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Genitourinary Syndrome of Menopause (GSM) defines a set of symptoms associated with an estrogen deficit involving alterations in organs genitourinary and that results in several urinary, genital, and sexual alterations. Brazilian women live about a third of their life after menopause, where hormonal changes occur along with clinical manifestations, characterized by vaginal and vulvar dryness, burning sensation, discomfort, vulvovaginal irritation, lack of lubrication, dyspareunia and urinary incontinence. Fractionated photothermolysis and radiofrequency systems, alone or in combination were tested to improve GSM. The goal of this study is to elaborate a protocol to evaluate the clinical response of patients with symptoms of GSM after the application of photobiomodulation in the vulvar region. In this randomized, double-blind, placebo-controlled study protocol, women over 50 years of age who are in the postmenopausal period (amenorrhea for at least 12 months, with no pathology involved) with one or more symptoms of GSM will be randomly divided into two groups. The treatment group (n = 30) will receive four consecutive applications, weekly, using DMC laser diode (λ = 808 nm), 4J per point, 100mW of power, 1,016W/cm2, 8 sites in the vulvar region, The Placebo Group (n = 30) will be handled as treated, but with the laser turned off. The quality of life will be assessed using female sexual functioning index (FSFI-6), urinary incontinence questionnaire (ICIQ-SF), Quality of life will be analyzed using the female sexual functioning index (FSFI-6). The intensity of menopausal symptoms will be evaluated using a visual analogue scale (VAS), the vulvo vaginal atrophy will be measured by the Vaginal Health Index (VHI). Also, the vaginal temperature will be measured using a thermal camera, the pressure of the pelvic floor force (vaginal dynamometer) and a 1-hour Pad Test will be performed to quantify the urinary loss. With this procedure, we intend to obtain an overall better life quality and diminished symptoms in women with GSM. All assessments will be performed prior to the first irradiation and after the last one. This protocol is registered at ClinicalTrials.gov under the number NCT05557799.

Purpose The study aimed to evaluate and compare the efficacy and safety of treating atrophied labia majora with hyaluronic acid (HA) and calcium hydroxyapatite (CaHA). Methods Ten participants complaining of sagging or loss of volume in the labia majora were evaluated and randomly assigned to two groups—treated with CaHA or AH. Photographic documentation was taken and appreciated by the participants and by blind observers. Results The study showed an improvement in labia majora regarding volumization and flaccidity that was more significant after 90 days of treatment in both treatments. Besides flaccidity, volume replacement resulted in better balance and proportion between the labia majora and labia minora. The evaluators, independent and blind, judged that in 80% of the cases of the HA group and in 50% of cases of the CaHA group, there was an excellent improvement. Conclusion CaHA and HA are both effective and safe for treating the intimate region, and this study cannot prove the superiority of one over the other. An appropriate assessment involving the analysis of sagging and/or volume loss and the creation of a sequential treatment protocol, involving CaHA and HA, seems to be the best solution. Level of Evidence I Evidence obtained from at least one properly designed randomized controlled trial. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Female sexual dysfunction is highly prevalent among postmenopausal females approaching 50%, with vulvovaginal atrophy (VVA) being a cardinal sign. For decades, hormone replacement therapy was the only solution to relieve symptoms associated with this atrophy. However, it was limited by its serious side effects, raising the need for new treatment strategies. This study aims to compare the efficacy and safety of injection of hyaluronic acid (HA) versus platelet rich plasma (PRP) in post-menopausal females presented with VVA to improve female sexual dysfunction. Twenty post-menopausal females presented with VVA were randomly divided into two groups, 10 patients in each group. Both groups received three sessions of injections into the vulva and vagina, one month apart. Group I was injected with non cross linked HA while Group II received PRP injection. Subjective assessment was carried out through female sexual function index questionnaire and global aesthetic improvement scale.While objective assessment was carried out by measuring the labia majora length and reviewing the histopathological changes occurring in the vulva through skin biopsies before and after treatment. The change in vaginal thickness was estimated by transvaginal ultrasound. Results showed that both HA as well as PRP were effective in the treatment of post-menopausal vulvovaginal atrophy. However, HA showed more significant improvement in female sexual dysfunction. There were also higher values in vaginal wall thickness as measured by transvaginal ultrasound in favor of HA injected group. Histopathological assessment showed more collagen deposition in papillary dermis in HA treated group. No complications were reported in both groups.

Objectives The use of Plasma-Rich Platelets (PRP) in the vaginal mucosa for vulvovaginal atrophy (VVA) symptom relief is still being studied. This trial aimed to assess the efficacy of PRP injections in alleviating VVA symptoms. Methods A prospective randomized controlled trial was conducted at Ain Shams University Hospital, involving 60 postmenopausal women experiencing vaginal atrophy from August 2019 to May 2021. Thirty participants received intramucosal PRP injections, while the other 30 received saline as a placebo. Clinical evaluations occurred after 4 months using the Female Sexual Function Index (FSFI) as the primary outcome measure, alongside assessments of quality of life domains using the 36-item short-form survey (SF-36).The independent t-test and paired t-test were utilized for comparisons. Results At baseline, both groups exhibited impaired FSFI scores (9.2 ± 4.2 vs. 9.8 ± 4.3, P  > 0.05). After four months of treatment, the FSFI scores significantly improved in the PRP group (19.0 ± 4.5 vs. 9.7 ± 4.3, P  < 0.001). Specific domain analysis revealed no significant differences before treatment ( P  > 0.05), but the PRP group showed significant improvements in lubrication (2.26 ± 0.99 vs. 1.15 ± 0.81, P  = 0.02), satisfaction (5.27 ± 0.63 vs. 1.31 ± 0.78, P  < 0.001), and pain (5.18 ± 0.59 vs. 2.51 ± 1.63, P  < 0.001). No differences were seen in desire, arousal, and orgasm ( P  > 0.05). The PRP group also demonstrated notable improvements in role limitations due to physical health (52.5 ± 10.1 vs. 25.8 ± 12.3, P  < 0.001), emotional problems (56.6 ± 15.5 vs. 24.4 ± 17.3, P  < 0.001), and energy/fatigue (56.6 ± 15.5 vs. 24.4 ± 17.3, P  < 0.001), among others, all significant at P  < 0.001. Conclusions PRP injections show promise for treating postmenopausal VVA but require further larger RCT studies before becoming a standard treatment. Trial registration The study was prospectively registered in the clinical trials registry (NCT03898401) on 19.3.2019, https//clinicaltrials.gov/study/NCT03898401.

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.

The efficacy of the quadrivalent Human Papillomavirus (HPV) vaccine is thought to be mediated by humoral immunity. We evaluated the correlation between quadrivalent HPV vaccine-induced serum anti-HPV responses and efficacy. 17,622 women were vaccinated at day 1, and months 2 and 6. At day 1 and at 6–12 months intervals for up to 48 months, subjects underwent Papanicolaou and genital HPV testing. No immune correlate of protection could be found due to low number of cases. Although 40% of vaccine subjects were anti-HPV 18 seronegative at end-of-study, efficacy against HPV 18-related disease remained high (98.4%; 95% CI: 90.5–100.0) despite high attack rates in the placebo group. These results suggest vaccine-induced protection via immune memory, or lower than detectable HPV 18 antibody titers.

Vulvar squamous cell carcinomas and their precursors are currently classified by the World Health Organization based on their association with high-risk human papillomavirus (HPV). HPV independent lesions often harbor driver alterations in TP53, usually seen in the setting of chronic vulvar inflammation. However, a group of pre-invasive vulvar squamous lesions is independent from both HPV and mutant TP53. The lesions described within this category feature marked acanthosis, verruciform growth and altered squamous maturation, and over the last two decades several studies have added to their characterization. They have a documented association with verrucous carcinoma and conventional squamous cell carcinoma of the vulva, suggesting a precursor role. They also harbor recurrent genomic alterations in several oncogenes, mainly PIK3CA and HRAS, indicating a neoplastic nature. In this review, we provide a historical perspective and a comprehensive description of these lesions. We also offer an appraisal of the terminology used over the years, going from Vulvar Acanthosis with Altered Differentiation and Verruciform Lichen Simplex Chronicus to Differentiated Exophytic Vulvar Intraepithelial Lesion and Vulvar Aberrant Maturation, the latter term having been recently proposed by the International Society for the Study of Vulvovaginal Diseases. In line with the recognition of these lesions by the 2020 World Health Organization Classification of Tumours as a neoplastic precursor, we herein propose the term HPV-independent, p53-wild-type verruciform acanthotic Vulvar Intraepithelial Neoplasia (HPVi(p53wt) vaVIN), which better conveys not only the pathology but also the neoplastic nature and the biologic risk inherent to these uncommon and challenging lesions. We outline strict morphologic and immunohistochemical criteria for its diagnosis and distinction from mimickers. Immunohistochemistry for p16 and p53 should be performed routinely in the diagnostic work-up of these lesions, and the morphologic alternative term vaVIN should be reserved for instances in which p16/HPV/p53 status is unknown. We also discuss management considerations and the need to further explore precursors within and beyond the spectrum of verruciform acanthotic vulvar intraepithelial neoplasia.

This book is a practical guide to the diagnosis and management of vulval disorders. It offers guidance for all those who are treating patients with vulval disease at trainee and specialist level, helping to improve management for the patient and prevent delays in diagnosis, including referrals to specialists. It contains key information about diagnosis, investigation and basic management, with a section on signs and symptoms guides the reader to the correct chapter for the treatment of that disease. The experienced authors include updated classification and terminology of vulval disease with an explanation of how this should be useful in clinical practice and guidance as to when the patient should be referred on to a specialist. As vulval diseases are different to those of the rest of the skin patients with vulval disease present a large unmet need, often with delays in diagnosis due to a lack of training from physicians. This practical guide provides the specialist knowledge required for diagnosis and treatment of these conditions.

Context Intravaginal testosterone (IVT) is a potential treatment of vulvovaginal atrophy (VVA) associated with aromatase inhibitor (AI) use. Objective To investigate the effects of IVT on sexual satisfaction, vaginal symptoms, and urinary incontinence (UI) associated with AI use. Design Double-blind, randomized, placebo-controlled trial. Setting Academic clinical research center. Participants Postmenopausal women taking an AI with VVA symptoms. Intervention IVT cream (300 μg per dose) or identical placebo, self-administered daily for 2 weeks and then thrice weekly for 24 weeks. Main Outcomes and Measures The primary outcome was the change in the sexual satisfaction score on the Female Sexual Function Index (FSFI). Secondary outcomes included vaginal symptoms and responses to the Profile of Female Sexual Function, the Female Sexual Distress Scale–Revised (FSDS-R), and the Questionnaire for UI Diagnosis. Serum sex steroids were measured. Results A total of 44 women were randomly assigned and 37 provided evaluable data, (mean age 56.4 years, SD 8.8 years). At 26 weeks, the mean between-group difference in the baseline-adjusted change in FSFI satisfaction scores was significantly greater for the IVT group than the placebo group (mean difference 0.73 units; 95% CI, 0.02 to 1.43; P = 0.043). IVT cream resulted in significant improvements, compared with placebo, in FSDS-R scores (P = 0.02), sexual concerns (P < 0.001), sexual responsiveness (P < 0.001), vaginal dryness (P = 0.009), and dyspareunia (P = 0.014). Serum sex steroid levels did not change. Few women had UI symptoms, with no treatment effect. Conclusion IVT significantly improved sexual satisfaction and reduced dyspareunia in postmenopausal women on AI therapy. The low reporting of UI among women on AI therapy merits further investigation.

PurposeVulvovaginal atrophy (VVA) is a commonly reported issue among breast cancer patients, and its aetiology is multifactorial. Treatment is difficult in these women, particularly because the use of oestrogens has traditionally been discouraged. Vaginal laser treatment has been reported to improve symptoms. We aimed to assess the impact on symptoms and sexual function of vaginal laser in women with early breast cancer (EBC).MethodsWe performed a single-arm investigator initiated pilot study of female EBC patients with symptomatic VVA. A total of 3 vaginal laser treatments were administered 4 weeks apart. Questionnaires were completed at baseline, 4, 8 and 12 weeks. Our primary endpoint was symptomatic improvement of VVA at 12 weeks on 10 cm visual analogue scales. Our secondary endpoints were improvement in sexual function using the Female Sexual Function Index (FSFI) and patient-reported improvements in symptoms, sexual function and quality of life. Statistical analysis was performed with a Wilcoxon Signed Rank test.Results26 patients were enrolled between February 2016 and August 2017. All patients were post-menopausal, 25 of whom had received anti-oestrogen therapy for their breast cancer. Questionnaire compliance was high (98%) and all patients received the three pre-planned treatments. There was significant improvement in each of the VVA symptoms: dryness (p < 0.001), itch (p < 0.001), burning (p = 0.003), dysuria (p < 0.001) and dyspareunia (p < 0.001). Patients also reported improvement in sexual function on the FSFI (p ≤ 0.001).ConclusionsPatients receiving vaginal laser had improvement in VVA symptoms and sexual function. Further randomised sham-controlled trials are needed to further assess this treatment.