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Objective: This study aims to compare the effects of vaginal estrogen and hyaluronic acid on vulvovaginal atrophy., Patients and Methods: This randomized controlled study included a total of 300 patients, with 150 patients in each group (Group E and Group H). The VHI score was determined based on a pre-treatment evaluation conducted by a gynecologist. After one month of receiving vaginal estrogen in Group E and vaginal hyaluronic acid in Group H, the patients were re-evaluated by their physicians., Results: A statistically significant difference was found between the pre- and post-treatment VHI scores in Group E and Group H (p = 0.000; p = 0.000). No statistical difference was found between Group E and Group H in terms of treatment efficacy (p = 0.712). The pre- and post-treatment complaints of dryness, itching, dyspareunia, burning, and dysuria were found to be statistically significant in Group E and Group H (p = 0.000; p = 0.000; p = 0.000; p = 0.000; p = 0.000 in Group E, respectively) (p = 0.000; p = 0.000; p = 0.000; p = 0.000; p = 0.000 in Group H, respectively). No statistical difference was observed regarding dyspareunia, dysuria, and burning complaints (p = 0.632; p = 0.106; p = 0.128, respectively). However, hyaluronic acid was found to be significantly more effective for itching complaints (p = 0.002), while estrogen was found to be significantly more effective for dryness complaints (p = 0.012)., Conclusions: Hyaluronic acid and estrogen were equally effective in vaginal treatment. Hyaluronic acid may be preferred for patients in whom hormonal therapy is contraindicated or for those who prefer non-hormonal therapy.

Importance: Ospemifene is a novel selective estrogen receptor modulator developed for the treatment of moderate to severe postmenopausal vulvovaginal atrophy (VVA)., Objective: 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., Evidence Review: 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., Findings: 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., Conclusions and Relevance: 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., Competing Interests: Financial disclosure/conflicts of interest: C.B. is a partner at PeriPharm, Inc, and A.C. and C.R. are employees at PeriPharm, Inc, a company that has served as a consultant to Duchesnay, Inc, and has received funding from Duchesnay, Inc. A.F. and D.B. have served as consultants for Duchesnay, Inc. D.B. currently receives funding from AbbVie, Bayer, BioSyent, Duchesnay, Merck, Organon, Pfizer, and Searchlight. R.M. is an employee at Duchesnay, Inc. J.A.S. receives grant/research support from the following: AbbVie, Bayer Healthcare, Dare Bioscience, Enteris BioPharma, Mylan/Viatris, Myovant Sciences, ObsEva, and Viveve Medical; is on consulting/advisory boards of the following: Bayer Healthcare, Besins Healthcare, California Institute of Integral Studies (CIIS), Dare Bioscience, DEKA M.E.L.A S.r.l., Duchesnay, Inc, Femasys, KaNDy/NeRRe Therapeutics, Khyria, Madorra, Mitsubishi Tanabe Pharma Development America, QUE Oncology, Scynexis, Inc, Sprout Pharmaceuticals, Vella Bioscience; serves on the speaker's bureaus of the following: Mayne Pharma, Myovant Sciences, Pfizer, Pharmavite, Scynexis, and TherapeuticsMD; and is a stockholder (direct purchase) in Sermonix Pharmaceuticals., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The North American Menopause Society.)

Objective: To assess the correlation of different vulvovaginal atrophy therapeutic options with the quality of life of postmenopausal women., Study Design: The CRETA study is a descriptive, observational, cross-sectional, multicenter study designed to measure, besides treatment satisfaction and adherence, the quality of life of postmenopausal women diagnosed with vulvovaginal atrophy in 29 hospitals and centers across Spain., Main Outcome Measures: The study enrolled postmenopausal women currently receiving treatment with vaginal moisturizers, local estrogen therapy or ospemifene. Clinical features and treatment perceptions were collected by self-report questionnaire and quality of life was evaluated using the Cervantes scale., Results: Among the 752 women included, the ospemifene cohort showed a statistically significant lower global score (44.9 ± 21.7) on the Cervantes scale (and therefore, a better quality of life) than the cohorts treated with moisturizers (52.5 ± 21.6, p = 0.003) or local estrogen therapy (49.2 ± 23.8, p = 0.0473). In the analysis by domains, ospemifene-treated women showed statistically significant better scores in menopause & health and psychological status than moisturizers-treated women (p < 0.05). In the domains of sexuality and couple relations, the score for the quality of life of the ospemifene cohort was statistically significantly better than the scores in either of the cohorts treated with moisturizers (p < 0.001) or local estrogen therapy (p < 0.05)., Conclusions: Postmenopausal women diagnosed with vulvovaginal atrophy and treated with ospemifene have better quality of life than women treated with vaginal moisturizers or local estrogen therapy. The improvement observed with ospemifene is more remarkable in those aspects related to sex life and couple relations. CLINCIALTRIALS., Gov Number: NCT04607707., Competing Interests: Declaration of competing interest Shionogi S.L.U. sponsored the study and provided support for the medical writing assistance by Kalispera medical writing S.L. RS-B has received consulting fees and speaker's honoraria from Shionogi. SP has received consulting fees and speaker's honoraria from Shionogi and Bayer HC, Exeltis, Gedeon Richter, NovoNordisk, Procare H, Serelys, Lacer, Sandoz, Pfizer, Theramex. MJC has received consulting fees and speaker's honoraria from Shionogi. JGC and JJQM are currently working at Shionogi S.L.U. The other authors declare that they have no competing interest., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

Objective: A common symptom of genitourinary syndrome of menopause (GSM) is dyspareunia, attributed to vulvovaginal atrophy. Our objective was to systematically describe the pain characteristics and anatomic locations of tenderness in a cohort with moderate/severe dyspareunia likely due to GSM., Methods: This cross-sectional study reports the baseline data of postmenopausal women with dyspareunia screened for an intervention trial of topical estrogen. Postmenopausal women not using hormone therapy who had moderate or severe dyspareunia were eligible if estrogen was not contraindicated. Biopsychosocial assessments were performed using the Vulvar Pain Assessment Questionnaire, and participants underwent a systematic vulvovaginal examination that included a visual assessment and cotton swab testing for tenderness rated using the Numerical Rating Scale (0-10). Vaginal pH and mucosal sensitivity were assessed; pelvic floor muscles and pelvic viscera were palpated for tenderness., Results: Fifty-five eligible women were examined between July 2017 and August 2019. Mean age was 59.5 ± 6.8 years, and duration of dyspareunia was 6.2 ± 4.3 years. The mean intercourse pain score was 7.3 ± 1.8, most often described as "burning" and "raw." Ninety-eight percent had physical findings of vulvovaginal atrophy. Median pain scores from swab touch at the vulvar vestibule (just outside the hymen) were 4 to 5/10, and topical lidocaine extinguished pain. Median vaginal mucosal pain was zero., Conclusions: Participants described their pain as "burning" and "dry." Tenderness was most severe and most consistently located at the vulvar vestibule. Correlating the symptom of dyspareunia with genital examination findings may further our understanding of treatment outcomes for GSM., Competing Interests: Financial disclosures/conflicts of interest: A.L.C.: Legal Consultant Butler Snow LLC for Ethicon regarding pelvic mesh litigation and Hart Wagner LLC for general malpractice; Member of the Provider Executive Group for Ms. Medicine LLC. The other authors have nothing to report. Clinicaltrials.gov NCT03240081, (Copyright © 2022 by The North American Menopause Society.)

Female genitourinary treatments in aesthetics utilize energy-based treatments and other noninvasive modalities. These include CO 2 and Erbium YAG lasers, radiofrequency, high-intensity focused electromagnetic energy, hyaluronic acid injection, platelet-rich plasma, and silicone thread treatments with an objective to treat sexual dysfunction and symptoms of genitourinary syndrome associated with menopause, which include atrophic vaginitis, urinary incontinence, and vulvovaginal laxity that is characterized by vaginal dryness, thinning of the epithelium, laxity, prolapse, incontinence, dyspareunia, and increased bacterial infections. The body of evidence is growing for the use of these modalities to improve signs and symptoms of the genitourinary syndrome associated with menopause and sexual function, as well as for rejuvenating the appearance of the external female genitalia. We reviewed the currently available modalities in this rapidly advancing area of expertise., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Deep infiltrating endometriosis frequently affects the rectosigmoid region. It clinically presents as a chronic painful condition affecting women in their reproductive time. Here, we present a case of a 28-yr-old female patient who had a history of dysmenorrhea, dyspareunia, chronic abdominal and pelvic pain, and constipation secondary to rectal wall endometriosis. Microscopic examination of the resected rectal segment showed endometriosis with vascular and lymph node involvement. Vascular involvement is an uncommon histologic finding that may raise concern for potential malignancy. The aim of this report is to alert pathologists and physicians about this infrequent pitfall that can be mistaken for a neoplastic process and to discuss the underlying pathophysiology of vascular involvement by endometrial tissue in otherwise benign conditions., Competing Interests: The authors declare no conflict of interest., (Copyright © 2020 by the International Society of Gynecological Pathologists.)

Background: 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., Objectives: The authors aimed to assess the safety and efficacy of microfat and nanofat grafting for vulvovaginal rejuvenation., Methods: 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., Results: 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., Conclusions: 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., (© 2020 The Aesthetic Society. Reprints and permission: journals.permissions@oup.com.)

Objective: The 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 Design: Postmenopausal 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 Measure: The 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., Results: Meclon 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)., Conclusions: The 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., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: Vulvo-Vaginal Atrophy (VVA) affects about fifty percent of postmenopausal women, contributing more vulnerable sexual and psycho-relational equilibrium. To date, no psychometric instruments have been designed to assess the impact of coital pain associated with VVA on sexual quality of life., Aim: To validate a new psychometric tool, the Gynogram, able to investigate coital pain and to quantify its impact on sexual well-being in menopause., Methods: 214 sexually active postmenopausal women were enrolled in the study during clinical consultations in gynecological outpatient clinics in Italy. After gynecological examination and evaluation of the presence of VVA, the study sample was divided in a clinical group (103 women with certified diagnosis of VVA) and in a control group (111 women without certified diagnosis of VVA) according to the Vaginal Health Index (VHI) cut-off. Factor, Reliability and Receiving Operating Characteristics (ROC) analysis were performed in order to validate our newly created Gynogram., Outcomes: A structured questionnaire, named Gynogram, to assess coital pain and its impact, and the Female Sexual Function Index (FSFI)., Results: The factor analysis performed on the original form (80 items) reduced the Gynogram to 24 items. Reliability analysis conducted with Cronbach's Alpha coefficients showed high values in all the components (ranging from .813 to .972), both in the long and in the short form. The sensitivity analysis demonstrated that the Gynogram, with a cut-off ≤93, is able to recognize a clinically significant coital pain. With respect to the FSFI, statistically significant differences were found for all the domains. In addition, statistically significant differences were found for all the twelve factors of the Gynogram, showing that VVA profoundly affects the sexual quality of life of women in post-menopause., Clinical Translation: The utility of this tool consists in the possibility to improve prognosis, compliance/adherence and treatment outcomes., Strengths and Limitations: The Gynogram is able to evaluate and to quantify the impact of coital pain associated with VVA. Moreover, it can also recognize the areas of biopsychosocial functioning being more affected by this clinical condition. The main limit of the study is the impossibility to evaluate both mental health and partner's general and sexual health., Conclusions: The Gynogram is a new and validated psychometric tool able to detect the impact of symptomatic VVA on sexual quality of life among post-menopausal women, with a specific focus on the different areas of sexual functioning. Nappi RE, Graziottin A, Mollaioli A, et al. The Gynogram: A Multicentric Validation of a New Psychometric Tool to Assess Coital Pain Associated With VVA and Its Impact on Sexual Quality of Life in Menopausal Women. J Sex Med 2021;18:955-965., (Copyright © 2021 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Importance: Genitourinary syndrome of menopause (GSM) consists of genitourinary tract symptoms that occur due to physical changes caused by estrogen concentrations decline after menopause. Unlike menopausal symptoms, which subside with time, GSM symptoms persist throughout a woman's life., Objective: This article aimed to systematically review the literature to investigate the prevalence of GSM and its treatment., Evidence Review: The search was conducted in the electronic databases PubMed, CENTRAL, and EMBASE until October 2020. Eligible for the systematic review were studies and surveys conducted via questionnaires or medical interviews evaluating the existence of GSM symptoms with or without gynecological examination in postmenopausal women or women >40 years of age., Findings: After the application of predefined inclusion/exclusion criteria, 27 studies were included in the systematic review. The prevalence of GSM-related symptoms, such as vaginal dryness, irritation, itching, and dyspareunia, ranged from 13% to 87%. The use of GSM-specific treatment varied from 13% to 78%. Over-the-counter lubricants and moisturizers were the most popular therapeutic options (24.0%-85.5%), followed by low-dose vaginal estrogens (4.8%-35.0%). Vaginal health is not frequently discussed during doctor visits and awareness about the condition and the number of treatment options is low. Women are concerned about the long-term safety and side effects of hormonal treatment. The majority of women who suffer from genitourinary symptoms are dissatisfied by the treatment they have used., Conclusions and Relevance: GSM is a highly prevalent condition among women. Nevertheless, women are frequently not aware of its cause and its treatment options. The findings of this review underline the need for education of patients and healthcare professionals regarding GSM diagnosis and treatment options., Competing Interests: Financial disclosure/conflicts of interest: None reported., (Copyright © 2021 by The North American Menopause Society.)

Abstract: Genitourinary syndrome of menopause (GSM) refers to a collection of symptoms resulting from diminished hormonal, primarily estrogenic stimulation to the vulvovaginal or lower urinary tract and may affect up to 50% of postmenopausal women. Symptoms, which are typically progressive and unlikely to resolve spontaneously, may include, but are not limited to, vulvovaginal dryness, burning or irritation, dyspareunia, or urinary symptoms of urgency, dysuria or recurrent urinary tract infection. These symptoms are typically progressive and unlikely to resolve spontaneously. Diagnosis is clinical. Telemedicine may play a role in diagnosis, initiation of treatment, and follow-up of women with GSM. Effective treatments include moisturizers and lubricants, local hormonal therapy with estrogen or dehydroepiandrosterone, and oral selective estrogen receptor agonists. Laser or radiofrequency procedures, although currently utilized, are being studied to comprehensively understand their overall effectiveness and safety. Additionally, the influence and effect of the vaginal microbiome, as well as potential of treatment via its manipulation, is being studied. We performed a literature search of PubMed, Google Scholar, and Ovid with search terms of vulvovaginal atrophy and GSM and reviewed major US Society Guidelines to create this narrative review of this topic. The literature suggests that healthcare providers can make a significant impact of the health and quality of life of women by being proactive about discussing and providing interventions for GSM. A systematic approach with consideration of current guidelines and attention to developing protocols for interventions should be employed., Competing Interests: Financial disclosure/conflicts of interest: None reported., (Copyright © 2021 by The North American Menopause Society.)

Objective: The objective of this video is to demonstrate different clinical presentations of peritoneal defects (peritoneal retraction pockets) and their anatomic relationships with the pelvic innervation, justifying the occurrence of some neurologic symptoms in association with these diseases., Design: Surgical demonstration of complete excision of different types of peritoneal retraction pockets and a comparison with a laparoscopic retroperitoneal cadaveric dissection of the pelvic innervation., Setting: Private hospital in Curitiba, Paraná, Brazil., Interventions: A pelvic peritoneal pocket is a retraction defect in the surface of the peritoneum of variable size and shapes [1]. The origin of defects in the pelvic peritoneum is still unknown [2]. It has been postulated that it is the result of peritoneal irritation or invasion by endometriosis, with resultant scarring and retraction of the peritoneum [3,4]. It has also been suggested that a retraction pocket may be a cause of endometriosis, where the disease presumably settles in a previously altered peritoneal surface [5]. These defects are shown in many studies to be associated with pelvic pain, dyspareunia, and secondary dysmenorrhea [1-4]. Some studies have shown that the excision of these peritoneal defect improves pain symptoms and quality of life [5]. It is important to recognize peritoneal pockets as a potential manifestation of endometriosis because in some cases, the only evidence of endometriosis may be the presence of these peritoneal defects [6]. In this video, we demonstrate different types of peritoneal pockets and their close relationship with pelvic anatomic structures. Case 1 is a 29-year-old woman, gravida 0, with severe dysmenorrhea and catamenial bowel symptoms (bowel distension and diarrhea/constipation) that were unresponsive to medical treatment. Imaging studies were reported as normal, and a laparoscopy showed a posterior cul-de-sac peritoneal pocket infiltrating the pararectal fossa, with extension to the lateral border of the rectum. Case 2 is a cadaveric dissection of a posterior cul-de-sac peritoneal pocket infiltrating the pararectal fossa, with extension to the pelvic sidewall. After dissection of the obturator fossa, we can observe that the pocket is close to the sacrospinous ligament, pudendal nerve, and some sacral roots. Case 3 is a 31-year-old woman, gravida 1, para 1, with severe dysmenorrhea that was unresponsive to medical treatment and catamenial bowel symptoms (catamenial bowel distention and diarrhea). Imaging studies were reported as normal and a laparoscopy showed left uterosacral peritoneal pocket infiltrating the pararectal fossa in close proximity to the rectal wall. Case 4 is a cadaveric dissection of the ovarian fossa and the obturator fossa showing the proximity between these structures. Case 5 is a 35-year-old woman, gravida 0, with severe dysmenorrhea that was unresponsive to medical treatment, referring difficulty, and pain when walking only during menstruation. A neurologic physical examination revealed weakness in thigh adduction, and the magnetic resonance imaging showed no signs of endometriosis. During laparoscopy, we found a peritoneal pocket infiltrating the ovarian fossa, with involvement in the area between the umbilical ligament and the uterine artery. This type of pocket can easily reach the obturator nerve. Because the obturator nerve and its branches supply the muscle and skin of the medial thigh [7,8], patients may present with thigh adduction weakness or difficulty ambulating [9,10]. Case 6 is a cadaveric dissection of the sacrospinous ligament and the pudendal nerve from a medial approach, between the umbilical artery and the iliac vessels. Case 7 is a 34-year-old woman, gravida 1, para 1, with severe dysmenorrhea and catamenial bowel symptoms as well as deep dyspareunia. The transvaginal ultrasound showed focal adenomyosis and a 2-cm nodule, 9-cm apart from the anal verge, affecting 30% of the bowel circumference. In the laparoscopy, we found a posterior cul-de-sac retraction pocket associated with a large deep endometriosis nodule affecting the vagina and the rectum. In all cases, endometriosis was confirmed by histopathology, and in a 6-month follow-up, all patients showed improvement of bowel, pain, and neurologic symptoms., Conclusion: Peritoneal pockets can have different clinical presentations. Depending on the topography and deepness of infiltration, they can be the cause of some neurologic symptoms associated with endometriosis pain. With this video, we try to encourage surgeons to totally excise these lesions and raise awareness about the adjacent key anatomic structures that can be affected., (Copyright © 2020 AAGL. Published by Elsevier Inc. All rights reserved.)

Background: The decline in postmenopausal serum estrogen concentration results in several changes in the vulvovaginal and vesicourethral areas, resulting in the genitourinary syndrome of menopause, including symptoms such as vaginal atrophy., Aim: To evaluate the effects of hyaluronic acid in vaginal atrophy., Methods: A search strategy was developed using the following terms: "Hyaluronic Acid vaginal gel," "vaginal estrogens," "Vaginitis, Atrophic," and "Postmenopause." This strategy was used in major databases such as MEDLINE, EMBASE, Scopus, Cochrane library, Web of Science, Virtual Health Library (BVS), Congress Abstracts, and Gray Literature (Google Scholar and British Library) for studies published until June 2020., Outcomes: A systematic review was carried out to assess the results of atrophic vaginitis/vaginal dryness, dyspareunia, vaginal pH, and cell maturation of the studies found by the search strategy., Results: A total of 833 studies were identified, 528 studies were directed for reading titles and abstracts, and 515 were excluded for not meeting the selection criteria. A total of 13 studies were selected for reading the full text. 5 primary studies involving 335 women met the criteria and were included. The studies were published between the years 2011 and 2017. It was not possible to perform meta-analysis owing to the substantial heterogeneity present in the studies. The results presented suggest that treatment with hyaluronic acid, when compared with the use of estrogens, does not present a significant difference in the results obtained for the outcomes: epithelial atrophy, vaginal pH, dyspareunia, and cell maturation., Clinical Translation: Hyaluronic acid appears to be an alternative to non-hormonal treatments for the signs of vaginal atrophy and dyspareunia., Strengths & Limitations: The analysis of the studies in this systemic review suggests that hyaluronic acid has efficacy similar to vaginal estrogens for the treatment of the signs of vaginal atrophy and dyspareunia. However, the included studies measured the data in different ways, causing the performance of meta-analysis to be impaired., Conclusion: The comparisons presented suggest that hyaluronic acid has a profile of efficacy, safety, and tolerability comparable with vaginal estrogens for the treatment of symptoms of vaginal atrophy. It is a possible alternative for women who cannot use hormonal treatment. dos Santos CCM, Uggioni MLR, Colonetti T, et al. Hyaluronic Acid in Postmenopause Vaginal Atrophy: A Systematic Review. J Sex Med 2021;18:156-166., (Copyright © 2020 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Introduction: Vulvar and vaginal atrophy (VVA) affects up to two thirds of postmenopausal women, with symptoms of vaginal dryness, dyspareunia, and vulvar/vaginal irritation. Despite the availability of various treatments, women express dissatisfaction with their options. An estradiol (E2; 4-µg and 10-µg) softgel vaginal insert was approved by the Food and Drug Administration (FDA) to treat moderate to severe dyspareunia, a symptom of VVA, due to menopause. These inserts were designed to treat VVA effectively and safely while avoiding some of the drawbacks of other administration methods., Areas Covered: This article reviews the physical characteristics and pharmacokinetic data of the E2 softgel vaginal insert. Primary and secondary efficacy endpoints and safety data are reviewed from the pivotal REJOICE trial (NCT02253173), and substudies that explore response rates, changes in vaginal epithelium by visual assessment, efficacy in patient subgroups, effects on sexual function, and patient satisfaction compared with other treatments., Expert Opinion: The E2 insert shows that vaginal drug delivery is an optimal route of administration for locally treating VVA. This E2 softgel vaginal insert is a safe and effective treatment for symptoms of postmenopausal VVA. The E2 insert's pharmacokinetic characteristics are related to its unique formulation, rapid dissolution, and minimal systemic absorption., Abbreviations: AE: adverse event; AUC: area under the concentration-time curve; BMI: body mass index; C avg : average concentration; CI: confidence interval; C max : maximum concentration; C min : minimum concentration; E2: estradiol; FDA: Food and Drug Administration; FSFI: Female Sexual Function Index; GSM: genitourinary symptoms of menopause: MBS: most bothersome symptom; NAMS: North American Menopause Society; OR: odds ratio; PI: pulsatility index; PK: pharmacokinetic; REVIVE: Real Women's Views of treatment options for menopausal Vaginal changEs; RI: resistance index; ROC: receiver operating characteristic; TEAE: treatment-emergent adverse event; t max : time to maximum concentration; VVA: vulvar and vaginal atrophy.

Background: Female sexual dysfunction (FSD) is prevalent in women with genitourinary syndrome of menopause (GSM). Vaginal estrogen is effective GSM treatment. This study was primarily aimed to evaluate the effects of vaginal administration of conjugated estrogens tablet on postmenopausal FSD using the Female Sexual Function Index (FSFI). Secondary aims were to evaluate vaginal pH, Vaginal Maturation Value (VMV), Normal Flora Index (NFI) and Most Bothersome Symptoms (MBS) changes., Methods: A double-blind trial was conducted in postmenopausal women with FSD (FSFI ≤26.55). Sixty-seven participants were randomized into two arms; vaginally administered conjugated estrogens tablet (0.625 mg, daily for 3 weeks then twice weekly for 9 weeks, n = 33), or placebo (n = 34)., Results: There was no significant improvement of FSFI observed in estrogens arm compared to placebo in each domain and overall index (p = 0.182). The estrogens significantly improved vaginal pH and VMV, toward more acidity (p = < 0.001), higher VMV (p = < 0.001) and more superficial cells (p = < 0.001). We observed no significant difference in NFI and MBS between arms (p = 0.282, 0.182)., Conclusion: We found no significant changes in FSFI, NFI, and MBS, but significant improvement in vaginal pH and VMV in postmenopausal women with FSD treated with vaginally administered conjugated estrogens tablet. Few side-effects were reported., Trial Registration: Thai Clinical Trial Registry identification number TCTR20180219001 , prospectively registered since 2018-02-19 11:33:21.

Studies have been published on the efficacy of Dienogest in the management of pain symptoms in endometriosis. Nonetheless, few data are available on the reducing effect on endometrioma's size. The aim of the study was to evaluate if Dienogest could determine significant changes in size, as well as in symptoms. In this prospective observational study, patients were enrolled with pain symptoms and at least one endometrioma diagnosed via TV-US. The volume of the endometrioma and pain symptoms was measured according to the LxDxWx0.5233 formula and VAS, respectively. Dienogest 2 mg was administered daily. Follow-up visits were scheduled after 6 and 12 months of treatment to assess changes in patients' symptoms and endometrioma's volume. Seventy patients were enrolled, 63 patients completed a 6-month treatment. The reduction of the mean volume after 6 months was 66.71%. Fifty-eight patients completed the 12 month-treatment. The reduction of the mean volume after 12 months was 76.19%. Dysmenorrhea showed a 74.05% reduction after 6 months and a 96.55% reduction after 12 months. Patients reported a reduction in dyspareunia and chronic pelvic pain of 42.71% and 48.91% after 6 months and 51.93% and 59.96% after 12 months, respectively. Dienogest leads to a statistically significant reduction of endometrioma's volume and pain symptoms.

Objectives: This study aimed to investigate the correlation between cervicovaginal fluid zinc levels and participants' menopausal status and the presence of vulvovaginal symptoms of genitourinary syndrome of menopause., Methods: Women included in the study underwent a pelvic examination, collection of vaginal cytology, and cervicovaginal lavage was performed in a standardized fashion. The cervicovaginal lavage zinc content was determined. The vaginal health index was calculated, and the visual analog scale was obtained based on the participant's burning, itching, vaginal pain, dyspareunia, dryness, and dysuria., Results: One hundred twenty women participated in the study. Eighty-two participants were menopausal. The mean vaginal health index was 15 ± 6, while the total visual analog scale score was 14 ± 14. We found significant differences between cervicovaginal lavage zinc level and age group, menopausal status, presence of vaginal dryness, and vaginal atrophy. We also found a moderate positive correlation between Vaginal Maturation Value and cervicovaginal lavage zinc levels (r = 0.495, P value < 0.01) in the correlation analysis. However, in the multivariate regression model, including all significant factors, only vaginal atrophy remained significant., Conclusions: We found a significant association between vaginal atrophy (vaginal maturation value < 50) and cervicovaginal lavage zinc levels. Zinc levels of cervicovaginal lavage could be used as a new marker of vaginal atrophy. : Video Summary:http://links.lww.com/MENO/A575.

Objective: Genitourinary atrophy is a menopausal pathological change determined by the definitive drop of ovarian hormones' production that can impact heavily on the health status of women, with important direct and indirect social costs. Unfortunately, available treatments are only symptomatic, and they are not able to reverse the atrophy and other related symptoms. Regenerative medicine, with single local injection of autologous micro-fractured fat tissue, could represent a viable new solution for these patients as it not only helps to relieve symptoms, but it also counteracts the mechanisms that lead to the menopausal genitourinary atrophy. The objective of this paper is to evaluate the long-term effectiveness of micro-fractured fat vulvar injection for genito-urinary atrophy in patients, affected by severe genitourinary atrophy (at least 4 symptoms lasting for at least 4 years)., Patients and Methods: We present a case series of 35 patients followed for 36 months to evaluate the effectiveness and safety of a single subcutaneous vulvar injection of autologous micro-fragmented fat tissue (MFAT)., Results: We have not observed any adverse effects in any patients. All symptoms, and especially pelvic pain and dyspareunia, improved in almost half of patients within 3 months. Ninety-nine percent of patients recovered completely from all symptoms after 9-12 months, reporting no relapse of the symptoms up to the third year of follow up., Conclusions: Our case series is the first case series, evaluating the long-term (3 years) safety and effectiveness of micro-fragmented adipose tissue graft for urogenital atrophy.

Approximately 50% of postmenopausal women experience vulvovaginal symptoms associated with genitourinary syndrome of menopause (GSM). GSM is a chronic and progressive condition with a well-defined treatment algorithm. Analysis of the MsFLASH Vaginal Health Trial data produced two main conclusions, which were that prescribed vaginal 10 μg estradiol tablet and over-the-counter (OTC) vaginal moisturizer did not provide additional benefit over placebo vaginal tablet and placebo gel in reducing postmenopausal vulvovaginal symptoms; or increasing the proportions of women reporting sexual activity or improving pain scores with sexual activity. These treatment conclusions are contrary to all prior robust clinical trial data for dyspareunia and vaginal dryness, and not in line with the good clinical practice for GSM management presented by the American College of Obstetricians and Gynecologists, The North American Menopause Society, and the Endocrine Society. Overall, the flaws of the MsFLASH Vaginal Health Trial were to incorrectly identify the therapeutic outcomes of most interest using metrics that exhibit high degrees of placebo bias; and to utilize low statistical power with which to appreciate any significant differences between groups.

Vulvovaginal atrophy (VVA) has an impact on the quality of life (QoL) of women. This post hoc analysis of the EVES study provides an overview of the QoL in postmenopausal Italian women in relation with VVA severity. We included 1066 women attending menopause/gynaecologic centres. A face-to-face survey (including QoL and sexual life questionnaires), joining an objective gynaecological examination to confirm VVA, were performed. The 65.5% of the participants presented severe vaginal, vulvar and/or urinary symptoms; an 86.9% had an objective confirmed VVA. Women with severe symptoms presented with significantly worse QoL scores than the women without. We found there were moderately significant correlations between vaginal and vulvar symptoms' severity and lower overall DIVA QoL scores (p<.0005, in both cases). Women with a confirmed VVA presented worse QoL scores than women without confirmation. Our data suggest a clear relationship between VVA severity and a decrease in QoL in postmenopausal Italian women.IMPACT STATEMENT What is already known on this subject? Vulvovaginal atrophy (VVA) appears as a common chronic disorder in postmenopausal women that, as soon as the oestrogen levels decrease, becomes a severe condition affecting their quality of life (QoL). What do the results of this study add? We provide new insight about QoL related to VVA severity in Italian postmenopausal women. Our local data demonstrates that QoL in Italian women suffering from menopause is directly related to the severity of vaginal and vulvar symptoms. The same correlation exists for urinary symptoms. QoL is also reduced in patients with an objectively confirmed VVA diagnosis. What are the implications of these findings for clinical practice and/or further research? The implications of our findings involve the need for a better management, not only of the physical aspects of VVA, but also of the non-physical dimensions. Clinicians should ask for the impact of VVA on QoL aspects, making postmenopausal women aware about the possible affected spheres. Medical personnel should conduct future campaigns in the Italian general population, not only in those asking for medical help, to make all women conscious about this silent disorder affecting physical and non-physical dimensions and in order to treat it at early stages.

Introduction: It has previously been suggested in the literature that ultrasound measurement of total vaginal wall thickness (TVT) differs significantly between pre- and postmenopausal women, indicating that it may be a useful and noninvasive objective assessment to correlate the degree of vaginal atrophy to patient-reported symptoms., Aim: The purpose of this cross-sectional pilot study was to determine whether TVT in postmenopausal women, as measured with transabdominal ultrasound, is associated with patient-reported dyspareunia and symptoms related to genitourinary symptomatology., Methods: Postmenopausal women presenting for pelvic ultrasound had TVT and total mucosal thickness (TMT) measured via transabdominal ultrasound. A questionnaire also was administered assessing menopausal status, relevant medical history, and self-report of dyspareunia and other symptoms related to the genitourinary syndrome of menopause (GSM). This questionnaire was derived from the Vulvovaginal Symptom Questionnaire, which has been validated in the literature., Main Outcome Measure: The main outcome measures included the average TVT and TMT for postmenopausal women reporting any symptom of GSM and average TVT and TMT of women reporting no symptoms of GSM., Results: Data from 44 postmenopausal women showed no significant association between transabdominal ultrasound-measured TVT or TMT and patient report of dyspareunia or other genitourinary symptoms. Data were stratified by individual GSM symptoms, sexual symptoms as an aggregate, and individual sexual symptoms. Neither of these subgroups showed a statistically significant difference in TVT or TMT between symptomatic and asymptomatic women., Clinical Implications: Although no statistically significant data were derived from this study, we propose that future studies investigating the longitudinal relationship between TVT and GSM symptomatology may show an association between total vaginal thickness measurement change over time as determined by ultrasound with the presence of patient-reported dyspareunia and other GSM symptoms., Strengths & Limitations: This study is limited by its small sample size as well as the patient population, which was restricted to postmenopausal women with a clinical indication for ultrasound. A major strength of this investigation is that it is the first study to look at the relationship between sexual pain and other GSM symptoms and TVT using transabdominal ultrasound, which is a readily available, non-invasive tool in most clinical settings., Conclusion: Based on the results of this small pilot study, transabdominal pelvic ultrasound cannot be used at this time to objectively quantify the presence of sexual pain or other GSM symptoms; however, future studies should continue to investigate the longitudinal relationship between these 2 variables. Balica AC, Cooper AM, McKevitt MK, et al. Dyspareunia Related to GSM: Association of Total Vaginal Thickness via Transabdominal Ultrasound. J Sex Med 2019; 16:2038-2042., (Copyright © 2019 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: The softgel 17β-estradiol (E2) vaginal inserts (4 and 10 μg; Imvexxy; TherapeuticsMD, Boca Raton, FL) are FDA approved for treating moderate to severe dyspareunia associated with postmenopausal vulvar and vaginal atrophy (VVA). The objective here was to determine responder rates at week 2 and whether week-2 findings predicted week-12 responders in the REJOICE trial., Methods: Postmenopausal women received E2 vaginal inserts 4, 10, or 25 μg, or placebo for 12 weeks. Proportion of responders (having ≥2 of the following: vaginal superficial cells >5%, vaginal pH <5.0, or dyspareunia improvement of ≥1 category) were calculated. Odds ratios (ORs) for positive response at week 12 given a positive response at week 2 were determined in the efficacy evaluable (EE) population., Results: The responder rate (in EE population [n = 695]) was 74% to 82% with E2 inserts versus 24% with placebo at week 2, and 72% to 80% versus 33% at week 12. Positive treatment responses were 9- to 14-fold higher with vaginal E2 than with placebo at week 2, and 5- to 8-fold higher at week 12. Response at week 2 predicted response at week 12 in the total population (OR 13.1; 95% CI, 8.8-19.7) and with active treatment only (OR 7.9; 95% CI, 4.7-13.2)., Conclusions: A high percentage of postmenopausal women with moderate to severe dyspareunia responded with the E2 softgel vaginal insert at week 2, and a positive response at week 2 predicted a positive response at week 12.

Vulvovaginal atrophy (VVA) is a progressive condition commonly seen in postmenopausal women. The cessation of ovarian estrogen secretion and a fall in serum levels of dehydroepiandrosterone (DHEA), the remaining source of estrogens and androgens, are thought to promote the development of VVA in this population. Intravaginal prasterone (Intrarosa ® ) is a synthetic form of DHEA indicated for the treatment of VVA in postmenopausal women presenting with moderate to severe symptoms in the EU; prasterone is also approved in the USA for the treatment of dyspareunia due to menopause. Approval for the treatment of VVA was based on the results of the phase III ERC-231 and -238 trials in which intravaginal prasterone 6.5 mg/day significantly improved the signs and symptoms of VVA (as assessed by the percentage of parabasal and superficial cells, vaginal pH and the severity of dyspareunia) compared with placebo. The beneficial effects of prasterone were also evident during 52 weeks' treatment in the phase III ERC-230 safety trial. Prasterone was generally well tolerated, with the most common treatment-emergent adverse event being application site discharge. During 52 weeks of treatment with prasterone, changes in serum concentrations of estrogenic and androgenic metabolites of DHEA increased from baseline but remained within the normal postmenopausal ranges. Thus, intravaginal prasterone is an effective and generally well-tolerated option for the treatment of VVA in postmenopausal women.

Objective: The aim of this study is to confirm the local beneficial effects of intravaginal dehydroepiandrosterone (DHEA, Prasterone) on moderate to severe dyspareunia or pain at sexual activity, the most frequent symptom of vulvovaginal atrophy due to menopause or genitourinary syndrome of menopause (GSM)., Methods: In a prospective, randomized, double-blind, and placebo-controlled phase III clinical trial, the effect of daily intravaginal 0.50% DHEA (6.5 mg) (Prasterone, EndoCeutics) was examined on four coprimary objectives, namely percentage of parabasal cells, percentage or superficial cells, vaginal pH, and moderate to severe pain at sexual activity (dyspareunia) identified by the women as their most bothersome vulvovaginal atrophy symptom. The intent-to-treat population included 157 and 325 women in the placebo and DHEA-treated groups, respectively., Results: After daily intravaginal administration of 0.50% DHEA for 12 weeks, when compared to baseline by the analysis of covariance test, the percentage of parabasal cells decreased by 27.7% over placebo (P < 0.0001), whereas the percentage of superficial cells increased by 8.44% over placebo (P < 0.0001), vaginal pH decreased by 0.66 pH unit over placebo (P < 0.0001), and pain at sexual activity decreased by 1.42 severity score unit from baseline or 0.36 unit over placebo (P = 0.0002). On the other hand, moderate to severe vaginal dryness present in 84.0% of women improved at 12 weeks by 1.44 severity score unit compared to baseline, or 0.27 unit over placebo (P = 0.004). At gynecological evaluation, vaginal secretions, epithelial integrity, epithelial surface thickness, and color all improved by 86% to 121% over the placebo effect (P < 0.0001 for all comparisons with placebo). Serum steroid levels remained well within the normal postmenopausal values according to the involved mechanisms of intracrinology. The only side effect reasonably related to treatment is vaginal discharge due to melting of the vehicle at body temperature and this was reported in about 6% of the participants., Conclusions: The daily intravaginal administration of 0.50% (6.5 mg) DHEA (Prasterone) has shown clinically and highly statistically significant effects on the four coprimary parameters suggested by the US Food and Drug Administration. The strictly local action of Prasterone is in line with the absence of significant drug-related adverse events, thus showing the high benefit-to-risk ratio of this treatment based upon the novel understanding of the physiology of sex steroids in women.

Dyspareunia can be described as continuous unremitting or intermittent pain associated with intercourse. It can be classified based on the location of the pain - entry or deep dyspareunia, or based on when the pain was first experienced - primary or secondary dyspareunia. There are different causes of dyspareunia and some of the most important causes include the following: vulvodynia, postpartum dyspareunia, endometriosis, inadequate vaginal lubrication or arousal, and other anogenital causes such as hemorrhoids and anal fissures. In this review, our objective is to apply the anatomical knowledge of dyspareunia to patient care, increase awareness among clinicians about the diverse etiology of dyspareunia and ensure that the whole patient, not just the pain of dyspareunia is being treated as the causes of dyspareunia can be due to various pathologies. Clin. Anat., 31:1013-1017, 2018. © 2018 Wiley Periodicals, Inc., (© 2018 Wiley Periodicals, Inc.)

Objective: The aim of the study was to determine the utility of vaginal pH as a marker of menopause and vulvar and vaginal atrophy (VVA) before and after local estrogen treatment., Methods: Vaginal pH was determined using standard pH paper strips in two clinical trials involving postmenopausal women with signs and symptoms of VVA evaluated before and after intervention with vaginal estradiol in softgel capsules. The utility of vaginal pH was evaluated as a screening method for VVA due to menopause and correlations were analyzed between vaginal pH and VVA symptoms, physical changes, and maturation of the vaginal epithelium., Results: Changes in vaginal pH were significantly correlated with changes in superficial and parabasal cell counts; vaginal epithelial changes of color, integrity, thickness, and secretion; and the VVA symptoms of vaginal dryness and dyspareunia (vaginal pain with intercourse)., Conclusions: Vaginal pH consistently correlated with parabasal and superficial cells and the visual vaginal epithelial changes and symptoms of dryness and dyspareunia, and is thus a simple outpatient procedure that reflects the hormonal milieu and its effects on the vaginal epithelium.

Objectives: Vaginal atrophy (VA) is a chronic medical condition. It is managed unsatisfactorily, despite its high prevalence and negative impact on female quality of life. In order to meet their needs, it would be useful to know what women perceive to be the most bothersome symptom (MBS) of VA., Study Design: Cross-sectional, multicenter study of 913 postmenopausal women consulting 22 gynecological outpatient services., Main Outcome Measures: Prevalence of the MBS perceived by postmenopausal women of different age and vaginal condition., Results: Vaginal dryness was the most prevalent MBS (54.4%), followed by dyspareunia (17.6%), itching (7.8%), dysuria (5.9%) and burning (2.0%). The prevalence of vaginal dryness as the MBS increased with years since menopause, while that of itching, dysuria and burning remained approximately constant over time. The prevalence of dyspareunia as the MBS was 26.2% in the first 6 years after menopause and declined thereafter, to 8.8%., Conclusions: Among all postmenopausal women vaginal dryness per se, independent of dyspareunia, is the most commonly reported MBS. In each woman, the identification of the MBS may help to define more appropriate VA management., (Copyright © 2017. Published by Elsevier B.V.)

Objectives: The aim of this prospective study was to assess the efficacy of 3, 4 or 5 CO 2 -laser sessions for the management of the genitourinary syndrome of menopause (GSM)., Methods: Postmenopausal women with moderate to severe symptoms of dyspareunia, wanting to resume/retain sexual activity, were treated with 3-5 laser sessions depending on symptom severity/presence, sexual function, clinical findings and women's preference following the third laser application., Main Outcomes: Severity of dyspareunia, dryness, sexual function, sexual satisfaction and frequency of sexual intercourse defined the primary outcomes. Vaginal Maturation Value (VMV) and Vaginal Health Index Score (VHIS) defined the secondary ones., Results: Fifty-five women received three sessions, 53 an extra fourth and 22 an extra fifth. Following the third, fourth and fifth laser sessions, respectively: dyspareunia completely regressed in 15/55 (27%), 32/55 (58%) and 38/47 (81%) of participants; dryness completely regressed in 20/55 (36%), 36/55 (66%) and 44/51 (86%); normal sexual function resumed in 23/55 (41%), 37/54 (69%) and 41/49 (84%); VMV regained non-atrophic values in 29/55 (53%), 38/55 (69%) and 42/50 (84%); and VHIS regained non-atrophic values in 44/55 (80%), 53/55 (96%) and 55/55 (100%) of participants., Conclusion: Results of this study indicate that CO 2 -laser therapy may contribute to complete regression of dyspareunia and dryness and reestablishment of normal sexual function in postmenopausal women, in a dose-response manner. An extra fourth or fifth session may further increase the GSM symptom-free rate., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Objectives: To assess safety and efficacy of a fractional CO2 laser therapy for the treatment of genitourinary syndrome of menopause (GSM) with follow-up to 1 year posttreatment., Methods: Women presenting with GSM and meeting inclusion criterion were enrolled. Visual Analog Scales were used to grade vaginal pain, burning, itching, dryness, dyspareunia, and dysuria. Dilators were used to rate vaginal elasticity at baseline and at each follow-up visit. Before each treatment and at follow-up, Vaginal Health Index scoring and Female Sexual Function Index questionnaires were completed. Women received three vaginal laser treatments spaced 6 weeks apart. Participant satisfaction was measured on 5-point Likert scales (1 = very dissatisfied, 5 = very satisfied)., Results: Of 30 women (mean age 58.6 ± 8.8 years), three were lost to follow-up at 3 months and six at 1 year. None were discontinued or withdrew due to an adverse event. Average improvement in Visual Analog Scale scores for all symptom categories was statistically significant at 3 months and remained so through 1 year, except dysuria. Differences between data at 3 months and 1 year were not statistically significant, indicating persistence of positive outcomes. Average overall improvement in pain was 1.9 (±3.4), burning 1.9 (±3.1), itching 1.4 (±1.9), dryness 5.9 (±2.8), dyspareunia 4.9 (±3.3), and dysuria 0.9 (±3.1). Improvement in average Vaginal Health Index and Female Sexual Function Index scores was also statistically significant (P < 0.0001). Of 19 women undergoing dilator examination at 1 year, 18 (94.8%) were comfortable with the same or larger dilator size. Twenty-two of 24 women (92%) were satisfied or extremely satisfied with the treatment at 1 year., Conclusions: Based on study data up to 1 year, the fractional CO2 laser may be an effective and safe treatment for women suffering from symptoms of GSM, although additional studies with larger populations and placebo control is needed to confirm these results.

Background: The 12-week, randomized, double-blind, placebo-controlled, multicenter, phase 3 REJOICE trial demonstrated that TX-004HR, an investigational, applicator-free, low-dose vaginal softgel capsule containing solubilized 17β-estradiol, effectively and rapidly treats symptoms of vulvar and vaginal atrophy (VVA) with negligible to very low systemic absorption. The aim of this analysis was to assess whether the efficacy of TX-004HR varies with age, body mass index (BMI), uterine status, pregnancy status, and vaginal delivery., Methods: The REJOICE trial evaluated the efficacy of 4-, 10-, and 25-μg doses of TX-004HR in postmenopausal women (40-75 years) with VVA and a self-identified most bothersome symptom of moderate-to-severe dyspareunia. Prespecified subgroup analyses of the four co-primary endpoints (percentages of superficial cells and parabasal cells, vaginal pH, and severity of dyspareunia) were analyzed with respect to age, BMI, uterine status, pregnancy status, and vaginal births. Each dose was compared with placebo for change from baseline to week 2 through week 12, respectively., Results: TX-004HR significantly improved superficial cells, parabasal cells, and vaginal pH from baseline to weeks 2 and 12 in most subgroups. All TX-004HR doses numerically reduced the severity of dyspareunia by 2 weeks and maintained efficacy over 12 weeks, with many of the subgroups having statistically significant improvement relative to placebo., Conclusions: TX-004HR was efficacious for treating symptomatic VVA, and it demonstrated a consistency of effect when women's age, BMI, uterine status, pregnancy status, and vaginal births were evaluated. Clinical Trial Identifier: NCT02253173.

Introduction: Vulvar and vaginal atrophy (VVA) affects up to two thirds of postmenopausal women, but most symptomatic women do not receive prescription therapy., Aim: To evaluate postmenopausal women's perceptions of VVA and treatment options for symptoms in the Women's EMPOWER survey., Methods: The Rose Research firm conducted an internet survey of female consumers provided by Lightspeed Global Market Insite. Women at least 45 years of age who reported symptoms of VVA and residing in the United States were recruited., Main Outcome Measures: Survey results were compiled and analyzed by all women and by treatment subgroups., Results: Respondents (N = 1,858) had a median age of 58 years (range = 45-90). Only 7% currently used prescribed VVA therapies (local estrogen therapies or oral selective estrogen receptor modulators), whereas 18% were former users of prescribed VVA therapies, 25% used over-the-counter treatments, and 50% had never used any treatment. Many women (81%) were not aware of VVA or that it is a medical condition. Most never users (72%) had never discussed their symptoms with a health care professional (HCP). The main reason for women not to discuss their symptoms with an HCP was that they believed that VVA was just a natural part of aging and something to live with. When women spoke to an HCP about their symptoms, most (85%) initiated the discussion. Preferred sources of information were written material from the HCP's office (46%) or questionnaires to fill out before seeing the HCP (41%).The most negative attributes of hormonal products were perceived risk of systemic absorption, messiness of local creams, and the need to reuse an applicator. Overall, HCPs only recommended vaginal estrogen therapy to 23% and oral hormone therapies to 18% of women. When using vaginal estrogen therapy, less than half of women adhered to and complied with posology; only 33% to 51% of women were very to extremely satisfied with their efficacy., Conclusion: The Women's EMPOWER survey showed that VVA continues to be an under-recognized and under-treated condition, despite recent educational initiatives. A disconnect in education, communication, and information between HCPs and their menopausal patients remains prevalent. Kingsberg S, Krychman M, Graham S, et al. The Women's EMPOWER Survey: Identifying Women's Perceptions on Vulvar and Vaginal Atrophy and Its Treatment. J Sex Med 2017;14:413-424., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: Postmenopausal women's knowledge about vulvar and vaginal atrophy (VVA) and available treatment options has historically been inadequate. Recent direct-to-consumer marketing and educational efforts would have been expected to increase awareness and treatment options., Aim: To compare results of the Women's EMPOWER survey with other available VVA surveys to assess progress in women's understanding and approaches to treatment of VVA., Methods: The Women's EMPOWER survey, an internet-based survey of US women with VVA symptoms, assessed women's awareness of VVA and their behaviors and attitudes associated with symptom treatment., Main Outcome Measures: These survey results were compared with previously published results of the Revealing Vaginal Effects at Mid-Life (REVEAL), Women's Voices in Menopause (WVM), Vaginal Health: Insight, Views, & Attitudes (VIVA), Clarifying Vaginal Atrophy's Impact on Sex and Relationship (CLOSER), and Real Women's Views of Treatment Options for Menopausal Vaginal Changes (REVIVE) surveys., Results: Results of the Women's EMPOWER survey were consistent with those of past VVA surveys and showed that postmenopausal women generally failed to recognize VVA and its chronic, progressive process and that they were reluctant to discuss vaginal or sexual symptoms with their health care professionals (HCPs). However, women indicated a strong desire for accurate medical information about VVA from their health care professionals and a willingness to learn if HCPs would initiate the conversation. Most women believed that vaginal symptoms are a normal part of aging and they just need to cope with the symptoms. In the United States, women were most concerned with safety-related issues, including increased risk of breast cancer, side effects, and systemic absorption., Conclusion: The Women's EMPOWER survey demonstrates and reinforces that even with multimedia marketing and educational strategies in the years after other major VVA surveys, minimal progress has been made toward increasing women's awareness of, knowledge about, or understanding of VVA. Based on these data, a focus on initiating discussions and education with postmenopausal women so that they better comprehend VVA as a chronic progressive medical condition (not just aging), the symptoms associated with VVA, and the benefit-risk profile regarding treatment options is warranted. Krychman M, Graham S, Bernick B, et al. The Women's EMPOWER Survey: Women's Knowledge and Awareness of Treatment Options for Vulvar and Vaginal Atrophy Remains Inadequate. J Sex Med 2017;14:425-433., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: The aim of this prospective observational study was to obtain a better understanding of the anatomy and to classify the observed different perineal presentations at the time of posterior colporrhaphy and to describe specific surgical techniques used., Methods: To classify the observed perineal findings, the Pelvic Organ Prolapse Quantification System with a newly introduced additional measurement of the perineal ridge (PR) was taken intraoperatively and postoperatively in 121 consecutive women undergoing posterior colporrhaphy. Dependent on the preoperative classification of the perineum as being normal (type 1), deficient (type 2), or with a PR (type 3), a specific surgical repair was performed for each type of perineal presentation., Results: The perineal presentations were categorized into 3 defined groups. Type 1 (normal perineum) was seen in 40%, type 2 (deficient perineum) in 13%, and type 3 (PR) in 47%. A type 1 correlates with prior cesarean section (P = 0.29), a type 2 correlates with prior vaginal delivery (P = 0.05), and type 3 perineum with prior pelvic floor surgery (P < 0.0001). When perineal type-specific surgical techniques were performed, the perineal body length increased postoperatively in type 2 (P < 0.05), decreased in type 3 (P < 0.05), and remained unchanged in those with type 1 defects., Conclusions: This study demonstrates that the perineal region can be clearly defined into 3 categories. The distinct perineal presentation correlates with the previous gynecological history. With a specific perineal repair at the time of posterior colporrhaphy, the perineal anatomy can be restored in the short term.

Purpose of Review: The purpose of this review is to describe new terminology for vulvovaginal atrophy and female sexual dysfunction and to highlight recent findings related to vaginal moisturizers, lubricants and prescription estrogen preparations., Recent Findings: Sexual health is a marker for overall health. A minority (40%) of healthcare providers routinely ask about sexual problems and its impact on quality of life. New terminology by the American Psychiatric Association divides female sexual disorders into three categories: arousal/interest disorder, orgasmic disorder and genital pain and penetration disorder. First-line therapy for genitourinary syndrome of menopause includes over-the-counter vaginal lubricants and moisturizers, followed by topical estrogen formulations. Progesterones are generally not needed when topical low-dose estrogen is prescribed. A systemic selective estrogen receptor modulator, designed specifically for genitourinary menopausal symptoms, is an option for patients who do not tolerate local estrogen., Summary: Female sexual dysfunction is prevalent and causes distress, particularly among women at midlife. Although hypoactive sexual desire disorder may be the most prevalent dysfunction, dyspareunia and pain, particularly related to genitourinary and vulvovaginal atrophy, are also very common. Over-the-counter lubricants and prescription strength estrogen formulations are generally effective and well tolerated.

Introduction: Ospemifene is a selective estrogen receptor modulator recently approved by the FDA for the treatment postmenopausal women experiencing moderate-to-severe dyspareunia and by the EMA for the treatment of moderate-to-severe symptomatic genitourinary syndrome of menopause (GSM) in women who are not suitable candidates for local vaginal estrogen therapy., Areas Covered: This review offers an explanation of the pharmacodynamics and of the pharmacokinetics of ospemifene, and gives readers a complete overview of Phase II and III studies on the clinical efficacy, tolerability and safety of this agent in the setting of GSM., Expert Opinion: Ospemifene is efficacious for improving vaginal dryness or dyspareunia as the patient-identified most bothersome symptom, and Phase III clinical trials (4648 patients) have shown good efficacy in terms of improvement of objective and subjective signs and measures of GSM in postmenopausal women. Future studies with a long-term follow-up are required to better elucidate its safety profile. In particular, on the basis of preclinical and early clinical findings of antagonistic to neutral effect on breast tissue, more research is needed to assess the treatment with ospemifene in breast cancer survivors.

Background: Hypermobile Ehlers-Danlos syndrome (hEDS), is probably the most common disease among heritable connective tissue disorders. It affects women more than men and causes symptoms in multiple organs. It is associated with chronic pain, skin fragility and abnormal bleeding. These characteristics may hamper reproductive life. We conducted a study to evaluate the gynecologic and obstetric outcomes in women with hEDS. We also explored a possible hormonal modulation of the hEDS symptoms. The gynecologic and obstetric history of 386 consecutive women diagnosed with hEDS was collected by a standardized questionnaire and a medical consultation performed by a senior gynecologist in an expert centre for hEDS between May 2012 and December 2014., Results: We observed a high frequency of gynecologic complaints, specifically: menorrhagia (76 %), dysmenorrhea (72 %) and dyspareunia (43 %). Endometriosis was not highly prevalent in this population. The obstetric outcomes were similar to those of the general French population for deliveries by cesarean section (14.6 %) and premature births (6.2 %) but the incidence of multiple spontaneous abortion (13 %) and spontaneous abortion (28 %) were significantly higher. A subset of women were sensitive to hormonal fluctuations with more severe symptoms occurring during puberty, prior to menstruation, during the postpartum period as well as on oral contraception., Conclusions: Increased awareness of the gynecological symptomatology in women with hEDS can help discriminate between endometriosis and thus prevent useless, and potentially dangerous, surgery. This study also suggests that hormonal modulation may be an appropriate treatment for a subset of women with hEDS.

The etiology of deep dyspareunia in endometriosis is unclear. Our objective was to determine whether nerve bundle density in the cul-de-sac/uterosacrals (zone II) is associated with deep dyspareunia in women with endometriosis. We conducted a blinded retrospective immunohistochemistry study (n = 58) at a tertiary referral center (2011-2013). Patients were stringently phenotyped into a study group and 2 control groups. The study group (tender endometriosis, n = 29) consisted of patients with deep dyspareunia, a tender zone II on examination, and an endometriosis lesion in zone II excised at surgery. Control group 1 (nontender endometriosis, n = 17) consisted of patients without deep dyspareunia, a nontender zone II on examination, and an endometriosis lesion in zone II excised at surgery. Control group 2 (tender nonendometriosis, n = 12) consisted of patients with deep dyspareunia, a tender zone II on examination, and a nonendometriosis lesion (eg, normal histology) in zone II excised at surgery. Protein gene product 9.5 (PGP9.5) immunohistochemistry was performed to identify nerve bundles (nerve fibers surrounded by perineurium) in the excised zone II lesion. PGP9.5 nerve bundle density (bundles/high powered field [HPF]) was then scored by a pathologist blinded to the group. We found a significant difference in PGP9.5 nerve bundle density between the 3 groups (analysis of variance, F2,55 = 6.39, P = .003). Mean PGP9.5 nerve bundle density was significantly higher in the study group (1.16 ± 0.56 bundles/HPF [±standard deviation]) compared to control group 1 (0.65 ± 0.36, Tukey test, P = .005) and control group 2 (0.72 ± 0.56, Tukey test, P = .044). This study provides evidence that neurogenesis in the cul-de-sac/uterosacrals may be an etiological factor for deep dyspareunia in endometriosis., (© The Author(s) 2015.)

Objective: The aim of the study was to compare efficacy of conjugated estrogens (CE)/bazedoxifene (BZA) for treatment of menopausal symptoms and prevention of postmenopausal osteoporosis in minorities (black/Hispanic) versus whites., Methods: In a post hoc analysis, data were pooled from 3,424 white or minority nonhysterectomized postmenopausal women randomized to CE 0.45 or 0.625 mg/BZA 20 mg or placebo in four double-blind, phase 3 Selective Estrogens, Menopause, and Response to Therapy (SMART) trials. Outcomes included hot flush frequency/severity (daily diary) in women with at least seven moderate-to-severe hot flushes per day (SMART-1, -2), vaginal cytology in women with at most 5% superficial cells (SMART-1, -3), lumbar spine and total hip bone mineral density (BMD) (SMART-1, -5), and the Menopause-Specific Quality of Life (MENQOL) questionnaire (SMART-1, -2, -3, -5)., Results: The analysis included 2,907 white (84.9%), 315 black (9.2%), and 202 Hispanic (5.9%) women. The reduction in hot flush frequency/severity versus placebo (P < 0.05; week 12) was similar in white and minority women. In both populations, both doses significantly (P < 0.05 vs placebo) improved MENQOL vasomotor function, sexual function, and total scores at 3 months; decreased the percentage of parabasal cells at 2 years; and increased the percentage of BMD responders at 12 and 24 months. Significant differential treatment effects by race/ethnicity were observed only for effects on vaginal superficial cells at month 24 and vaginal pH at month 3., Conclusions: Notwithstanding a limited sample size, CE/BZA had a similar and beneficial impact on hot flushes, MENQOL, and BMD in minorities and whites.

Objective: to describe the frequency, severity and persistence of dyspareunia in the first 18 months after the birth of a first child., Design: prospective pregnancy cohort study., Setting: Melbourne, Victoria, Australia., Population: 1507 nulliparous women., Methods: women ≤24 weeks gestation were recruited from six public hospitals. Self-administered written questionnaires were completed at recruitment and at three, six, 12 and 18 months post partum., Outcome Measures: study-designed self-report measure of dyspareunia on first vaginal sex, and on second and subsequent sex at all time-points, utilising the rating scale from the McGill Pain Intensity Scale., Findings: overall, 961/1122 (85.7%) of women experienced pain on first vaginal sex postnatally. The proportion of women experiencing dyspareunia reduced over time, from 431/964 (44.7%) at three months post partum to 261/1155 (22.6%) at 18 months post partum. Of the women who reported dyspareunia at each time-point, around 10% of women described the pain as׳distressing׳,׳horrible׳ or׳excruciating׳. Women who had a caesarean section were more likely to report more intense dyspareunia at six months post partum (aOR=2.35, 95% CI=1.2-4.6)., Conclusions: postnatal dyspareunia decreases over time, but persists beyond 12 months for one in five women. Caesarean section appears to be associated with more intense dyspareunia., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Purpose of Review: This article reviews the literature regarding the safety and efficacy of the use of a pulsed CO2 laser for the treatment of vulvovaginal atrophy (VVA)., Recent Findings: Prospective observational studies have demonstrated histological changes after the use of pulsed CO2 laser vaginally in atrophic conditions. Increased collagen and extracellular matrix production has been reported together with an increase in the thickness of the vaginal epithelium with the formation of new papilla. Three different observational studies reported a significant improvement of VVA assessed subjectively (with a 10-point visual analogue scale) and objectively (using the Vaginal Health Index) after a cycle of three treatments of pulsed CO2 laser. Also sexual function (assessed with the Female Sexual Function Index) and quality of life (evaluated with the SF12 questionnaire) significantly improved. No complications or side-effects were reported during or after the laser procedure that was performed in an outpatient setting., Summary: Increasing evidence with histological and clinical data supports the use of pulsed CO2 lasers in the treatment of VVA; however, no randomized control trial (sham versus treatment) has yet been produced and no data on the duration of therapy are currently available.

Objective: This study aims to confirm the local effects of intravaginal prasterone on moderate to severe dyspareunia, a symptom of vulvovaginal atrophy (VVA) associated with menopause., Methods: In a prospective, randomized, double-blind, placebo-controlled phase III clinical trial, we examined the effects of daily intravaginal prasterone (6.5 mg) on four co-primary objectives, namely, percentage of vaginal parabasal cells, percentage of vaginal superficial cells, vaginal pH, and moderate to severe dyspareunia identified by women as the most bothersome VVA symptom., Results: After daily intravaginal prasterone administration for 12 weeks, the percentage of parabasal cells decreased by 45.8% compared with placebo (P < 0.0001), the percentage of superficial cells increased by 4.7% over placebo (P < 0.0001), and vaginal pH decreased by 0.83 pH units compared with placebo (P < 0.0001). The severity of most bothersome dyspareunia decreased by 46% over placebo (P = 0.013) at 12 weeks, whereas moderate to severe vaginal dryness decreased by 0.43 severity score units (or 42%) compared with placebo (P = 0.013). On gynecologic evaluation, a 14.4% to 21.1% improvement in vaginal secretions, epithelial integrity, epithelial surface thickness, and color over placebo (P = 0.0002 to P < 0.0001) was observed. Serum steroids, in agreement with the physiology of intracrinology and menopause, remained well within reference postmenopausal concentrations. All endometrial biopsies at 12 weeks have shown atrophy., Conclusions: Daily intravaginal prasterone (0.50%; 6.5 mg) treatment has clinically and statistically significant beneficial effects on the four co-primary objectives of VVA, according to US Food and Drug Administration guidelines. No significant drug-related adverse effect in line with the strictly local action of treatment has been reported, thus providing a high benefit-to-risk ratio for intravaginal prasterone.

Background: Vulvovaginal atrophy (VVA) is a condition associated with decreased estrogenization of the vaginal tissue, which can result in vaginal dryness, irritation, and dyspareunia. This study quantified the burden associated with VVA symptoms across the United States and Europe and compared this burden with other chronic conditions., Methods: Data were analyzed from the International Women's Health Study, a cross-sectional Internet survey of women aged 40-75 years in the United States and Europe. All postmenopausal women aged 40-75 years were included in the analyses (Germany n=970, Spain n=294, France n=1054, Italy n=387, United Kingdom n=1096, United States n=3267). VVA symptom severity (none, mild, moderate, severe) was assessed using the Menopause Rating Scale and included in general linear models to predict EuroQol-5D (EQ-5D) quality of life scores., Results: The prevalence of VVA symptoms varied between 40.00% (Germany) and 54.42% (Spain), with half of women reporting their symptoms as either moderate or severe. Pooling data from all countries together, each incremental level of severity (none through severe) was associated with a significant decrement in EQ-5D scores (none=0.84 vs. mild=0.81 vs. moderate=0.79 vs. severe=0.74; p<0.05). The decrements in EQ-5D scores associated with moderate to severe VVA symptoms were comparable to those observed in other serious conditions including arthritis, chronic obstructive pulmonary disease, asthma, and irritable bowel syndrome., Conclusions: VVA symptoms are associated with clinically meaningful decrements in quality of life that may be comparable to serious conditions such as arthritis, chronic obstructive pulmonary disease, asthma, and irritable bowel syndrome. Improved management of VVA symptoms may be required to alleviate the impact of VVA on the quality of life of affected women.

Objective: To evaluate the efficacy of topical vaginal estrogens in comparison to hyaluronic acid for the treatment of de novo dyspareunia in women using hormonal oral contraceptive (COC)., Study Design: Consecutive sexually active women using COC and complaining of de novo dyspareunia were enrolled in the study. Two attending physicians were involved in the study: the first, prescribed a 12-week vaginal estrogenic therapy with estriol 50 μg/g gel twice a week (group 1) and the second a hyaluronic acid vaginal gel therapy once a day (group 2). We evaluated dyspareunia levels using visual analogic scale (VAS) and sexual function using Female Sexual Function Index (FSFI). Vaginal atrophy was graded per the vaginal maturation index (VM)., Results: Overall, 31 women were enrolled. Seventeen and 14 patients were allocated in group 1 and 2, respectively. In both groups, after the topical therapy, dyspareunia, sexual function and VM were significantly improved. However, patients in group 1 experienced a significantly lower score of dyspareunia than patients in the group 2 (2 (1-7) vs. 4 (2-7); p=0.02). Additionally, women in the group 1 had higher FSFI (29.20 (24.60-34.50) vs. 28.10 (23.60-36.50); p=0.04) scores and VM (73.80 (±8.78) vs. 64.50 (±12.75); p=0.003) values in comparison to the patients in group 2., Conclusions: Our study showed that vaginal supplementation with estriol 50 μg/g gel or with hyaluronic acid could reduce the de novo dyspareunia related to COC. In this cluster of patients, both treatments improve sexuality. However, estriol 50 μg/g gel appears to be significantly more effective in comparison with hyaluronic acid., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Objective: This pilot study aimed to assess the efficacy and feasibility of fractional CO2 laser in the treatment of vulvovaginal atrophy (VVA) in postmenopausal women., Methods: VVA symptoms were assessed before and after three applications of laser over 12 weeks in 50 women (age 59.6 ± 5.8 years) dissatisfied with previous local estrogen therapies. Subjective (visual analog scale) and objective (Vaginal Health Index Score, VHIS) measures were used during the study period to assess VVA. Quality of life was measured by using the SF-12. A subjective scale to evaluate the degree of pain related to the laser application and the degree of difficulty to perform the laser procedure was used., Results: Fractional CO2 laser treatment was effective to improve VVA symptoms (vaginal dryness, vaginal burning, vaginal itching, dyspareunia, dysuria; p < 0.001) at 12-week follow-up, as well as the VHIS (13.1 ± 2.5 at baseline vs. 23.1 ± 1.9; p < 0.001). Both physical and mental scores of quality of life were significantly improved in comparison with baseline (p < 0.001). Satisfaction with the laser procedure was reported by 42 women (84%) and a minimal discomfort was experienced at the first laser application, mainly because of the insertion and the movements of the probe. Finally, the technique was very easy to perform in all women starting from the second application at week 4 and no adverse events were recorded during the study period., Conclusions: A 12-week treatment with the fractional CO2 laser was feasible and induced a significant improvement of VVA symptoms by ameliorating vaginal health in postmenopausal women. Further controlled studies should be performed to confirm the present data and to assess the long-term effects of the laser procedure on vaginal tissues.

Introduction: Ospemifene, a novel selective estrogen receptor modulator, has been developed for the treatment of vulvovaginal atrophy and dyspareunia in postmenopausal women., Aim: We carried out a systematic review and meta-analysis to assess the efficacy and safety of the drug for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy., Methods: A literature review was performed to identify all published randomized double-blind, placebo-controlled trials of ospemifene for the treatment of vulvovaginal atrophy and dyspareunia. The search included the following databases: MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. The reference lists of the retrieved studies were also investigated. A systematic review and meta-analysis was conducted., Main Outcome Measures: Six publications involving a total of 1,772 patients were used in the analysis, including three randomized controlled trials (RCTs) that were short-term (12 weeks) comparisons of ospemifene with placebo and three RCTs that were long-term (1 year) comparisons of ospemifene with placebo., Results: For the comparison of short-term ospemifene with placebo, parabasal cells (the standardized mean difference [SMD] = -37.5, 95% confidence interval [CI] = -41.83 to -33.17, P < 0.00001), superficial cells (SMD = 9.24, 95% CI = 7.70 to 10.79, P < 0.00001), vaginal PH (SMD = -0.89, 95% CI = -0.98 to -0.80, P = 0.00001), and dyspareunia (SMD = -0.37, 95% CI = -0.43 to -0.30, P = 0.00001) indicated that ospemifene was more effective than the placebo. For the comparison of long-term ospemifene with placebo, endometrial thickness (SMD = 0.90, 95% CI = 0.58 to 1.23, P = 0.00001), treatment emergent adverse event, discontinuations due to adverse event, and serious adverse event indicated that ospemifene was generally safe., Conclusions: This meta-analysis indicates that ospemifene to be an effective and safe treatment for dyspareunia associated with postmenopausal vulvar and vaginal atrophy., (© 2013 International Society for Sexual Medicine.)

Introduction: Vulvar and vaginal atrophy (VVA) is a chronic medical condition experienced by many postmenopausal women. Symptoms include dyspareunia (pain with intercourse), vaginal dryness, and irritation and may affect sexual activities, relationships, and activities of daily life., Aim: The aim of this study is to characterize postmenopausal women's experience with and perception of VVA symptoms, interactions with healthcare professionals (HCPs), and available treatment options., Methods: An online survey was conducted in the United States in women from KnowledgePanel(®) , a 56,000-member probability-selected Internet panel projectable to the overall US population. Altogether, 3,046 postmenopausal women with VVA symptoms (the largest US cohort of recent surveys) responded to questions about their knowledge of VVA, impact of symptoms on their activities, communication with HCPs, and use of available treatments., Main Outcome Measures: Percent is calculated as the ratio of response over total responding for each question for all and stratified participants., Results: The most common VVA symptoms were dryness (55% of participants), dyspareunia (44%), and irritation (37%). VVA symptoms affected enjoyment of sex in 59% of participants. Additionally, interference with sleep, general enjoyment of life, and temperament were reported by 24%, 23%, and 23% of participants, respectively. Few women attributed symptoms to menopause (24%) or hormonal changes (12%). Of all participants, 56% had ever discussed VVA symptoms with an HCP and 40% currently used VVA-specific topical treatments (vaginal over-the-counter [OTC] products [29%] and vaginal prescription therapies [11%]). Of those who had discussed symptoms with an HCP, 62% used OTC products. Insufficient symptom relief and inconvenience were cited as major limitations of OTC products and concerns about side effects and cancer risk limited use of topical vaginal prescription therapies., Conclusions: VVA symptoms are common in postmenopausal women. Significant barriers to treatment include lack of knowledge about VVA, reluctance to discuss symptoms with HCPs, safety concerns, inconvenience, and inadequate symptom relief from available treatments., (© 2013 International Society for Sexual Medicine.)

Ospemifene (Osphena™) is an oral selective estrogen receptor modulator (SERM), with tissue-specific estrogenic agonist/antagonist effects. QuatRx Pharmaceuticals conducted the global development of the agent before licensing it to Shionogi for regulatory filing and commercialization worldwide. Ospemifene is the first non-estrogen treatment approved for moderate to severe dyspareunia in women with menopause-related vulvar and vaginal atrophy. The drug is approved in the USA, and application for EU regulatory approval is underway. This article summarizes the milestones in the development of ospemifene leading to this first approval for moderate to severe dyspareunia, a symptom of postmenopausal vulvar and vaginal atrophy.

Objective: The aim of this study was to introduce a new method of labiaplasty. Here we describe the surgical procedure, outcomes and the advantages and disadvantages of this method., Method: The medical records of 167 patients aged between 20 and 43 years who underwent reduction of the labia minora from May 2006 to March 2011 were reviewed. The procedures performed in these studies used de-epithelialised reduction of the middle and posterior sections of the labia minora., Results: All the surgeries were performed successfully, and 164 patients experienced an uneventful postoperative period. A minor dehiscence occurred in one patient, who recovered with no requirement for additional treatment. Another two women felt that the reduction was not fully achieved. All of the patients were satisfied with the eventual aesthetic appearance., Conclusions: The de-epithelialised reduction of the middle and posterior portion of the labia minora is a simple and safe method that is associated with satisfactory outcomes., (Copyright © 2012 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Introduction: Although dyspareunia experienced after menopause is widely attributed to declining estrogen levels and vulvovaginal atrophy, critical reviews of the literature have suggested that these factors are incomplete as explanatory mechanisms. Little is known about psychosocial factors that may also be implicated in postmenopausal dyspareunic pain., Aim: To determine the extent to which levels of estrogens and progesterone, vulvovaginal atrophy, cognitive-emotional factors, and dyadic adjustment are predictive of postmenopausal dyspareunic pain intensity., Methods: A total of 182 postmenopausal dyspareunia sufferers underwent a structured interview concerning sociodemographic status as well as medical and pain histories, gynecological examination, cytological evaluation, a blood draw, and answered a series of self-report questionnaires. Given the large number of genital and pelvic pain variables measured, a principal components analysis was undertaken to identify a smaller number of components representing meaningful dimensions of genital and pelvic pain., Main Outcome Measures: Pain severity ratings during intercourse were obtained using the McGill Pain Questionnaire. Pain ratings were also obtained during gynecological assessment. Serum estrone, estradiol, and progesterone levels were measured via immunoassay. The Vaginal Atrophy Index and maturation value were used to determine vulvovaginal atrophy severity. Participants completed the Pain Catastrophizing Scale, State-Trait Anxiety Inventory, The Beck Depression Inventory-II, and Dyadic Adjustment Scale., Results: Hormone levels were not found to be consistent predictors of pain severity. Maturation value and cognitive-emotional variables (e.g., catastrophization, depression, anxiety) were significant predictors of vestibular pain, which affected over 90% of our sample. Relationship adjustment variables were inversely associated with pain severity within several genital locations., Conclusions: Results suggest that the traditional hypoestrogen and vulvovaginal atrophy conceptualization of postmenopausal dyspareunia is an insufficient explanatory model, and that pain is also influenced by cognitive, affective, and dyadic factors., (© 2012 International Society for Sexual Medicine.)