A randomized trial on the effectiveness and safety of 5 water-based personal lubricants.

BACKGROUND: A range of personal lubricants with different formulations and subsequent properties are available for relief of discomfort associated with vaginal dryness; however, there are limited clinical data to support the efficacy and safety of many commercially available lubricants. AIM: To determine the effectiveness and safety of 5 water-based personal lubricants for the relief of intimate discomfort associated with vaginal dryness in pre- and postmenopausal women: 4 that were formulated to meet the World Health Organization (WHO) guidelines for osmolality and pH and 1 preexisting lubricant of higher osmolality and pH. METHODS: An open-label, parallel-design study was performed in women aged 18 to 65 years with mild-to-moderate vaginal dryness and dyspareunia. Participants were randomized to 1 of 5 lubricants (A-E) from 3 brands (Durex, KY, Queen V). They were instructed to use their allocated lubricants during vaginal intercourse at least once a week over a 4-week period. The Female Sexual Function Index (FSFI) measured sexual functioning after 4 weeks of use as an indicator of lubricant performance. OUTCOMES: The primary outcome was change from baseline in total FSFI score after 4 weeks of product use. RESULTS: A total of 174 women completed the study. The primary end point-a prespecified increase in FSFI ≥4 points from baseline after 4 weeks of use-was met by all 5 lubricants tested. A statistically significant improvement was observed across all 6 domains of the FSFI from baseline to 4 weeks of use with all 5 lubricants (P < .0001 for lubrication and pain reduction and P < .05 for all other domains). No serious adverse events occurred in the study, and the tolerance of all 5 lubricants was good/very good. CLINICAL IMPLICATIONS: The efficacy and safety of the tested lubricants are not compromised when formulated to meet the WHO criterion of osmolality ≤1200 mOsm/kg. The lubricants tested in this investigation can be used not only to relieve symptomatology of vaginal dryness and dyspareunia but also to enhance overall sexual satisfaction. STRENGTHS AND LIMITATIONS: This study provides clinical evidence for the efficacy and safety of 5 lubricants, including those formulated to meet WHO guidelines, in relieving symptoms of vaginal dryness and improving the overall sexual experience. The open-label design may have introduced bias into the study. CONCLUSION: All 5 lubricants, including those formulated to be compliant with guidelines on pH and osmolality, can be considered effective and well tolerated for the relief of discomfort associated with vaginal dryness.

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.

Topical Alpha-1 Adrenergic Receptor Agonist Applied to the Nipple/Areola Complex Improves Female Orgasmic Function.

Background: The impact of nipple sensation and its relationship to sexual function have often been neglected in medical literature. However, several recent studies report the importance of the nipple/areola complex (NAC) in sexual arousal and overall function. The nipple is composed of smooth muscle that can be erected via adrenergic nerves. In two complementary studies, we demonstrate that stimulation of the alpha-1 adrenergic receptor in the NAC with topical adrenergic agents can initiate erection of the nipple, increase NAC sensitivity, and improve sexual function. Materials and Methods: Thirteen breast surgery patients with nipple sensitivity loss were recruited to an unblinded study of topical phenylephrine hydrochloride. Sensitivity to pressure was measured before and after the application of the intervention to the NAC. In a second pilot study, 35 women completed a double-blinded placebo-controlled trial of a novel formulation, RJ101, containing a norepinephrine releasing agent. The intervention or placebo was applied to the NAC 30 minutes before sexual activity over the 4-week trial period. The arousal, lubrication, and orgasm domains of the female sexual function index (FSFI) were used to measure sexual function. Results: The application of phenylephrine hydrochloride was shown to increase nipple sensitivity to pressure by an average of 20% in our cohort of 13 breast augmentation patients. In addition, it was shown that intermittent application of the alpha-1 agonist for 8 weeks increased basal NAC sensitivity. In the follow-up pilot study, we demonstrate that stimulation of the NAC with RJ101 produced statistically significant increases versus placebo in the lubrication and orgasm domains of the FSFI, p = 0.0226 and p = 0.0269, respectively. Conclusion: For the first time, we demonstrate that the application of a topical alpha-1 adrenergic receptor agonist or a norepinephrine-releasing agent increases the sensitivity of the NAC and subsequently significantly improves sexual function.

Laser-Based Devices for Female Genitourinary Indications: Position Statements From the European Society for Sexual Medicine (ESSM).

BACKGROUND: Laser-based technologies have been commercially marketed as "wonder treatments" without a sufficient and adequate body of evidence. In addition, on July 30, 2018, the U.S. Food and Drug Administration issued a warning regarding the safety of the use of laser-based devices for the following indications: vaginal "rejuvenation" or cosmetic vaginal procedures, vaginal conditions and symptoms related to menopause, urinary incontinence, and sexual function. AIM: To perform a thorough review of the available literature regarding laser-based vaginal devices for the treatment of female genitourinary indications and summarize the results in several short statements according to the level of evidence. METHODS: A comprehensive review of the literature regarding laser treatments for gynecological indications was performed based on several databases. Eligible were studies that included at least 15 patients. OUTCOMES: Several aspects, including preclinical data, have been investigated. For each topic covered, data on laser-based devices were analyzed. RESULTS: Despite the high heterogeneity of studies and its limitations, the committee released several statements regarding the use of laser-based devices for genitourinary indications. CLINICAL IMPLICATIONS: Available data in the clinical setting are still poor, and the impact of these technologies on vaginal symptoms and signs has not been clearly established. STRENGTHS & LIMITATIONS: All studies have been evaluated by a panel of experts providing recommendations for clinical practice. CONCLUSION: It is too early in the evolution and research of laser-based devices to make decisive recommendations regarding vaginal treatments. There is grave need to carry out randomized controlled trials with proper design for safety reasons, possible harm, and short-/long-term benefits for the different indications studied.

Radiofrequency-Based Devices for Female Genito-Urinary Indications: Position Statements From the European Society of Sexual Medicine.

INTRODUCTION: Radiofrequency (RF)-based treatment has been introduced as an esthetic alternative treatment for various medical indications without the scientific backup of a satisfactory body of evidence. Furthermore, the United States Food and Drug Administration issued a warning regarding the safety of energy-based technologies for indications such as vaginal "rejuvenation," cosmetic vaginal treatment, vaginal conditions related to menopause, and symptoms of urinary incontinence and sexual function on July 30, 2018. AIM: To perform a thorough review of the existing literature regarding RF-based vaginal devices for the treatment of female genitourinary indications and summarize the evidence available in a few short statements. METHODS: A thorough review of the literature regarding RF treatments for gynecological indications was performed based on several databases. Studies that included at least 15 patients were eligible for analysis. MAIN OUTCOME MEASURE: Efficacy of RF devices for different genitourinary indications. RESULTS: Although a high level of heterogeneity of studies poses a serious challenge, the committee reached a decision on several statements related to the use of RF-based devices for genitourinary indications. CLINICAL IMPLICATIONS: RF-based vaginal treatments have not been studied thoroughly enough in order to establish decisive recommendations regarding their safety and efficacy. STRENGTH & LIMITATIONS: These position statements have been established by a group of experts. The lack of strong evidence makes it difficult to give decisive recommendations. CONCLUSIONS: Further randomized controlled trials with proper methodology and design are required to establish both benefits and possible harm these treatments may have in both short and long term for all the different indications studied. Otero JR, Lauterbach R, Aversa A, et al. Radiofrequency-Based Devices for Female Genito-Urinary Indications: Position Statements From the European Society of Sexual Medicine. J Sex Med 2020;17:393-399.

Novel topical formulation applied to the nipple-areola complex improves female orgasm.

BACKGROUND: The nipple-areola complex (NAC) is an often overlooked but important erogenous zone in the female sexual response and sexual functional repertoire. Research suggests that nipple stimulation is significant to female sexual satisfaction in as many as 80% of women. Previously, we have reported that stimulation of the arrector pili muscle in the NAC increases nipple sensitivity and has a positive impact on female sexual function. AIMS: To study the effect of RJ-101 on female orgasm. METHODS: A randomized double-blinded placebo-controlled study of RJ101, a novel topical formulation that stimulates the arrector pili muscle of the NAC, in 59 women. Each subject completed a survey composed of Likert scale questions in order to identify changes in orgasm after topical application of RJ101 or placebo. RESULTS: We demonstrated a positive increase in the perceived intensity of orgasm and orgasmic satisfaction/pleasure in women using RJ101 vs those in the placebo group. After 4 weeks of treatment, 76% of the women in the RJ101 arm reported a positive improvement in satisfaction with orgasm versus 47% in the placebo cohort. The mean change in score for overall satisfaction with orgasm in the RJ101 group was statistically significant (P = .007) compared to placebo. CONCLUSION: The application of RJ101 to the NAC 30 minutes prior to sexual activity can improve orgasmic strength, pleasure, and satisfaction.

Efficacy of a web-based women's health survivorship care plan for young breast cancer survivors: a randomized controlled trial.

PURPOSE: Breast cancer survivorship care plans (SCP) have limited content addressing women's health issues. This trial tested if young breast cancer survivors who receive a web-based, women's health SCP were more likely to improve on at least one of the four targeted issues (hot flashes, fertility-related concerns, contraception, and vaginal symptoms) compared to attention controls. METHODS: A randomized controlled trial recruited female survivors ages 18-45 at diagnosis, 18-50 at enrollment, completed primary cancer treatment, and had a significant women's health issue: moderate or higher fertility-related concerns; ≥ 4 hot flashes/day with ≥ 1 of moderate severity; ≥ 1 moderate vaginal atrophy symptoms; or not contracepting/using less effective methods. Survivors underwent stratified, block randomization with equal allocation to intervention and control groups. The intervention group accessed the online SCP; controls accessed curated resource lists. In intention-to-treat analysis, the primary outcome of improvement in at least one issue by 24 weeks was compared by group. RESULTS: 182 participants (86 intervention, 96 control), mean age 40.0 ± 5.9 and 4.4 ± 3.2 years since diagnosis, were randomized. 61 intervention group participants (70.9%) improved, compared to 55 controls (57.3%) (OR 1.82, 95% CI 0.99-3.4, p = 0.057). The following issue-specific improvements were observed in the intervention versus control arms: fertility-related concerns (27.9% vs. 14.6%, OR 2.3, 95% CI 1.1-4.8); hot flashes (58.5% vs. 55.8%, OR 1.1, 95% CI 0.57-2.2); vaginal symptoms (42.5% vs. 40.7%, OR 1.1, 95% CI 0.6-2.0); contraception (50% vs. 42.6%, OR 1.4, 95% CI 0.74-2.5). CONCLUSIONS: In young breast cancer survivors, a novel, web-based SCP did not result in more change in the primary outcome of improvement in at least one of the four targeted women's health issues, than the attention control condition. The intervention was associated with improved infertility concerns, supporting efficacy of disseminating accessible, evidence-based women's health information to this population.

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.

WISDOM survey: attitudes and behaviors of physicians toward vulvar and vaginal atrophy (VVA) treatment in women including those with breast cancer history.

OBJECTIVE: To evaluate and compare physicians' behaviors and attitudes regarding vulvar and vaginal atrophy (VVA) treatment in menopausal women, including women with breast cancer, using an internet-based survey. METHODS: The WISDOM survey queried obstetricians and gynecologists (OB/GYNs) and primary care physicians (PCPs) with 23 multipart questions assessing behaviors and attitudes towards VVA treatment. RESULTS: Of 2,424 surveys sent, 945 (39%) responded and 644 (27%) were completed. Of the menopausal women seen by OB/GYNs and PCPs, 44% to 55% reported having VVA symptoms. Physicians prescribed VVA treatments primarily because of effectiveness. Only 34% of OB/GYNs and 17% of PCPs felt comfortable prescribing VVA therapies to women with a personal history of breast cancer. In general, the most common VVA treatment recommended by all was prescription therapy (49%; with or without other therapies) in the form of US Food and Drug Administration-approved vaginal estrogen creams. More OB/GYNs (72%) than PCPs (47%) disagreed that VVA was best treated with over the counter than prescription products. Out-of-pocket cost and fear of risks associated with estrogens were believed to be the main barriers for why women choose not to get treated and why they discontinue treatment. CONCLUSIONS: More OB/GYNs than PCPs prescribed VVA treatment, especially vaginal estrogens, for menopausal women, but both groups generally had similar attitudes and behaviors regarding VVA treatment. Physician comfort was low when prescribing to women with a history of breast cancer, despite women's health medical societies supporting vaginal estrogen use in women with a history of estrogen-dependent breast cancer who were unresponsive to nonhormonal therapies when offered in consultation with their oncologist.

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.

Design of a randomized controlled trial on the efficacy of a reproductive health survivorship care plan in young breast cancer survivors.

BACKGROUND: Young breast cancer survivors (YBCS) have unmet needs for managing hot flashes, fertility-related concerns, sexual health, and contraception. PURPOSE: Describe the design and participant characteristics of a randomized controlled trial testing the efficacy of the survivorship care plan on reproductive health (SCP-R) intervention on improving hot flashes, fertility-related concerns, sexual health, and contraception in YBCS. METHODS: SCP-R is a web-based intervention with text message support encompassing evidence- based practices on four reproductive health issues. YBCS with ≥1 reproductive health issue are randomized to intervention (full SCP-R access) or attention control (access to list of online resources) arms with 24-week follow-up. The primary outcome will be improvement of at least one reproductive health issue measured by validated self-report instruments. Each YBCS nominated one healthcare provider (HCP), who can access the same materials as their patient. HCP outcomes are preparedness and confidence in discussing each issue. RESULTS: Among 318 YBCS screened, 57.2% underwent randomization. Mean age was 40.0 (SD 5.9), and mean age at cancer diagnosis was 35.6 (SD 5.4). Significant hot flashes, fertility-related concerns, vaginal symptoms, and inadequate contraception were reported by 50.5%, 50%, 46.7%, 62.1% of YBCS, respectively; 70.9% had multiple issues. Among 165 nominated HCPs, 32.7% enrolled. The majority of HCPs reported preparedness (68.5-90.7%) and confidence (50.0-74.1%) in discussing reproductive health issues with YBCS. HCPs were least likely to report preparedness or confidence in discussing fertility-related concerns. CONCLUSION: Conducting a trial for improving YBCS reproductive health online is feasible, providing a mechanism to disseminate evidence-based management.

Self-Reported Vaginal Laxity-Prevalence, Impact, and Associated Symptoms in Women Attending a Urogynecology Clinic.

INTRODUCTION: Vaginal laxity is increasingly recognized as an important condition, although little is known regarding its prevalence and associated symptoms. AIM: To report the prevalence of self-reported vaginal laxity in women attending a urogynecology clinic and investigate its association with pelvic floor symptoms and female sexual dysfunction. METHOD: Data were analyzed from 2,621 women who completed the electronic Personal Assessment Questionnaire-Pelvic Floor (ePAQ-PF). MAIN OUTCOME MEASURE: Response data from ePAQ-PF questionairre. RESULTS: Vaginal laxity was self-reported by 38% of women and significantly associated with parity, symptoms of prolapse, stress urinary incontinence, overactive bladder, reduced vaginal sensation during intercourse, and worse general sex life (P < .0005). CLINICAL IMPLICATIONS: Clinicians should be aware that vaginal laxity is prevalent and has an associated influence and impact on sexual function. STRENGTH & LIMITATIONS: The main strength of this study is the analysis of prospectively collected data from a large cohort of women using a validated questionnaire. The main limitation is lack of objective data to measure pelvic organ prolapse. CONCLUSION: Vaginal laxity is a highly prevalent condition that impacts significantly on a woman's sexual health and quality of life. Campbell P, Krychman M, Gray T, et al. Self-reported vaginal laxity-Prevalence, impact, and associated symptoms in women attending a urogynecology clinic. J Sex Med 2018;15:1515-1517.

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.

Review and clinical experience exploring evidence, clinical efficacy, and safety regarding nonsurgical treatment of feminine rejuvenation.

INTRODUCTION: The use of energy-based devices for the treatment of vaginal laxity, orgasmic dysfunction, and stress incontinence, such as minimally ablative fractional laser and radiofrequency, is gaining momentum. This review aims to answer clinical questions on the application of energy-based devices for feminine genital rejuvenation. METHODS: The target group includes physicians involved in esthetic medicine and feminine genital rejuvenation. A literature review was conducted on technologies in use for feminine rejuvenation to explore their safety, efficacy, tolerability, patient satisfaction, and clinical usability. A panel of physicians with clinical experience conducting these types of treatment reviewed and discussed the results of the literature search and gave clinical evidence-based recommendations. RESULTS: Energy-based devices may induce wound healing, stimulating new collagen, and elastin fiber formation. Radiofrequency treatment may also increase small nerve fiber density in the papillary dermis, improving nerve sensitivity, sexual function, including arousal and orgasmic dysfunction. Both minimally ablative fractional laser and radiofrequency has been shown to be effective when treating mild to moderate primary or secondary vulvovaginal laxity and associated secondary conditions. These treatments are reported to be safe, effective, and well tolerated with a rapid return to activities of daily living. CONCLUSIONS: As this is an evolving medical field, clinical evidence often lacks robustness. Studies and clinical experience suggest that feminine genital rejuvenation using energy-based devices seems an attractive option for patients with mild-to-moderate medical conditions. The treatment can be safely and effectively delivered by trained staff as part of the comprehensive care, that is, currently available to women.