Vaginal Dilators: Issues and Answers.

INTRODUCTION: Vaginal dilators are often prescribed to facilitate an adaptive brain-body connection to decrease anxiety and pain that can be experienced in anticipation of sexual intercourse among populations of women with sexual pain syndromes. Postmenopausal women, cancer survivors, and women with a wide variety of pelvic floor disorders who experience genito-pelvic pain/penetration disorder (GPPPD) are often advised to incorporate vaginal dilators into their pelvic floor rehabilitation program and treatment regimens to enable penetrative intercourse with less pain. However, little is known about the behaviors of dilator users, what treatment protocols are most effective, how patients are currently using their dilators, and how effective are clinicians in helping their patients achieve success with their dilation therapy. METHODS: A recent PubMed literature search was performed using the key words vaginal dilator, vaginal dilator therapy, sexual quality of life, vaginal stenosis, vaginal dilation, vaginismus. A total of 29 English articles were reviewed and summarized. Articles were excluded for the following reasons: not in English and unrelated to dilator therapy. MAIN OUTCOME MEASURE: This article will summarize the current research on vaginal dilators and discuss needs for future research to maximize patients' compliance and success with this treatment. Much of the summary data regarding user behavior will come from the early survey data with Milli, a novel, patient-controlled electronic dilator that slowly expands 1 mm at a time from its smallest diameter, 15 mm to a maximum diameter of 40 mm. Milli is currently being used by more than 1,000 women, and 3-month follow-up data were recorded on 335 of those patients. RESULTS: Dilators exist in multiple forms (plastic, latex, and medical grade material), may come individually or in sets, and many have special features such as vibration or the ability to be heated or cooled before use. Little is known about patients' use of dilators and the Milli's 3-month survey serves as an insight to patient dilator behavior. The most common medical goals for patients undergoing dilation treatment were return to penetrative intercourse and pain reduction during coitus. Patients were dilated on average 2.72 days/week; 56.8% of patients had suffered from sexual pain for 2 or more years and 36.3% had previously used static dilators. More than 70% of Milli users purchased Milli and are using Milli without the direct guidance of a clinician. The most common emotions patients used to describe their treatment were not only "anxious," "frustrated," but also "empowered" and "optimistic." The most common dilatory session duration was 6-10 minutes, mostly in the evening/bedtime (68.3%), located in the bedroom (96.8%). Adjunctive treatment included the following: vaginal moisturizers, local estrogen products, coital lubricants, and genital pelvic floor physical therapy. During the dilation sessions, women most often watched TV/videos, practiced mindfulness, or listened to soothing music. Factors that showed trends toward improved patient outcomes were length of dilation treatment (greater than 3 months) and use of meditation and soothing music. Factors not associated with improvement trends were as follows: when/where patients dilated and patient demographics including age, race, or religious preferences. CONCLUSION: Patients who purchase dilators have often suffered with their condition for a long time and had difficulty finding a competent health-care clinician well versed in sexual pain syndromes that can help them. When patients did find a clinician, there were no clinically proven standardized protocols or formalized guidelines to give to patients about how to best use their dilators. Larger long-term interventions investigating a standardized dilation protocol are planned in future studies to better elucidate the effective and optimal dilation treatment plans. Liu M, Juravic M, Mazza G, et al. Vaginal Dilators: Issues and Answers. Sex Med Rev 2021;9:212-220.

Sleep and Sex: A Review of the Interrelationship of Sleep and Sexuality Disorders in the Female Population, Through the Lens of Sleeping Beauty Syndrome.

INTRODUCTION: For many, sleep and sex are crucial for physical, emotional, and mental well-being. Poor sleep quality is linked to a myriad of ailments from coronary artery disease to major depressive disorder. Likewise, a decrease in the frequency of sexual activity is associated with a decrease in self-rated health status. Kleine-Levin syndrome (KLS) is a rare sleep disorder that provides a unique lens to examine the intricate interplay between sleep and sex as it is one of the few sleep disorders defined by concomitant sexual dysfunction. OBJECTIVES: This study reviews the literature on links between sleep disorders and sexuality with a focus on women's health followed by a case study of unusual patient with KLS with persistent genital arousal disorder. METHODS: Literature searches were conducted for English language publications, including foreign language publications with English abstracts with ninety-five articles reviewed. The literature review is followed by a case report. RESULTS: We review the known literature linking sleep and women's sexual health with a focus on insomnia, circadian rhythm sleep disorder, obstructive sleep apnea, restless leg syndrome, sexsomnia, and KLS. We then present a case of KLS-associated persistent genital arousal disorder, which was amenable to treatment with a multimodal approach aimed at symptomatic relief with intravaginal diazepam suppositories, topical clitoral lidocaine, and duloxetine. CONCLUSION: This case highlights that hypersexuality and persistent arousal cannot effectively be treated in isolation but rather must be contextualized within a patient's broader medical history and diagnoses. Specifically, sleep quality and potential sleep disorders should be assessed for those presenting with sexual health complaints (and vice versa). Zwerling B, Keymeulen S, Krychman ML. Sleep and Sex: A Review of the Interrelationship of Sleep and Sexuality Disorders in the Female Population, Through the Lens of Sleeping Beauty Syndrome. Sex Med Rev 2021;9:221-229.

Rethinking the techno vagina: a case series of patient complications following vaginal laser treatment for atrophy.

OBJECTIVE: The treatment of genitourinary syndrome of menopause (GSM) includes prescription hormone therapy, nonhormonal over-the-counter products, and most recently, laser treatment. Although the Food and Drug Administration has cleared fractional carbon dioxide (CO2) laser for a variety of dermatologic and gynecologic indications, lasers have not to date, been approved for use for vulvar/vaginal atrophy, or sexual dysfunction. METHODS: Four case studies that were referred to a tertiary sexual medicine center regarding laser treatment complications for GSM are reported. Patient data were Health Insurance Portability and Accountability Act of 1996 protected and informed consent was obtained by all patients. RESULTS: Four cases are presented, which demonstrate complications after completion of three consecutive laser treatments for GSM. Case 1 is a 65-year-old woman with GSM and moderate vaginal stenosis who had two vaginal wall lacerations after resumption of intercourse. Case 2 is a 61-year-old woman who had persistent dyspareunia following vaginal laser treatments. Case 3 is a 68-year-old woman who reported worsening dyspareunia and had a fibrous band mid vagina that impinged on the canal. Case 4 is a 55-year-old woman who complained of dyspareunia and insertional pain, after her laser. Assessment and follow-up treatment are presented. CONCLUSIONS: Laser therapy for the vagina shows excellent promise for the treatment of GSM in some women; however, complications such as fibrosis, scarring, agglutination, and penetration injury have been documented. Food and Drug Administration-approved products for GSM should be considered frontline treatments until long-term, prospective, randomized, sham-controlled trials are conducted that confirm efficacy and safety for device treatments.

Women's experience of vulvovaginal symptoms associated with menopause.

OBJECTIVE: This study describes women's experiences of the genitourinary syndrome of menopause (GSM) elicited through focus groups and cognitive debriefing sessions during development of a novel patient-reported outcome measure (PROM) designed for use in both clinical care and research. METHODS: A draft questionnaire to identify and assess bothersome genitourinary symptoms associated with estrogen deficiency in menopausal women was developed in five discrete phases from multiple sources of information in accordance with standards for PROM development. GSM was confirmed by report of symptoms in conjunction with a confirmatory pelvic examination and laboratory assessments. RESULTS: Qualitative content interviews were completed in 36 menopausal women with GSM. Cognitive testing of draft PROM items was performed in nine focus groups, including 26 menopausal women with and 15 without GSM. Participants reported a range of symptoms and described associated impacts on more than 15 quality-of-life domains. The majority of women reported that their symptoms impacted their sexual functioning and had a negative effect on their overall quality of life. GSM affected many aspects of menopausal women's lives beyond sexual function, with descriptions of pain when walking, urinating, wearing tight clothes, and with other activities of daily living. CONCLUSIONS: Women's own words methodically recorded and analyzed during qualitative interviews and cognitive debriefing focus groups illuminate the subjective experience of women with GSM. It is hoped that the PROM currently in development will provide an effective tool for increasing our understanding of the prevalence, predictors, and impact of GSM in menopausal women's lives.

Management of genitourinary syndrome of menopause in women with or at high risk for breast cancer: consensus recommendations from The North American Menopause Society and The International Society for the Study of Women's Sexual Health.

The objective of The North American Menopause Society (NAMS) and The International Society for the Study of Women's Sexual Health (ISSWSH) Expert Consensus Panel was to create a point of care algorithm for treating genitourinary syndrome of menopause (GSM) in women with or at high risk for breast cancer. The consensus recommendations will assist healthcare providers in managing GSM with a goal of improving the care and quality of life for these women. The Expert Consensus Panel is comprised of a diverse group of 16 multidisciplinary experts well respected in their fields. The panelists individually conducted an evidence-based review of the literature in their respective areas of expertise. They then met to discuss the latest treatment options for genitourinary syndrome of menopause (GSM) in survivors of breast cancer and review management strategies for GSM in women with or at high risk for breast cancer, using a modified Delphi method. This iterative process involved presentations summarizing the current literature, debate, and discussion of divergent opinions concerning GSM assessment and management, leading to the development of consensus recommendations for the clinician.Genitourinary syndrome of menopause is more prevalent in survivors of breast cancer, is commonly undiagnosed and untreated, and may have early onset because of cancer treatments or risk-reducing strategies. The paucity of evidence regarding the safety of vaginal hormone therapies in women with or at high risk for breast cancer has resulted in avoidance of treatment, potentially adversely affecting quality of life and intimate relationships. Factors influencing decision-making regarding treatment for GSM include breast cancer recurrence risk, severity of symptoms, response to prior therapies, and personal preference.We review current evidence for various pharmacologic and nonpharmacologic therapeutic modalities in women with a history of or at high risk for breast cancer and highlight the substantial gaps in the evidence for safe and effective therapies and the need for future research. Treatment of GSM is individualized, with nonhormone treatments generally being first line in this population. The use of local hormone therapies may be an option for some women who fail nonpharmacologic and nonhormone treatments after a discussion of risks and benefits and review with a woman's oncologist. We provide consensus recommendations for an approach to the management of GSM in specific patient populations, including women at high risk for breast cancer, women with estrogen-receptor positive breast cancers, women with triple-negative breast cancers, and women with metastatic disease.

Developing a post-treatment survivorship care plan to help breast cancer survivors understand their fertility.

PURPOSE: Reproductive-aged breast cancer survivors (BCS) who have completed initial cancer treatment frequently want to know about their future fertility potential. The purpose of this qualitative study was to assess if the fertility-related content presented in the survivorship care plan prototype met the informational needs of post-treatment BCS and to provide an opportunity for the target audience to review and react to the proposed content and design. METHODS: We conducted and analyzed transcripts from seven focus groups with BCS to evaluate their reactions to the survivorship care plan prototype. We independently coded transcripts for consistent themes and sub-themes and used a consensus-building approach to agree on interpretation of results. RESULTS: We identified five themes that describe the post-treatment BCS' responses to the prototype survivorship care plan in the context of their informational needs and experiences: (1) the prototype's fertility-related information is relevant; (2) desire for clinical parameters to help survivors understand their infertility risk; (3) fertility-related information is important throughout survivorship; (4) evidence-based content from a neutral source is trustworthy; and (5) the recommendation to see a fertility specialist is helpful, but cost is a barrier. CONCLUSIONS: BCS have concerns and needs related to their fertility potential after initial breast cancer treatment. The evidence-based information offered in our prototype survivorship care plan was acceptable to BCS and has significant potential to address these needs. Additional primary data that identify post-cancer treatment indicators of fertility would advance this effort.

Management of sexual dysfunction in breast cancer survivors: a systematic review.

Female sexual dysfunction occurs frequently in midlife breast cancer survivors (BCS) and encompasses problems with sexual desire, interest, arousal, orgasm and genitopelvic pain. Although common, sexual problems are under-diagnosed and under-treated in BCS. The objective of this review was to assess primary studies that intervene on sexual dysfunction in BCS. In February 2015, PubMed, SCOPUS, CINAHL, COCHRANE and Web of Science databases were systematically searched for randomized controlled clinical trials (RCTs) of vaginal (lubricants, moisturizers, estrogens, dehydroepiandrosterone [DHEA], testosterone, vibrators, dilators), systemic (androgens, anti-depressants, flibanserin, ospemifene), physical therapy (physical activity, pelvic floor training), counseling and educational interventions on sexual function in BCS. Observational studies of vaginal interventions were also included due to the paucity of RCTs. The search yielded 1414 studies, 34 of which met inclusion criteria. Both interventions and outcomes, measured by 31 different sexual function scales, were heterogeneous, and therefore data were not pooled. The review found that regular and prolonged use of vaginal moisturizers was effective in improving vaginal dryness, dyspareunia, and sexual satisfaction. Educational and counseling interventions targeting sexual dysfunction showed consistent improvement in various aspects of sexual health. No consistent improvements in sexual health were observed with physical activity, transdermal testosterone or hot flash interventions. There was a lack of BCS-specific data on vaginal lubricants, vibrators, dilators, pelvic floor therapy, flibanserin or ospemifene. Overall, the quality of evidence for these studies was moderate to very low. Because each of the interventions with BCS data had limited efficacy, clinical trials to test novel interventions are needed to provide evidence-based clinical recommendations and improve sexual function in BCS.

Sexual dysfunction in female cancer survivors.

Cancer survivors face a myriad of long-term effects of their disease, diagnosis, and treatment, and chief among many are problems associated with sexual dysfunction. Yet despite their frequency and the degree of distress they cause patients, sexual dysfunction is not effectively screened for or treated, and this is particularly true in female survivors. Inconsistently performed general sexual health screening at all facets of cancer care and survivorship ultimately translates into missed attempts to identify and treat dysfunction when it does arise. In this paper, we will review the current research and clinical practices addressing sexual dysfunction in female cancer survivors and propose questions in need of future research attention. This article will review the phases of sexual response and how each may be affected by the physical and emotional stress of cancer diagnosis and treatment. We will then discuss existing tools for assessment of sexual function and approaches to their treatment. Finally, we will conclude with advice to health care professionals based on current research and suggest questions for future study.

Laxity of the vaginal introitus after childbirth: nonsurgical outpatient procedure for vaginal tissue restoration and improved sexual satisfaction using low-energy radiofrequency thermal therapy.

INTRODUCTION: Vaginal childbirth may result in vaginal introital laxity, altered genital sensation during sexual intercourse, and reduced sexual satisfaction. We report the long-term effectiveness of a single nonsurgical procedure with radiofrequency (RF) energy for laxity at the vaginal introitus. MATERIALS AND METHODS: Prospective single-arm study of 30 premenopausal women (21-52 year) with one 30-minute office procedure using RF applied to the vaginal introitus; 12-month outcome assessments included the linguistic validated Japanese versions of the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised (FSDS-R) and the Vaginal Laxity and Sexual Satisfaction Questionnaires. RESULTS: Sexual function improved significantly throughout 6 months (30 subjects); mean FSFI total score was 22.4±6.7 before treatment and then improved to mean 26.0±5.8 at month 6 (P=0.002), inclusive of improved scores in five of six FSFI domains except desire (P<0.001 -<0.01). In the 22 of 30 subjects remaining evaluable at 12 months, the mean was 26.0±5.2 (P=0.08). Distress related to sexual activity decreased significantly; baseline FSDS-R mean score of 15.8±11.7 improved to 9.8±8.0 at one month and was sustained throughout 12 months (P<0.001 - 0.002). Subjects reported decreased vaginal laxity within the first month after the procedure (P<0.001); responses peaked, and effectiveness was sustained through 12 months (P<0.001). CONCLUSIONS: A single nonsurgical office-based RF procedure for vaginal introital laxity achieved significant and sustainable 12-month effectiveness with respect to improved integrity at the vaginal introitus and improved sexual satisfaction. Treatment was well-tolerated with no adverse events.

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.

Vulvar and vaginal atrophy in postmenopausal women: findings from the REVIVE (REal Women's VIews of Treatment Options for Menopausal Vaginal ChangEs) survey.

INTRODUCTION: Vulvar and vaginal atrophy (VVA) is a chronic medical condition experienced by many postmenopausal women. Symptoms include dyspareunia (pain with intercourse), vaginal dryness, and irritation and may affect sexual activities, relationships, and activities of daily life. AIM: The aim of this study is to characterize postmenopausal women's experience with and perception of VVA symptoms, interactions with healthcare professionals (HCPs), and available treatment options. METHODS: An online survey was conducted in the United States in women from KnowledgePanel(®) , a 56,000-member probability-selected Internet panel projectable to the overall US population. Altogether, 3,046 postmenopausal women with VVA symptoms (the largest US cohort of recent surveys) responded to questions about their knowledge of VVA, impact of symptoms on their activities, communication with HCPs, and use of available treatments. MAIN OUTCOME MEASURES: Percent is calculated as the ratio of response over total responding for each question for all and stratified participants. RESULTS: The most common VVA symptoms were dryness (55% of participants), dyspareunia (44%), and irritation (37%). VVA symptoms affected enjoyment of sex in 59% of participants. Additionally, interference with sleep, general enjoyment of life, and temperament were reported by 24%, 23%, and 23% of participants, respectively. Few women attributed symptoms to menopause (24%) or hormonal changes (12%). Of all participants, 56% had ever discussed VVA symptoms with an HCP and 40% currently used VVA-specific topical treatments (vaginal over-the-counter [OTC] products [29%] and vaginal prescription therapies [11%]). Of those who had discussed symptoms with an HCP, 62% used OTC products. Insufficient symptom relief and inconvenience were cited as major limitations of OTC products and concerns about side effects and cancer risk limited use of topical vaginal prescription therapies. CONCLUSIONS: VVA symptoms are common in postmenopausal women. Significant barriers to treatment include lack of knowledge about VVA, reluctance to discuss symptoms with HCPs, safety concerns, inconvenience, and inadequate symptom relief from available treatments.

Resistance and barriers to local estrogen therapy in women with atrophic vaginitis.

INTRODUCTION: Vaginal atrophy results from a decrease in circulating estrogen and is experienced by approximately 50% of postmenopausal women. Its symptoms affect multiple dimensions of genitopelvic health, sexuality, and overall quality of life. Nonhormonal over-the-counter treatments may provide temporary symptom relief, but the condition is progressive, and hormonal treatment may be warranted. AIM: The study aims to review the literature and discuss the impact of atrophic vaginitis and various treatment options, including the resistance and barriers to the use of local estrogen therapy for atrophic vaginitis. This article also aims to provide a greater awareness of the condition and the difficulties in communicating effectively with patients, and to provide strategies to help healthcare professionals acquire effective communication skills to initiate a candid dialogue with patients who may be suffering in silence and may benefit from therapy. METHODS: This review was based on peer-reviewed publications on the topic of atrophic vaginitis and local estrogen therapy identified from key word searches of PubMed, in addition to landmark studies/surveys and treatment guidelines/recommendations on menopause available in the literature and on the Internet. MAIN OUTCOME MEASURES: The main outcomes are the impact of atrophic vaginitis and the various treatment options, including the resistance and barriers to the use of local estrogen therapy. RESULTS: Minimally absorbed local vaginal estrogen therapy enables administration of estrogen doses much lower than systemic doses used for vasomotor symptoms. Local therapy is also the first-line pharmacologic treatment recommended by the North American Menopause and International Menopause Societies. Despite treatment options, the sensitive nature of the condition and embarrassment may prohibit or limit many women from openly discussing symptoms with healthcare professionals. Many are hesitant to initiate hormonal treatment because of safety concerns. CONCLUSIONS: Healthcare professionals should initiate and encourage frank and candid conversation about vaginal atrophy at annual visits and provide follow-up and treatment as needed.

Characteristics of premenopausal and postmenopausal women with acquired, generalized hypoactive sexual desire disorder: the Hypoactive Sexual Desire Disorder Registry for women.

OBJECTIVE: Little is known about the natural history of hypoactive sexual desire disorder (HSDD). We examined the sociodemographic, relationship, help seeking, sexual function, and medical characteristics of women with a clinical diagnosis of generalized, acquired HSDD by menopause status. METHODS: This study was a cross-sectional baseline data analysis from the HSDD Registry for Women (N = 1,574, from 33 US clinical sites). HSDD was clinically diagnosed and confirmed. Validated measures of sexual function, relationship factors, and health, as well as newly developed questions on help seeking were assessed using the questionnaire. RESULTS: Participants were predominantly married or living with a partner (81.7%) and represented a range of race/ethnic backgrounds and ages (mean ± SD, 42.9 ± 11.9 y). Most (56.8%) described their HSDD severity as "moderate to severe," with 26.5% rating the problem severe. Nonetheless, most women (69.8%) reported being happy in their relationship, and 61.8% were satisfied with their partner communication. Postmenopausal women had lower Female Sexual Function Index total scores, indicating worse sexual function (14.0 ± 7.5) than premenopausal women (16.7 ± 6.8, P < 0.001), although both groups had similarly low scores on the sexual desire domain (3.4 ± 1.3 vs 3.3 ± 1.4). Less than half of the overall sample had sought professional help, among whom hormonal treatments had been used by 23.7% of postmenopausal women and by 7.6% of premenopausal women. CONCLUSIONS: Most women with HSDD were in long-term partner relationships with high levels of overall relationship satisfaction. Postmenopausal women were more likely to seek help for their disorder, despite similarly high levels of distress associated with HSDD. Further research is needed to examine treatment outcomes.

Breast cancer and sexuality: multi-modal treatment options.

The sexual consequences of breast cancer and its treatments are well known and previously reviewed. Alterations in body image, with or without breast reconstruction, changes in sexual self-esteem and self-efficacy, vulvovaginal atrophy as a result of chemotherapy and/or adjuvant hormone therapy, and loss of libido secondary to dyspareunia and body image issues are common in survivors of breast cancer. Medications that are prescribed for long-term use including those in the class of aromatase inhibitors can have far-reaching implications on quality of life by contributing to vulvar and vaginal atrophic changes. While this is an important issue, there are few widely accepted treatments that have been evaluated for efficacy and safety for these sexual challenges in the breast cancer population. However, progress is being made in finding new and innovative solutions for many of the sexual problems faced by breast cancer survivors and their partners. Many institutions are now compelled to address survivorship concerns and addressing sexuality and intimacy are paramount issues in survivorship care. In this article, we present the evidence for the multimodal approach to the management of sexuality concerns in the breast cancer survivor. Pharmacologic, nonpharmacologic, and psychosocial interventions will be reviewed.