Search

Background: Vulvovaginal atrophy (VVA) includes a wide range of conditions affecting the reproductive and urinary systems, often requiring careful evaluation and management for optimal health., Aims: This study aims to evaluate the symptom management effects of a real time temperature-monitored non-ablative RF device for the treatment of postmenopausal Chinese women with VVA symptoms., Methods: This pilot study involved 24 postmenopausal Chinese women with one or more VVA symptoms, who wished to remain sexually active. VHIS, VAS, and FSFI were used to track and evaluate various aspects of the patient's condition. Analyses were conducted at the end of the study to verify the statistical significance of the treatment's results., Results: All patients reported substantial, statistically significant, improvements on every VVA symptom tracked. Approximately 80% of the patients reported total symptom reversal at 12-week post-treatment follow-up., Conclusion: This pilot study demonstrated that non-ablative, monopolar RF technology equipped with real time temperature monitoring is feasible and safe in the treatment of postmenopausal women with VVA symptoms, and efficacious at up to 12 weeks post-treatment., (© 2024 The Authors. Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.)

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 CO 2 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., (Copyright © 2021 Elsevier Inc. All rights reserved.)

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., Competing Interests: Declaration of Competing Interest Dr. Vargo reports personal fees from Elselvier, Clinical Pathways Director Lymphoma, outside the submitted work. Dr. Beriwal reports personal fees from Varian, personal fees from Via oncology, outside the submitted work., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Device-based therapeutic approaches have been developed to treat women&rsquo;s genitourinary post-menopausal symptoms. Fractional carbon dioxide laser resurfacing (FxCO2) has been demonstrated to be safe and effective in the treatment of GSM symptoms, however the results begin to wane by 12-months post-treatment., Objective: This study aims at assessing the application of an at-home transvaginal red and infrared light device as a maintenance treatment commencing 12 months following FxCO2 laser treatment for genitourinary syndrome of menopause (GSM)., Study Design: Subjects completing 12-month follow-up after three fractional CO2 laser vulvovaginal treatments received an at-home device and monitored for GSM symptoms with long-term follow-up to 12 months (2 years post-laser)., Methods: 10 post-menopausal subjects completing 12-months follow-up after three FxCO2 vulvovaginal treatments for GSM were treated with an at-home red and infrared LED device. Treatment consisted of intravaginal application three times per week, and subjects were followed to 1, 3, 6, and 12 months. Subjects completed the vaginal assessment scale subject satisfaction, and QUID to assess for vulvovaginal and stress urinary incontinence (SUI) symptoms., Results: Vulvovaginal symptoms measured by VAS were mean 89% improved at 12-month follow-up after FxCO2 and maintained at 73% improved over baseline (2 years post-laser) following an additional 12 months of at-home transvaginal light therapy (P&lt;0.05). VAS symptoms gradually increased over the 12 months maintenance period by a mean of 17% (P&lt;0.05). Mean subject satisfaction was 0 at baseline, 1.86 at 1 year following FxCO2, and 1.00 after an additional 1 year of at-home light therapy. SUI symptoms as measured by QUID were mean 81% improved at 12-month follow-up after FxCO2and maintained at 38% improved over baseline (2 years post-laser) following an additional 12-months of at-home light therapy (P&lt;0.05). SUI symptoms gradually increased by a mean of 43% over the 12-month maintenance period (P&lt;0.05)., Conclusions: At-home transvaginal red and near infrared light therapy commencing at 12 months post-FxCO2 vulvovaginal treatment in a post-menopausal population maintained statistically significant improvements in vulvovaginal and SUI symptoms over the additional12-month period (2 years post-laser); however, a gradual return of symptoms suggests that laser re-treatment or combination withhormone therapy may be necessary to maintain optimal outcomes.J Drugs Dermatol. 2020;19(11):1076-1079. doi:10.36849/JDD.2020.1012.

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.

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.

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.

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.

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 (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.

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.

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.

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., Competing Interests: The authors have declared that no competing interests exist.

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.

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: Twenty‐three 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., (© 2016 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.)

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.

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 .

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., (© 2016 Wiley Periodicals, Inc.)

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.

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.

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.

Background: There have been a very small number of reported cases of radiotherapy-induced autoimmune bullous disease. We describe a case of generalised autoimmune sub-epidermal bullous pemphigoid (BP) induced by radiotherapy in a female patient presenting squamous cell carcinoma of the vulva., Case Report: In June 2008, a 48-year-old woman underwent vulvectomy with lymph node curettage for squamous cell carcinoma of the vulva. Following surgery, adjuvant radiotherapy was indicated. At the 16th session (dose of 32 Gy), erythema occurred on the irradiation field. At the 23rd session (46 Gy), the patient presented bullous lesions that became generalised after four days with involvement of the oral mucosa. Skin biopsy revealed sub-epidermal bullae and direct immunofluorescence showed continuous linear deposits of IgG and of C3 along the dermal-epidermal junction. Indirect immunofluorescence revealed the presence of antibodies directed against the basement membrane. A favourable outcome was achieved under systemic corticosteroids. No immunotransfer analysis of serum or any other immunological investigations were performed., Discussion: The clinical and histological features of this autoimmune bullous disease were evocative of BP, despite the absence of any formal proof. Radio-induced BP is extremely rare, with only 28 cases being described to date in the literature. The trigger mechanism is poorly understood; radiotherapy appears to cause changes in the antigenic properties of proteins in the dermal-epidermal junction resulting in production of autoantibodies. The radio-induced nature of BP does not affect therapeutic response. The case we report is novel in terms of both generalisation of the eruption and mucosal involvement., (Copyright © 2011 Elsevier Masson SAS. All rights reserved.)

Background: Surgery is the standard in the management of vulvar cancer. Several studies assessed the feasibility of radiochemotherapy as definitive therapy and/or neoadjuvant procedure in order to limit the extent of surgery. Combined radiochemotherapy is associated with considerable toxicity. The authors report on a modified neoadjuvant radiochemotherapy schedule which is isoeffective to the GOG (Gynecologic Oncology Group) protocol, but associated with less therapy-related toxicity., Case Report: A 36-year-old woman with stage IV vulvar cancer and long-distance rectal infiltration is reported. Laparoscopic pretherapeutic staging confirmed pelvic and paraaortic lymph node metastases., Result: The patient received a neoadjuvant radiochemotherapy. After complete remission, a simple vulvectomy carried out 3 months later showed no evidence of tumor. Up to now, there is no evidence of tumor progression or recurrence., Conclusion: Preoperative conventionally fractionated simultaneous radiochemotherapy seems to be a feasible and safe treatment option for patients with locally advanced vulvar cancer in order to avoid exenterative surgery.

Background: Invasive cancers of the vagina and vulva are treated with radiation-based therapy when proximity of the bladder and/or rectum precludes conservative surgical resection. Patient factors affect non-malignant tissue tolerance to radiation exposure., Case: A smoker with atherosclerotic disease developed tissue necrosis and the worsening of claudication after chemoradiation treatment of locally advanced squamous cell carcinoma of the vulva and vagina. Healing occurred after surgical revascularization., Conclusion: Conditions with impaired microvasculature, such as smoking and atherosclerotic disease, are associated with an increased incidence and severity of complications after radiation treatment. Patients undergoing pelvic radiation treatment should be counseled to modify their vascular risk factors. If this fails and patients develop significant radiation necrosis due to compromised arteriole flow, revascularization or stenting may offer important treatment options.

We have developed a tissue model of radiation-induced reproductive cell death in the nematode Caenorhabditis elegans. Reproductive cell death is the primary mode of death in tissue multipotential precursor cells, or "clonogens," the targets of cytotoxic therapy, whose elimination results in normal tissue damage as well as solid-tumor eradication. Through extensive morphologic and genetic analysis, we have confirmed that cell death in this model represents reproductive cell death in isolation from apoptotic cell death, affording the opportunity to define the genetic pathways required for protection from reproductive cell death. We have additionally found that the DNA damage response pathway is necessary for protection from reproductive cell death, supporting the long-held tenet that DNA damage is the cause of reproductive cell death and further validating this model. This genetic tissue model provides a valuable tool for oncology-based research and affords a platform to broaden our insight into responses to cytotoxic therapy in tissues.

Background: Tumor hypoxia has been linked to the development of treatment resistance, tumor progression, and poor prognosis. Since anemia is a major causative factor for the development of hypoxia, the association between blood hemoglobin concentration (cHb) and tumor oxygenation was examined in this study., Patients and Methods: Pretreatment O(2) tension (pO(2)) measurements were performed in 59 primary carcinomas of the uterine cervix in which a stringent histopathologic examination of the electrode tracks was mandatory in order to exclude measurements in necrotic, stromal or normal cervical tissue. In addition, pO(2) readings in twelve primary cancers and 17 local recurrences of vulvar cancers were included in this study. cHb was determined at the time of pO(2) measurements., Results: Data presented clearly show that an optimal Hb level with regard to the median pO(2) values of cervical and vulvar cancers should prevail at cHb values of between 12 and 14 g/dl (7.45-8.60 mmol/l). In anemic patients (cHb < 12 g/dl), the deterioration of the tumor oxygenation status can be explained by a reduced O(2) transport capacity. At cHb values > 14 g/dl, a worsening of the tumor oxygenation is apparent, most probably due to a drop in perfusion following a drastic increase in viscous resistance to flow. This pathogenetic mechanism is thought to counteract and finally to abrogate the high O(2) transport capacity in this cHb range., Conclusions: This study suggests that cHb values of between 12 and 14 g/dl are optimal with regard to the oxygenation status in the tumor entities investigated, a finding which may have far-reaching implications in the clinical setting.

Background: Acute and late injuries of vulva and vagina are frequent and potentially serious complications in radiotherapy of gynecologic tumors. They still are reported poorly in literature., Methods: Based on a literature search a survey will be given of the modalities, which are used or recommended for prophylaxis or treatment of these radiation injuries. The principles of the different measures will be discussed with available study results., Results: Hygiene measures and the topical application of antimicrobial or granulation stimulating substances, which is mostly based on long standing clinical experience, are the principles of the treatment of acute reactions of vulva and vagina. The topical use of estrogen, which promotes proliferation of epithelium, is generally described in connection with treatment and prophylaxis of late radiation injuries. As a prophylaxis for the late reaction of vaginal stenosis, vaginal dilatation is recommended in literature., Conclusions: With the exception of a few reports on estrogen, there are no data about the effectiveness of the currently used medical substances. The local application of estrogen as prophylaxis of the acute reactions will therefore be examined in a prospective study.

Background: The acute radiation related morbidity is an essential factor for the patient's outcome in radiotherapy. The prophylactic and therapeutic management of acute side effects has a wide clinical range between different radiation oncology departments. In this work, it was to evaluate the remedies, which are used for prevention and therapeutic management of acute radiation related morbidity of the skin and mucosa (mouth, pharynx, esophagus, small and large bowel, rectum and vagina)., Methods: A questionnaire was sent to 130 radiotherapeutic departments in Germany in July 1995. The questionnaire had been designed with 22 open questions concerning the preventive and therapeutic management of acute radiation related morbidity of skin and mucosal sites. It has been correlated to the scoring system of the RTOG/EORTC and its German modification according to Seegenschmiedt and Sauer. The evaluation was performed anonymously., Results: From 130 questionnaires, 89 (68.4%) were sent back till August 1995. All of them were evaluable. The recommendations showed a broad spectrum for each site. Especially the oral mucositis was treated in many different ways and combinations. The prevention and therapy of complicating superinfections seem to be the joint principle of most of the recommendations., Conclusions: The management of the acute radiation related morbidity has a wide clinical spectrum among different radiation therapy centers. Systematic prospectively designed investigations are necessary in order to achieve a further reduction in the radiation related acute morbidity. Therefore, a multicenter collaborative working group has been founded.

Reporting and scoring complications after radiotherapy of gynaecological cancers is difficult because of the variety of treatment techniques involved. Use of an international classification is necessary to compare results obtained in series of patients treated in different institutions. An international group of experts designed in the early nineties the so-called French-Italian glossary. This classification of late effects is now completed with the new LENT SOMA scales. This paper contains details of these late changes, including their pathophysiology, clinical syndromes, potential treatment, and prevention.

The purpose of this article is to review the late effects of cancer therapy on the female reproductive tract. The anatomic sites detailed are the vulva, vagina, cervix, uterus, fallopian tubes, and ovaries. The available pathophysiology is discussed. Clinical syndromes are presented. Tolerance doses of irradiation for late effects are rarely presented in the literature and are reviewed where available. Management strategies for surgical, radiotherapeutic, and chemotherapeutic late effects are discussed. Endpoints for evaluation of therapeutic late effects have been formulated utilizing the symptoms, objective, management, and analytic (SOMA) format. Late effects on the female reproductive tract from cancer therapy should be recognized and managed appropriately. A grading system for these effects is presented. Endpoints for late effects and tolls for the evaluation need to be further developed.

The transposition of the gracilis muscle is shown as a reliable modality of treatment in chronic soft tissue problems and fistulas of the anogenital region. A short summary of the specific anatomy is given. The clinical application is illustrated with 2 case reports.

The inferior epigastric vessels are a reliable and easily accessible vascular pedicle for free tissue transplantation to the perineum, genital area, and the abdominal wall. Two cases serve to illustrate the procedure: the first involves a post-radiation ulcer following recurring carcinoma of the vulva with loss of the symphysis; the second involves a reconstruction of the abdominal wall employing a two-fold latissimus dorsi flap in a patient with malignant fibrous histiocytoma.

446 patients with malignant tumour of the vulva were treated from 1956 to 1978. In 432 patients with invasive squamous cell carcinoma, a five-year survival rate of 43.1% was obtained after exclusive exposure to electron radiation. Severe complications were seen in 10.9% of the treated patients. On comparing the results with those obtained after electrocoagulation or vulvectomy, it was seen that a therapy based on electron radiation only yielded more favourable results, especially in cases with advanced stage carcinomas. In younger women with early tumour stages, surgery should be given preference.

By means of 5 examples it is demonstrated, in which way large defects in the vulvar region can be covered plastically. Dependent on the situation a simple local tissue displacement (according to the principle of transpositionplasty) or a myocutaneous flapplasty using the m. tensor fasciae latae or the m. gluteus maximus will be favourable. These expanded possibilities for treatment of carcinoma of the vulva by own experiences are so convincing, that their application is recommendable on a larger scale and will be an enrichment in operative gynaecology. The techniques described can be used by gynaecologists with appropriate operative and clinical experience.