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Simple Summary: Vulvar cancer is a rare gynecological malignant neoplasm that makes necessary accurate preoperative management in order to stage the patient as best as possible, both locally and at the inguinofemoral lymph node level. The aim of this review is to perform a wide evaluation of all the tools that the clinician has at their disposal for a proper diagnosis, such as vulvoscopy, MRI, PET and ultrasound. Vulvoscopy remains essential to carrying out histological diagnosis. Furthermore, for the evaluation of the local extension of the disease and inguinofemoral and/or pelvic lymph nodes, MRI, PET and, more recently, ultrasound are fundamental. Vulvar carcinoma is a rare cancer affecting the genital tract, constituting 4% of gynecological tumors. Vulvar squamous cell carcinoma (VSCC) is the most common type. Diagnosis relies on biopsy during vulvoscopy, plus imaging such as ultrasonography (USG), magnetic resonance imaging (MRI) and positron emission tomography (PET). This review aims to lay out a thorough overview as to the current preoperative management of VSCC, both in case of vulvar and lymph node involvement. The data research was conducted using the following databases: MEDLINE, EMBASE, Web of Sciences, Scopus, ClinicalTrial.gov, OVID and Cochrane Library from 2010 to 2024. The selection criteria included only original articles. Seventeen studies were assessed for eligibility. A concordance rate of 62.3% for vHSIL and 65.2% for carcinoma at vulvoscopy, with a sensitivity of 98%, specificity of 40%, PPV (Positive Predictive Value) of 37% and NPV (Negative Predictive Value) of 98% in identifying malignant lesions was found. Regarding the reliability of PET for staging and assessing lymph node involvement, a mean SUV (Standardized Uptake Value) for malignant vulvar lesions of 8.4 (range 2.5–14.7) was reported. In the case of MRI, useful for the evaluation of loco-regional infiltration and lymph node involvement, the ratio of the short-to-long-axis diameter and the reader's diagnostic confidence for the presence of lymph node metastasis yielded accuracy of 84.8% and 86.9%, sensitivity of 86.7% and 87.5%, specificity of 81.3% and 86.2%, PPV of 89.7% and 87.5% and NPV of 76.5% and 86.2%, respectively. A long lymph node axis >10 mm and a short diameter >5.8 mm were found to be predictors of malignancy. At USG, instead, the two main characteristics of potentially malignant lymph nodes are cortical thickness and short axis length; the combination of these ultrasound parameters yielded the highest accuracy in distinguishing between negative and positive lymph nodes. Despite the heterogeneity of the included studies and the lack of randomized clinical trials, this review provides a broad overview of the three imaging tools used for the presurgical management of VSCC. Nowadays, although MRI and PET represent the gold standard, ultrasound evaluation is taking on a growing role, as long as it is carried out by expert sonographer. The management of this rare disease should be always performed by a multidisciplinary team in order to precisely stage the tumor and determine the most suitable treatment approach. [ABSTRACT FROM AUTHOR]

Background Data are limited regarding fractional CO2 laser as a nonhormonal treatment for vestibular pain. Aim We sought to perform what is, to our knowledge, the first multisite prospective randomized, double-blind, sham-controlled clinical trial to assess the safety and efficacy of fractional CO2 laser treatment to the vestibule in women with vestibular pain. Methods Subjects (n  = 70) meeting inclusion/exclusion criteria at each of 3 sites were randomized 2:1 to active or sham (zero energy) fractional CO2 laser treatment using the vestibular probe (SmartXide2 V2LR - MonaLisa Touch, DEKA, Florence, Italy). Subjects in each treatment arm received 3 treatments 4 weeks apart. At the initial follow-up (week 12), subjects were unblinded and those initially assigned to sham started active treatment. Outcomes Outcome measures included changes from baseline in sexual activity diaries and scores for the Vulvoscopic Genital Tissue Appearance Scale (VGTA), vestibular cotton-tipped swab testing, McGill Pain Questionnaire, Female Sexual Function Index (FSFI), Female Sexual Distress Scale–Revised (FSDS-R), and the O'Leary-Sant voiding and pain indices, the Interstitial Cystitis Symptom Index (ICSI) and Interstitial Cystitis Problem Index (ICPI). Results After active treatment, VGTA scores significantly improved in 5 parameters. Pain associated with cotton-tipped swab testing was significantly reduced at weeks 4 through 16 (mean change from baseline −0.64 [95% CI, −0.79 to −0.50] and −1.31 [95% CI, −1.46 to −1.16], respectively). FSFI pain domain scores improved significantly at weeks 12 and 16 (mean change from baseline 0.925 [95% CI, 0.10-1.75] and 1.22 [95% CI, 0.40-2.05], respectively). FSFI total scores increased significantly at weeks 12 and 16 (mean change from baseline 6.24 [95% CI, 2.64-9.85] and 4.96 [95% CI, 1.36-8.57], respectively). FSDS-R scores decreased significantly at weeks 12 and 16 (mean change from baseline −5.84 [95% CI, −8.80 to −2.87] and −9.15 [95% CI, −12.11 to −6.18], respectively). ICSI scores decreased significantly at weeks 12 and 16 (mean change from baseline −0.91 [95% CI, −1.65 to −0.18] and −0.754 [95% CI, −1.49 to −0.02], respectively). ICPI scores decreased significantly at week 16 (mean change from baseline −0.99 [95% CI, −1.63 to −0.34]). In contrast, there were no significant changes in outcomes in the sham arm. No serious adverse events occurred. Clinical Implications Fractional CO2 laser treatment in women with vestibular pain resulted in improvement from baseline in multiple key outcome measures of vestibular health. Strengths and Limitations Strengths of the study were that it was a multisite prospective randomized double-blind, sham-controlled clinical trial that included multiple measures related to vestibular pain and sexual function. Limitations were the nonvalidated primary outcome measure and limited study cohort. Conclusion Fractional CO2 laser therapy is a safe and effective nonhormonal treatment for vestibular pain. [ABSTRACT FROM AUTHOR]

Background: Prasterone, an intravaginal dyspareunia treatment in menopausal women, improves vaginal health through intracellular conversion of dehydroepiandrosterone into androgens and estrogens. Phase 3 trials for prasterone showed significant improvement in vaginal tissue health and reduction of pain. Aim: To assess vestibular changes with daily use of intravaginal prasterone in menopausal women with moderate to severe dyspareunia. Methods: This open-label prospective pilot study was conducted over 20 weeks. It included 11 menopausal women (median age, 56 years) who were treated daily with intravaginal inserts of 6.5-mg prasterone and assessed monthly. During vulvoscopy, vestibular pain was assessed by cotton-tipped swab testing, and vestibular and vaginal health was independently assessed with the Visual Scale (VS). In addition, vulvoscopic photographs were obtained and assessed via the Vulvoscopic Genital Tissue Appearance (VGTA) scale to evaluate overall genital tissue health. Mean changes from baseline for genital tissue health and pain assessments were analyzed by repeated measures 1-way analysis of variance, followed by a Dunnett post hoc test. Sexual event diaries were completed and adverse events recorded. Outcomes: Outcomes included indices of genital tissue health: pain assessment by cotton-tipped swab testing, VS of the vestibule and vagina, VGTA, and sexual event diary. Results: Aggregate scores from the cotton-tipped swab test progressively improved, reaching statistical significance at week 16, which was maintained through week 20 (−7.27, P = .019). VS scores significantly improved from baseline by week 4 and were maintained through week 20 for the vestibule (−3.00, P = .004) and vagina (−4.00, P = .002). An overall 1607 vulvoscopic photographs were examined; all showed reduction in vestibular erythema and pallor at the end of the study. The mean change from baseline at week 20 for the VGTA score was −7.9 (P = .0016). Intercourse associated with pain was reduced from 81.3% of initiated events during the first month of the study to 8.3% during the last month. Sexual activities that were discontinued due to discomfort were reduced from 45.8% to 6.3%. No prasterone-related serious adverse events were reported. Clinical Implications: Prasterone, a safe and effective intravaginal hormone treatment, significantly improves vestibular health parameters. Strengths and Limitations: Strengths are the prospective study design and the use of multiple outcome measures to assess vestibular tissue health and pain associated with sexual activity. Limitations are the small study cohort and use of nonvalidated outcome measures. Conclusion: Our findings suggest that intravaginal prasterone exerts biologic activity on the androgenic endodermal vestibule, as the medication passes from vagina to vestibule, resulting in amelioration of pain associated with sexual activity. [ABSTRACT FROM AUTHOR]

Vulvar and vaginal cancers are relatively rare cancers, but their incidence is increasing worldwide. Overall, 78% of vaginal cancers and 25% of vulvar cancers are associated with Human papillomavirus (HPV) infection. Immunization could be an option for the management of these cases. We researched and assessed the evidence on the efficacy of HPV vaccination administered to women previously treated with surgery, radiotherapy, or chemotherapy with respect to the recurrence of vulvovaginal disease. From 2006 to November 2022, only one study evaluated the efficacy of HPV vaccination with respect to preventing vulvovaginal recurrences in treated women and showed that a quadrivalent HPV vaccine administered after the surgical treatment of vulvar high-grade squamous intraepithelial lesion (HSIL) can reduce vulvar recurrence of the disease. Therefore, the efficacy of HPV vaccination with respect to vulvovaginal recurrence is still an unexplored field. Further studies are needed to produce stronger evidence in order to appropriately support interventions to protect women's health. [ABSTRACT FROM AUTHOR]

Timely diagnosis and effective treatment of precancerous diseases of the female genital organs prevent the development of oncogynecological diseases. Vulvar intraepithelial neoplasia is a precancerous disease characterized by lesions of the stratified squamous epithelium with impaired maturation and normal keratinization of cells, but without inclusion of the basement membrane in the pathological process. The main methods of diagnosis of vulvar intraepithelial neoplasia are vulvoscopy, cytological and histological examination. The aim of this study was to assess the clinical significance and effectiveness of different sampling methods for cytological examination in comparison with histological report. Materials and methods. The study involved 235 women aged 35-79 years, with a mean age of 57±11.3 years with complaints of pain, burning, discomfort and itching in the vulva. All patients underwent a simple vulvoscopy, where atrophy of the mucosa, partial or complete loss of the clitoris and / or labia minora, fissures, ecchymoses (haemorrhages), eroded surfaces, exophytic growths from 1 to 5 cm were detected. Material sampling was performed by various cytological methods. Results. According to the results of the study, no significant differences between the methods of cytological sampling were observed. The cytological report was compared to the result of histological examination of biopsies. According to the results of cytological examination, squamous cell carcinoma of the vulva was detected in 12 patients, atrophy was identified in 5 women and squamous epithelial scales cytologically detected in the remaining 218 women. Conclusions. The sensitivity and specificity of cytological examination methods were high in the presence of eroded surfaces and exophytic lesions. It was found that cytological research methods were not informative enough to detect vulvar cancer, which is in the stratum of hyperkeratosis, and was diagnosed in 5.1 % of patients. Therefore, for the reliability of the results and confirmation of the diagnosis it is necessary to conduct histological examination, with the help of which 14.9 % of patients were diagnosed with squamous cell carcinoma [ABSTRACT FROM AUTHOR]

Vulvar and vaginal cancers are relatively rare cancers, but their incidence is increasing worldwide. Overall, 78% of vaginal cancers and 25% of vulvar cancers are associated with Human papillomavirus (HPV) infection. Immunization could be an option for the management of these cases. We researched and assessed the evidence on the efficacy of HPV vaccination administered to women previously treated with surgery, radiotherapy, or chemotherapy with respect to the recurrence of vulvovaginal disease. From 2006 to November 2022, only one study evaluated the efficacy of HPV vaccination with respect to preventing vulvovaginal recurrences in treated women and showed that a quadrivalent HPV vaccine administered after the surgical treatment of vulvar high-grade squamous intraepithelial lesion (HSIL) can reduce vulvar recurrence of the disease. Therefore, the efficacy of HPV vaccination with respect to vulvovaginal recurrence is still an unexplored field. Further studies are needed to produce stronger evidence in order to appropriately support interventions to protect women’s health.

Simple Summary: The spectrum of vulvar disorders is wide and varies from infections, dermatoses, manifestations of hormonal and systemic conditions to vulvar intraepithelial neoplasia (VIN) and invasive cancer. It is not always possible to distinguish vulvar lesions on the basis of macroscopical aspects and the distribution of changes. For definite diagnosis of a vulvar lesion, a biopsy is needed. However, in practice, the decision to perform a biopsy is often delayed due to a lack of specificity of symptoms at the early stages of the neoplastic disease. The aim of this article is to provide clinicians, both gynecologists and dermatologists, with the main features of vulvar precancerous lesions, in order to recognize and treat them on time, thus preventing vulvar cancer. Clinical appearance of VIN is variable with significant variations present in color, surface, and topography. Evaluation of all VIN lesions should be conducted very carefully, because an underlying early invasive squamous cancer appears to be present in a significant percentage of patients. The spectrum of vulvar lesions ranges from infective and benign dermatologic conditions to vulvar precancer and invasive cancer. Distinction based on the characteristics of vulvar lesions is often not indicative of histology. Vulvoscopy is a useful tool in the examination of vulvar pathology. It is more complex than just colposcopic examination and presumes naked eye examination accompanied by magnification, when needed. Magnification can be achieved using a magnifying glass or a colposcope and may aid the evaluation when a premalignant or malignant lesion is suspected. It is a useful tool to establish the best location for biopsies, to plan excision, and to evaluate the entire lower genital system. Combining features of vulvar lesions can help prediction of its histological nature. Clinically, there are two distinct premalignant types of vulvar intraepithelial neoplasia: HPV-related VIN, more common in young women, multifocal and multicentric; VIN associated with vulvar dermatoses, more common in older women and usually unicentric. For definite diagnosis, a biopsy is required. In practice, the decision to perform a biopsy is often delayed due to a lack of symptoms at the early stages of the neoplastic disease. Clinical evaluation of all VIN lesions should be conducted very carefully, because an underlying early invasive squamous cancer may be present. [ABSTRACT FROM AUTHOR]

Purpose: Vulvar high-grade squamous intraepithelial lesion (VHSIL) involving the clitoris is a rare and ill-defined condition. The authors evaluated the patient characteristics associated with clitoral vs. non-clitoral VHSIL and the clinical correlates of the disease. Materials and Methods: Data from 216 consecutive patients seen at an Italian tertiary referral centre (1981-2014) were analysed using the chi-square test and multiple logistic regression models. Results: Clitoral VHSIL was detected in 41 (19%) patients. HIV infection, associated cervical and vaginal intraepithelial neoplasia, and multifocality were significantly (p < 0.05) associated with clitoral VHSIL. In multivariate analysis, multifocality retained a strong effect [odds ratio (OR), 17.5; 95% confidence interval (CI), 6.9-44.7]. Clitoral VHSIL was a weak risk factor for patient loss to follow-up in univariate (24.4% vs. 13.1%; p = 0.072) and multivariate analysis (OR, 2.13; 95% CI, 0.92-4.92). The 60-month persistence/recurrence-free survival was non-significantly lower for patients with clitoral VHSIL. Conclusion: Multifocality was independently associated with clitoral VHSIL and this, in turn, with patient loss to follow-up. [ABSTRACT FROM AUTHOR]

Background Vulvar lichen sclerosus is a chronic and incurable disease that causes various unpleasant symptoms and serious consequences. Objective The purpose of the study was to assess the effectiveness of photodynamic therapy in the treatment of vulvar lichen sclerosus. Methods Participants in the study included 102 female patients aged 19–85 suffer from vulvar lichen sclerosus. The patients underwent photodynamic therapy (PDT). In the course of PDT the 5% 5- aminolevulinic acid was used in gel form. The affected areas were irradiated with a halogenic lamp PhotoDyn 501 (590–760 nm) during a 10-min radiation treatment. The treatment was repeated weekly for 10 weeks. Result PDT has brought about a good therapeutic effect (complete or partial clinical remission), with 87.25% improvement rate in patients suffering from lichen sclerosus. The greatest vulvoscopic response was observed in the reduction of subepithelial ecchymoses and teleangiectasia (78.95%), and the reduction of erosions and fissures (70.97%). A partial remission of lichenification with hyperkeratosis was observed in 51.61% of cases. The least response was observed in the atrophic lesions reduction (improvement in 37.36% of cases). Conclusion Our patients suffering from vulvar lichen sclerosus demonstrated positive responses to photodynamic therapy and the treatment was well tolerated. Photodynamic therapy used to treat lichen sclerosus yields excellent cosmetic results. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the prevalence and risk factors for unrecognized invasive carcinoma in a series of patients undergoing surgical excision after an office biopsy of vulvar high-grade squamous intraepithelial lesion (VHSIL). Methods: Two hundred and sixteen consecutive patients treated in a tertiary-level referral center for vulvar disease in north-western Italy were recruited. Patients' records were reviewed by trained personnel. Factors showing a statistically significant (p<0.05) association with detection of stromal invasion at excisional surgery in univariate analysis were further examined in a backward stepwise multiple logistic regression model. Results: The median patient age was 50 years (range, 19-88). More than 25% patients with VHSIL at biopsy had associated cervical/vaginal intraepithelial neoplasia, and more than 35% had a multifocal lesion. Invasive carcinoma was detected in surgical specimens from 24 patients (11%). The depth of stromal invasion varied between 0.1 mm and 3.0 mm with a median of 0.5 mm. In multivariate analysis, the risk of invasive carcinoma detection was greater for patients in the highest tertile of age (p=0.008), for patients with a lesion ≥20 mm in size (p=0.013) and with clitoral involvement (p<0.001), and for patients presenting with a nodular lesion (p=0.078). Conclusion: Our study suggests that patient age, lesion size, clitoral involvement and nodular appearance in patients with VHSIL at vulvoscopy-directed biopsy are independently associated with the risk of unrecognized invasive carcinoma. [ABSTRACT FROM AUTHOR]

Background: Data are limited regarding fractional CO2 laser as a nonhormonal treatment for vestibular pain., Aim: We sought to perform what is, to our knowledge, the first multisite prospective randomized, double-blind, sham-controlled clinical trial to assess the safety and efficacy of fractional CO2 laser treatment to the vestibule in women with vestibular pain., Methods: Subjects (n = 70) meeting inclusion/exclusion criteria at each of 3 sites were randomized 2:1 to active or sham (zero energy) fractional CO2 laser treatment using the vestibular probe (SmartXide2 V2LR - MonaLisa Touch, DEKA, Florence, Italy). Subjects in each treatment arm received 3 treatments 4 weeks apart. At the initial follow-up (week 12), subjects were unblinded and those initially assigned to sham started active treatment., Outcomes: Outcome measures included changes from baseline in sexual activity diaries and scores for the Vulvoscopic Genital Tissue Appearance Scale (VGTA), vestibular cotton-tipped swab testing, McGill Pain Questionnaire, Female Sexual Function Index (FSFI), Female Sexual Distress Scale-Revised (FSDS-R), and the O'Leary-Sant voiding and pain indices, the Interstitial Cystitis Symptom Index (ICSI) and Interstitial Cystitis Problem Index (ICPI)., Results: After active treatment, VGTA scores significantly improved in 5 parameters. Pain associated with cotton-tipped swab testing was significantly reduced at weeks 4 through 16 (mean change from baseline -0.64 [95% CI, -0.79 to -0.50] and -1.31 [95% CI, -1.46 to -1.16], respectively). FSFI pain domain scores improved significantly at weeks 12 and 16 (mean change from baseline 0.925 [95% CI, 0.10-1.75] and 1.22 [95% CI, 0.40-2.05], respectively). FSFI total scores increased significantly at weeks 12 and 16 (mean change from baseline 6.24 [95% CI, 2.64-9.85] and 4.96 [95% CI, 1.36-8.57], respectively). FSDS-R scores decreased significantly at weeks 12 and 16 (mean change from baseline -5.84 [95% CI, -8.80 to -2.87] and -9.15 [95% CI, -12.11 to -6.18], respectively). ICSI scores decreased significantly at weeks 12 and 16 (mean change from baseline -0.91 [95% CI, -1.65 to -0.18] and -0.754 [95% CI, -1.49 to -0.02], respectively). ICPI scores decreased significantly at week 16 (mean change from baseline -0.99 [95% CI, -1.63 to -0.34]). In contrast, there were no significant changes in outcomes in the sham arm. No serious adverse events occurred., Clinical Implications: Fractional CO2 laser treatment in women with vestibular pain resulted in improvement from baseline in multiple key outcome measures of vestibular health., Strengths and Limitations: Strengths of the study were that it was a multisite prospective randomized double-blind, sham-controlled clinical trial that included multiple measures related to vestibular pain and sexual function. Limitations were the nonvalidated primary outcome measure and limited study cohort., Conclusion: Fractional CO2 laser therapy is a safe and effective nonhormonal treatment for vestibular pain., (© The Author(s) 2023. Published by Oxford University Press on behalf of The International Society of Sexual Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objectives: We describe vulvoscopic findings, their correspondence with certain pathological processes, and the grouping of vulvoscopic findings to facilitate clinical practice.Materials and Methods: We performed vulvoscopy on 2,352 patients and described what we saw. We then classified the images by groups, according to the diagnoses suggested. Finally, we compared the frequency of the different images as a function of the symptoms, the clinical and histological diagnoses, the history of cervical lesions (cervical human papillomavirus, cervical intraepithelial neoplasia, or cervical carcinoma), and the microbiological studies.Results: We found 2.33% human papillomavirus-vulvar intraepithelial neoplasia (HPV-VIN) type 1 lesions, 0.52% herpes simplex lesions, and 0.08% VIN2 lesions in asymptomatic patients without a history of cervical lesions. In 95% of patients in whom raised acetowhite patches were found on the skin, vaginal exudate revealed Candida species. The images showing cobbled mucosa and white and red punctation primarily suggested a nonviral infection, though a small percentage of cases were of viral origin. The history of cervical lesions was significant (p < .000001) in the HPV-VIN1 lesion group. For the diagnosis of more severe vulvar lesions (VIN3 and vulvar carcinoma), we found that the joint presence of pruritus and a history of cervical lesions was significant (p < .004).Conclusions: Vulvoscopy performed as a routine examination procedure enables the detection of some disorders in asymptomatic patients who lack a history of cervical lesions and precludes the need for histological studies in some cases, though in others the image is inconclusive and a biopsy is required. Given that a description of normal findings is available, we are able to eliminate suspect pathological processes through a vulvoscopic examination. The proposed classification can serve as a guide to diagnosis and therapy. [ABSTRACT FROM AUTHOR]

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Introduction: The glans clitoris is covered by a prepuce that normally moves over the glans surface and can be retracted beyond the corona. Clitoral adhesions, ranging from mild to severe, occur when preputial skin adheres to the glans. Physical examination consistent with clitoral adhesions is based on the inability to visualize the entire glans corona. In this closed compartment, the space underneath the adherent prepuce and clitoris can become irritated, erythematous, or infected and can result in sexual dysfunction., Aim: To determine the prevalence of clitoral adhesions in a sexual medicine practice and assess risk factors associated with clitoral adhesions., Methods: This research involved retrospective examinations of vulvoscopy photographs taken from August 2007 to December 2015. Clitoral adhesions were considered absent when preputial retraction enabled full glans corona visualization. The study group consisted of women with mild, moderate, or severe clitoral adhesions based on more than 75%, 25% to 75%, or less than 25% glans clitoris exposure without full corona visualization, respectively. 2 independent reviewers evaluated photographs; a 3rd analyzed study group health record data., Main Outcome Measure: Prevalence of severity of clitoral adhesions., Results: Of the 1,261 vulvoscopy photographs, 767 (61%) were determined adequate for assessment and 614 photographs represented individual patients. The study group with clitoral adhesions consisted of 140 women (23%) of whom 44%, 34%, and 22% demonstrated mild, moderate, and severe clitoral adhesions, respectively. In the study group, 14% presented with clitorodynia. Risk factors included a history of sexual pain, yeast infection, urinary tract infection, blunt perineal or genital trauma, lichen sclerosus, low calculated free testosterone, and other sexual dysfunctions including persistent genital arousal disorder., Conclusion: Women with sexual dysfunction should routinely undergo clitoral physical examination. If the glans corona is not fully visualized, then clitoral adhesions should be suspected. Education, counseling, and/or referral for sexual pain management should be considered. Aerts L, Rubin RS, Randazzo M, et al. Retrospective Study of the Prevalence and Risk Factors of Clitoral Adhesions: Women's Health Providers Should Routinely Examine the Glans Clitoris. Sex Med 2018;6:115-122., (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: Ospemifene, an oral selective estrogen receptor modulator approved for the treatment of mild to moderate dyspareunia from menopause, has been shown to moderate sexual pain and vaginal epithelial cell characteristics. However, no prospective vulvoscopic studies have been performed., Aim: To examine, in menopausal women taking ospemifene 60 mg daily, changes to the vulva, vestibule, urethral meatus, and vaginal region over 20 weeks using vulvoscopy in a prospective open-label pilot study., Methods: Vulvoscopic photographs taken at screening and the end of therapy assessed for changes in the appearance of the vulva, vestibule, urethral meatus, and vagina rated by a single reviewer using a 10-parameter Likert rating scale, the Vulvoscopic Genital Tissue Appearance Scale (VGTA). In addition, the cotton-tipped swab test and subject diary scores were assessed over the 20-week treatment period and compared before and after the intervention using Wilcoxon signed-rank test., Main Outcome Measure: Changes in VGTA score from baseline to end of study., Results: 8 subjects (age = 59 ± 4.7 years) completed all visits and were included in the analysis of vulvoscopic photographs (n = 258). There were significant changes during the study period for urethral meatal prominence, introital stenosis, vestibular pallor, vestibular erythema, mucosal moisture, vaginal rugation, and anterior wall prominence (P < .05). Total pain score during cotton-tipped swab testing decreased from 11 (interquartile range = 10-16) before the intervention to 1 (interquartile range = 0-3) at the end of the study. Quantitative diary analysis indicated an increase in the number of sexual events, decrease in rates of pain during foreplay and intercourse, and decrease in use of lubricant at study completion (P < .05)., Conclusions: Ospemifene 60 mg daily for 20 weeks showed improvement in physical examination findings in this prospective study of menopausal women with dyspareunia, as documented on vulvoscopic photography. These changes were consistent with improvements in subject-reported pain and sexual function. Goldstein SW, Winter AG, Goldstein I. Improvements to the Vulva, Vestibule, Urethral Meatus, and Vagina in Women Treated With Ospemifene for Moderate to Severe Dyspareunia: A Prospective Vulvoscopic Pilot Study. Sex Med 2018;6:154-161., (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: To evaluate the prevalence and risk factors for unrecognized invasive carcinoma in a series of patients undergoing surgical excision after an office biopsy of vulvar high-grade squamous intraepithelial lesion (VHSIL)., Methods: Two hundred and sixteen consecutive patients treated in a tertiary-level referral center for vulvar disease in north-western Italy were recruited. Patients' records were reviewed by trained personnel. Factors showing a statistically significant (p<0.05) association with detection of stromal invasion at excisional surgery in univariate analysis were further examined in a backward stepwise multiple logistic regression model., Results: The median patient age was 50 years (range, 19-88). More than 25% patients with VHSIL at biopsy had associated cervical/vaginal intraepithelial neoplasia, and more than 35% had a multifocal lesion. Invasive carcinoma was detected in surgical specimens from 24 patients (11%). The depth of stromal invasion varied between 0.1 mm and 3.0 mm with a median of 0.5 mm. In multivariate analysis, the risk of invasive carcinoma detection was greater for patients in the highest tertile of age (p=0.008), for patients with a lesion ≥20 mm in size (p=0.013) and with clitoral involvement (p<0.001), and for patients presenting with a nodular lesion (p=0.078)., Conclusion: Our study suggests that patient age, lesion size, clitoral involvement and nodular appearance in patients with VHSIL at vulvoscopy-directed biopsy are independently associated with the risk of unrecognized invasive carcinoma., Competing Interests: No potential conflict of interest relevant to this article was reported., (Copyright © 2017. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology)