The impact of rurality on vulvodynia diagnosis and management: Primary care provider and patient perspectives.

Objective: The objective of this study was to better understand how rurality impacts the knowledge, diagnosis and management of vulvodynia by primary care providers (PCPs) practising in the geographically disparate province of Newfoundland and Labrador, Canada. Design: This was a qualitative case study using questionnaires and semi-structured interviews with PCPs, compared with semi-structured focus groups and interviews with vulvodynia patients conducted in a previous study phase. Results: Ten family physicians and 6 nurse practitioners participated. Over half had baseline knowledge that vulvodynia has a relatively high prevalence, but most underestimated the likelihood they would see a patient with vulvodynia in their practice. Three barriers to discussing and managing vulvodynia emerged: (1) discomfort initiating sexual/vulvar health conversations; (2) concerns about protecting patient privacy and confidentiality; and (3) time constraints and building therapeutic relationships. These issues were largely corroborated by previous findings with vulvodynia patients. Rural-informed solutions might include: (1) supporting increased education in vulvodynia and sexual health more broadly, including funding to attend continuing professional education and developing more clinical tools; (2) following practice guidelines regarding standardised initiation of sexual health conversations; (3) incentivising retention of rural providers and extending appointment times by reconsidering fee-for-service structures; and (4) researching a tailored vulvodynia toolkit and the potential advantage of mobile health units. Conclusion: Rurality exacerbates common concerns in the identification and management of vulvodynia. Acting on recommended solutions may address the impact of rurality on the provision of timely care for those experiencing vulvodynia and other sexual health concerns.

Résumé Objectif: Mieux comprendre l'impact de la ruralité sur la connaissance, le diagnostic et la prise en charge de la vulvodynie par les prestataires de soins primaires exerçant dans la province géographiquement disparate de Terre-Neuve-et-Labrador, au Canada. Conception: Étude de cas qualitative utilisant des questionnaires et des entretiens semi-structurés avec des prestataires de soins primaires, comparés à des groupes de discussion semi-structurés et à des entretiens avec des patientes atteintes de vulvodynie menés lors d'une phase précédente de l'étude. Résultats: Dix médecins de famille et six infirmières praticiennes y ont participé. Plus de la moitié d'entre eux savaient au départ que la vulvodynie a une prévalence relativement élevée, mais la plupart sous-estimaient la probabilité de voir une patiente atteinte de vulvodynie dans leur pratique. Trois obstacles à la discussion et à la prise en charge de la vulvodynie sont apparus: (1) la gêne à entamer des conversations sur la santé sexuelle/vulvaire; (2) les préoccupations relatives à la protection de la vie privée et de la confidentialité des patientes; et (3) les contraintes de temps et l'établissement de relations thérapeutiques. Ces problèmes ont été largement corroborés par les résultats obtenus précédemment avec des patientes atteintes de vulvodynie. Les solutions adaptées au milieu rural pourraient inclure (1) soutenir une meilleure formation sur la vulvodynie et la santé sexuelle en général, notamment le financement de la formation professionnelle continue et l'élaboration d'outils cliniques supplémentaires; (2) suivre les directives de pratique concernant l'amorce normalisée des conversations sur la santé sexuelle; (3) encourager la rétention des fournisseurs ruraux et prolonger les délais de rendez-vous en reconsidérant les structures de rémunération à l'acte; et 4) faire des recherches sur une trousse d'outils sur mesure pour la vulvodynie et sur l'avantage potentiel des unités de santé mobiles. Conclusion: La ruralité exacerbe les problèmes courants liés à l'identification et à la prise en charge de la vulvodynie. La mise en œuvre des solutions recommandées peut permettre de remédier à l'impact de la ruralité sur la fourniture de soins en temps opportun aux personnes souffrant de vulvodynie et d'autres problèmes de santé sexuelle. Mots-clés: Douleur vulvaire, dyspareunie, santé rurale, santé sexuelle, éducation sexuelle, structures tarifaires, administration des soins de santé, disparités géographiques dans les soins de santé, recherche qualitative, étude de cas qualitative.

Vulvodynia: A practical guide in treatment strategies.

Vulvodynia is a debilitating condition characterized by chronic vulvar pain, with a detrimental impact on the patient's overall quality of life. Its etiology is multifactorial, but still in the process of being clearly outlined. Vulvodynia is not a single entity. It is a heterogeneous condition characterized by multiple triggers, making it challenging to define a reference standard for its treatment. In this manuscript we selected all articles including the following key criteria: "vulvodynia". The primary outcomes observed included the resolution of chronic pelvic pain, dyspareunia and sexual satisfaction, psychological well-being, and overall quality of life. Most pharmacologic treatments require further evidence to be recommended. On the other hand, non-pharmacologic approaches such as psychotherapy, physical therapy, and surgery have received stronger support. This review summarizes pros and cons of adopting available treatments. Multimodal approaches should be introduced to improve patient outcomes. Further investigations are warranted to improve patients' quality of life.

Nocturnal Vulval Pain in Girls-A Subset of Vulvodynia?

OBJECTIVES: The aims of the authors' case series were to outline the clinical features of prepubertal nocturnal vulval pain syndrome and to look at management and outcomes. METHODS: Clinical details of prepubertal girls experiencing episodes of nocturnal vulval pain with no identifiable cause were recorded and analyzed. Parents completed a questionnaire to look at outcomes. RESULTS: Eight girls with age at onset of symptoms between 3.5 and 8 years (mean 4.4 years) were included. Each patient described intermittent episodes of vulval pain lasting between 20 minutes and 5 hours, starting 1-4 hours after falling asleep. They were crying and rubbing or holding the vulva with no obvious cause seen. Many were not fully awake and 75% had no recollection of the events. Management focused on reassurance alone. The questionnaire showed that 83% had full resolution of symptoms with a mean duration of 5.7 years. CONCLUSIONS: Prepubertal nocturnal vulval pain syndrome may be a subset of vulvodynia (generalized, spontaneous, intermittent) to be included in the clinical spectrum of night terrors. Recognizing the clinical key features should aid prompt diagnosis and reassurance of the parents.

"It's all my fault": a qualitative study of how heterosexual couples experience living with vulvodynia.

INTRODUCTION: Vulvodynia, a chronic genital pain disorder with a high lifetime prevalence among women, has a significant negative impact on both women and their partners. Although there is a growing body of literature on the experiences of women with vulvodynia, there has been little research on the condition's implications for partners and romantic relationships. The aim of this study is to explore how heterosexual couples experience living with vulvodynia. MATERIAL AND METHODS: Eight Norwegian women diagnosed with vulvodynia by gynecologists were recruited with their partners (couples aged 19-32 years). Data was collected via individual semi-structured interviews and analyzed using inductive thematic analysis. RESULTS: Three main themes were identified in the analysis: Mysterious disorder, Social exclusion and Sexual expectations. The results show that the couples struggle with understanding the pain, as well as navigating their social and sexual lives. We discuss these findings in light of a new theoretical model: the fear-avoidance-endurance model of vulvodynia. CONCLUSIONS: Heterosexual couples living with vulvodynia experience communication difficulties with partners, health professionals, and their social network. This sustains avoidance and endurance behavior, increasing pain and dysfunction over time and giving rise to feelings of powerlessness and loneliness. Social expectations regarding male and female sexuality also promote guilt and shame for both parties in couples affected by vulvodynia. Our results suggest that heterosexual couples living with vulvodynia, as well as health professionals treating them, should be helped to communicate more effectively in order to break vicious circles of maladaptive avoidance and endurance behavior.

Current Practices in Brazil on Diagnosis and Management of Women With Vulvodynia.

OBJECTIVE: Vulvodynia (VVD) is a frequent and harrowing condition for which diagnosis and management remain insufficient. Our study aimed to describe and compare vulvovaginal signs and symptoms of Brazilian women with VVD and controls and describe previous medical assessment, past treatments, and vulvar pain relief among women with VVD. METHODS: This cross-sectional descriptive study included Brazilian women with (n = 151) and without VVD (n = 106). All women were assessed for vaginal infection, vulvar pain intensity by means of a cotton swab test based on a numerical rate scale, and answered the Female Sexual Function Index questionnaire and a structured instrument about current vulvar symptoms. Previous treatments were assessed in the VVD group, and vulvar pain relief achieved with previous treatments was qualified through a 4-point Likert scale. RESULTS: Volunteers were mainly White, with mean age of 30 years. Vulvovaginal signs and symptoms were significantly more frequent in women with VVD (p < .05), and vulvar pain duration was 5.8 (±4) years. More than 50% consulted with three or more physicians, and 49% remained without a conclusive diagnosis. Previous diagnosis and treatment of vulvovaginal infection were often reported by women with VVD. Most of the tried prescriptions were self-reported as providing only low vulvar pain relief. CONCLUSIONS: Prolonged duration of vulvar pain, multiple visits to health care professionals, and poor relief of pain are common aspects in the clinical history of women with VVD. In addition to pain, vulvar fissure, edema, erythema, vaginal discharge, and foul odor are common and should be considered to avoid misdiagnosis. Appropriate treatments to VVD are still poorly reported.

Evaluation and Treatment of Vulvodynia: State of the Science.

Vulvodynia affects 7% of American women, yet clinicians often lack awareness of its presentation. It is underdiagnosed and often misdiagnosed as vaginitis. The etiology of vulvodynia remains unknown, making it difficult to identify or develop effective treatment methods. The purpose of this article is to (1) review the presentation and evaluation of vulvodynia, (2) review the research on vulvodynia treatments, and (3) aid the clinician in the selection of vulvodynia treatment methods. The level of evidence to support vulvodynia treatment varies from case series to randomized controlled trials (RCTs). Oral desipramine with 5% lidocaine cream, intravaginal diazepam tablets with intravaginal transcutaneous electric nerve stimulation (TENS), botulinum toxin type A 50 units, enoxaparin sodium subcutaneous injections, intravaginal TENS (as a single therapy), multimodal physical therapy, overnight 5% lidocaine ointment, and acupuncture had the highest level of evidence with at least one RCT or comparative effectiveness trial. Pre to posttest reduction in vulvar pain and/or dyspareunia in non-RCT studies included studies of gabapentin cream, amitriptyline cream, amitriptyline with baclofen cream, up to 6 weeks' oral itraconazole therapy, multimodal physical therapy, vaginal dilators, electromyography biofeedback, hypnotherapy, cognitive behavioral therapy, cold knife vestibulectomy, and laser therapy. There is a lack of rigorous RCTs with large sample sizes for the treatment of vulvodynia, rendering it difficult to determine efficacy of most treatment methods. Clinicians will be guided in the selection of best treatments for vulvodynia that have the highest level of evidence and are least invasive.

Exclusive manual perineal rehabilitation with lidocaine 2% gel in the treatment of provoked vestibulodynia: results from a single-arm interventional study.

As of now, there is no adequate therapeutic strategy for provoked vestibulodynia (PVD). Pelvic Floor Muscle Therapy (PFMT) is a widely used technique in general pelvic floor rehabilitation. The objective of this study is to examine the effects of exclusive manual perineal rehabilitation with lidocaine 2% gel on PVD. During the first session, recruited patients (n = 68; mean age 31 ± 8.6; range: 18-52) received a questionnaire (Q1) on general well-being and health, pain of the genital area, sexual function, and symptoms during vaginal penetration. This questionnaire was based on a generalised questionnaire on the quality of life, the Medical Outcomes Study 36-item (SF-36), the Female Sexual Function Index (FSFI), and the Visual Analogue Scale (VAS). A second identical questionnaire with an additional set of open-ended questions concerning the assessment of the treatment was collected after treatment (Q2). A total of 45 questionnaires were completed. Statistical results showed a significant improvement of all items before and after treatment (p < 0.001): perceived general well-being and health, perceived vulvar pain, perceived sexual function, and perceived vaginal penetration. In conclusion, exclusive manual perineal rehabilitation using lidocaine 2% gel seems to be a safe and effective treatment option for vulvodynia in women.

Image-based documentation of vulvodynia pain location.

Aims: Better documentation of vulvar pain is needed. We examined pain locations marked on general body and genital specific outlines among women with vulvodynia. Methods: 62 women (mean age 32.1 ± 9.5 years) with vulvodynia marked their pain on a digital genital specific outline (22 segments) and 59 of those women also marked their pain on a digital general body outline (48 segments). We used ImageJ software to determine body surface area (BSA) for each outline. Results: On the general body outline, 24/48 segments were marked; 22/22 segments were marked on the genital specific outline. There was a moderate correlation (r = 0.43; p = 0.001) between the BSA marked on the general body outline and the BSA marked on the genital area outline. Conclusions: Findings support concurrent validity of the BSA as a measure of pain location using either outline.

Women with genital pain need to be able to show their healthcare provider where they have pain, and providers need to document where women have pain. In total, 62 women with vulvodynia used a computer tablet to mark their pain on a general body outline and a genital specific outline. We used computer software to document the location of women's pain looking at percent body surface area. Women marked half of the segments on the general body outline and all the segments on the genital specific outline. Because women marked almost the same percent of body surface area on the general body outline as they did on the genital specific outline, percent body surface may be used to measure pain location.

Vulvodynia in prepubertal girls: diagnosis.

OBJECTIVES: To identify specific features of vulvodynia in prepubertal girls, highlight potential triggers and concomitant diseases, outline diagnostic criteria is neglected problem in adolescent gynecology. MATERIAL AND METHODS: A retrospective study, based on medical records of an outpatient clinic, a cohort of 54 vulvodynia cases was evaluated, aged 3-10 years, seen between January 2016 and July 2018. RESULTS: The study cohort presented with pain (61%), sometimes aggravated at night, pruritus (44%) and a range of other varied and unusual vulvar complaints (26%). Concomitant diseases and/or psychological problems were present in 61% of cases. Overactive pelvic muscles accompanying symptoms like urological or gastrological problems were noted in half of children. Several potential triggers were identified in a third of the cases that were emotionally stressful to the children. From the commencement of symptoms, 93% of the girls have consulted more than one doctor with 43% seeing more than three doctors, without receiving a diagnosis of vulvodynia. CONCLUSIONS: A diagnosis of vulvodynia needs to be considered in the absence of vulva pathology with wide range of vulvar pain, pruritus and discomfort. All persistent or recurrent vulvar discomfort must be taken into consideration as a vulvodynia symptom, also various non-specific, worrisome complaints. Comorbid urological and gastrological symptoms associated with overactive pelvic muscles should not be overlooked. Chronic pain can be triggered by the psychological distress in some prepubertal girls. Proper diagnosis may prevent long-term negative sequelae, what emphasizes the need for professional education of healthcare providers in adolescent vulvar pain and discomfort.

[Multidisciplinary examination and treatment of vulvodynia].

Women suffering from chronic vulvar pain seek help in the healthcare system on numerous occasions. The most common type is provoked localized vulvodynia (PVD) in which the pain has been persistent for more than three months without identifiable cause. The aetiology of PVD is multifactorial and the diagnosis is based upon medical history and gynaecological assessment including a bio-psycho-social evaluation. Danish and international guidelines point to the advantages of a multidisciplinary approach, where physical, psycho-sexual assessment is integrated in a multidisciplinary treatment programme as summarized in this review.

Vulvodynia - an evolving disease.

Vulvodynia is a common vulval pain syndrome that occurs most commonly in reproductive women of all ages. It can, in some cases, present for the first time after menopause. Up to about 15% of adult women have had symptoms of vulvodynia, with 4-5% currently symptomatic. Since there are no specific tests for diagnosis, vulvodynia is a diagnosis of exclusion. The condition is commonly associated with other chronic pain disorders and can be exceedingly debilitating, resulting in sexual dysfunction, severe depression and/or anxiety. It can significantly impair quality of life. Goals for long-term team approach management should be discussed with the patient at the commencement of each intervention as effectiveness of therapy is not assured. Currently, there is no intervention that effects cure in all individuals and a combination of pharmacological therapy, psychotherapy and physiotherapy, reserving surgery as a last-line option, is the best option for treatment. There are no long-term data on how long women will have symptoms and, if resolved, what provokes symptoms again in the future, whilst correlation between the etiology of vulvodynia and efficacy of treatment is not known.

Dysregulation in Sphingolipid Signaling Pathways is Associated With Symptoms and Functional Connectivity of Pain Processing Brain Regions in Provoked Vestibulodynia.

Provoked vestibulodynia (PVD) is a chronic pain disorder characterized by local hypersensitivity and severe pain with pressure localized to the vulvar vestibule. Despite decades of study, the lack of identified biomarkers has slowed the development of effective therapies. The primary aim of this study was to use metabolomics to identify novel biochemical mechanisms in vagina and blood underlying brain biomarkers and symptoms in PVD, thereby closing this knowledge gap. Using a cross-sectional case-control observational study design, untargeted and unbiased metabolomic profiling of vaginal fluid and plasma was performed in women with PVD compared to healthy controls. In women with PVD, we also obtained assessments of vulvar pain, vestibular and vaginal muscle tenderness, and 24-hour symptom intensity alongside resting-state brain functional connectivity of brain regions involved in pain processing and modulation. Compared to healthy controls, women with PVD demonstrated differences primarily in vaginal (but not plasma) concentrations of metabolites of the sphingolipid signaling pathways, suggesting localized effects in vagina and vulvar vestibule rather than systemic effects. Our findings reveal that dysregulation of sphingolipid metabolism in PVD is associated with increased vulvar pain and muscle tenderness, sexual dysfunction, and decreased functional connectivity strength in pain processing/modulatory brain regions. This data collectively suggests that alterations in sphingolipid signaling pathways are likely an important molecular biomarker in PVD that could lead to new targets for therapeutic intervention. PERSPECTIVE: This manuscript presents the results of a robust, unbiased molecular assessment of plasma and vaginal fluid samples in women with provoked vestibulodynia compared to healthy controls. The findings suggest that alterations in sphingolipid signaling pathways are associated with symptoms and brain biomarkers and may be an important molecular marker that could provide new targets for therapeutic intervention.

The Tampon Test as a Primary Outcome Measure in Provoked Vestibulodynia: A Mixed Methods Study.

BACKGROUND: Provoked vestibulodynia (PVD) is characterized by severe pain, often induced by penetrative sex. This may lead to women abstaining from sexual intercourse, hence the recording of pain intensity levels in PVD research is often challenging. The standardized tampon test was designed as an alternative outcome measure to sexual intercourse pain and has frequently been used in clinical studies. AIM: The aim of this mixed methods study is to evaluate the tampon test as a primary outcome measure for an upcoming randomized clinical trial for women with PVD. METHODS: An explanatory sequential design was applied, integrating quantitative and qualitative methods. In phase one, pain intensity levels were evaluated with the tampon test amongst 10 women, aged 18-33, with PVD. The test was repeated on day 1, 7 and 14. Pain intensity was rated on the Numerical Rating Scale (NRS), (0-10), 10 being worst possible pain. In phase two, the participants' experiences with the test were explored with semi-structured interviews using a descriptive and inductive qualitative design. All participants were recruited from the Vulva Clinic, Oslo University Hospital, Norway. OUTCOMES: The tampon test data and interviews were brought together to see how the interviews could refine and help to explain the quantitative findings. RESULTS: The tampon test data demonstrated large intra- and inter-individual variability. Median tampon pain intensity was 4.5 (min=1.7; max=10; Q1=2.5; Q3=6). Many experienced the test as an inadequate representation of pain during intercourse as it was less painful, different in nature and conducted in an entirely different context. Four participants had a mean score of four or lower on the NRS, whilst concurrently reporting high levels of pain during sexual intercourse. CLINICAL IMPLICATIONS: The findings indicate that the tampon test may underestimate severity of pain among some women with PVD. Participants with low pain scores would be excluded from studies where the tampon test is part of the trial eligibility criteria, even though severe pain was experienced during sexual intercourse. Large intra-individual variability in pain scores also reduces the test's ability to register clinical meaningful changes and hence necessitates repeated measurements per assessment time point. CONCLUSION: Although the tampon test has many advantages, this study indicates several potential problems with the application of the test as a primary outcome measure in PVD. In our opinion the test is most useful as a secondary outcome, preferably undertaken repeatedly in order to increase precision of the pain estimation. Kaarbø MB, Danielsen KG, Haugstad GK, et al. The Tampon Test as a Primary Outcome Measure in Provoked Vestibulodynia: A Mixed Methods Study. J Sex Med 2021;18:1083-1091.

Predictors of Mucosal and Muscle Pain in Vulvodynia: A Cross-Sectional Analysis From the National Vulvodynia Registry.

Diagnostic criteria for provoked vestibulodynia (PVD) rely on mucosal pain in the vulvar vestibule, with less emphasis on pain from pelvic floor muscles. It is unknown how psychosocial variables associated with PVD are differentially associated with mucosal versus muscle pain. Analysis of data from the National Vulvodynia Registry (n = 202) revealed several factors associated with increased mucosal pain: pain duration (P = .043), the McGill sensory subscore (P = .0086) and the Gracely pain scale (P< .001). Increased mucosal pain was also associated with decreased arousal (P = .036). On the other hand, factors significantly associated with greater muscle pain included number of comorbid pain conditions (P = .001), decreased intercourse frequency post PVD onset (P = .02) and higher scores on the McGill sensory (P = .0001) and affective (P = .0002) subscores, the Gracely pain scale (P = .0012), and state anxiety (P < .001). Sexual function was also significantly impacted by high pelvic floor muscular pain, with lower scores for arousal (P = .046), orgasm (P = .0014) and satisfaction (P = .013), and higher pain (P = .01). Significant differences in the relationship between muscle and mucosal pain for pain duration (P = .005), McGill affective score (P = .001), orgasm (P = .049), change in intercourse frequency (P = .027), and state anxiety (P = .030) suggest the possibility of mucosal or muscle pain predominant PVD subtypes. PERSPECTIVE: Patients with higher pelvic floor muscle pain scores than mucosal pain scores may represent different subgroups or characteristics of patients with provoked vestibulodynia. This research highlights the importance of assessment of the pelvic floor muscles in addition to the cotton swab test of the vestibule.

#ItsNotInYourHead: A Social Media Campaign to Disseminate Information on Provoked Vestibulodynia.

Provoked Vestibulodynia (PVD) is a type of localized vulvodynia (or pain in the vulva). The estimated prevalence of this condition is about 12% of the general population and approximately 20% of women under the age of 19. Many women who live with PVD suffer in silence for years before receiving a diagnosis. Whereas cognitive behavioral therapy (CBT) was already known to be effective for managing symptoms of PVD, there has recently been a published head-to-head comparison of CBT versus mindfulness-based therapy for the primary outcome of pain intensity with penetration. The trial revealed that both treatments were effective and led to statistically and clinically meaningful improvements in sexual function, quality of life, and reduced genital pain, with improvements retained at both 6- and 12-month follow-ups. We then undertook an end-of-grant knowledge translation (KT) campaign focused on the use of social media to disseminate an infographic video depicting the findings. Social media was strategically chosen as the primary mode of dissemination for the video as it has broad reach of audience, the public can access information on social media for free, and it presented an opportunity to provide social support to the population of women with PVD who are characterized as suffering in silence by starting a sensitive and empowering dialogue on a public platform. In this paper, we summarize the social media reach of our campaign, describe how and why we partnered with social media influencers, and share lessons learned that might steer future KT efforts in this field.

Vulvodynia.

Vulvodynia is a heterogenous, chronic pain condition of unknown etiology that affects 7% to 15% of women. It affects sexual function and quality of life. Vulvodynia can be primary or secondary, localized or generalized, and spontaneous or provoked. Contributing factors for provoked vulvodynia might include vulvovaginal infections, low estrogen states, and underlying anxiety disorder. Generalized vulvodynia likely arises from underlying connective tissue or neurological dysfunction. Vulvodynia treatment must be individualized on the basis of the patient's presentation and physical examination findings. Surgical excision of the vulvar vestibule has high success rates but other modalities showing success include pelvic floor physical therapy and cognitive-behavioral therapy.

Common Benign Chronic Vulvar Disorders.

Common benign chronic vulvar conditions include genitourinary syndrome of menopause (formerly called vulvovaginal atrophy), lichen sclerosus, lichen planus, lichen simplex chronicus, and vulvodynia. Genitourinary syndrome of menopause results from the hypoestrogenic state that leads to atrophy of normal vulvar and vaginal tissues. It is typically treated with lubricants, moisturizers, and intravaginal estrogen. Lichen sclerosus is an inflammatory condition characterized by intense vulvar itching. It is treated with topical steroids or, in some cases, topical calcineurin inhibitors. Patients with lichen sclerosus are at risk of vulvar squamous cell carcinoma and should be monitored closely for malignancy. Lichen planus is an inflammatory autoimmune disorder that can affect the vulva and vagina in addition to other skin and mucosal surfaces. The first-line treatment is topical steroids, and significant scarring can occur if left untreated. Lichen simplex chronicus manifests as persistent itching and scratching of the vulvar skin that leads to thickened epithelium. Breaking the itch-scratch cycle, often with topical steroids, is the key to treatment. Vulvodynia is a common vulvar pain disorder and is a diagnosis of exclusion. A multimodal treatment approach typically includes vulvar hygiene, physical therapy, psychosocial interventions, and antineuropathy medications.

The Vulvodynia Experience Questionnaire: Qualitative Development of a New Patient-Reported Outcome Measure for Vulvodynia.

INTRODUCTION: Vulvodynia is defined as vulvar pain of at least 3 months duration without a clear identifiable cause. There are currently no validated questionnaires that assess the experience of women with localized vulvodynia of the vestibule (vestibulodynia, previously known as vulvar vestibulitis) that meet the requirements of the Food and Drug Administration's Patient Reported Outcome (PRO) Guidance. AIM: To develop a new content-valid PRO assessment in accordance with the Food and Drug Administration's PRO guidance to assess the symptoms and impacts of localized vulvodynia. MATERIAL AND METHODS: Participants were recruited for concept elicitation interviews (ie, interviews with open-ended questions with the goal of eliciting volunteered data about the symptoms and impacts of vulvodynia). Participants were identified as having localized vulvodynia by clinicians who were experts in treating vulvar disorders. Eligibility was confirmed by the recruiting clinician, and informed consent was obtained; participants were then scheduled for in-person interviews. 25 participants were interviewed from United States (US). After concept elicitation interviews, the draft Vulvodynia Experience Questionnaire (VEQ) was developed based on the results. Cognitive interviews were conducted with 20 participants from US sites to assess the content validity of the VEQ (eg, interpretation and clarity of the items, relevance of concepts). The VEQ was further revised after cognitive interviews. All interviews were conducted face-to-face, audio-recorded, transcribed verbatim, anonymized, and analyzed using a qualitative data analysis software program. RESULTS: 17 unique symptoms and 32 unique impacts were reported during concept elicitation interviews. Pain (n = 25, 100%) and burning (n = 24, 96%) were the most frequently reported symptoms of localized vulvodynia, and negative impact on emotional well-being (n = 25, 100%) was the most frequently reported impact. After analysis, item generation, and cognitive interviews, the resulting VEQ v2.0 contains 3 parts (part 1, pain; part 2, associated symptoms; part 3, impacts) with a total of 25 items that measure the most frequently reported symptoms and impacts of localized vulvodynia. STRENGTH AND LIMITATIONS: The VEQ is a multidimensional assessment of the core symptoms and impacts of localized vulvodynia that, after additional psychometric testing including the ability to detect change, may be used in clinical trials to characterize the benefits of novel treatments. The VEQ requires additional testing to establish its cultural relevance and linguistic validity in other countries. CONCLUSION: The VEQ is a novel method of collecting information on localized vulvodynia symptoms and impacts that may be suitable for use in clinical trials after psychometric testing. Goldstein AT, Diez PMQ, Kapanadze S, et al. The Vulvodynia Experience Questionnaire: Qualitative Development of a New Patient-Reported Outcome Measure for Vulvodynia. J Sex Med 2020;17:2055-2066.