Microablative Fractional CO2 Laser for Vulvovaginal Atrophy in Women With a History of Breast Cancer: A Pilot Study at 4-week Follow-up.

BACKGROUND: Breast cancer (BC) is the most common female cancer worldwide. Menopausal symptoms are a well-known side effect in women with BC and have a significant negative impact on quality of life (QoL) and sexuality. Nowadays, hormonal replacement therapy and local estrogens are the most common prescriptions to treat vulvovaginal (VVA) symptoms. However, in women with a history of BC, proper therapy for such conditions remains an often inadequately addressed clinical problem. A treatment with microablative fractional CO2 laser (MLT) can produce a remodeling of the vaginal connective tissue without causing damage to the surrounding tissue. The aim of this pilot study is to assess the efficacy and safety of MLT for treating VVA symptoms in women with a history of BC at 20-week follow-up since the first laser treatment. PATIENTS AND METHODS: Women with BC and VVA symptoms were enrolled in the study and treated with 5 laser applications (one every 4 weeks). The rate of satisfied patients at 20 weeks of follow-up was evaluated with a 5-point Likert scale. Changes of the Vaginal Health Index (VHI) after treatment was compared with baseline. Effects of the laser treatment on VVA symptoms was measured using a 10-cm visual analog scale (VAS). Changes in overall QoL were assessed with a generic QoL questionnaire: the Short Form 12 (SF-12) that we analyzed considering its physical (PCS12) and mental (MCS12) domains. Sexual function was evaluated by the Female Sexual Function Index (FSFI). RESULTS: In this prospective cohort study, we enrolled 40 women with a history of BC and who currently were or (Group 2) who had been (Group 1) on treatment with endocrine therapy for their condition. Six (15.0%) women were very satisfied, 25 (62.5%) were satisfied, 6 (15.0%) were uncertain, and 3 (7.5%) were dissatisfied with the MLT. VVA symptoms and VHI improved significantly at 20 weeks from baseline (P < .05) with no differences between the 2 groups (P > .05). In terms of QoL measured by the SF-12, the PCS12 and the MCS12 significantly improved at the 20-week follow-up. A significant improvement in total FSFI and in all domains was reported in both study groups (P < .05) with no differences between groups (P > .05). CONCLUSION: MLT was safe and effective in treating VVA symptoms in women with a history of BC, irrespective of being previously or currently on endocrine therapies.

A Systematic Review of Nonsurgical Vulvovaginal Restoration Devices: An Evidence-Based Examination of Safety and Efficacy.

BACKGROUND: The efficacy and safety of vulvovaginal restoration devices were called into question in a U.S. Food and Drug Administration statement on July 30, 2018, claiming that women are being harmed by laser and other energy-based devices. The goal of this systematic literature review was to assess existing data, determine gaps in evidence, and propose opportunities for continued investigation pertaining to laser and energy-based vaginal restoration techniques. METHODS: A review of literature using PubMed, Cochrane Library databases, Embase, MEDLINE, and the Cumulative Index to Nursing and Allied Health Literature was conducted on January 9, 2019, and articles up to this point were considered. For inclusion, studies had to be available or translated in English and relate to clinical medicine, direct patient care, and nonsurgical energy-based vulvovaginal procedures. RESULTS: The authors found five level I studies, 19 level II studies, four level III studies, and 46 level IV studies that used 15 different devices. Various degrees of improvement of symptoms were reported in all studies. Adverse events/side effects were noted in two of the 13 radiofrequency device studies, 15 of the 23 erbium:yttrium-aluminum-garnet device studies, and 17 of the 37 carbon dioxide device studies. The majority of adverse events were considered mild. CONCLUSIONS: The majority of studies resulted in mild to no adverse side effects. However, there is a large gap in level I evidence. As a result, the authors emphasize the necessity of supplemental data surrounding this subject and suggest that additional randomized sham-controlled studies be conducted to further investigate vulvovaginal restoration devices in an effort to address women's health issues.

Dose-escalated intensity modulated radiation therapy in patients with locally-advanced vulvar cancer - does it increase response rate?

PURPOSE: GOG 205 safely increased clinical (cCR) and pathologic complete response (pCR) in locally-advanced vulvar cancer through dose escalation using three-dimensional radiotherapy (RT). The aim of this study is to assess the response of dose-escalated intensity modulated radiotherapy (IMRT) in locally-advanced vulvar cancer. METHODS: A retrospective review of patients treated with dose-escalated (≥ 55Gy) IMRT from 2012 to 2018 for locally-advanced vulvar cancer was performed. Patients treated with preoperative or definitive intent were included. Rates of cCR and pCR were assessed, and predictors of disease-free survival (DFS) were analyzed using the Kaplan Meier method with log rank test between groups and a parsimonious multivariate Cox model. RESULTS: Median dose to the vulva was 66.0 Gy (Interquartile Range [IQR]: 66.0-68.0) for definitive and 59.4 Gy (IQR: 58.0-59.4) for preoperative IMRT. The overall rates of cCR and pCR were 76% and 70%, respectively. DFS at two years was 65% (95% Confidence Interval [CI] 50-80%) for all patients, 81% (95% CI 63% - 98%) for definitive IMRT, and 55% (95% CI 35% - 76%) for preoperative IMRT. On multivariate analysis, cCR predicted for disease-free survival (HR 0.21; 95% CI 0.06-0.76; p = 0.02), and pCR predicted for OS (HR 0.12; 95% CI 0.02-0.60; p = 0.01). Grade 3 acute and late RT toxicity was seen in 14 (29%) and 3 (6%) of patients, respectively. CONCLUSION: Dose-escalated IMRT for locally-advanced vulvar cancer is well tolerated, with rates of cCR and pCR that compare favorably with published data.

Inguino-femoral radiotherapy in vulvar squamous cell carcinoma: clues to revised indications in patients with only one intracapsular lymph node metastasis.

Background and objectives: The aim was to review the clinical impact of groin metastatic nodal disease in women with vulvar squamous cell carcinoma (VSCC) and to evaluate the impact of adjuvant radiotherapy on women with single intracapsular lymph node metastasis (SILNM).Methods: Cohort study of women with vulvar squamous cell carcinoma (VSCC) managed between January 2005 and December 2015 in five institutions in France with prospectively maintained databases (French multicentre tertiary care centres). We evaluated Impact of SILNM on outcome.Results: A total of 176 women (34.6%) had at least one positive lymph node (LN). There were no significant differences for the 5-year overall survival rates between women with one extracapsular LN metastasis and women with one intracapsular LN metastasis, or with two node metastases (p = .62, p = .63 respectively). In women with a SILNM: (1) lymphovascular invasion (LVSI) was an independent negative predictive factor recurrence-free survival (RFS) (HR = 0.10 (95%CI, 0.01-0.90), p = .04) and (2) Adjuvant inguino-femoral radiotherapy was a positive independent factor associated with RFS (HR = 5.87 (95%CI 1.21-28.5), p = .02).Conclusion: A potential positive effect of adjuvant radiotherapy in node positive VSCC, irrespective of the number of affected LN, should be considered especially in the case of LVSI.

Treatment to External Labia and Vaginal Canal With CO2 Laser for Symptoms of Vulvovaginal Atrophy in Postmenopausal Women.

Background: Increasingly, women have sought alternatives to traditional options (lubricants, estrogen products, and hormone replacement therapy) for unwelcome vaginal changes of menopause. Objectives: This study evaluated whether a series of three monthly fractional CO2 laser treatments significantly improves and maintains vaginal health indices of elasticity, fluid volume, pH level, epithelial integrity, and moisture. Self-reported symptoms of vaginal atrophy were also measured. Biopsy samples after a series of three treatments were evaluated for histological changes to vaginal canal tissue. Methods: Forty postmenopausal women were treated extravaginally and internally with a fractional CO2 laser. Objective measurements of vaginal health index, as well as subjective measurements of symptoms of vulvovaginal atrophy (VVA), urinary incontinence, and sexual function were reported at baseline. Follow-up evaluations were at one, three, six, and 12 months after the third treatment. Results: Vaginal health index improved significantly after the first treatment and was maintained with mean improvement of 9.6 ± 3.3 (P < 0.001) and 9.5 ± 3.3 (P < 0.001) at the 6- and 12-month follow ups, respectively. Vaginal symptoms of dryness, itching, and dyspareunia improved significantly (P < 0.05) at all evaluations. Histological findings showed increased collagen and elastin staining, as well as a thicker epithelium with an increased number of cell layers and a better degree of surface maturation. Conclusions: Fractional CO2 laser treatments were well tolerated and were associated with improvement in vaginal health and amelioration of symptoms of VVA. Histological changes in the epithelium and lamina propria, caused by fractional CO2 laser treatments, correlated with clinical restoration of vaginal hydration and pH to premenopausal levels.

Histologic and Clinical Changes in Vulvovaginal Tissue After Treatment With a Transcutaneous Temperature-Controlled Radiofrequency Device.

BACKGROUND: Although transcutaneous temperature-controlled radiofrequency (TTCRF) may effectively treat vulvovaginal laxity (VVL), atrophic vaginitis (AV), orgasmic dysfunction (OD), and stress urinary incontinence (SUI), there is a lack of histopathologic evidence to validate its use. OBJECTIVE: Evaluate clinical and histological changes induced by vulvovaginal TTCRF. MATERIALS AND METHODS: This was a prospective, nonrandomized trial. Ten female subjects with mild-to-moderate VVL, with or without AV, OD, and/or SUI underwent 3 TTCRFs at 4-week intervals. Five subjects underwent pre- and post-treatment biopsies of the labia majora and vaginal canal for histology. Assessments were performed at baseline and Days 10, 30, 60, and 120. RESULTS: Investigator-rated VVL improved significantly from baseline to Day 10, with improvement maintained through Day 120 (p = .001 and .001, respectively). Sexual satisfaction improved significantly by Day 60 (p = .001). Improvement in AV reached significance at Day 120 (p = .048). Although OD and SUI improved steadily, the difference in improvement did not reach statistical significance. Histology revealed that post-treatment increases in collagen, elastin, vascularity, and small nerve fibers. CONCLUSION: Transcutaneous temperature-controlled RF resulted in significant improvements in AV, VVL, and sexual satisfaction with milder improvements in OD and SUI. Post-treatment histology demonstrated neocollagenesis, neoelastogenesis, neoangiogenesis, and the first reported finding of TTCRF-related neurogenesis.

Labial tissue rejuvenation and sexual function improvement using a novel noninvasive focused monopolar radio frequency device.

INTRODUCTION: With aging, the vulvar tissue loses its vitality and elasticity due to collagen fibers fatigue. Such changes and functional characteristics of the external genitalia often cause negative psychological effects resulting in impeded sexual function. The objective of this study is to evaluate the safety and efficacy of a radio frequency (RF) device when used for treating labial laxity and for improvement of female sexual fuction. MATERIALS AND METHODS: Using a monopolar RF device, 19 women received four once-a-week treatments. Images taken at the baseline and at the 1-month follow-up were evaluated for improvement in vulvar appearance on a scale of 0-3. The female sexual function index (FSFI) scores were calculated and compared between the baseline, the 1-month follow-up visit, and the 12-month follow-up visit. RESULTS: Average improvement in the vulvar appearance according to the patients and the physician was 2.00 ± 0.58 and 1.79 ± 0.54, respectively. Both values represent "moderate change" according to the applied scale. The average FSFI increased by 9.79 ± 4.35 and 7.10 ± 5.17 when comparing the baseline to the 1-month and the 12-month follow-up, respectively. No adverse events were reported. DISCUSSION: Efficacy and safety of the investigated device were proven. Longevity of results was proven by the 12-month follow-up.

Nonsurgical Vulvovaginal Rejuvenation With Radiofrequency and Laser Devices: A Literature Review and Comprehensive Update for Aesthetic Surgeons.

Nonsurgical vulvovaginal rejuvenation (NVR) is growing in popularity as a treatment for restoration of youthful female genitalia. Numerous radiofrequency (RF) and laser devices have entered the market claiming improvement in vaginal laxity and genitourinary syndrome of menopause. There is a paucity of evidence existing concerning the effectiveness of these devices for both pre- and postmenopausal women with laxity and/or atrophy at the histologic and clinical level. Therefore, the goal of this review is to scrutinize the peer-reviewed data on NVR with RF and laser devices, identify gaps in existing literature, and propose opportunities for further investigation.

New therapeutic option in genitourinary syndrome of menopause: pilot study using microablative fractional radiofrequency / Nova opção terapêutica na síndrome geniturinária da menopausa: estudo piloto utilizando radiofrequência fracionada microablativa

ABSTRACT Objective: To evaluate the clinical response of patients with symptoms of genitourinary syndrome of menopause after application of microablative fractional radiofrequency in the vagina and vaginal introitus. Methods: Fourteen patients with symptoms of genitourinary syndrome of menopause underwent three applications of microablative fractional radiofrequency with a 30-day interval, using the Wavetronic 6000HF-FRAXX device and a fractional vaginal electrode. The questionnaires World Health Organization Quality of Life (for quality of life evaluation), Female Sexual Function Index and Quality of Life Adapted Questionnaire in the Domain of Sexual Satisfaction (for sexual function and satisfaction evaluation) were administered before and after the applications (30 to 60 days after the last procedure), in addition to the satisfaction questionnaire after procedure. Results: There was an increase in almost all dimensions on average in quality of life, with statistical significance only in the health domain. There was a significant improvement in the sexual domains in almost all dimensions. All patients stopped using lubricant during intercourse after treatment. In the satisfaction questionnaire after treatment, we observed that the vast majority felt cured or much better (29% and 64%, respectively, total of 92.6%) and were very satisfied or satisfied (43 and 57%, respectively, total of 100%). The only patient who reported little improvement had an 18-year postmenopausal history and was treatment naïve. Conclusion: Microablative fractional radiofrequency was effective in treating symptoms of vaginal dryness and dyspareunia, and eliminated the use of vaginal lubricant during the period observed. Since this is a pilot study with a small number of patients, further studies are required to corroborate our findings and evaluate the long-term effects of microablative fractional radiofrequency on the vaginal tissue.

RESUMO Objetivo: Avaliar resposta clínica de pacientes com sintomas da síndrome geniturinária da menopausa após aplicação de radiofrequência fracionada microablativa na vagina e no introito vaginal. Métodos: Quatorze pacientes com sintomas de síndrome geniturinária da menopausa foram submetidas a três aplicações de radiofrequência fracionada microablativa com intervalo de 30 dias, utilizando aparelho Wavetronic 6000HF-FRAXX e eletrodo vaginal fracionado. Foram aplicados os questionários World Health Organization Quality of Life (para avaliar qualidade de vida), Female Sexual Function Index e Quality of Life Adapted Questionnaire in the Domain of Sexual Satisfaction (para verificar função sexual e satisfação) antes e depois das aplicações (30 a 60 dias após último procedimento), além do questionário de satisfação após procedimento. Resultados: Na qualidade de vida, houve aumento na média em geral, com significância estatística apenas no quesito saúde. No domínio sexual, houve melhora significativa em quase todas as dimensões. Todas as pacientes cessaram o uso de lubrificante na relação sexual após o tratamento. No questionário de satisfação após tratamento, a maioria se sentiu curada ou muito melhor (29 e 64%, respectivamente; total de 92,6%) e estava muito satisfeita ou satisfeita (43 e 57%, respectivamente; total de 100%). A única paciente que relatou pouca melhora tinha história de 18 anos de pós-menopausa e era virgem de tratamento. Conclusão: Radiofrequência fracionada microablativa foi efetiva em tratar sintomas de ressecamento vaginal e dispareunia, e eliminou o uso de lubrificante vaginal durante o período observado. Por se tratar de estudo piloto com pequena quantidade de pacientes, mais estudos são necessários para corroborar estes achados e avaliar os efeitos a longo prazo da radiofrequência fracionada microablativa no tecido vaginal.

Propensity Scoring after Multiple Imputation in a Retrospective Study on Adjuvant Radiation Therapy in Lymph-Node Positive Vulvar Cancer.

Propensity scoring (PS) is an established tool to account for measured confounding in non-randomized studies. These methods are sensitive to missing values, which are a common problem in observational data. The combination of multiple imputation of missing values and different propensity scoring techniques is addressed in this work. For a sample of lymph node-positive vulvar cancer patients, we re-analyze associations between the application of radiotherapy and disease-related and non-related survival. Inverse-probability-of-treatment-weighting (IPTW) and PS stratification are applied after multiple imputation by chained equation (MICE). Methodological issues are described in detail. Interpretation of the results and methodological limitations are discussed.

Interaction between Radioadaptive Response and Radiation-Induced Bystander Effect in Caenorhabditis elegans : A Unique Role of the DNA Damage Checkpoint.

Although radioadaptive responses (RAR) and radiation-induced bystander effects (RIBE) are two important biological effects of low-dose radiation, there are currently only limited data that directly address their interaction, particularly in the context of whole organisms. In previous studies, we separately demonstrated RAR and RIBE using an in vivo system of C. elegans . In the current study, we further investigated their interaction in C. elegans , with the ratio of protruding vulva as the biological end point for RAR. Fourteen-hour-old worms were first locally targeted with a proton microbeam, and were then challenged with a high dose of whole-body gamma radiation. Microbeam irradiation of the posterior pharynx bulbs and rectal valves of C. elegans could significantly suppress the induction of protruding vulva by subsequent gamma irradiation, suggesting a contribution of RIBE to RAR in the context of the whole organism. Moreover, C. elegans has a unique DNA damage response in which the upstream DNA damage checkpoint is not active in most of somatic cells, including vulval cells. However, its impairment in atm-1 and hus-1 mutants blocked the RIBE-initiated RAR of vulva. Similarly, mutations in the atm-1 and hus-1 genes inhibited the RAR of vulva initiated by microbeam irradiation of the vulva itself. These results further confirm that the DNA damage checkpoint participates in the induction of RAR of vulva in C. elegans in a cell nonautonomous manner.

Emerging Trends in Nonsurgical Female Genital Rejuvenation.

BACKGROUND: Aging, childbearing, and hormonal changes can lead to vulvovaginal laxity and mucosal atrophy that negatively affect a woman's quality of life. As more minimally and noninvasive options for genital rejuvenation become available in the outpatient setting, it becomes increasingly important for the dermatologic surgeon to be familiar with these popular procedures. OBJECTIVE: To familiarize dermatologists with the nonsurgical options available for female genital rejuvenation, patient motivations for pursuing these procedures, relevant anatomy, and potential adverse events. MATERIALS AND METHODS: A MEDLINE search was performed on nonsurgical female genital rejuvenation from 1989 to 2015, and results are summarized. RESULTS: Reports of nonsurgical female genital rejuvenation procedures using fractional carbon dioxide lasers, nonablative lasers, monopolar radiofrequency devices, hyaluronic acid fillers, and fat transfer are concisely summarized for the practicing dermatologist. CONCLUSION: Review of the literature revealed expanding options for nonsurgical female genital rejuvenation.

Transcutaneous temperature controlled radiofrequency for orgasmic dysfunction.

BACKGROUND AND OBJECTIVES: To evaluate the safety, tolerability, and clinical efficacy of transcutaneous temperature controlled radiofrequency (TTCRF) on vulvovaginal tissue for orgasmic dysfunction. STUDY DESIGN/MATERIALS AND METHODS: Subjects included 25 sexually active women, ages 21-65, with self-reported difficulty in achieving orgasms during sex (anorgasmic or slow-to-orgasm). Each patient received three sessions at intervals of about 1 month. Treatment was performed using a slim S-shaped probe with a stamp-sized metal radiofrequency emitter on one surface of the tip (25 minutes total time on average). External treatments covered the labia majora and minora, lower mons pubis, perineal body, clitoral hood, and clitoris. Full length treatment of the vagina with concentration on the anterior wall was performed. Tissue temperature during therapy was elevated to and maintained between 40°C and 45°C. No anesthesia was required. After treatment, patients immediately resumed normal activities, including sex. RESULTS: Twenty­three of 25 patients reported an average reduction in time to orgasm of 33%. Patients also noted significant vaginal tightening effects, increased vaginal moisture, and improved vulvar and clitoral sensitivity. All anorgasmic patients reported the ability to achieve orgasms. Two patients had minimal response. CONCLUSION: TTCRF is an effective non-hormonal, non-surgical option for women having difficulty achieving orgasm. Treatment also has visible tightening effects on feminine tissues and appears to increase local blood flow, resulting in increased vaginal tightness and moisture. Improved appearance and friction resulted in improved confidence and reduced performance anxiety. Lasers Surg. Med. 48:641-645, 2016. © 2016 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.

Radioadaptive Response for Reproductive Cell Death Demonstrated in In Vivo Tissue Model of Caenorhabditis elegans.

Reproductive cell death (RCD) occurs after one or more cell divisions resulting from an insult such as radiation exposure or other treatments with carcinogens or mutagens. The radioadaptive response for RCD is usually investigated by in vitro or in vivo clonogenic assay. To date, this has not been demonstrated in the vulval tissue in Caenorhabditis elegans ( C. elegans ), which is a well established in vivo model for radiation-induced RCD. In this study to determine whether radioadaptive response occurs in the vulval tissue model of C. elegans , early larval worms were gamma irradiated with lower adaptive doses, followed by higher challenge doses. The ratio of protruding vulva was used to assess the RCD of vulval cells. The results of this study showed that the radioadaptive response for RCD in this vulval tissue model could be well induced by dose combinations of 5 + 75 Gy and 5 + 100 Gy at the time point of 14-16 h in worm development. In addition, the time course analysis indicated that radioresistance in vulval cells developed within 1.75 h after an adaptive dose and persisted for only a short period of time (2-4 h). DNA damage checkpoint and non-homologous end joining were involved in the radioadaptive response, exhibiting induction of protruding vulva in worms deficient in these two pathways similar to their controls. Interestingly, the DNA damage checkpoint was not active in the somatic vulval cells, and it was therefore suggested that the DNA damage checkpoint might mediate the radioadaptive response in a cell nonautonomous manner. Here, we show evidence of the occurrence of a radioadaptive response for RCD in the vulval tissue model of C. elegans . This finding provides a potential opportunity to gain further insight into the underlying mechanisms of the radioadaptive response for RCD, in view of the abundant genetic resources of C. elegans .

Short time efficacy and safety of focused monopolar radiofrequency device for labial laxity improvement-noninvasive labia tissue tightening. A prospective cohort study.

BACKGROUND AND OBJECTIVE: To evaluate safety and efficacy of focused monopolar radio frequency (RF) device for non-invasive labia tissue tightening and improvement of labial laxity. METHODS: This prospective cohort study participants were 17 female subjects aged between 27 and 56 years with lax skin at the labia area. All subjects received four consecutive treatments at 7-day intervals with RF device (Exilis Protege IntimaR, BTL Industries Inc., Boston, MA). The primary efficacy outcome measure was defined as one or more point improvement on 1-4 scale for vulva appearance determined by three blinded evaluators. Digital photographs were taken at the baseline and 1 month after the last treatment. Sexual gratification was assessed with Female Sexual Functioning Index (FSFI) and patient discomfort by Visual Analogue Scale (VAS). RESULTS: An average 2.9 (of maximum 4) points improvement rate in vulvar appearance was observed (P < 0.01). Mean of the total FSFI score enhanced from initial 75-87% (P < 0.001). Resultant 4.7 (18%) points increase was achieved. Ninety four percent of subjects reported mild to none discomfort during the treatment. No adverse events during the study course were reported. CONCLUSION: The present study demonstrates the positive effect of focused monopolar RF device for non-invasive labia tissue tightening. The treatment is effective and safe with high patient satisfaction.

Fractional CO2 Laser for Vulvovaginal Atrophy.

Objective: To evaluate the short term efficacy and safety of Fractional CO2 laser for the treatment of vulvovaginal atrophy. Material and Method: From March 2015 to October 2015, 112 menopausal women were recruited. All women with VVA were treated by using Fractional CO2 laser; power 30 watts, 1-3 stacks with 360° vaginal probe for 3 consecutive times, 4 weeks apart. Before laser treatment, the subjective measurement of VVA symptoms was evaluated by using a questionnaire and the objective measurements were evaluated by using pH paper and VMI. Visual analog pain-score was used to scaling their discomfort during and immediately after each treatment. At 3 months after the last procedure, the subjective and objective measurements were re-assessed. Any short-term and long-term adverse events were recorded. Statistical analysis was performed by using SPSS program with p-value <0.05. Results: The median of pre-screening VVA symptom score was 4 and the most bothersome symptom was the "feeling of dryness around vulvar". There was a significant reduction of the score after laser treatment. The average percentage of pretreatment VMI was 34.7±16.1% and at one and three months after complete laser course, it was significantly increased with the mean change of 25.0±12.2% and 34.8±15.5%, respectively. For the vaginal pH, the average pH before treatment was 7.5±1.0 and the average decrement after 3 months was 0.9±1.3 with statistical significance, p-value <0.01. There were no serious complications and all were satisfied with the treatment. Conclusion: Fractional CO2 laser could ameliorate the VVA symptoms with at least 3 months of long lasting improvement of vaginal health with safety.

A 12-week treatment with fractional CO2 laser for vulvovaginal atrophy: a pilot study.

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.

Sentinel lymph node status in vulval cancer: systematic reviews of test accuracy and decision-analytic model-based economic evaluation.

BACKGROUND: Vulval cancer causes 3-5% of all gynaecological malignancies and requires surgical removal and inguinofemoral lymphadenectomy (IFL). Complications affect > 50% of patients, including groin wound infection, lymphoedema and cellulitis. A sentinel lymph node (SLN) is the first groin node with the highest probability of malignancy. SLN biopsy would be useful if it could accurately identify patients in whom cancer has spread to the groin, without removing all groin nodes. SLNs can be identified by isosulfan blue dye and/or technetium-99 ((99m)Tc) radioactive tracer during lymphoscintigraphy. The blue dye/(99m)Tc procedure only detects SLN, not metastases - this requires histological examination, which can include ultrastaging and staining with conventional haematoxylin and eosin (H&E) or immunohistochemistry. OBJECTIVES: To determine the test accuracy and cost-effectiveness of the SLN biopsy with (99m)Tc and/or blue dye compared with IFL or clinical follow-up for test negatives in vulval cancer, through systematic reviews and economic evaluation. DATA SOURCES: Standard medical databases, including MEDLINE, EMBASE, Science Citation Index and The Cochrane Library, medical search gateways, reference lists of review articles and included studies were searched to January 2011. METHODS: For accuracy and effectiveness, standard methods were used and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Searches were to January 2011, with no language restrictions. Meta-analyses were carried out with Meta-Disc version 1.4 (Javier Zamora, Madrid, Spain) for accuracy; none was appropriate for effectiveness. The economic evaluation from a NHS perspective used a decision-tree model in DATA TreeAge Pro Healthcare 2001 (TreeAge Software, Inc., Williamstown, MA, USA). Six options (blue dye with H&E, blue dye with ultrastaging, (99m)Tc with H&E, (99m)Tc with ultrastaging, blue dye/(99m)Tc with H&E, blue dye/(99m)Tc with ultrastaging) were compared with IFL. Deterministic and probabilistic sensitivity analyses were conducted. RESULTS: For accuracy, of the 26 included studies, most evaluated (99m)Tc/blue dye combined. Four studies had clinical follow-up only for test negatives and five had clinical follow-up for all and IFL for test negatives. Numbers with no SLN found were difficult to distinguish from those with negative SLN biopsies. The largest group of 11 studies using (99m)Tc/blue dye, ultrastaging and immunohistochemistry had a pooled sensitivity of 95.6% [95% confidence interval (CI) 91.5% to 98.1%] and a specificity of 100% (95% CI 99.0% to 100%). Mean SLN detection rates were 94.6% for (99m)Tc, 68.7% for blue dye and 97.7% for both. One study measured global health status quality of life (QoL) and found no difference between SLN biopsy and IFL. One patient preference evaluation showed that 66% preferred IFL rather than a 5% false-negative rate from SLN biopsy. For effectiveness, of 14,038 references, one randomised controlled trial, three case-control studies and 13 case series were found. Approximately 50% died from vulval cancer and 50% from other causes during follow-ups. Recurrences were in the ratio of approximately 4 : 2 : 1 vulval, groin and distant, with more recurrences in node-positive patients. No studies reported QoL. For cost per death averted, IFL was less costly and more effective than strategies using SLN biopsy. For morbidity-free survival and long-term morbidity-free survival, (99m)Tc with ultrastaging was most cost-effective. Strategies with blue dye only and H&E only were never cost-effective. The incremental cost-effectiveness ratio for (99m)Tc with ultrastaging compared with IFL was £4300 per case of morbidity-free survival and £7100 per long-term morbidity-free survival. LIMITATIONS: The main limitations of this study include the lack of good-quality evidence on accuracy, effectiveness and QoL. A large project such as this takes time to publish, so the most recent studies are not included. CONCLUSIONS: A sensitive and specific combined metastatic SLN detection test and information on generic QoL in vulval cancer is urgently required. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

[Pregnancy and malignant diseases. Part III--. Vulvar cancer].

Vulvar cancer is among the rarest gynecological tumors. It is extremely rare in pregnant women. In the scientific literature, data has been recorded for no more than 50 cases of vulvar cancer during pregnancy. The etiological and pathogeneteic role of the HPV infection is discussed. The early histological diagnosis and treatment of every vulvar neoplasia during pregnancy are preconditions for a favorable prognosis for the disease and the pregnancy likewise. The management for women with vulvar cancer and pregnancy needs to be determined by a multidisciplinary staff with obstetrician-gynecologists, oncologists and neonatologists, while the point of view of the patient also has to be taken into account.