Safety and efficacy of fractional CO2 laser treatment to the vestibule: a randomized, double-blind, sham-controlled, prospective 3-site clinical study in women with vestibular pain.

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

International Society for the Study of Women's Sexual Health (ISSWSH) Review of Epidemiology and Pathophysiology, and a Consensus Nomenclature and Process of Care for the Management of Persistent Genital Arousal Disorder/Genito-Pelvic Dysesthesia (PGAD/GPD).

BACKGROUND: Persistent genital arousal disorder (PGAD), a condition of unwanted, unremitting sensations of genital arousal, is associated with a significant, negative psychosocial impact that may include emotional lability, catastrophization, and suicidal ideation. Despite being first reported in 2001, PGAD remains poorly understood. AIM: To characterize this complex condition more accurately, review the epidemiology and pathophysiology, and provide new nomenclature and guidance for evidence-based management. METHODS: A panel of experts reviewed pertinent literature, discussed research and clinical experience, and used a modified Delphi method to reach consensus concerning nomenclature, etiology, and associated factors. Levels of evidence and grades of recommendation were assigned for diagnosis and treatment. OUTCOMES: The nomenclature of PGAD was broadened to include genito-pelvic dysesthesia (GPD), and a new biopsychosocial diagnostic and treatment algorithm for PGAD/GPD was developed. RESULTS: The panel recognized that the term PGAD does not fully characterize the constellation of GPD symptoms experienced by patients. Therefore, the more inclusive term PGAD/GPD was adopted, which maintains the primacy of the distressing arousal symptoms and acknowledges associated bothersome GPD. While there are diverse biopsychosocial contributors, there is a common underlying neurologic basis attributable to spontaneous intense activity of the genito-pelvic region represented in the somatosensory cortex and its projections. A process of care diagnostic and treatment strategy was developed to guide the clinician, whenever possible, by localizing the symptoms as originating in any of five regions: (i) end organ, (ii) pelvis/perineum, (iii) cauda equina, (iv) spinal cord, and (v) brain. Psychological treatment strategies were considered critical and should be performed in conjunction with medical strategies. Pharmaceutical interventions may be used based on their site and mechanism of action to reduce patients' symptoms and the associated bother and distress. CLINICAL IMPLICATIONS: The process of care for PGAD/GPD uses a personalized, biopsychosocial approach for diagnosis and treatment. STRENGTHS AND LIMITATIONS: Strengths and Limitations: Strengths include characterization of the condition by consensus, analysis, and recommendation of a new nomenclature and a rational basis for diagnosis and treatment. Future investigations into etiology and treatment outcomes are recommended. The main limitations are the dearth of knowledge concerning this condition and that the current literature consists primarily of case reports and expert opinion. CONCLUSION: We provide, for the first time, an expert consensus review of the epidemiology and pathophysiology and the development of a new nomenclature and rational algorithm for management of this extremely distressing sexual health condition that may be more prevalent than previously recognized. Goldstein I, Komisaruk BR, Pukall CF, et al. International Society for the Study of Women's Sexual Health (ISSWSH) Review of Epidemiology and Pathophysiology, and a Consensus Nomenclature and Process of Care for the Management of Persistent Genital Arousal Disorder/Genito-Pelvic Dysesthesia (PGAD/GPD). J Sex Med 2021;18:665-697.

Practical Treatment Considerations in the Management of Genitourinary Syndrome of Menopause.

Genitourinary syndrome of menopause is a condition comprising the atrophic symptoms and signs women may experience in the vulvovaginal and bladder-urethral areas as a result of the loss of sex steroids that occurs with menopause. It is a progressive condition that does not resolve without treatment and can adversely affect a woman's quality of life. For a variety of reasons, many symptomatic women do not seek treatment and, of those who do, many are unhappy with their options. Additionally, many healthcare providers do not actively screen their menopausal patients for the symptoms of genitourinary syndrome of menopause. In this review, we discuss the clinical presentation of genitourinary syndrome of menopause as well as the treatment guidelines recommended by the major societies engaged in women's health. This is followed by a review of available treatment options that includes both hormonal and non-hormonal therapies. We discuss both the systemic and vaginal estrogen products that have been available for decades and remain important treatment options for patients; however, a major intent of the review is to provide information on the newer, non-estrogen pharmacologic treatment options, in particular oral ospemifene and vaginal prasterone. A discussion of adjunctive therapies such as moisturizers, lubricants, physical therapy/dilators, hyaluronic acid, and laser therapy is included. We also address some of the available data on both the patient and healthcare providers perspectives on treatment, including cost, and touch briefly on the topic of treating women with a history of, or at high risk for, breast cancer.

A Clinical Reference Guide on Sexual Devices for Obstetrician-Gynecologists.

In the United States, more than half of all women have used a vibrator, nearly one third of women have used a dildo, and more than three quarters of women who have sex with women have used a vibrator. Sexual devices can be used by patients with decreased libido, anorgasmia, conditions inhibiting vaginal penetration, partner erectile dysfunction, and motor or sensory disabilities. Basic knowledge of sexual devices can help obstetrician-gynecologists counsel patients about device safety, sharing, cleaning, disinfection, and material selection. Common sexual devices include vibrators, penetrative devices, anal-specific devices, and air pulsation devices. Collision dyspareunia aids can assist patients who experience difficulty with deep penetration owing to pain and structural limitations. Although rare, the most common risks of sexual devices are traumatic injury and infection. Barrier use over sexual devices and proper disinfection can help reduce, but not eliminate, the risk of transmission of common viral and bacterial sexually transmitted infections. Sexual devices made of nonporous materials are the safest and easiest to clean and disinfect. Porous materials should be avoided given inability to disinfect and risk of material breakdown. Sexual devices can benefit specific patient populations, including women who are pregnant or postpartum, those with disorders of sexual function or pelvic floor, menopausal patients, cancer patients undergoing treatment, and women with disability and chronic illness.

Treatment of Vulvodynia: Pharmacological and Non-Pharmacological Approaches.

Vulvodynia is a common, recurrent, vulvar pain condition with debilitating consequences for affected women's health and quality of life. The heterogeneity of women suffering from vulvodynia as well as its uncertain and likely multifactorial etiology pose a significant challenge to identifying any kind of "gold standard" treatment. Thus, treatment providers must be well versed in the various options and the evidence for each. In this review, we begin with pharmacological treatments, followed by non-pharmacological treatments, surgery, and finally multimodal treatments. For each approach, we briefly discuss the method, mechanism of action, and empirical support for the treatment. In sum, pharmacological treatments that may be beneficial but require further research include antinociceptive agents (lidocaine, capsaicin), anti-inflammatory agents (corticosteroids, interferon), neuromodulating medications (anticonvulsants and antidepressants), hormonal agents, and muscle relaxants (e.g., botulinum toxin). There is strong evidence to support and recommend non-pharmacological interventions including psychological therapy, pelvic floor physical therapy, as well as surgery (i.e., vestibulectomy for provoked vestibulodynia) for the treatment of vulvodynia. We conclude this review with a discussion of issues that may have hindered progress of treatment efficacy and effectiveness, and recommendations for moving the field forward.

Thermal and Mechanical Pain Thresholds of Women With Provoked Localized Vulvodynia: A Pilot Study.

CONTEXT: Vulvodynia is a chronic pain condition defined as vulvar pain lasting at least 3 months in the absence of gross anatomic or neurologic findings. Provoked, localized vulvodynia (PLV), a subtype of vulvodynia, is characterized by vestibular pain in response to light touch. The cause of PLV remains largely unknown, and triggering events have yet to be determined. OBJECTIVE: To evaluate vestibular and peripheral experimental pain thresholds in patients with PLV to further define the somatosensory profile of these patients. METHODS: After informed consent was provided, eligible participants completed a questionnaire and underwent quantitative sensory testing at the forearm and posterior vestibule. Detection and pain thresholds to thermal (cold and heat) and mechanical (pressure) stimuli were measured. RESULTS: Seventeen participants with PLV and 16 control participants were included. Participants in the PLV group scored lower on the patient health questionnaire 9 (PHQ-9) compared with those in the control group (P<.05) and had higher ratings of self-reported genital pain with sex (P<.001) and daily activity (P<.05). Forearm pain thresholds to cold (P<.01) and heat (P<.01) stimuli were also lower in the PLV group compared with those in the control group. Vestibular pain thresholds to cold (P<.05) and pressure (P<.01) stimuli were also lower in the PLV group. CONCLUSION: Lower scores on the PHQ-9 and higher self-reported genital pain ratings of patients with PLV highlight the significant impact of this poorly understood condition on quality of life. Quantitative sensory testing results demonstrated that vestibular cold allodynia may be a somatosensory feature of PLV. Reduced forearm pain thresholds in these patients suggest altered sensory processing at extrapelvic sites, although it is unclear whether these measurements are related to central sensitization.

Bacterial vaginosis: a primer for clinicians.

Bacterial vaginosis (BV) affects approximately one third of women in the United States. While often asymptomatic, BV infection may be accompanied by serious health consequences, such as preterm birth and pelvic inflammatory disease, and may facilitate acquisition of sexually transmitted infections. Identifying appropriate patients for screening, such as pregnant women, women planning pregnancy, and women with multiple and/or new sexual partners, is imperative for treatment. Diagnosis of BV has traditionally depended on the presence of vaginal discharge and odor, elevated pH, and clue cells as determined by microscopy, but newer diagnostic modalities that utilize molecular techniques allow for more convenient and accurate testing for BV. Approved treatment options consist of antibiotics administered as oral or intravaginal formulations. Patient counseling and education regarding treatment options, including adherence to prescribed treatments, appropriate hygienic practices, and treatment of symptomatic same-sex partners, are crucial to optimize patient outcomes and prevent recurrence.

The role of androgens in the treatment of genitourinary syndrome of menopause (GSM): International Society for the Study of Women's Sexual Health (ISSWSH) expert consensus panel review.

OBJECTIVE: The objective of this consensus document is to broaden the perspective on clinical management of genitourinary syndrome of menopause to include androgens. METHODS: A modified Delphi method was used to reach consensus among the 14 international panelists representing multiple disciplines and societies. RESULTS: Menopause-related genitourinary symptoms affect over 50% of midlife and older women. These symptoms have a marked impact on sexual functioning, daily activities, emotional well-being, body image, and interpersonal relations. Tissues in the genitourinary system are both androgen and estrogen-dependent. The clitoris, vestibule, including minor and major vestibular glands, urethra, anterior vaginal wall, periurethral tissue, and pelvic floor are androgen-responsive. Historically, treatment of postmenopausal genitourinary symptoms involved both androgens and estrogens. This subsequently gave rise to predominantly estrogen-based therapies. More recently, double-blind, placebo-controlled clinical trials have demonstrated that local vaginal dehydroepiandrosterone improves symptoms in postmenopausal women, including moderate to severe dyspareunia. Limited data suggest that systemic testosterone treatment may improve vaginal epithelial health and blood flow. Open-label studies that have used high doses of intravaginal testosterone in the presence of aromatase inhibitor therapy for breast cancer have resulted in supraphysiological serum testosterone levels, and have been reported to lower vaginal pH, improve the vaginal maturation index, and reduce dyspareunia. CONCLUSIONS: Vaginal dehydroepiandrosterone, hypothesized to enhance local production of both androgen and estrogen, is effective for the management of dyspareunia in menopause. Vaginal testosterone offers potential as a treatment for genitourinary syndrome of menopause, but more studies are needed.

Vulvodynia: Assessment and Treatment.

INTRODUCTION: Vulvodynia constitutes a highly prevalent form of sexual pain in women, and current information regarding its assessment and treatment is needed. AIM: To update the scientific evidence published in 2010, from the Third International Consultation on Sexual Medicine, pertaining to the assessment and treatment of women's sexual pain. METHODS: An expert committee, as part of the Fourth International Consultation on Sexual Medicine, was comprised of researchers and clinicians from biological and social science disciplines for the review of the scientific evidence on the assessment and treatment of women's genital pain. MAIN OUTCOME MEASURES: A review of assessment and treatment strategies involved in vulvodynia. RESULTS: We recommend the following treatments for the management of vulvodynia: psychological interventions, pelvic floor physical therapy, and vestibulectomy (for provoked vestibulodynia). We also support the use of multidisciplinary treatment approaches for the management of vulvodynia; however, more studies are needed to determine which components are most important. We recommend waiting for more empirical evidence before recommending alternative treatment options, anti-inflammatory agents, hormonal agents, and anticonvulsant medications. Although we do not recommend lidocaine, topical corticosteroids, or antidepressant medication for the management of vulvodynia, we suggest that capsaicin, botulinum toxin, and interferon be considered second-line avenues and that their recommendation be revisited once further research is conducted. CONCLUSION: A comprehensive assessment is needed to understand the pain experience of women presenting with vulvodynia. In addition, treatment typically progresses from less invasive to more invasive, and several treatment options are worth pursuing.

Vulvodynia: Definition, Prevalence, Impact, and Pathophysiological Factors.

INTRODUCTION: Vulvodynia constitutes a highly prevalent form of chronic genital pain in women, and current information regarding its definition, prevalence, impact, and pathophysiologic factors involved is needed. AIM: To update the scientific evidence published in 2010 from the Third International Consultation of Sexual Medicine pertaining to the definition, prevalence, impact, and pathophysiologic factors of women's sexual pain. METHODS: An expert committee, as part of the Fourth International Consultation of Sexual Medicine, comprised of researchers and clinicians from biological and social science disciplines, reviewed the scientific evidence on the definition, prevalence, impact, and pathophysiologic factors related to chronic genital pain. MAIN OUTCOME MEASURES: A review of the definition, prevalence, impact, and pathophysiological factors involved in vulvodynia. RESULTS: Vulvodynia is a prevalent and highly impactful genital pain condition. Numerous factors have been implicated in its development and maintenance. CONCLUSION: What is becoming increasingly apparent is that it likely represents the end point of different factors that can differ from patient to patient. Longitudinal research is needed to shed light on risk factors involved in the expression of vulvodynia, as well as in potential subgroups of affected patients, in order to develop an empirically supported treatment algorithm.

Vulvar Dermatoses: A Primer for the Sexual Medicine Clinician.

INTRODUCTION: Vulvar dermatoses are common dermatological conditions that affect the vulva, and can cause considerable pain, irritation, pruritus, and burning, and have an adverse impact on a woman's sexual function. AIM: To provide an overview of the clinical features, etiology, and management options for the common vulvar dermatoses, including lichen sclerosus, lichen planus, lichen simplex, contact dermatitis, and vulvar psoriasis, and briefly describe the impact of vulvar dermatoses on sexual function. METHODS: The key words "vulvar dermatoses," "lichen sclerosus," "lichen planus," "lichen simplex chronicus," "vulvar dermatitis," and "vulvar psoriasis," were utilized to search Medline and PubMed for articles, with special attention given to those published within the past 5 years. MAIN OUTCOME MEASURE: Five hundred thirty-six results were generated from the literature search. Publications that were judged current and relevant to the pathophysiology, evaluation, and treatment of vulvar dermatoses were included in the review. RESULTS: Fifty-seven articles were selected for inclusion in this review. CONCLUSIONS: Vulvar dermatoses can cause chronic pain, itching, and dyspareunia, and can have a profound effect on a woman's sexual expression and comfort. Delay in diagnosis is often due to hesitancy to seek treatment on the part of the patient or delay in biopsy on the part of the provider. This can result in failed prescriptive and self-treatment measures, worsening symptoms, and frustration and sexual dysfunction for the patient, and potentially the development of squamous cell carcinoma. It is imperative for sexual medicine providers, who commonly treat women with vulvar concerns, to be familiar with the presentation, diagnosis, and treatment of common vulvar dermatoses and their effect on sexual function. Kellogg Spadt S and Kusturiss E. Vulvar dermatoses: A primer for the sexual medicine clinician. Sex Med Rev 2015;3:126-136.

Sexual health and religion: a primer for the sexual health clinician (CME).

INTRODUCTION: Sexual health is an integral part of the multifaceted human experience that is driven both by biological factors and psychological facets. Religion may provide a moral code of conduct or a sexual compass as to sexual norms and behaviors. AIM: The aim of this study was to summarize the integration of sexuality and religion. METHOD: A review of published literature and religious texts was conducted. RESULTS: The integration of religion with country or state politics and laws is a complicated dilemma and will not be discussed in the scope of this article. The extent to which an individual incorporates their religious doctrine into their sexual life is a personal and individualized choice. The sexual medicine health professional will likely encounter a diverse patient population of distinct religious backgrounds, and a primer on religion and sexuality is a much needed adjunctive tool for the clinician. CONCLUSION: Because religion can influence sexuality and dictate, in part, the behavioral and medical treatments for sexual complaints, the clinician should be familiar with religious guidelines regarding sexuality, and treatment should be customized and individualized. Failure to do so can impact compliance with the therapeutic interventions. Religious awareness also solidifies the therapeutic alliance between clinician and patient as it demonstrates respect and acknowledgment for patient's beliefs and autonomy.

Impact of vulvovaginal health on postmenopausal women: a review of surveys on symptoms of vulvovaginal atrophy.

Several recent, large-scale studies have provided valuable insights into patient perspectives on postmenopausal vulvovaginal health. Symptoms of vulvovaginal atrophy, which include dryness, irritation, itching, dysuria, and dyspareunia, can adversely affect interpersonal relationships, quality of life, and sexual function. While approximately half of postmenopausal women report these symptoms, far fewer seek treatment, often because they are uninformed about hypoestrogenic postmenopausal vulvovaginal changes and the availability of safe, effective, and well-tolerated treatments, particularly local vaginal estrogen therapy. Because women hesitate to seek help for symptoms, a proactive approach to conversations about vulvovaginal discomfort would improve diagnosis and treatment.

Urogynecological causes of pain and the effect of pain on sexual function in women.

Female Sexual Dysfunction (FSD) is a complex biopsychosocial phenomenon. Screening, identifying and managing urogenital and sexual symptoms often result in significant improvement in women's quality of life. Providers must proactively question patients about possible presence of FSD. When a sexual problem is present, identify the type of FSD, counsel patients on the appropriate approaches to treatment. No single therapeutic approach is effective in treating all types of FSD.