there was a statistically significant improvement at the 6-month follow-up. Satisfaction was very high (4.7 out of 5), with 95.7% of patients being satisfied, more than or very satisfied. Preliminary results of SSVL treatment of VVA and dyspareunia in BCSs after AI treatment suggest clinical improvement, without relevant side effects and with a high degree of satisfaction.

Efficacy, tolerability, and endometrial safety of ospemifene compared with current therapies for the treatment of vulvovaginal atrophy: a systematic literature review and network meta-analysis.

Ospemifene is a novel selective estrogen receptor modulator developed for the treatment of moderate to severe postmenopausal vulvovaginal atrophy (VVA). The aim of the study is to perform a systematic literature review (SLR) and network meta-analysis (NMA) to assess the efficacy and safety of ospemifene compared with other therapies used in the treatment of VVA in North America and Europe. Electronic database searches were conducted in November 2021 in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Randomized or nonrandomized controlled trials targeting postmenopausal women with moderate to severe dyspareunia and/or vaginal dryness and involving ospemifene or at least one VVA local treatment were considered. Efficacy data included changes from baseline in superficial and parabasal cells, vaginal pH, and the most bothersome symptom of vaginal dryness or dyspareunia, as required for regulatory approval. Endometrial outcomes were endometrial thickness and histologic classifications, including endometrial polyp, hyperplasia, and cancer. For efficacy and safety outcomes, a Bayesian NMA was performed. Endometrial outcomes were compared in descriptive analyses. A total of 44 controlled trials met the eligibility criteria (N = 12,637 participants). Network meta-analysis results showed that ospemifene was not statistically different from other active therapies in most efficacy and safety results. For all treatments, including ospemifene, the posttreatment endometrial thickness values (up to 52 wk of treatment) were under the recognized clinical threshold value of 4 mm for significant risk of endometrial pathology. Specifically, for women treated with ospemifene, endometrial thickness ranged between 2.1 and 2.3 mm at baseline and 2.5 and 3.2 mm after treatment. No cases of endometrial carcinoma or hyperplasia were observed in ospemifene trials, nor polyps with atypical hyperplasia or cancer after up to 52 weeks of treatment. Ospemifene is an efficacious, well-tolerated, and safe therapeutic option for postmenopausal women with moderate to severe symptoms of VVA. Efficacy and safety outcomes with ospemifene are similar to other VVA therapies in North America and Europe.

Expert opinion on the treatment of vulvovaginal atrophy with ospemifene based on new evidence

Vulvovaginal atrophy (VVA) is an underdiagnosed and undertreated chronic condition resulting in physiological and histological changes in the genitourinary tract of postmenopausal women. Treatment of moderate to severe VVA includes local estrogens, dehydroepiandrosterone (DHEA) and oral ospemifene, a third-generation selective estrogen receptor modulator (SERM). Due to venous thromboembolism (VTE) safety concerns classically associated with the SERM class, and as part of its original marketing authorization approval (MAA), the European Medicines Agency (EMA) requested the performance of a 5-year post-authorization safety study (PASS) to study the incidence rate of VTE among women receiving ospemifene. The results have led to important regulatory changes to ospemifene’s labeling, extending its indication and eliminating concerted risk management measures. A panel of experts discussed and reached consensus on the impact of these regulatory changes on clinical practice, reflecting on the reassurance of ospemifene’s benefit–risk balance and recommending its positioning as a first-line pharmacological treatment option for moderate to severe VVA together with local therapies. In a scenario where different treatments present similar efficacy and safety profiles, a shared decision between clinician and patient, according to her needs and preferences over time, is fundamental to improve adherence and persistence with sequential treatment, contributing to the achievement of health outcomes.

Effects of ospemifene on overactive bladder in postmenopausal women with vulvovaginal atrophy

Objective Overactive bladder (OAB) is a complex and multifactorial syndrome associated with urinary frequency, urgency and incontinence. The menopause-associated hormonal changes play a role in the development of this condition. Vaginal estrogens are effective in improving OAB in postmenopausal women (PMW) with vulvovaginal atrophy (VVA). Ospemifene is a selective estrogen receptor modulator licensed for the treatment of VVA. This study aimed to evaluate the effects of ospemifene on OAB symptoms in PMW with VVA. Methods Forty PMW suffering from OAB and VVA received oral ospemifene (60 mg/day) for 12 weeks. All patients were assessed with a urodynamic study, a 3-day bladder diary and validated questionnaires (International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form [ICIQ-UI SF] and International Consultation on Incontinence Questionnaire – Overactive Bladder [ICIQ-OAB]) at enrollment and at the end of the study. Results Cytometric capacity, bladder compliance and verbal sensory threshold responses during bladder filling were improved after treatment. The voiding diary showed a significant reduction of daily voids, urge urinary incontinence episodes and nocturnal events. The median overall scores of the ICIQ-UI and ICIQ-OAB were also significantly improved. Conclusions Our study suggest that treatment with ospemifene in PMW suffering from OAB is associated with a reduction of OAB symptoms due to a decreased bladder sensitivity and with an improvement in quality of life.

Efficacy of laser remodeling in the genitourinary syndrome of menopause: A review

The real-world treatment of genitourinary syndrome of menopause has several limitations: contraindications to topical estrogen therapy, which is currently recognized as the "gold standard" treatment for vulvovaginal atrophy (VVA), fear of the systemic effects of topical estrogens or/and carcinophobia, and poor compliance of patients to intravaginal agents. Therefore, there is an unmet need for alternative noninvasive or minimally invasive therapies, mostly non-hormonal. A PubMed, Cochrane Library, Science Direct, and ELibrary databases were searched for the keywords CO2-laser, Er:YAG-laser, vulvovaginal atrophy, genitourinary syndrome of menopause, treatment, postmenopausal age for 20122022. Remodeling microablative laser therapy using carbon dioxide (CO2) is a promising method for treating VVA, acting pathogenetically and symptomatically. CO2 laser relieves VVA symptoms and improves the condition of the vaginal mucosa by enhancing regeneration and restoring vaginal pH. However, evidence of the efficacy and long-term safety of the method, obtained in high-quality studies, is needed before the method can be introduced into widespread clinical practice.
 Aim. To analyze and summarize the evidence-based and experimental data on the efficacy and safety of laser therapy for VVA and genitourinary syndrome of menopause.

Short-Term Efficacy and Safety of Non-Ablative Laser Treatment Alone or with Estriol or Moisturizers in Postmenopausal Women with Vulvovaginal Atrophy

Among treatments for vulvo-vaginal atrophy (VVA), there is a new kind of energy-based device, the non-ablative CO2 laser. This study aimed to assess the efficacy and safety of the non-ablative CO2 laser in menopausal women with VVA as a monotherapy or in association with vaginal estriol or moisturizer. Seventy-five women with VVA received laser treatment (Laser group), laser plus estriol gel (Laser+E) or laser plus moisturizers (Laser+M). The study protocol consisted of 3 monthly laser sessions (t0, t1, t2) and a gynecological examination at baseline and 1 month after last laser treatment (t3). Objective measures included VHI (Vaginal Health Index) and VuHI (Vulvar Health Index); subjective symptoms of VVA (Dryness, Burning, Itching, Dysuria) evaluated via visual analog scales, sexual function evaluated by FSFI (Female Sexual Function Index), FSDS (Female Sexual Distress Score) and MENQOL (Mopause-specific Quality Of Life). Adverse events and discomfort encountered during the procedure were also assessed. Primary outcomes were the evaluation of VHI and VuHI and secondary outcomes were changes in VVA symptoms (VAS), sexual function (MENQOL, FSFI, FSDS) and discomfort during the procedure. Seventy-five women (25 in Laser, 25 in Laser+E and 25 in Laser+M group) completed the study. At t3, mean VHI, VuHI, dryness, burning and itching VAS scores improved significantly with no differences between the groups. The lubrication domain of FSFI improved significantly only in the Laser+M group, while the pain domain improved significantly in all women with no differences between the groups. FSFI and FSDS overall scores and MENQOL sexual domain improved in all women with no significant difference between the groups. The mean score of the pain during the procedure was low at t0 and did not change throughout the study. This study extends knowledge concerning the effectiveness of a new non-ablative CO2 laser in post-menopausal women with VVA. This is one of the first studies on this kind of laser and is the first to compare the effectiveness of laser treatment alone or in combination with vaginal estriol or moisturizers. Parameters of VVA and sexual function were evaluated using validated tools. Study limitations include short follow-up time, the limited number of participants and the absence of a sham-controlled group. Non-ablative CO2 laser seems to be an effective treatment for VVA in menopausal women. Our preliminary data shows that it can be effective as monotherapy or with adjuvant treatments.

Vulvar Craurosis due to Severe Genitourinary Syndrome of Menopause Complicated by Lichen Sclerosus: Two Case Reports and Literature Review

Background: Vulvovaginal atrophy affects approximately 45% of middle-aged women, as a result of decreased estrogen circulating levels and is often associated with vulvovaginal discomfort in menopausal patients. The spectrum of adverse consequences makes long-term treatment essential, not only for symptom relief, but also to avoid further complications. These symptoms can even be worsened if other vulvar conditions coexist, such as inflammatory dermatoses. Clinical presentation: We present two cases of patients with severe vulvar atrophy and craurosis, who required vulvo-vaginal opening associated with medical treatment. In both patients, we diagnosed severe genitourinary syndrome of menopause (GSM) complicated by vulvar lichen sclerosus, a very rare clinical situation. In case 1, the symptoms had progressed despite local estrogen treatment for vulvovaginal atrophy, and lichen wasn’t considered in previous check-ups. In contrast, patient nº 2 presented in the ER with impossibility to urinate and was then diagnosed and treated for underlying causes. Conclusions: GSM treatment should be a priority. The absence of improvement or progression of genital atrophy should alert the specialist to the coexistence of other vulvar pathologies.

Treatment of Vulvovaginal Atrophy with Fractional CO2 Laser: Evaluating Real-World Data.

Objective: We aimed to evaluate real-world data for the use of fractional CO2 laser therapy for treating symptoms of vulvovaginal atrophy (VVA). Background: VVA is widespread and can reduce the patients' quality of life. There is a lack of data regarding its therapy with laser, especially for daily practice (i.e., real-world data). Methods: Thirty-six patients were treated in a single medical center. They consisted of pre- and postmenopausal women and received three fractional CO2 laser therapy treatments with 3-6 weeks between each treatment. Each patient financed the treatment privately. The symptoms pain, pruritus, dyspareunia, burning, dryness, and dysuria were recorded with a visual analog scale (1-10) before the first, second, and third laser treatment. The data were examined retrospectively. Results: Pain was reduced from a mean of 2.5 points (minimum 0, maximum 9 points) to 1.1 (minimum 0, maximum 8 points) before the third laser treatment. Pruritus showed a mean score of 3.8 (minimum 0, maximum 10 points). This decreased to 1.4 (minimum 0, maximum 8 points). Dyspareunia scored a mean of 6.8 (minimum 0, maximum 10 points). After two laser therapies, the score was 3.3 (minimum 0, maximum 8 points). Burning showed 4.2 points (minimum 0, maximum 10 points). Having experienced two laser therapy sessions, the patients scored 1.5 (minimum 0, maximum 9 points) points. The severity of dryness dropped from 6.5 (minimum 0, maximum 10 points) to 3.3 (minimum 0, maximum 9 points). Dysuria was stated with 1.8 points (minimum 0, maximum 10 points) before the first and 0.5 points (minimum 0, maximum 6 points) before the third laser therapy. All changes showed statistical significance (p < 0.002). Conclusions: This real-world data propose fractional CO2 laser to reduce VVA-associated genital discomfort, thus being a valuable therapy option for pre- and postmenopausal women.

A Pilot Randomized, Double-blind, Placebo-controlled Clinical Trial on the Efficacy and Safety of a Transdermal Gel that Delivers CO2 in the Treatment of Vulvovaginal Atrophy

This prospective study aimed to assess the efficacy of a transdermal CO2 gel in promoting regeneration in the vulvovaginal area in postmenopausal women experiencing symptoms as part of genitourinary syndrome of menopause (GSM). Transdermal carboxytherapy refers to the application of CO2 through the skin's superficial layer, which is intended to increase oxygenation (through the Bohr effect) and angiogenesis, thus helping to reduce symptoms of GSM. In this study, 20 women with moderate or severe signs or symptoms of vulvovaginal atrophy were randomized to receive either transdermal CO2 therapy (n=10) or a placebo gel (ultrasound gel, n=10). The gels (transdermal CO2 gel or the placebo) were applied by the patients at home. The gels were applied in two treatment cycles (10 days of total treatment). Each cycle involved daily applications of the gel to the vulvovaginal area, from Monday to Friday, with no application on weekends. The Female Sexual Function Index (FSFI) and Day-to-Day Impact of Vaginal Aging (DIVA) questionnaires were used to gather standardized information, and biopsy samples were obtained from the vagina and vulva for histological analysis, both on the first day of treatment and 10 days after the final application of gel. Patients who received the transdermal CO2 gel showed significant improvements on the FSFI and DIVA questionnaires and the biopsies revealed that the CO2 gel had a regenerative effect on vulvovaginal tissues.

Efficacy and safety of a new vaginal gel for the treatment of symptoms associated with vulvovaginal atrophy in postmenopausal women: A double-blind randomized placebo-controlled study

ObjectiveThe aim of the present randomized placebo-controlled single-center study was to assess the efficacy and safety of a new vaginal gel (Meclon Idra - Alfasigma) in the treatment of vulvovaginal atrophy (VVA). The gel is composed of sea buckthorn (Hippophaë rhamnoides) oil, aloe vera, 18β-glycyrrhetic acid, hyaluronic acid and glycogen. The study assessed whether the gel can reduce VVA symptoms (vaginal dryness, itching, burning sensation) and improve sexual function in postmenopausal women over 12 weeks. Study DesignPostmenopausal women (n° = 60) reporting VVA symptoms were recruited and randomized in a 1:1 ratio to the gel or placebo. Active vaginal gel or placebo was applied for 14 days and then twice a week for 90 consecutive days. Main outcome measureThe Vaginal Health Index (VHI), including vaginal pH, was used to assess changes in objective signs, whereas the self-reported Female Sexual Function Index (FSFI) was used to investigate sexual function. ResultsMeclon Idra was effective in reducing vaginal pain, dyspareunia and vaginal pH, with the VHI showing significant improvement at day 90 (P < .0001), and in reducing each VVA symptom (vaginal dryness, vaginal itching, burning sensation) at weeks 2 and 4, and the end of the study (P < .0001). The analysis of FSFI scores showed, after the end of treatment, an improvement of sexual function in the active-treatment group, with a statistically significant increase (P < 0.001) in all domains scores and total score (P < 0.001). ConclusionsThe present single-center randomized clinical trial demonstrated the efficacy, tolerability and safety of 12-week treatment with a new vaginal gel in postmenopausal women with symptoms associated with VVA. Based on this trial, the gel seems to be a valid choice as a single, local agent for relieving VVA symptoms and improving sexual function, and to have good compliance.This trial is registered prospectively with the Clinical Trials Registry – India, number CTRI/2019/05/01911.

Clinical Efficacy of Hormonal and Nonhormonal Agents in the Treatment of Vulvovaginal Atrophy.

ObjectivesSymptomatic local treatment of vaginal atrophy (VA) in menopausal women includes hormonal and nonhormonal preparations. Some women may be reluctant to use vaginal estradiol preparations because of the concern for developing breast cancer and endometrial hyperplasia. Therefore, it is necessary to compare the therapeutic effectiveness of alternative vaginal drugs, such as promestriene, an estrogen agonist, and sodium hyaluronate (NaH), a nonhormonal, water-based agent.MethodsNinety-one postmenopausal women diagnosed with symptomatic VA were divided into three groups and treated for 12 weeks; 30 women with vaginal estradiol (VE), 30 women with promestriene, and 31 women with NaH. Composite scoring, vaginal maturation index (VMI), pH, frequency of sexual activity, serum hormone levels, and endometrial thickness were evaluated VA before and after treatment.ResultsIn the comparison of VA examination findings composite scoring, VMI, and vaginal pH values, three different drugs were found to be effective in the treatment (P < 0.05). The VMI following VE treatment was significantly higher than that after NaH treatment (P = 0.031), whereas the promestriene group had a more positive change than the others in terms of increase in after treatment composite scoring and sexual activity frequency (P = 0.031, P = 0.020). There were no differences between the groups in terms of pre and after treatment serum E2 levels and endometrial thickness.ConclusionsBased on these findings, we can conclude that the use of promestriene or NaH can prove to be as effective and well tolerated as vaginal estradiol in the symptomatic treatment of vaginal atrophy.

The Effectiveness of Prasterone vs Placebo Therapy as the Vulvovaginal Atrophy Treatment in Menopausal Women: Meta-Analysis

Background : Vulvovaginal atrophy is a condition that often occurs in menopausal women due to Estrogen decreased. Prasterone (DHEA) is a steroid hormone that can be converted into Estrogen in the target tissue. Objective : This paper aims to evaluate the effectiveness of administering Prasterone as Vulvovaginal Atrophy therapy in menopausal women. Methods : A systematic data search was performed on a medical database (PUBMED, Google scholar, Cochrane). Inclusion criteria: (1) randomized study of Prasterone as Vulvovaginal Atrophy therapy in postmenopausal women, (2) all-inclusive papers can be accessed completely, and (3) the data obtained can be accurately analysed. Results: Three RCTs with a total of 696 patients were analysed. The average number of Superficial Cells (mean difference [MD] 7.63, and 95% [CI] 7.57 to 7.70 (P &lt;0.00001). The average number of Parabasal Cells (mean difference [MD] -29.84, and 95% [CI] -30.25 to -29.44 (P &lt;0.00001). The average number of vaginal pH (mean difference [MD] -0.69, and 95% [CI] -0.70 to -0.68 (P &lt;0.00001). The average number of Dyspareunia (mean difference [MD] -0.38, and 95% [CI] -0.39 to -0.37 (P &lt;0.00001). All diamonds do not intersect the vertical line, and have p &lt;0.05, it proves that there are significant differences between the two groups. All non-hysterectomized women have an atrophic or inactive endometrium. Side effects that are often complained of is headache and application site discharge. Conclusion This meta-analysis concludes that Prasterone therapy has a significant therapeutic effect for Vulvovaginal Atrophy in menopausal women

Effectiveness of hyaluronate-based pessaries in the treatment of vulvovaginal atrophy in postmenopausal women

Objectives: This study aimed to assess the efficacy and safety of hyaluronic acid-based vaginal pessaries (Hydeal-D) in the treatment of vulvovaginal atrophy (VVA).Study design: The study was a prospective, multicenter clinical investigation of VVA topical treatment in 40 postmenopausal women. Patients applied one Hydeal-D pessary every 3 days for 3 months.Main outcome measures: The primary endpoint was the amelioration of VVA signs after treatment, evaluated by measuring the change from baseline of the Vaginal Health Index (VHI) score. Secondary endpoints included the evaluation of other VVA-related signs and symptoms, safety, and patient-reported and clinician-reported satisfaction and treatment tolerability.Results: The 3-month treatment with Hydeal-D vaginal pessaries showed efficacy for all analyzed endpoints. Improvement exceeded threshold values of VVA diagnosis, sexual dysfunction, and distress, confirming clinically relevant amelioration of VVA symptoms. Changes from baseline conditions confirmed significant improvement of all parameters including the VHI, vaginal pH, patients’ perception of VVA symptoms, sexual function, and vaginal maturation. Patients’ overall satisfaction was very high after 1 month of treatment and increased further after 3 months. No severe adverse events were reported.Conclusions: Significant amelioration of VVA-related signs indicates that Hydeal-D vaginal pessaries are an effective, safe, and well-tolerated non-hormonal therapeutic option for VVA in postmenopausal women.

Safety evaluation of fractional CO2 laser treatment in post-menopausal women with vaginal atrophy: A prospective observational study

ObjectivesTo evaluate the safety of and patient satisfaction with fractional CO2 laser for the treatment of vulvo-vaginal atrophy (VVA) in postmenopausal patients. Study designPatients affected by VVA were considered for the study. All women were treated using a Lumenis AcuPulse DUO (Lumenis, Yokneam, Israel) in fractionated mode with a 28 mm probe, FemTouch™. Pain during different steps of the procedure (introduction, rotation and extraction of probe and laser impulse transmission) was evaluated on a 7-point Likert scale. The occurrence of side-effects was evaluated at the end of the procedure, and in the three-month follow-up (after the last treatment) complications were classified as ‘early’ (occurring within 30 days) or late (after 30 days). Participant satisfaction was measured on a 7-point Likert scale (1= strongly disagree, 7= strongly agree). The institutional review board approved the study protocol. ResultsFifty-three women were enrolled in the study. No severe complications occurred after a median follow-up of six months. One patient (1.9 %) reported dizziness immediately after treatment, which completely resolved within 15 min. A minor bleeding occurred related to tip introduction and rotation. One patient (1.9 %) aborted the procedure because of discomfort on probe introduction but decided to repeat the procedure after two weeks. Two patients (3.7 %) reported symptoms of dysuria within 7 days of the procedure. The mean overall pain score at first treatment, evaluated on the 7-point Likert scale, was 3.57 ± 1.50. The mean pain scores related to probe introduction and rotation were 3.13 ± 1.37 and 2.32 ± 1.08, whereas pain scores for extraction and laser impulse transmission were 1.23 ± 0.27 and 1.13 ± 0.37 respectively. Mean overall pain score (1.27; CI 95 % 0.83–1.71, p < 0.001) and pain scores related to probe introduction (0.54; CI 95 % 0.18–0.90, p = 0.001) and probe rotation (0.46; CI 95 % 0.12–0.90, p = 0.003) all statistically significantly decreased between the first and third treatment (Fig. 1). Mean pain scores related to laser activation (0.01; CI 95 % −0.06 – 0.20, p = 0.07) and extraction (0.08; CI 95 % −0.04–0.19, p = 0.31) did not change over the course of treatment.Overall, patient satisfaction with the procedure was high: 89.7 % of patients would highly (value 5–7) recommend the procedure and 94.9 % would be ready to repeat the procedure to maintain results. Discomfort related to treatment was lower than expected for 41 % of patients (value 5–7) and as expected for 48.7 % (value 3–4). ConclusionFractional CO2 laser for treatment of VVA seems a safe therapeutic option. No severe complications occurred. A minority of patients reported mild complications, but these resolved without the need for treatment. Most discomfort was related to probe introduction and rotation. Overall, patients were highly satisfied, and they would repeat laser treatment.

Local ultra-low-dose estriol gel treatment of vulvo-vaginal atrophy: efficacy and safety of long-term treatment

Vulvo-vaginal atrophy (VVA) is a chronic condition affecting many postmenopausal women. Local estrogen treatment is recommended. Evaluating efficacy and safety of long-term VVA treatment with ultra-low-dose estriol gel, 120 postmenopausal VVA women were enrolled in a prospective study. They received the first cycle of 1 g/day vaginal gel containing 50 µg estriol for 3 weeks and then twice a week for 12 weeks. Moderate or severe VVA women received a second treatment cycle reaching treatment of 30 weeks. Vaginal pH measurement, subjective symptoms, and objective signs assessment of VVA, endometrial thickness and adverse events (AE) were recorded. Of the 99 women, completing the first phase, 43% experienced a complete VVA symptom relief, and 65% presented a milder VVA degree. After 30 weeks, VVA signs significantly improved (p<.01) compared with baseline and first phase results; total objective symptom evaluation including Schiller’s test, flattening of folds and vaginal pH significantly improved (p<.01). At study endpoint, none of the patients had severe VVA, 93% had a positive response, 75% had a complete symptom, and sign resolution. No treatment-related endometrial AE were observed. Postmenopausal VVA long term-treatment with ultra-low-dose estriol vaginal gel is safe and effective.

Joint recommendations for the diagnosis and treatment of vulvo-vaginal atrophy in women in the peri- and post-menopausal phases from the Società Italiana per la Menopausa (SIM) and the Società Italiana della Terza Età (SIGiTE).

Herein, joint recommendations for diagnosis and treatment of vulvo-vaginal atrophy (VVA) in women in the peri- and post-menopausal phases from the Società Italiana per la Menopausa (SIM) and the Società Italiana della Terza Età (SIGiTE) are presented. The recommendations are aimed at all healthcare personnel caring for women in the menopausal transition or postmenopausal phase, and are also intended to raise awareness of VVA. Recent data clearly indicate VVA is a highly prevalent condition among postmenopausal women, and that the vast majority of women with VVA are not adequately treated. In reality, diagnosis of VVA is simple and largely clinical. Many types of treatments are available for VVA, ranging from preventive education measures to local non-hormonal therapies, local agents that modulate hormonal receptors and systemic as well as laser therapy and radiofrequency. Regardless of the therapeutic approach adopted, greater communication between the physician and the woman with VVA should be actively encouraged. This is also in light of the difficulty of talking about the VVA and related disorders. Greater communication also encourages adequate therapy and thus minimizes the impact of VVA on the quality of life of the woman and her partner.

Use of Fractional CO2 Laser for the Treatment of Vulvovaginal Atrophy: a Double-blinded Randomized Placebo-controlled Clinical Trial.

Use of Fractional CO2 Laser for the Treatment of Vulvovaginal Atrophy: a Double-blinded Randomized Placebo-controlled Clinical Trial.