Vaginal Health Index Score Research Articles

A Novel Technique Combining Human Acellular Dermal Matrix (HADM) and Enriched Platelet Therapy (EPT) for the Treatment of Vaginal Laxity: A Single-Arm, Observational Study.

BackgroundThere is a paucity of knowledge about cosmetic vaginal tightening procedures; therefore, the present study aimed to describe the clinical effects of a novel combination technique of human acellular dermal matrix (HADM) and enriched platelet therapy (EPT) for the treatment of vaginal laxity.MethodsThis single-arm, observational study was conducted on 52 patients with grade II to III vaginal relaxation. HADM biological band (U-shaped) was implanted in these patients by submucosal puncture in vagina under anesthesia. This was followed by thrice administration of EPT injection, once at the time surgery followed by each dose at a time interval of one month. Patients were followed up for a period of 6 months based on Female Sexual Function Index (FSFI) and Vaginal Health Index (VHI) scores. Patient satisfaction was measured using Visual Analogue Score (VAS).ResultsAbout 52 women with median age of 39 years were included in the study. The average time reported to complete HADM surgery was reported as 27 minutes. Following implantation, it was found that labia minora was significantly closed and perineal length was increased from 1.5 to 2.2 cm. Moreover, there was improvement in elasticity, contractility and lubricity of vaginal mucosa. The sexual function scores from pre- to post-surgery were significantly increased (7.95 vs. 30.09; p value: <0.001). The mean VHI score also increased significantly after 6 months of treatment (mean ± S.D. before vs after treatment: 11.2 ± 3.3 vs. 19.6 ± 4.1, P < 0.0001). The mean VAS after surgery was 1.61 ± 0.31. About 96% of the patients did not feel any pain after treatment at 6-month follow-up. No adverse effects were reported in this study.ConclusionsThese findings supported that combination treatment with HADM and EPT was safe and associated with both improved vaginal laxity and sexual function. These results may provide a novel surgical technique for this prevalent and undertreated condition.Level of Evidence IV: Therapeutic Study This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Possibilities of using neodymium laser to improve the condition of vaginal mucosa in women of various ages with initial stages of genital prolapse

Genital prolapse is a sort of epidemic and is registered today in 30% to 56% of women of both reproductive and menopausal ages. Until now, the initial stages of prolapse were not taken into account; as a rule, the correction began immediately with surgical treatment, the results of which were not always satisfactory, and the recurrence rate with plastic correction with one’s own tissues ranged from 37 to 45%. One of the main manifestations of prolapse of the vaginal walls, especially n perimenopause, is vulvovaginal mucosal atrophy, which directly depends on the pH in the vagina. The study is devoted to the analysis of the effectiveness of using neodymium laser to improve the condition of the vaginal mucosa in women of different age groups with initial degrees of genital prolapse. Purpose: scientific substantiation of using neodymium laser in patients of different age groups with grade I–II cysto-rectocele. Material and research methods. Studies were carried out in 69 women aged 31 to 52 years with cysto-rectocele of grade I–II (ICD-10 code N81.6), with the duration of the disease from 4 to 15 years. All patients, depending on their age and the method of treatment used, were divided into 2 groups comparable in terms of clinical and functional characteristics — the main and control groups, each of which had 2 subgroups. In the main group: subgroup 1 included 27 patients of reproductive age with grade I–II cysto-rectocele, who underwent a neodymium laser course with Magic Gyno, consisting of 3 intravaginal procedures with an interval of 28 days; subgroup 2 included 22 patients of perimenopausal and menopausal age with grade I–II cysto-rectocele, who underwent a course of 3 intravaginal procedures with Magic Gyno neodymium laser with an interval of 28 days. The control group included 20 patients with grade I–II cysto-rectocele, who underwent a special complex of exercise therapy; depending on their age, they were also divided into two subgroups: 1 (10 patients) — of reproductive age, 2 (10 patients) — of perimenopausal and menopausal age. The results obtained indicate a pronounced effect of the course application of intravaginal exposure by a neodymium laser on the state of the vulvovaginal mucosa in patients with grade I–II cysto-rectocele, of both reproductive and, most importantly, peri-menopausal age, which was manifested in the normalization of the pH of vaginal discharge and elimination of signs of atrophy of the mucous membrane of the vulva and vagina and was confirmed by the data of pH-metry and the Vaginal Health Index Score. Conclusion. The course use of a neodymium laser in patients of different age groups with grade I–II cysto-rectocele contributes to the formation of a pronounced tropho-stimulating effect, which is manifested in the normalization of the pH of the vaginal discharge and the elimination of signs of atrophy of the mucous membrane of the vulva and vagina.

Effect of Fractional Carbon Dioxide Laser vs Sham Treatment on Symptom Severity in Women With Postmenopausal Vaginal Symptoms

Postmenopausal vaginal symptoms are common and frequently detrimental to a woman's quality of life. Fractional carbon dioxide vaginal laser is increasingly offered as a treatment, but the efficacy remains unproven. To determine the efficacy of fractional carbon dioxide laser for treatment of vaginal symptoms associated with menopause. A double-blind, randomized, sham-controlled trial with 12-month follow-up was undertaken at a single tertiary referral hospital in Sydney, Australia. Enrollment commenced on September 19, 2016, with final follow-up on June 30, 2020. Participants were postmenopausal women with vaginal symptoms substantive enough to seek medical treatment. Of 232 participants approached, 85 were randomized. Three treatments using a fractional microablative carbon dioxide laser system performed 4 to 8 weeks apart, with 43 women randomized to the laser group and 42 to the sham group. The co-primary outcomes were symptom severity assessed using a visual analog scale (VAS; range, 0-100; 0 indicates no symptoms and 100 indicates the most severe symptoms) and the Vulvovaginal Symptom Questionnaire (VSQ; range, 0-20; 0 indicates no symptoms and 20 indicates the most severe symptoms) at 12 months. The minimal clinically important difference was specified as a 50% decrease in both VAS and VSQ severity scores. There were 5 prespecified secondary outcomes, including quality of life (range, 0-100; higher scores indicate better quality of life), the Vaginal Health Index Score (range, 5-25; higher scores indicate better health), and vaginal histology (premenopausal or postmenopausal status). Of 85 randomized participants (mean [SD] age, 57 [8] years), 78 (91.7%) completed the 12-month follow-up. From baseline to 12 months, there was no significant difference between the carbon dioxide laser group and the sham group in change in symptom severity (VAS score for overall vaginal symptoms: -17.2 vs -26.6; difference, 9.4 [95% CI, -28.6 to 47.5]; VAS score for the most severe symptom: -24.5 vs -20.4; difference -4.1 [95% CI, -32.5 to 24.3]; VSQ score: -3.1 vs -1.6; difference, -1.5 [95% CI, -5.9 to 3.0]). There were no significant differences between the laser and sham group in the mean quality of life score (6.3 vs 1.4; difference, 4.8 [95% CI, -3.9 to 13.5]) and Vaginal Health Index Score (0.9 vs 1.3; difference, -0.4 [95% CI, -4.3 to 3.6]) or in histological comparisons between laser and sham treatment groups. There were 16 adverse events in the laser group and 17 in the sham group, including vaginal pain/discomfort (44% vs 68%), spotting, discharge, and lower urinary tract symptoms. No severe adverse events were reported in either group. Among women with postmenopausal vaginal symptoms, treatment with fractional carbon dioxide laser vs sham treatment did not significantly improve vaginal symptoms after 12 months. Australian and New Zealand Clinical Trials Registry: ACTRN12616001403426.

The CO2 ablative laser treatment in perimenopausal patients with vulvovaginal atrophy.

The aim of the study was to evaluate the effectiveness of CO₂ fractional laser therapy on perimenopausal urogenital symptoms. This prospective, open-label study included 205 patients who received three CO₂ laser treatments. Clinical assessment was checked at baseline as well as at six weeks and 12 months post-treatment. The following scores were measured Vaginal Health Index Score (VHIS), International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and assessment of the severity of selected urogenital symptoms. Significant improvements in dryness, dyspareunia, burning, vaginal laxity, urinary incontinence, as were the results on the VHIS and ICIQ-UI SF at six weeks post-treatment (p < 0.05 for all scores), which were maintained through the follow-up visit at 12 months. No complications were observed either during or after laser therapy. CO₂ ablative laser treatment can be effective in reducing vulvovaginal atrophy symptoms such as vaginal laxity, dryness, painful sexual intercourse, burning, and decreases the severity of stress urinary incontinence and urge incontinence symptoms. Positive results were maintained at 12 months after the laser treatment.

Pixel-CO2 laser for the treatment of stress urinary incontinence

The aim of this study was to assess the safety and efficacy of a minimally invasive pixel-CO2 laser procedure for the treatment of stress urinary incontinence (SUI). This was a prospective, open-label study with a cohort of 59 women. Patients were treated intravaginally with a fractional/pixel CO2 laser every 4–6 weeks for a total of three treatments and assessed at 3, 6, and 12 months. Evaluation tools included a Sandvik severity score based on a validated questionnaire, 1-h pad test, vaginal health index score (VHIS), validated female sexual function index (FSFI), patient’s impression of disease severity (PGI-S), global impression of improvement (PGI-I), and the short-term pelvic floor impact questionnaire (PFIQ-7) to assess improvements in quality of life. Reduction in SUI severity was noticed throughout the duration of the study, as compared to the baseline in which 2% of the patients were defined as “slight,” 73% “moderate,” and 25% “severe.” Gradual improvement of symptoms resulted in redistribution of severity score and the best outcome observed between 3 and 6 months. Sanitary pad weight declined from an average of 35.45 g per day at baseline to 12.47 g at the 3rd treatment, and increased to 23.06 g at 12 months. Vaginal acidity changes showed a similar pattern. No serious adverse events were reported. Pixel-CO2 laser is safe and effective for treating SUI. Additional maintenance treatments should be considered during the 6–12-month post-treatment period in order to maintain the beneficial effects.Brief summaryPixel-CO2 laser is a safe and effective treatment for SUI. Maintenance treatments should be considered at 6–12 months.

Vaginal collagen I and III changes after carbon dioxide laser application in postmenopausal women with the genitourinary syndrome: a pilot study

Objective The aim of the study was to evaluate the clinical response and collagen remodeling in the vaginal wall after three sessions of carbon dioxide (CO2) laser application. Methods Fourteen postmenopausal women with vulvovaginal atrophy, aged 45–65 years and sexually active, were evaluated with clinical questionnaires, gynecological examinations and histological techniques before and after 20 weeks of treatment (ClinicalTrials.gov NCT03939078). Treatment consisted of 3-monthly sessions of the CO2 laser. Clinical questionnaires included the Vaginal Health Index, the Female Sexual Function Index and the International Consultation on Incontinence Questionnaires Short Form. Biopsies were taken from the lateral vaginal wall at week 0 (left wall) and week 20 (right wall). Tissue samples were stained with hematoxylin and eosin, Periodic Acid-Schiff, Picrosirius Red Stain and Orcein dyes. Immunohistochemical study was used to quantify collagens I and III in the samples. Results The mean age was 54.4 ± 4.5 years, and the average time of amenorrhea was 7.6 ± 5.1 years. The Female Sexual Function Index and the Vaginal Health Index Score values increased while the International Consultation on Incontinence Questionnaire Short Form score decreased after the programmed treatment. There was no significant change in vaginal pH. Histological studies showed increases in the total and superficial epithelial cell layers, and type III collagen fibers (from 10.86 ± 7.66 to 16.87 ± 3.96, p < 0.05), and immunohistochemical studies confirmed the significant increase in collagen III. Conclusion Histological findings revealed epithelial atrophy reversal and collagen remodeling of the vaginal wall. Immunohistochemical analysis showed an increase in collagen type III fibers.

Nonablative, Noncoagulative Multipolar Radiofrequency and Pulsed Electromagnetic Field Treatment Improves Vaginal Laxity and Sexual Function.

Objective: This study investigated nonablative/noncoagulative multipolar radiofrequency and pulsed electromagnetic field (RF/PEMF) treatment for vaginal laxity (VL) and its impact on sexual function in parous women.Methods: This prospective, open-label single-center study enrolled 34 female subjects, 23–59 years of age, with ≥1 vaginal delivery and self-reported VL. Three monthly intravaginal treatments with RF/PEMF energy were performed. Treatment and follow-up assessments included the vaginal health index (VHI), vaginal pH, female sexual function index (FSFI), and VL/sexual satisfaction (SS) and subject satisfaction scores. Mean score and percent improvement over baseline were reported. Subject discomfort/pain was assessed after each treatment.Results: Total and each individual domain scores of the VHI improved significantly, while vaginal pH levels decreased from baseline to both 1 and 4 months (p < 0.01) after the last treatment. FSFI (<0.001), VL (<0.001), and SS (<0.001), including overall satisfaction scores (<0.01), improved post-treatment, with positive effects further sustained until at least 4 months post-treatment. Pain/discomfort post-treatment was reported as none to mild. No noticeable adverse events (AEs) or unanticipated side effects were reported.Conclusions: Nonablative/noncoagulative multipolar RF/PEMF is safe and is associated with significant 1- and 4-month post-treatment improvements in symptoms associated with VL and sexual dysfunction, as assessed by the VHI, vaginal pH, FSFI, and VL subject satisfaction score. SS and overall satisfaction scores also improved. The treatment was well tolerated with no or little pain, and no adverse events were reported.Clinical Trial Registration number: NCT04607798.

Fractional CO2 laser treatment effect on cervicovaginal lavage zinc and copper levels: a prospective cohort study

BackgroundThe basic principle of vaginal laser therapy is the rejuvenation of the affected tissue. Zinc and copper are essential nutritional trace elements and have a key role in connective tissue homeostasis. We aimed to investigate the effect of vaginal, fractional CO2 laser treatment on cervicovaginal lavage (CVL) zinc and copper levels.MethodsTwenty-nine postmenopausal women with symptoms of vaginal dryness were enrolled in our prospective cohort study. Three treatments with MonaLisa Touch CO2 laser system were performed four weeks apart. At each treatment CVL was collected, Vaginal Health Index (VHI) was obtained, and Visual Analog Scale (VAS) for vaginal dryness was assigned by patients. Zinc and copper concentrations were measured with optical emission spectrometry before each treatment and six weeks after the 3rd treatment.ResultsThe VHI scores significantly improved after each laser treatment (mean ± SD VHI score, 13.03 ± 4.49 before vs. 15.55 ± 4.35 after the 1st, 17.79 ± 4.57 after the 2nd and 19.38 ± 4.39 after the 3rd treatment, P < 0.01). Similarly, VAS scores reflected improvement (mean ± SD VAS score 6.59 ± 2.86 before vs. 4.17 ± 2.86 after the 1st, 2.45 ± 2.43 after the 2nd and 1.41 ± 1.94 after the 3rd treatment, P < 0.01). CVL zinc levels were significantly higher compared to copper levels (0.06 ± 0.04 vs. 0.006 ± 0.006 mg/L, P < 0.01) at baseline. While copper levels remained the same through treatments, the CVL zinc level was significantly higher after the second laser treatment compared to the baseline.ConclusionsFractional CO2 laser treatment of the vagina impacts CVL zinc and copper levels differently. While CVL copper levels were not different after each laser treatment, zinc levels were significantly higher after the second treatment before returning to baseline values.

Microablative radiofrequency versus pelvic floor muscle training for stress urinary incontinence: a randomized controlled trial.

The efficacy of radiofrequency (RF) in stress urinary incontinence (SUI) is as yet unknown. The aim was to compare the effect of fractional microablative RF and pelvic floor muscle training (PFMT) against the combination of both therapies (RF + PFMT) in the SUI and on genitourinary syndrome (GSM). This was a three-arm randomized clinical trial including 117 climacteric women with SUI. In group 1 the treatment consisted of three monthly sessions of RF; in group 2 it was 12 weekly PFMT sessions; in group 3 it was RF + PFMT simultaneously. Assessments at baseline and 30days after the end of therapy were conducted using validated questionnaires and scales for urinary, vaginal, and sexual functions and cytology for vaginal trophy. Urinary scores improved significantly in all three groups post-treatment (p < 0.001) with a higher improvement in the RF + PFMT group (p = 0.002). One-hour pad test results were equal in the three groups. Vaginal symptoms showed an incremental improvement in RF (p < 0.007), and vaginal laxity showed a similar improvement in the three groups (p = 0.323). Vaginal Health Index score was more significant in RF and RF + PFMT groups. Sexual function improved in RF and PFMT. The association between RF and PFMT showed significant improvement in the SUI symptoms assessed by questionnaire. The vaginal symptoms and dryness showed greater improvement in the RF treatment and vaginal laxity showed similar improvement in the three groups. The combination of RF and PFMT in sexual function did not show benefits superior to those achieved by the therapies alone.

Vaginal Fractional Carbon Dioxide Laser Treatment and Changes in Vaginal Biomechanical Parameters.

Vaginal fractional carbon dioxide (CO2 ) laser treatment has emerged in the past two decades as a non-surgical option for vaginal tightening. Mounting evidence supports the effectiveness and safety of this treatment for female sexual dysfunction. A newly developed vaginal tactile imaging (VTI) technique accurately evaluates the biomechanical parameters of the female pelvic floor and vagina, including tissue elasticity, pelvic support, and pelvic muscle function in high definition. In the current study, we evaluated changes in objective biomechanical parameters using VTI, following vaginal CO2 laser treatment for vaginal tightening and sexual dysfunction. We conducted a prospective cohort between June 2018 and January 2020. Inclusion criteria were vaginal looseness, decreased local sensation during sexual intercourse, and sexual dysfunction. All the participants were treated with a vaginal carbon dioxide laser. They underwent a gynecological evaluation based on the Vaginal Health Index (VHI) and sexual function assessment according to the Female Sexual Function Index (FSFI). Vaginal biomechanical parameters were assessed by VTI. Initial evaluations were performed at the pre-treatment consult visit, 1 week prior to the first treatment and at a 6-month post-treatment follow-up visit. Twenty-five women were included in the final analysis. Compared with baseline, the post-treatment mean scores for vaginal elasticity and tightening were higher (54.8 ± 5.2 vs. 41.5 ± 6.3, P = 0.0027 and 1.97 ± 0.25 vs. 1.32 ± 0.31, P = 0.0014, respectively). Post-treatment increases were demonstrated in pelvic muscle contraction strength (25.9 ± 3.5 vs. 16.5 ± 4.2, P = 0.0011) and in reflex pelvic muscle contraction (2.93 ± 0.44 vs. 2.12 ± 0.47, P = 0.0022); the mean FSFI and VHI scores were higher following treatment (28.47 ± 1.73 vs. 21.12 ± 1.58, P = 0.036 and 19.15 ± 1.27 vs. 11.6 ± 0.97, P = 0.0032). The quantification of vaginal biomechanical parameters using VTI technology offers objective evidence of the beneficial effect of vaginal CO2 laser treatment. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.

Vaginal elasticity is significantly decreased in vaginal atrophy: a strain elastography study.

Strain elastography is a novel method to assess the elasticity of tissues. We aimed to evaluate the value of vaginal strain elastography in women with vulvovaginal atrophy (VVA). Women with or without VVA were enrolled in this prospective study. Participants underwent vaginal cytology and vaginal wall elastography. Vaginal Health Index (VHI) was calculated. Based on Vaginal Maturation Value (VMV), participants were divided into atrophic and nonatrophic groups. Elastography parameters of the vaginal walls were measured in nine regions of interest (ROI). Elastography Index (EI) was defined by the average color score of nine ROIs. Groups were compared with unpaired t test or Mann-Whitney U test. Pearson correlation was used to determine the strength of association between EI and selected parameters. Multiple regression was used to evaluate the association between EI and age, VMV, and vaginal atrophy. Ten women were diagnosed with VVA, and twenty had no cytological signs of vaginal atrophy (age-range 38-79 y). VHI score was significantly lower in the atrophic group (mean ± SD, 9.4 ± 2.011 vs 16.6 ± 4.22, P < 0.0001). In the atrophic group, EI was significantly lower than in nonatrophic group (mean ± SD, 20 ± 21 vs 47 ± 4, P < 0.01). We found a strong negative correlation between EI and vaginal atrophy (r = -0.706, P < 0.0001; 95% CI: 0.8501 to -0.4639). In the multiple regression model, only atrophy remained statistically significant for the prediction of EI (P = 0.004). Vaginal elasticity is significantly decreased in women with vaginal atrophy, measured by EI. Our results suggest that strain elastography might be useful in the diagnosis of vaginal atrophy.

Effect of Menopausal Hormone Therapy on the Vaginal Microbiota and Genitourinary Syndrome of Menopause in Chinese Menopausal Women.

Genitourinary syndrome of menopause (GSM) is a chronic and progressive condition with a series of vulvovaginal, sexual, and lower urinary tract discomforts, mainly due to hypoestrogenism. Menopausal hormone therapy (MHT) has generally been considered as the most effective treatment for GSM. In addition, vaginal microbiota is of particular significance to gynecological and reproductive illnesses and potentially has some intimate connections with GSM. Consequently, we sought to evaluate how MHT impacts the composition and structure of vaginal microbiota while alleviating GSM in Chinese menopausal women aged 45–65 years, which has not been investigated previously. 16S rRNA gene sequencing was performed to analyze microbial diversity and composition using vaginal swabs obtained from 100 menopausal women, classified as MHT women who have been taking tibolone regularly (n = 50) and non-treated women who never received any treatment (n = 50). Vaginal Health Index Score (VHIS) and GSM symptoms inquiry were also performed. We found that the vaginal microbial diversity decreased and that the abundance of Lactobacillus increased to be the dominant proportion significantly in the MHT group, in considerable contrast to vaginal microbiota of the non-treated group, which significantly comprised several anaerobic bacteria, namely, Gardnerella, Prevotella, Escherichia-Shigella, Streptococcus, Atopobium, Aerococcus, Anaerotruncus, and Anaerococcus. In this study, women without any MHT had significantly more severe GSM symptoms than those receiving tibolone, especially with regard to vulvovaginal dryness and burning, as well as decreased libido (P < 0.01). However, there was no significant difference in the severity of urological symptoms between the groups (P > 0.05). Furthermore, Lactobacillus was demonstrated to be associated with VHIS positively (r = 0.626, P < 0.001) and with GSM negatively (r = −0.347, P < 0.001). We also identified Chlamydia (r = 0.277, P < 0.01) and Streptococcus (r = 0.270, P < 0.01) as having a prominent association with more serious GSM symptoms. Our study provided an elucidation that MHT could notably alleviate GSM and conspicuously reshape the composition of the vaginal microbiota, which is of extreme importance to clinical practice for the management of GSM.

The Fractional CO2 Laser for the Treatment of Genitourinary Syndrome of Menopause: A Prospective Multicenter Cohort Study.

Background and ObjectivesGenitourinary syndrome of menopause (GSM) is a common condition affecting of most postmenopausal women, which greatly impacks the quality of life,and need to treat. This prospective multicenter cohort study aimed to compare the efficacy and safety of the fractional carbon dioxide (CO2) laser with that of topical estrogen for vaginal treatment and relieving symptoms of genitourinary syndrome of menopause (GSM).Study Design/Materials and MethodsThis study included 162 postmenopausal patients who received vaginal laser or topical Estriol cream therapy between January 2017 and May 2019 at eight study centers in China. The degree of GSM‐related symptoms (vaginal burning, dryness, and dyspareunia) was evaluated using the Vaginal Health Index score (VHIS) and Visual Analog Scale (VAS) at baseline, 1, 3, 6, and 12 months posttreatment. The primary endpoint was the improvement in vaginal burning, dryness, and dyspareunia at 6 months after treatment. Multivariate logistic regression was used to compare the rate of improvement in the two groups.ResultsAt baseline, the laser and control groups showed no significant difference in the mean age, time after menopause, and the VHIS (all P > 0.05). In the laser group, compared with baseline, significant differences were seen in the VHIS after the first or second treatment session and at 1, 3, 6, and 12 months posttreatment (P < 0.01). In the control group, compared with baseline, the VHIS showed significant differences after 1, 3, and 6 months of treatment (P < 0.05). However, there was no significant difference after 3 and 6 months of follow‐up between the two groups (P > 0.05). The VHIS scores were significantly higher after 1 month (16.63 ± 2.79 vs. 15.57 ± 2.43) and 12 months (15.72 ± 2.59 vs. 12.12 ± 4.08) of treatment in both the groups (P < 0.05). At 6 months after treatment, both groups showed improvement in vaginal burning, vaginal dryness, and dyspareunia (P > 0.05). The VAS findings at 6 months posttreatment were significantly different when compared with the pretreatment findings (P < 0.001). There were no significant adverse effects in the two groups.ConclusionsFractional CO2 laser vaginal treatment could be a safe and effective option for treating symptoms of GSM, including vaginal burning, dryness, and dyspareunia. The improvement in symptoms was comparable with that seen with topical estrogen therapy and lasted for at least 6–12 months posttreatment. Lasers Surg. Med. © 2020 Wiley Periodicals LLC

The European Vulvovaginal Epidemiological Survey (EVES). Impact of history of breast cancer on prevalence, symptoms, sexual function and quality of life related to vulvovaginal atrophy

Objective Women with history of breast cancer (HBC) frequently suffer from vulvovaginal atrophy (VVA). European Vulvovaginal Epidemiology Survey (EVES) sub-analysis assesses the impact of HBC on VVA, sexual life and quality of life (QoL) in postmenopausal women. Materials and methods Women with at least one VVA symptom aged 45–75 years were included. EuroQol (EQ-5D-3L) and Day-to-Day Impact of Vaginal Aging (DIVA) questionnaires were filled to investigate QoL. VVA diagnosis was confirmed with objective gynecological examination. Comparison of postmenopausal women with and without HBC, and evaluation of treatment impact on VVA were performed. Results 1985 postmenopausal women without HBC and 175 with HBC were included. VVA was confirmed in 90.4% of women without HBC and 91.4% of women with HBC. There were no differences in VVA symptoms severity or vulvovaginal discomfort between groups. However, women with HBC who had completed treatment and had surgery 11–20 years previously versus those without HBC presented significantly worse Vaginal Health Index scores, as well as a higher prevalence of VVA objective diagnosis, although their overall symptom severity score was lower. Health status and QoL comparisons were similar. Conclusions Results support a similar burden in terms of VVA prevalence and symptoms, QoL and sexual function in postmenopausal women with and without HBC.

Carbon dioxide laser treatment for vulvovaginal atrophy in women treated for breast cancer: Preliminary results of the feasibility EPIONE trial

Quality of life preservation after anti-cancer therapy is a major challenge for breast cancer survivors. Approximately 42-70% of patients who receive systemic therapy for breast cancer, including endocrine therapy, will develop vulvovaginal atrophy (VVA). For these patients, the commonly proposed gel-based treatments for topical applications are restrictive. Recently, innovative, non-hormonal therapeutic approaches, such as laser therapy, have emerged. The purpose of this feasibility study is to investigate the safety and efficacy of CO2 laser therapy in women with a history of breast cancer. This prospective monocentric study included 20 patients with vulvovaginal atrophy who were treated at Henri Mondor University Hospital between 2017 and 2018. We included patients with a vaginal health index (VHI) score<15 and a contraindication for hormone administration due to a history of breast cancer. Two carbon dioxide laser sessions were used. The treatment was delivered using the following settings: vaginal tightening, FinePulse (pulse width 0.9ms), and energy density of 11.5J/cm2 that allows coverage of 70% of the targeted vaginal area to be treated. All patients had their follow-up visit at one (M1), three (M3), and six (M6) months after the first treatment to evaluate efficacy of the treatment on vulvovaginal atrophy. Vaginal health index score and female sexual distress (FSD) score were used to assess treatment efficacy and its impact on sexual quality of life. A score≥11 was associated with sexual dysfunction. The vaginal health index and female sexual distress scores were evaluated at baseline, M1, M3, and M6 of follow-up. The mean age of the patients was 56.1±8.8 years (range, 27-69 years). Seventeen of the 20 patients had experienced menopause (mean menopausal age, 51.25±1.5 years). At inclusion, the mean vaginal health index and the female sexual distress scores were 10.58±1.71 and 21.36±15.10, respectively. Fourteen out of 20 patients (70%) had FSD scores≥11 at the baseline. At M1, the mean vaginal health index score increased significantly to 13.42±2.3 (P=0.03), which represented an improvement of 21% from the baseline. A persistent and significant improvement in the vaginal health index score was observed at M6, with the score increasing to 16.75±4.23 post-treatment (P<0.0001), representing a 34% improvement from the mean baseline score. The mean female sexual distress at M1 was 19.83±13.57, representing a 7% decrease compared to the baseline scores (P<0.01). At M3, the female sexual distress significantly decreased to 13.88±15.58, representing an improvement of 35% (P=0.006). It increased to 10.35±14.7 at M6, representing an improvement of 52% (P=0.001). At M3, 35% of the patients had a female sexual distress score>11, and at M6, only 15% had a female sexual distress score>11. No side effects were reported during follow-up. This pilot feasibility study showed that carbon dioxide laser treatment appears to be an effective and safe method to improve the trophicity and decrease vaginal mucosal dryness in women with vulvovaginal atrophy that developed after systemic breast cancer therapy.

Efectividad y seguridad del policresuleno en el tratamiento del síndrome genitourinario de la menopausia. Estudio controlado y aleatorizado

Objetivo: evaluar la efectividad y seguridad del policresuleno frente al estriol y el lubricante vaginal, en el tratamiento del síndrome genitourinario de la menopausia en mujeres de Armenia (Quindío, Colombia). Materiales y métodos: en mujeres diagnosticadas con síndrome genitourinario de la menopausia, se hizo un ensayo clínico controlado aleatorizado y triple ciego. Se asignaron tres grupos (estriol, n=86, lubricante vaginal, n=83 y policresuleno, n=82). El principal parámetro indicador de efectividad fue la elevación de la puntuación del índice de salud vaginal (ISV), mejoría de la función sexual de acuerdo al índice de Función Sexual Femenina Abreviado-6 (IFSFA-6), porcentaje de mejoría de la sintomatología e incidencia de efectos adversos. Resultados: la efectividad fue mayor con el uso del estriol, seguida del policresuleno y menor con el lubricante vaginal (92,82%, 75,69% y 63,74%, respectivamente, p = 0,012); también se encontraron diferencias en la mejoría de la función sexual, según los puntajes del IFSFA-6 [29,29 ± 6,23 (estriol), 28,66 ± 6,12 (policresuleno) y 25,38 ± 6,27 (lubricante vaginal), p = 0,021], con diferencias en el porcentaje tanto de la mejoría de la sintomatología como en la presentación de efectos adversos (p = 0,001). Conclusiones: El policresuleno tiene una significativa efectividad en el tratamiento del síndrome genitourinario de la menopausia, superior frente al lubricante vaginal, pero inferior comparado con el estriol. Es evidente la presencia de efectos adversos, mayores con el estriol, seguido del policresuleno y luego del lubricante vaginal, sin cuestionar el notable perfil de seguridad del policresuleno.

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.

Microfat and Nanofat Grafting in Genital Rejuvenation.

Genitourinary syndrome of menopause (GSM) is a major problem in many post- or perimenopausal women. Lipofilling has long been considered to be an effective technique for restoring volume, but the discovery of its trophic proprieties has made it the most widely utilized method in regenerative medicine. The authors aimed to assess the safety and efficacy of microfat and nanofat grafting for vulvovaginal rejuvenation. Women with GSM who met the inclusion criteria were enrolled. Women received microfat in the labia majora and nanofat in the vagina; follow-up was conducted 1, 3, 6, 12, and 18 months. The vaginal health index (VHI) and Female Sexual Distress (FSD) were utilized to assess improvement in vulvovaginal atrophy, orgasm, and sexual desire posttreatment. Fifty women were included; their average age was 53 years (range, 45-63 years). The VHI score significantly increased at 1 and 3 months after treatment (P < 0.0001). Moreover, the average FSD score showed a significant improvement at 1 and 3 months posttreatment. This score stabilized from 6 to 12 months but showed further improvement at 18 months. At 6 months posttreatment, for both scales, data pertaining to 80% of patients appeared normalized. There was a particular benefit noted for dryness and dyspareunia. At 18 months, the results remained stable for all of patients. No major side effects were observed. There are now many ways to rejuvenate the intimate sphere, but microfat and nanofat grafting seem to offer good results with an autologous procedure. Their utilization appears promising for genital rejuvenation.

Treatment for vaginal atrophy using microablative fractional CO2 laser: a randomized double-blinded sham-controlled trial.

The aim of this study was to evaluate the efficacy of vaginal CO2 laser for the treatment of vaginal atrophy compared to the sham procedure. Between June 2016 and May 2017, postmenopausal women with moderate to severe intensity of any vaginal atrophy symptoms (VAS) were invited to participate in the study. A total of 88 women were randomized to receive treatment with either vaginal CO2 laser or sham procedures every 4 weeks for three sessions. Both the participants and the evaluators were blinded to the treatment. Vaginal Health Index (VHI) score (primary outcome), VAS score, and the item for vaginal dryness from the International Consultation on Incontinence Modular Questionnaire-Vaginal Symptoms questionnaire were compared between the two groups by intention-to-treat analysis at 12 weeks after treatment. Eighty-eight women were enrolled into the study and nine women were lost to follow-up. After 12 weeks of laser treatment, the VHI, VAS, and International Consultation on Incontinence Modular Questionnaire-Vaginal Symptoms (item for vaginal dryness) scores were significantly improved. For VHI and VAS scores the mean difference between the laser group versus the sham group was 1.37 (95% CI: 0.12-2.63), P < 0.001 and -1.52 (95% CI: -2.21 to -0.82), P = 0.03, respectively. This study demonstrated that the application of microablative fractional CO2 laser was effective in treating vaginal atrophy. It could be a promising alternative treatment for postmenopausal women with vaginal atrophy. : Video Summary:http://links.lww.com/MENO/A582.

2053 the Fractional CO2 Laser in Korea: An Effective Treatment Option for Genitourinary Syndrome of Menopause

Study Objective The genitourinary syndrome of menopause (GSM) is associated with bothersome symptoms in menopausal women. The GSM may have a negative impact on the quality of life of postmenopausal women, and it should be treated with an appropriate therapy. This study is aimed to evaluate the efficacy of fractional CO2 laser therapy (Laser therapy) in the treatment of GSM. Design GSM patients treated with Laser therapy and evaluates the progress before and after treatment using objective and subjective indicators. Setting We use the fractional CO2 laser (SmartXide2 V2LR, Monalisa Touch, DEKA, Italy). The therapy was applicated every 4 weeks. Patients or Participants The total of 38 women presenting with GSM were enrolled to Laser therapy. 22 patients are survivors of breast cancer. Interventions The severity of symptoms was assessed with a visual analog scale(VAS) at the baseline and every visit. We also measured the objective scale using the vaginal health index score (VHIS) at baseline and after completion of laser procedure. At each procedure, patient's pain in VAS and the physician's difficulty was recorded at each time. At last visit, the patients evaluate their satisfaction with the laser therapy using a 5 points Likert scale. Measurements and Main Results In our study, almost all symptoms showed the mean VAS score improvement. But only the relief in vaginal dryness improved significantly(p Conclusion This study shows that fractional CO2 laser treatment is effective in patients who suffering from genitourinary syndrome of menopause. Further studies should be performed to confirm the results and to assess the long-term effects of the laser therapy.