Does One Measure Fit All? The Role of Experimentally Induced Pain Tests in the Assessment of Women with Provoked Vestibular Pain.

Purpose: A diagnostic algorithm was recently suggested to address the underlying mechanisms of provoked-vestibulodynia (PVD). It delineates four subgroups (Hormonal-associated, Augmented-anterior, Hymenal-associated and Hypertonicity-associated), each manifesting a distinctive vulvar pain-hypersensitivity regarding location (circumferential vs posterior-only vestibulodynia) and pain characteristics. We aimed to explore the significance of various experimentally induced vulvar pain measures in the manifestation of pain hypersensitivity in each subgroup. Methods: Women with PVD (n = 113) and 43 controls reported pain intensity provoked during vaginal penetration and tampon insertion. Vestibular tenderness (anterior and posterior) was assessed by Q-tip test, and pressure stimulation delivered to the puborectalis assessed muscle tenderness. Pain thresholds were measured using a vulvar-algesiometer. These measures were compared between patients and controls and among the PVD subgroups. Correlations between the clinical and experimentally induced-pain measures were assessed. Finally, to address whether the association between experimentally induced-pain measures and dyspareunia severity is mediated by hypertonicity, the conditional indirect effect was analyzed in each subgroup. Results: Compared to controls, augmented vulvar pain-hypersensitivity and hypertonicity were observed among patients (p < 0.001). ANOVA revealed no subgroup differences in dyspareunia severity. Nevertheless, some experimentally induced-pain measures were differently correlated with dyspareunia intensity in each subgroup, allowing discrimination of subgroups according to the unique findings of vulvar pain-hypersensitivity. The degree of pelvic floor muscle-hypertonicity mediated the association between vulvar pain-hypersensitivity and dyspareunia severity, emphasizing the key role of hypertonicity in distinguishing between subgroups. Conclusion: The findings offer more evidence of variations among PVD subtypes, demonstrating that insertional dyspareunia may originate from dissimilar alterations in the mucosal and muscular tissues. The results also emphasize the significance of utilizing a wide battery of tests to capture different experimentally induced-pain measures, revealing the unique patterns of vulvar pain-hypersensitivity in each subgroup.

Chronic graft-versus-host disease detected by tissue-specific cell-free DNA methylation biomarkers.

BACKGROUND: Accurate detection of graft-versus-host disease (GVHD) is a major challenge in the management of patients undergoing hematopoietic stem cell transplantation (HCT). Here, we demonstrated the use of circulating cell-free DNA (cfDNA) for detection of tissue turnover and chronic GVHD (cGVHD) in specific organs. METHODS: We established a cocktail of tissue-specific DNA methylation markers and used it to determine the concentration of cfDNA molecules derived from the liver, skin, lungs, colon, and specific immune cells in 101 patients undergoing HCT. RESULTS: Patients with active cGVHD showed elevated concentrations of cfDNA, as well as tissue-specific methylation markers that agreed with clinical scores. Strikingly, transplanted patients with no clinical symptoms had abnormally high levels of tissue-specific markers, suggesting hidden tissue turnover even in the absence of evident clinical pathology. An integrative model taking into account total cfDNA concentration, monocyte/macrophage cfDNA levels and alanine transaminase was able to correctly identify GVHD with a specificity of 86% and precision of 89% (AUC of 0.8). CONCLUSION: cfDNA markers can be used for the detection of cGVHD, opening a window into underlying tissue dynamics in patients that receive allogeneic stem cell transplants. FUNDING: This work was supported by grants from the Ernest and Bonnie Beutler Research Program of Excellence in Genomic Medicine, The Israel Science Foundation, the Waldholtz/Pakula family, the Robert M. and Marilyn Sternberg Family Charitable Foundation and the Helmsley Charitable Trust (to YD).

Diagnostic performance of an automated microscopy and pH test for diagnosis of vaginitis.

Vaginitis is a common gynecological problem, nevertheless, its clinical evaluation is often insufficient. This study evaluated the performance of an automated microscope for the diagnosis of vaginitis, by comparison of the investigated test results to a composite reference standard (CRS) of wet mount microscopy performed by a specialist in vulvovaginal disorders, and related laboratory tests. During this single-site cross-sectional prospective study, 226 women reporting vaginitis symptoms were recruited, of which 192 samples were found interpretable and were assessed by the automated microscopy system. Results showed sensitivity between 84.1% (95%CI: 73.67-90.86%) for Candida albicans and 90.9% (95%CI: 76.43-96.86%) for bacterial vaginosis and specificity between 65.9% (95%CI: 57.11-73.64%) for Candida albicans and 99.4% (95%CI: 96.89-99.90%) for cytolytic vaginosis. These findings demonstrate the marked potential of machine learning-based automated microscopy and an automated pH test of vaginal swabs as a basis for a computer-aided suggested diagnosis, for improving the first-line evaluation of five different types of infectious and non-infectious vaginal disorders (vaginal atrophy, bacterial vaginosis, Candida albicans vaginitis, cytolytic vaginosis, and aerobic vaginitis/desquamative inflammatory vaginitis). Using such a tool will hopefully lead to better treatment, decrease healthcare costs, and improve patients' quality of life.

Postpartum dyspareunia: clinical evaluation, causes, and treatment outcomes.

BACKGROUND: Dyspareunia affects approximately half of postpartum women and is attributed to multiple factors. Despite its high prevalence and resultant negative effects, data are lacking regarding the causes and different pain components, the usefulness of recommended treatments, and the prognosis. AIM: To evaluate causes of postpartum dyspareunia, targeted treatment modalities, and their effectiveness. METHODS: A retrospective observational study was conducted of women diagnosed with postpartum dyspareunia between September 2008 and January 2017 at a single designated vulvovaginal disorder clinic. The inclusion criterion was complaint of painful intercourse commencing postdelivery. The cohort was divided into 4 groups based on the causes of dyspareunia: muscle hypertonicity, scar tenderness, vestibular tenderness, and atrophy. OUTCOMES: The following were assessed for each group: patient background demographics, clinical and obstetric data, physical findings, recommended therapy, adherence to the suggested treatment, level of improvement at follow-up visits, and length of time until maximal improvement. RESULTS: A hundred women met the inclusion criterion; the majority (n = 60) presented with >1 causative factor. The most common finding was vestibular tenderness (n = 78, 78%), which was significantly associated with atrophy (adjusted odds ratio [aOR], 15.08; 95% CI, 2.45-93.35), contraceptive usage (aOR, 4.76; 95% CI, 1.07-21.39), and primiparity (aOR, 4.89; 95% CI, 1.01-23.88). Episiotomy was the only risk factor for scar tenderness (aOR, 5.43; 95% CI, 1.20-24.53), while the existence of a spontaneous perineal tear was not. No specific correlation was found with pelvic floor muscle hypertonicity. Targeted treatment resulted in significant improvement in most patients. CLINICAL IMPLICATIONS: A targeted diagnostic and treatment approach for postpartum dyspareunia is effective and can be beneficial for caregivers treating postpartum women. STRENGTHS AND LIMITATIONS: A uniform and consistent protocol for patient selection and management is a major strength, which magnifies the clinical implication of our findings. The retrospective nature of the study is the primary limitation. CONCLUSION: Postpartum dyspareunia is a common problem; however, many women refrain from discussing it with their providers. Therefore, it is important to assess this condition with all women during the postpartum visit as targeted diagnosis and treatment can significantly improve outcomes.

"Modified Schirmer Test" as an Objective Measurement for Vaginal Dryness: A Prospective Cohort Study.

None of the currently available parameters allow for a direct and objective measurement of vaginal moisture. We used a calibrated filter paper strip as a measurement tool for the quantification of vaginal fluid, in a similar manner as the ophthalmic "Schirmer test" (used for eye moisture measurement). The study aimed to evaluate the validity of this new, objective tool, to measure vaginal moisture. We compared vaginal moisture measurements using the "modified Schirmer test" in symptomatic women with genitourinary syndrome of menopause to those of women without vaginal dryness. The mean "modified Schirmer test" measurement in the control group was 21.7 mm compared to 3.3 mm in the study group, yielding a statistically significant difference (p < 0.001). Strong correlations were found between "modified Schirmer test" measurements and pH (correlation coefficient −0.714), Vaginal Health Index [VHI (0.775)], and Visual Analogue Score (VAS) of dryness during intercourse (−0.821). Our findings suggest that the "modified Schirmer test" can be used as an objective measurement for the assessment of vaginal fluid level. This test may also prove useful for evaluation of non-hormonal treatments aimed to treat vaginal dryness.

The Vaginal Microbiome: II. Vaginal Dysbiotic Conditions.

OBJECTIVE: This series of articles, titled The Vaginal Microbiome (VMB), written on behalf of the International Society for the Study of Vulvovaginal Disease, aims to summarize the recent findings and understanding of the vaginal bacterial microbiota, mainly regarding areas relevant to clinicians specializing in vulvovaginal disorders. MATERIALS AND METHODS: A search of PubMed database was performed, using the search terms "vaginal microbiome" with "dysbiosis," "bacterial vaginosis," "cytolytic vaginosis," "desquamative inflammatory vaginitis," and "aerobic vaginitis." Full article texts were reviewed. Reference lists were screened for additional articles. RESULTS: The second article in this series focuses on vaginal dysbiotic conditions. Dysbiosis is a term describing imbalances in bacterial communities. Given that lactobacillus-dominated microbiota are thought to be the most optimal, vaginal dysbiosis is usually considered as lactobacilli-depleted VMB. Bacterial vaginosis (BV), the most common vaginal dysbiotic condition, is a polymicrobial disorder, considered the leading cause for vaginal discharge in women worldwide. In addition, we review the VMB in other vaginal conditions associated with lactobacilli depletion: desquamative inflammatory vaginitis and aerobic vaginitis. We also discuss the controversial diagnosis of cytolytic vaginosis, related with lactobacilli overgrowth. CONCLUSIONS: Bacterial vaginosis displays complex microbiology. The heterogeneity and diversity within the genus Gardnerella may impact the progression of BV. Bacterial biofilms may contribute to the etiology and persistence of BV, and various bacteria may affect its clinical presentation and pathogenicity. Lack of lactobacilli is not always accompanied by an overgrowth of anaerobes.

The Vaginal Microbiome: I. Research Development, Lexicon, Defining "Normal" and the Dynamics Throughout Women's Lives.

OBJECTIVE: This series of articles, titled The Vaginal Microbiome, written on behalf of the International Society for the Study of Vulvovaginal Disease, aims to summarize the current findings and understanding of the vaginal bacterial microbiota, mainly regarding areas relevant to clinicians specializing in vulvovaginal disorders. MATERIALS AND METHODS: A database search of PubMed was performed, using the search terms "vaginal microbiome" (VMB) with "research," "normal," "neonate," "puberty," "adolescent," "menopause," and "ethnicities," as well as "human microbiome project." Full article texts were reviewed. Reference lists were screened for additional articles. RESULTS: In the last 2 decades, many studies applying molecular techniques were performed, intending to characterize the vaginal microbiota. These studies advanced our understanding of how vaginal health is defined. The first article in this series focuses on the advancement of VMB research, technical definitions, the definition of "normal" VMB, and the dynamics of VMB throughout women's lives. CONCLUSIONS: Understanding how microorganisms inhabiting the vagina interact with each other and with the host is important for a more complete understanding of vaginal health. The clinical application of microbial community sequencing is in its beginning, and its interpretation regarding practical clinical aspects is yet to be determined.

The Vaginal Microbiome: III. The Vaginal Microbiome in Various Urogenital Disorders.

OBJECTIVE: This series of articles, titled The Vaginal Microbiome (VMB), written on behalf of the International Society for the Study of Vulvovaginal Disease, aims to summarize the recent findings and understanding of the vaginal bacterial microbiota, mainly regarding areas relevant to clinicians specializing in vulvovaginal disorders. MATERIALS AND METHODS: A search of PubMed database was performed, using the search terms "vaginal microbiome" with "Candida," "vaginitis," "urinary microbiome," "recurrent urinary tract infections," "sexually transmitted infections," "human immunodeficiency virus," "human papillomavirus," "nonspecific vaginitis," "vulvodynia," and "vulvovaginal symptoms." Full article texts were reviewed. Reference lists were screened for additional articles. The third article in this series describes VMB in various urogenital disorders. RESULTS: Variable patterns of the VMB are found in patients with vulvovaginal candidiasis, challenging the idea of a protective role of lactobacilli. Highly similar strains of health-associated commensal bacteria are shared in both the bladder and vagina of the same individual and may provide protection against urinary tract infections. Dysbiotic VMB increases the risk of urinary tract infection. Loss of vaginal lactic acid-producing bacteria combined with elevated pH, increase the risk for sexually transmitted infections, although the exact protective mechanisms of the VMB against sexually transmitted infections are still unknown. CONCLUSIONS: The VMB may constitute a biological barrier to pathogenic microorganisms. When the predominance of lactobacilli community is disrupted, there is an increased risk for the acquisition of various vaginal pathogents. Longitudinal studies are needed to describe the association between the host, bacterial, and fungal components of the VMB.

The Vaginal Microbiome: IV. The Role of Vaginal Microbiome in Reproduction and in Gynecologic Cancers.

OBJECTIVE: This series of articles, titled The Vaginal Microbiome (VMB), written on behalf of the International Society for the Study of Vulvovaginal Disease, aims to summarize the recent findings and understanding of the vaginal bacterial microbiota, mainly regarding areas relevant to clinicians specializing in vulvovaginal disorders. MATERIALS AND METHODS: A search of PubMed database was performed, using the search terms "vaginal microbiome" with "reproduction," "infertility," "fertility," "miscarriages," "pregnancy" "cervical cancer," "endometrial cancer," and "ovarian cancer." Full article texts were reviewed. Reference lists were screened for additional articles. RESULTS: The fourth article of this series focuses on 2 distinct areas: the role of VMB in various aspects of human reproduction and, in sharp contrast, the association between the VMB and gynecologic malignancies. Several of the negative pregnancy outcomes have been associated with an altered VMB. Dysbiosis is remarkably linked with poor pregnancy outcomes from preconception to delivery. The associations between the microbiome and gynecologic cancers are described. CONCLUSIONS: The development of the microbiome research, enabled by molecular-based techniques, has dramatically increased the detection of microorganisms and the understanding of bacterial communities that are relevant to maternal-fetal medicine in health and disease, as well as in gynecological malignancies. Proving causation in cancer is difficult because of the complex interactive nature of potential causative factors. Certain elements of the microbiota have been shown to provoke inflammatory reactions, whereas others produce anti-inflammatory reactions; this balance might be impaired with a change in microbial variety.

The Vaginal Microbiome: V. Therapeutic Modalities of Vaginal Microbiome Engineering and Research Challenges.

OBJECTIVE: This series of articles, titled The Vaginal Microbiome (VMB), written on behalf of the International Society for the Study of Vulvovaginal Disease, aims to summarize the recent findings and understanding of the vaginal bacterial microbiota, mainly regarding areas relevant to clinicians specializing in vulvovaginal disorders. MATERIALS AND METHODS: A search of PubMed database was performed, using the search terms "vaginal microbiome" with "treatment," "diagnosis," and "research." Full article texts were reviewed. Reference lists were screened for additional articles. RESULTS: The currently available approaches for treating vaginitis or attempting to modulate the VMB are often insufficient. It has traditionally relied on the use of antibiotics, antiseptics, and antifungals. The fifth and last article of this series discusses the new and/or alternative therapeutic modalities. It addresses the role of probiotics, prebiotics and symbiotics, activated charcoal, biofilm disrupting agents, acidifying agents, phage therapy, and the concept of vaginal microbiome transplant. The challenges facing the research of VMB, including the clinical impact of microbiome manipulation, classification, and new diagnostic approaches are discussed. CONCLUSIONS: Microbiome research has grown dramatically in recent years, motivated by innovations in technology and decrease in analysis costs. This research has yielded huge insight into the nature of microbial communities, their interactions, and effects with their hosts and other microbes. Further understanding of the bacterial, fungal, phage, and viral microbiomes in combination with host genetics, immunologic status, and environmental factors is needed to better understand and provide personalized medical diagnostics and interventions to improve women's health.

Vestibular Anatomic Localization of Pain Sensitivity in Women with Insertional Dyspareunia: A Different Approach to Address the Variability of Painful Intercourse.

The pathophysiology underlying painful intercourse is challenging due to variability in manifestations of vulvar pain hypersensitivity. This study aimed to address whether the anatomic location of vestibular-provoked pain is associated with specific, possible causes for insertional dyspareunia. Women (n = 113) were assessed for "anterior" and "posterior" provoked vestibular pain based on vestibular tenderness location evoked by a Q-tip test. Pain evoked during vaginal intercourse, pain evoked by deep muscle palpation, and the severity of pelvic floor muscles hypertonicity were assessed. The role of potential confounders (vestibular atrophy, umbilical pain hypersensitivity, hyper-tonus of pelvic floor muscles and presence of a constricting hymenal-ring) was analyzed to define whether distinctive subgroups exist. Q-tip stimulation provoked posterior vestibular tenderness in all participants (6.20 ± 1.9). However, 41 patients also demonstrated anterior vestibular pain hypersensitivity (5.24 ± 1.5). This group (circumferential vestibular tenderness), presented with either vestibular atrophy associated with hormonal contraception use (n = 21), or augmented tactile umbilical-hypersensitivity (n = 20). The posterior-only vestibular tenderness group included either women with a constricting hymenal-ring (n = 37) or with pelvic floor hypertonicity (n = 35). Interestingly, pain evoked during intercourse did not differ between groups. Linear regression analyses revealed augmented coital pain experience, umbilical-hypersensitivity and vestibular atrophy predicted enhanced pain hypersensitivity evoked at the anterior, but not at the posterior vestibule (R = 0.497, p < 0.001). Distinguishing tactile hypersensitivity in anterior and posterior vestibule and recognition of additional nociceptive markers can lead to clinical subgrouping.

Prevalence and Characteristics of Postpartum Vulvovaginal Atrophy and Lack of Association With Postpartum Dyspareunia.

OBJECTIVE: Breastfeeding-related hypoestrogenic state has been reported as a possible risk factor for postpartum dyspareunia. This study aimed to evaluate the prevalence and characteristics of postpartum vulvovaginal atrophy according to 3 different diagnostic methods and to estimate its association with postpartum dyspareunia and daily vulvovaginal symptoms. METHODS: This is a prospective cohort study of puerperal women attending a routine postpartum checkup. Participants completed a questionnaire and underwent a gynecological examination. Atrophy was diagnosed separately according to gynecologist impression, vaginal pH measurement (≥5.1), and cytologic vaginal maturation index. Patients were followed up with a telephone survey 2-3 months later, inquiring about symptoms possibly associated with atrophy. RESULTS: Of 117 participants, vaginal atrophy was diagnosed in 48% by gynecological examination, 62% by a pH level of 5.1 or greater, and 40.2% had cytological atrophy. Of the 35.9% of women who had resumed sexual intercourse (42/117), 69% reported dyspareunia. No significant association was found between dyspareunia and atrophy parameters. There was no difference in the rates of dyspareunia among women who were exclusively breastfeeding (21/27 = 78%), partially breastfeeding (4/7 = 57%), or not breastfeeding (4/8, 50%). Atrophy was more common in breastfeeding women according to the 3 criteria (gynecological examination: 57.6% vs 16.7%, p = .006; pH: 70% vs 22%, p < .001; vaginal maturation index: 51.1% vs 0%, p < .001). Of the 117 participants, 47% reported daily vulvovaginal symptoms. Those with daily symptoms reported more dyspareunia as compared with those without daily symptoms (85% vs 52%, p = .025). CONCLUSIONS: A high prevalence of atrophy was observed in puerperal women in association with breastfeeding. There was no significant association between atrophy and dyspareunia or daily vulvovaginal symptoms.

Management and long-term consequences of genital graft versus host disease following hematopoietic stem cell transplantation.

Vulvovaginal Graft-versus-host disease (VV-GVHD) is an underdiagnosed complication of hematopoietic stem cell transplantation (HSCT). The severity of the disease varies greatly, ranging from minor discomfort to severe, irreversible anatomic changes. This study sought to assess the long-term course of VV-GVHD. A retrospective analysis was conducted of 64 women who underwent HSCT and were followed over 9 years in a designated vulvovaginal clinic. VV-GVHD was detected in 56% of transplanted women. Adherence with follow-up correlated with diagnosis of VV-GVHD (p < 0.001) and with sexual activity (p = 0.023). Most of the women with VV-GVHD were symptomatic; however, 22% were asymptomatic upon diagnosis. Women were treated with topical steroids, topical estrogen, vaginal dilators, and vaginal silicone rings. Vaginal silicone rings were associated with higher patient adherence and better results. VV-GVHD is a common complication of HSCT and can adversely impact patients' sexuality and quality of life. The disease pattern is chronic, necessitating long term follow-up and adherence with treatment. Vulvar anatomical changes occurred despite treatment; however, vaginal patency can be maintained by early diagnosis, constant surveillance, and early treatment, consequently allowing preservation of normal sexual function. Awareness of VV-GVHD must be raised in order to better serve female patients and facilitate early diagnosis and treatment.

Vaginal microbiome transplantation in women with intractable bacterial vaginosis.

We report the results of a first exploratory study testing the use of vaginal microbiome transplantation (VMT) from healthy donors as a therapeutic alternative for patients suffering from symptomatic, intractable and recurrent bacterial vaginosis (ClinicalTrials.gov NCT02236429 ). In our case series, five patients were treated, and in four of them VMT was associated with full long-term remission until the end of follow-up at 5-21 months after VMT, defined as marked improvement of symptoms, Amsel criteria, microscopic vaginal fluid appearance and reconstitution of a Lactobacillus-dominated vaginal microbiome. One patient presented with incomplete remission in clinical and laboratory features. No adverse effects were observed in any of the five women. Notably, remission in three patients necessitated repeated VMT, including a donor change in one patient, to elicit a long-standing clinical response. The therapeutic efficacy of VMT in women with intractable and recurrent bacterial vaginosis should be further determined in randomized, placebo-controlled clinical trials.

Algorithms for Managing Vulvovaginal Symptoms-a Practical Primer.

PURPOSE OF REVIEW: To present a comprehensive systematic approach for diagnosing correctly the cause(s) of bothersome genital symptoms. RECENT FINDINGS: We searched the PUBMED for practical clinical guidelines, written by a multidisciplinary team of healthcare providers directed for diagnosing bothersome genital symptoms. This search was performed by a professional information specialist using the keywords "vulvovaginal," "vulvar," "multidisciplinary diagnosis," "interdisciplinary consultation," and "vulvology." We found numerous publications defining the criteria for diagnosing specific disorders, but only a few publications presented a multidisciplinary clinical algorithm for diagnosing bothersome vulvovaginal symptoms. The authors, from three different specialities, gathered together (online), in aim to present a comprehensive systematic approach for accurate diagnosing of bothersome vulvovaginal symptoms. Six principles for accurately diagnosing a woman with bothersome genital symptoms were endorsed: (1) locate the discomfort (vulva, clitoris, vestibule, vagina, cervix, pelvis); (2) consider more than one entity; (3) evaluate each symptom separately (it is common to have more than one entity necessitating treatment for each); (4) use pH and wet mount microscopy; (5) obtain a follow-up visit in 2-4 weeks; (6) perform a biopsy for dermatological conditions that are resistant to treatment.

Delivery in patients with dyspareunia-A prospective study.

OBJECTIVE: Despite the high prevalence of dyspareunia, published data focused on childbirth is scarce. This study aimed to evaluate the prevalence of dyspareunia in a random primiparae parturient population, characterize their features, and describe associated perinatal outcomes. STUDY DESIGN: In this prospective observational study we approached primiparous women admitted to our labor ward. Women were asked to complete an interview, based on self-report of dyspareunia symptoms. Obstetrical outcomes were obtained and compared between women with (exposed) and without (controls) dyspareunia. Midwives completed a questionnaire regarding patients' cooperation, pain level, pelvic floor hypertonicity, difficulty with vaginal examinations and perceived anxiety level. RESULTS: One hundred seventy-three women completed a detailed questionnaire querying dyspareunia symptoms. Of them, 41.6% (n = 72) reported a certain degree of dyspareunia. Exposed women did not differ in demographic or clinical characteristics as compared to controls. Of the exposed group, 40.3% reported primary dyspareunia, 25.4% secondary dyspareunia, and 34.3% could not recall its beginning. Only 34.3% had consulted a practitioner regarding this problem. Rates of vaginal deliveries, vacuum deliveries, and cesarean deliveries were comparable (p = 0.845). There were no differences between the two groups in rates of analgesia usage, epidural anesthesia, episiotomy, and second stage duration. However, the severity of dyspareunia correlated with the incidence of perineal tears (66.7% in patients with severe dyspareunia, and 41.1% in controls, p = 0.011). Logistic regression analysis revealed that dyspareunia was independently associated with perineal tears (p = 0.029). Higher rates of anxiety and pelvic floor hypertonicity were reported in patients reporting severe dyspareunia (≥3/10 times). CONCLUSION: Dyspareunia is common among primiparous women, and these patients are more likely to suffer perineal tears and anxiety during delivery.

Low-Level Laser Therapy for the Treatment of Provoked Vestibulodynia-A Randomized, Placebo-Controlled Pilot Trial.

BACKGROUND: Low-level laser therapy (LLLT) is an emerging medical technology in which non-thermal laser irradiation is applied to treat pain. Because LLLT has been found effective in treating various pain syndromes without known side effects, we conducted a study evaluating the effect of LLLT on provoked vestibulodynia (PVD), a complex sexual pain disorder characterized by pain confined to the vulvar vestibule in response to contact or pressure. AIM: To investigate the effectiveness of LLLT for PVD in a randomized, placebo-controlled, double-blinded trial. METHODS: Patients with PVD were randomly assigned to receive treatment with LLLT or sham treatment. Patients were treated twice weekly for 6 weeks, for a total of 12 LLLT or placebo sessions. Patients who showed improvement after LLLT were followed for 1 year by clinical pain report and Q-tip examination. OUTCOMES: Change in pain scores obtained in response to the Q-tip test, clinical pain report, visual analog scale score, pain with tampon insertion, daily pain intensity, intercourse pain intensity, frequency of intercourse, and a battery of quality-of-life measures. RESULTS: Thirty-four patients with PVD participated, 18 received LLLT and 16 received placebo. In the clinical pain report at study completion, 14 of 18 patients (78%) receiving LLLT reported improvement compared with 7 of 16 (44%) in the placebo group (P = .042). This effect was not apparent in other outcome measurements. None of the patients reported side effects during the study. At 1-year follow-up, eight patients (57%) reported lasting improvement. CLINICAL IMPLICATIONS: Larger studies with various treatment protocols are needed to define which patients can benefit from LLLT therapy. STRENGTHS AND LIMITATIONS: Strengths include a placebo-controlled, double-blinded design, measurement of a large number of multidimensional end points, and a follow-up period of 1 year. Limitations include the small number of patients recruited, no improvement in measurable parameters, a high improvement rate in the placebo group, the absence of use of validated questionnaires, and the lack of evaluation of psychological and interpersonal factors that might have influenced the results. CONCLUSIONS: Given the results of this pilot study, LLLT cannot currently be recommended as a treatment for PVD. Further studies with a larger population, various treatment protocols, and evaluation of LLLT in different subgroups of PVD are needed to define which patients can benefit from this therapy. Lev-Sagie A, Kopitman A, Brzezinski A. Low-Level Laser Therapy for the Treatment of Provoked Vestibulodynia-A Randomized, Placebo-Controlled Pilot Trial. J Sex Med 2017;14:1403-1411.

Light and energy based therapeutics for genitourinary syndrome of menopause: Consensus and controversies.

Gynecologist and plastic surgeons pioneered the application of lasers in medicine and surgery almost 5 decades ago, initially used to treat cervical and vaginal pathologies. Ever since, energy-based devices have been deployed to treat pelvic pathologies and improve fertility. Recent technological developments triggered an unprecedented wave of publications, assessing the efficacy of fractional laser, and radiofrequency on the vaginal wall in reversing natural aging processes. Studies have shown that a certain degree of thermal energy deposited on the vaginal wall stimulates proliferation of the glycogen-enriched epithelium, neovascularization, and collagen formation in the lamina propria, and improves natural lubrication and control of urination. This review aimed to review such data and to guide future research. A unique assembly of experts from around the globe, compiled and edited this manuscript based on a thorough literature review and personal experience. Lasers Surg. Med. 49:137-159, 2017. © 2017 Wiley Periodicals, Inc.

Standards for Clinical Trials in Male and Female Sexual Dysfunction: IV. Unique Aspects of Clinical Trials in Female Sexual Dysfunction.

The focus of this article, the fourth in the series, Standards for Clinical Trials in Male and Female Sexual Dysfunction, is on aspects of clinical trial design and measurement that are specific to clinical trials for treatments of female sexual dysfunction. Challenges in this area include the limited extent of treatment development and clinical trial research across the spectrum of female sexual dysfunctions, changing regulatory considerations, changing diagnostic criteria for female sexual dysfunction, and the need to articulate assessment procedures to these changes. Discussion focuses on approaches to addressing these challenges in clinical trials in female sexual dysfunction.