Efficacy and safety of a novel pain management device, AT-04, for endometriosis-related pain: study protocol for a phase III randomized controlled trial.

BACKGROUND: Endometriosis-related pain encompassing dysmenorrhea, dyspareunia, and chronic pelvic pain, reduces the quality of life in premenopausal women. Although treatment options for endometriosis alleviate this pain, approximately one-third of women still experience pain even after receiving treatment, indicating the need for novel approaches to pain relief in those women. The Angel Touch device (AT-04) is a portable magnetic fields irradiation device that incorporates a combination of mixed alternative magnetic fields at 2 kHz and 83.3 MHz. A phase III trial confirmed the efficacy and safety of AT-02, a prototype of AT-04, for pain relief in patients with fibromyalgia. METHODS: This is a phase III, multicenter, prospective, randomized, sham device-controlled, double-blind, parallel study. The participants will be premenopausal women aged > 18 years who have endometriosis-related pain with at least moderate severity. Considering dropouts, 50 participants have been deemed appropriate. Eligible women will be centrally registered, and the data center will randomly allocate them in a 1:1 ratio to the intervention and control groups. Women in the intervention group will receive electromagnetic wave irradiation generated by AT-04 and those who in the control group will wear a sham device for 16 weeks, and both groups will wear AT-04 for another 4 weeks. The primary outcome measure is the change in the Numeric Rating Scale score at 16 weeks compared with the baseline. Secondary outcome measures are efficacy for pelvic pain including dysmenorrhea and non-menstrual pain, and chronic pelvic pain not related to menstruation, dysmenorrhea, and dyspareunia, and improvement of quality of life during the study period. Safety will be evaluated by device defects and the frequency of adverse events. The study protocol has been approved by the Clinical Study Review Board of Chiba University Hospital, Chiba, Japan, and will be conducted in accordance with the principles of the Declaration of Helsinki and the Japanese Clinical Trials Act and relevant notifications. DISCUSSION: This study aims to develop a novel method of managing endometriosis-related pain. The AT-04 is an ultralow-invasive device that can be used without inhibiting ovulation, suggesting potential benefits to women of reproductive-age. Trial registration number Japan Registry of Clinical Trials (jRCTs032230278).

Endometriosis is a chronic inflammatory disorder that negatively impacts reproductive health via endometriosis-related pain, infertility, and endometriosis-associated ovarian cancer. Although current therapeutic options for endometriosis are effective for the endometriosis-related pain, approximately one-third of women still experience pain even after receiving treatment, indicating the need for novel approaches to pain relief in those women. This is the first randomized controlled trial to investigate the efficacy and safety of a novel portable pain management device, AT-04, that incorporates a combination of mixed alternating magnetic fields, for endometriosis-related pain. This is a multicenter, prospective, sham device-controlled, double-blind, parallel study. Enrolled women will have undergone standard hormonal treatment for endometriosis at baseline, and this allows for assessing whether the device remains effective when used in conjunction with existing treatment methods. The study also will explore the impact of AT-04 on reducing the size of ovarian endometriotic cysts that reflect the activity of endometriosis. The study reflects the strong desire by physicians to liberate women from the unbearable pain associated with endometriosis. The sole efficacy of AT-04 in treating endometriosis-related pain is difficult to evaluate as there is a possibility that menstrual cycles may influence the assessment of pain and quality of life. However, the study findings regarding the effectiveness of AT-04 for the treatment of endometriosis-related pain may benefit women with endometriosis who have pain that is not effectively relieved by other treatments. Consequently, it may contribute to the improvement of reproductive health within society.

[Vaginal laxity: Semiology, diagnosis and treatments]. / L'hyperlaxité vaginale : sémiologie, diagnostic et traitements.

OBJECTIVES: Vaginal laxity concerns 24 to 38% of women but it's still poorly understood and studied. The objective of this study is to do an inventory of current scientific knowledge about its definition, its diagnostic criteria, and treatments. METHODS: We conducted a non systematic review of literature including original articles in French and English about the definition, diagnostic criteria and treatments of vaginal laxity using data bases such as Cochrane, Embase, Medline, PubMed et Science Direct. RESULTS: It is a feeling of excessive looseness that can alter the quality of sexual intercourses. The main risk factor is vaginal delivery. The feeling of vaginal laxity appears to be linked to an excessive distensibility of the levator ani muscle that can be evaluated during physical examination by the measure of the genital hiatus and the perineal body (GH and PB measures from the POP-Q classification) during vasalva or by the measure of genital hiatus area by translabial sonography during valsalva. Although pelvic muscle training is currently prescribed as a first line treatment, data are limited to confirm its effectiveness in this affection. Colpoperineorraphy with levator ani myorraphy which was mostly evaluated in case of genital prolapse is associated with a high success rate but is at risk of dyspareunia. New nonsurgical treatments such as radiofrequency and vaginal laser seems to lead to lower success rate than surgical treatments but they are less invasive. Their effectiveness and long-term effects are still unknown which restrict their application in this condition. CONCLUSION: Vaginal laxity is a frequent condition that impacts on the quality of life and sexual function. Further studies should be conducted to better understand its physiopathology and the optimal treatment.

Managing Menopausal Symptoms: Common Questions and Answers.

Menopausal symptoms are widespread and significantly impact quality of life. Common symptoms of menopause are vasomotor (i.e., hot flashes and night sweats) and genitourinary (e.g., vulvovaginal irritation and dryness, dyspareunia, urinary problems), although women may also experience changes in sexual function, mood, and sleep. Estrogen-containing hormone therapy is effective treatment for vasomotor symptoms. Nonhormonal medications for vasomotor symptoms include selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, and gabapentin. Selective serotonin reuptake inhibitors should not be administered to women taking tamoxifen. Cognitive behavior therapy and clinical hypnosis are effective for short-term reduction of vasomotor symptoms and associated sleep disturbances, but data are lacking to support the effectiveness of other nonpharmacologic treatments such as herbal or botanicalsupplements, exercise, and acupuncture. Hormone-free vaginal moisturizers are noninferior to estrogen-based therapies for treating genitourinary syndrome of menopause. Other treatment options for vaginal dryness and dyspareunia associated with menopause include ospemifene and intravaginal dehydroepiandrosterone. Management of menopausal symptoms should involve shared decision-making that is informed by the best available evidence and individual risks and preferences.

Functional and sexual outcomes following surgical vaginal introital reduction.

OBJECTIVE: Surgical introital reduction procedures are commonly performed for the treatment of vaginal laxity (VL), yet poorly studied. The aim of this study was to assess clinical outcomes following surgical vaginal introital reduction for VL. METHODS: This was an ambidirectional cohort study conducted in a single urogynecology center. All sexually active women who had vaginal introital surgical reduction for VL between March 2015 and September 2020 were included in this study. VL was defined as a genital hiatus distance ≥4cm according to the POP-Q classification, associated with symptoms of laxity. The primary endpoint was sexual health assessed by the Pelvi-Perineal Surgery Sexuality Questionnaire (PPSSQ), while the secondary endpoints included postoperative pain, perioperative complications, rate of dyspareunia, patient satisfaction and success rate based on the Patient Global Improvement Index (PGI-I) and Vaginal Laxity Questionnaire (VLQ). RESULTS: Of the 27 patients sent the questionnaires, 23 sexually active patients returned the completed ones and were included in the study. Participants had a mean age and BMI of 41 years (range 24-74) and 21.3 (range 17.6-31.9) respectively. The most prevalent preoperative symptom was feeling of VL in 82.6% followed by bulging sensation in 47.8%. Preoperative dyspareunia was reported in 8/23 (34.8%). Surgical interventions involved perineorrhaphy with (n=14) or without (n=9) levator ani plication. The PPSSQ mean sexual health score was 86.7/100 (SD 5.8; range 16.7-93.3) and the mean discomfort and pain score was 27.5/100 (SD 26.0; range 0-80). Postoperative sexuality was reported to better, identical or worse in 16 (69.6%), 2 (8.7%) and 5 (21.7%) patients respectively. On PGI-I, patients reported feeling much better, better, slightly better and no change in 10 (43.5%), 5 (21.7%), 5 (21.7%) and 3 (13.0%) respectively. None of the women reported feeling worse. The overall post-operative complication rate was 3/23 (13.0%), including a perineal hematoma, and two cases of reoperation for narrow introitus. De novo dyspareunia was reported by 11/18 (61.1%) patients, occurring often or more in 4/18 (22.2%) patients, due to narrow introitus (n=2), enlarge introitus (n=1) and vaginal dryness (n=1). CONCLUSION: Vaginal introital reduction surgery is a viable treatment option for symptoms of vaginal laxity after failure of conservative measures. However, patients should be made aware of the risk of de novo dyspareunia.

Diagnosis, causes, and treatment of dyspareunia in postmenopausal women.

IMPORTANCE AND OBJECTIVES: Evaluation and treatment of dyspareunia remains a significant unmet need despite the availability of safe and effective treatments. The objectives of this review are to consider evaluation techniques, the medical causes, and treatment options for dyspareunia in postmenopausal women. METHODS: This narrative review used PubMed to search for English-language articles related to postmenopausal dyspareunia. Search terms included, but were not limited to, dyspareunia, genitourinary syndrome of menopause, sexual dysfunction, postmenopausal dyspareunia, posthysterectomy dyspareunia, and postcancer dyspareunia. FINDINGS: Many postmenopausal women with dyspareunia do not discuss their symptoms with their physicians. Healthcare clinicians should broach the topic of dyspareunia with their patients using oral or written questionnaires. In addition to a thorough medical history and physical examination, various tools can be used as further assessments, including vaginal pH, vaginal dilators, imaging, vulvar biopsy, vulvoscopy and photography, the cotton swab test, sexually transmitted infection screening, and vaginitis testing. Although dyspareunia in postmenopausal women is often due to the genitourinary syndrome of menopause, other conditions can also cause dyspareunia, including hypertonic pelvic floor, hysterectomy, cancer treatment, lichen conditions, vulvar cancer, vestibulodynia, and pelvic organ prolapse. Some of the treatments discussed include lubricants, moisturizers, vaginal estrogen, ospemifene, dehydroepiandrosterone, local testosterone therapy, cannabidiol, and fractional CO 2 laser treatments. In some cases, dyspareunia may need to be specifically addressed by pelvic floor physical or sex therapists. CONCLUSIONS: Dyspareunia is a common issue in postmenopausal women, which remains largely untreated. Women with dyspareunia require a thorough history, targeted physical examination, and coordination of multiple disciplines including medical clinicians, pelvic floor physical therapists, and sex therapists.

Gynecological Cancer Survivors' Experiences of Dyspareunia and Factors Influencing Care-Seeking Behavior: A Qualitative Study.

Pain during sexual intercourse, also called dyspareunia, affects most women after treatment for gynecological cancer. Previous work adopted a biomedical approach to depict dyspareunia in this population, which provided a narrow perspective of this condition. Taking into account women's experiences of dyspareunia and the factors influencing their care-seeking behaviors would provide insight to improve care in the context of gynecological cancer. The aim of this study was to describe gynecological cancer survivors' experiences of dyspareunia and factors influencing care-seeking behavior. A qualitative study was performed with 28 gynecological cancer survivors with dyspareunia. Individual telephone interviews were conducted based on the Common-Sense Model of Self-Regulation. Interviews were recorded and transcribed for analysis using the interpretative description framework. Concerning their experience, participants reported the oncological treatments as the primary cause of dyspareunia. Loss of libido, lower vaginal lubrication, and smaller vaginal cavity were described as being linked with dyspareunia. Women explained how dyspareunia and these changes had led them to engage less in, and even interrupt, sexual activity. They expressed that they were distressed, felt less of a woman, and experienced low control and/or self-efficacy. Regarding the factors influencing women's care-seeking behaviors, participants emphasized that they were provided with insufficient information and support. Balancing priorities, denial or reluctance, misbeliefs, resignation and acceptance, and negative emotions were reported as barriers, whereas acknowledgement of sexual dysfunction, desire for improvement, awareness of treatment possibilities, willingness to undertake treatment and treatment acceptability were reported as facilitators to seeking care. Findings suggest that dyspareunia is a complex and impactful condition after gynecological cancer. While this study highlights the importance of alleviating the burden of sexual dysfunction in cancer survivors, it identified factors that should be considered in the provision of services to improve care.

Superficial dyspareunia treatment with hyperstacking of erbium:yttrium-aluminum-garnet SMOOTH laser: a short-term, pilot study in breast cancer survivors.

OBJECTIVE: This prospective pilot study aimed to evaluate the effects of a modified vaginal erbium laser (VEL) protocol, using the hyperstack mode on the vaginal vestibulum and introitus to treat superficial dyspareunia in postmenopausal breast cancer survivors suffering from the genitourinary syndrome of menopause. METHODS: In this pilot, prospective, randomized study, two groups of postmenopausal women suffering from superficial dyspareunia were included: 34 women (VEL group) were treated with erbium laser crystal yttrium-aluminum-garnet (XS Fotona SMOOTH; Fotona, Ljubljana, Slovenia) with a wavelength of 2,940 nm; for the other 34 (hyperstack group), a modified second step of the VEL protocol for the treatment of vestibulum and introitus was used, with hyperstacked (repeating a number of) subablative, long pulses with very low fluences. For each group, three laser applications at 30-day intervals were performed. Symptoms were assessed before, after each application, and after 1 and 3 months from the last laser application, using the visual analog scale score for superficial dyspareunia. RESULTS: Superficial dyspareunia improved in both groups over time (P < 0.001), regardless of age and years since menopause status. The reduction in visual analog scale score after the third laser application was 58% in VEL versus 73.5% in hyperstack. The hyperstack group, since the first laser application, showed a greater (P < 0.001) and persistent improvement of superficial dyspareunia. CONCLUSIONS: The hyperstack treatment of the introitus and vestibulum in breast cancer survivors leads to a more significant improvement in superficial dyspareunia than the VEL alone.

Acceptability of multimodal pelvic floor physical therapy to treat dyspareunia after gynecological malignancies: a qualitative study of women's views and experiences.

INTRODUCTION AND HYPOTHESIS: Multimodal pelvic floor physical therapy (PFPT) is recommended after gynecological malignancies to treat dyspareunia. However, data to strongly support its implementation in the cancer care continuum are lacking. The aim of this study was to explore the views and experiences of gynecological cancer survivors with dyspareunia regarding the acceptability of multimodal PFPT. METHODS: This qualitative study was conducted with the participants (n = 28) of a study investigating a 12-week multimodal PFPT treatment. Individual semi-structured telephone interviews served to collect qualitative data pertaining to women's views and experiences of the treatment they received. Interviews were recorded and transcribed for analysis using the interpretative description framework. RESULTS: Our cohort described the appropriateness of the treatment in terms of modalities, physical therapist, care delivery, and intensity (Theme 1). While the intensity was reported as demanding by a few, all participants stressed that it was relevant to see significant improvements (Theme 2). In addition to the treatment characteristics and women's beliefs and attitudes, noticing the treatment effects motivated their participation (Theme 2). Women expressed being highly satisfied with the treatment based on their positive experiences and the balance between their efforts and the results they obtained (Theme 3). As a result, they all recommended this treatment (Theme 3). CONCLUSIONS: This is the first study to examine the acceptability of multimodal PFPT in the context of gynecological malignancies. This treatment was found acceptable and can be offered to gynecological cancer survivors.

Efficacy of interventions to manage sexual dysfunction in women with cancer: a systematic review.

IMPORTANCE: Cancer and its treatment negatively affect female sexual health and function. The prevalence of female sexual dysfunction after cancer is between 33% and 43%. Numerous studies have addressed treatment options for sexual dysfunction in women with cancer, but it still remains a challenge to select the most efficacious option for patients. OBJECTIVE: To compile and appraise recent evidence of any interventions for managing sexual dysfunction in female cancer survivors. EVIDENCE REVIEW: A literature search of the electronic databases MEDLINE, EMBASE, PsycINFO, and Cochrane Central Register of Controlled Trials (January 2011 to February 2021) was conducted using general search terms of "women", "cancer", "intervention", "sexual dysfunction". We included randomized controlled trials (RCTs) and uncontrolled before-after studies that evaluated the efficacy of intervention for female sexual dysfunction in women with history of cancer. Methodological quality of studies was assessed using Risk of Bias (RoB) 2.0 for RCTs and National Institutes of Health (NIH) assessment tools for uncontrolled before-after studies. FINDINGS: Thirty-six studies were included for qualitative synthesis (14 RCTs (n = 1284), 17 uncontrolled trials (n = 589), and 5 cohort studies (n = 497). Only four studies were at low risk of bias. Topical interventions (vaginal gels or creams) were able to alleviate vaginal dryness and dyspareunia, with intravaginal dehydroepiandrosterone (DHEA) (6.5 mg) gel showing evidence of improved sexual function. Evidence for estriol-lactobacilli vaginal tablets was unreliable due to a small-scale study. Psychoeducational therapy (internet-based cognitive behavioral therapy [CBT]) studies typically were at high risk of bias, but all displayed significant improvements of sexual function. Both laser therapy (fractional CO2 and erbium) and multimodal approach studies were at concerning risk of bias, although suggesting beneficial effects on sexual function. CONCLUSIONS AND RELEVANCE: The most reliable evidence for improvement was from a study of DHEA vaginal gel, but in general, gels or creams were useful in reducing dyspareunia. Pharmacological, psychoeducational, laser therapy, and multimodal approaches demonstrated potential in managing cancer-related sexual issues, but most were small in size (10-70 participants), with moderate to high risk of bias. Therefore, large-scale, double-blind, RCTs with long-period follow-up, and at low risk of bias are needed to show efficacy for these interventions.

Video Summary : http://links.lww.com/MENO/A912 .

Changes in pelvic floor morphometry and muscle function after multimodal physiotherapy for gynaecological cancer survivors suffering from dyspareunia: a prospective interventional study.

OBJECTIVE: To investigate the changes in pelvic floor morphometry and muscle function after multimodal pelvic floor physiotherapy treatment in gynaecological cancer survivors suffering from painful intercourse (dyspareunia). DESIGN: Prospective interventional study. SETTING: Three university hospitals. PARTICIPANTS: Thirty-one gynaecological cancer survivors with dyspareunia. INTERVENTION: The treatment consisted of 12 weekly sessions of physiotherapy combining education, pelvic floor muscle exercises with biofeedback, manual therapy and home exercises. MAIN OUTCOME MEASURES: Women were assessed at baseline and post-treatment. Pelvic floor morphometry was evaluated at rest and on maximal contraction by measuring bladder neck position, anorectal and levator plate angles as well as levator hiatal dimensions with three-dimensional/four-dimensional transperineal ultrasound imaging. Pelvic floor muscle function was evaluated by measuring passive forces (muscle tone measure), flexibility, stiffness, strength, coordination and endurance with an intra-vaginal dynamometric speculum. RESULTS: Significant changes in pelvic floor morphometry and muscle function were found post-treatment. The parameters assessing the changes from rest to maximal contraction significantly improved (e.g., mean change of levator hiatal area narrowing 14%, 95% CI 11-18, Cohen's d effect size 1.48)), supporting the hypothesis of decreased muscle tone and improved muscle contractility following treatment. Women also presented with a significant decrease in tone (mean change -0.4N, 95% CI -0.7 to -0.1, Cohen's d effect size 0.57) and stiffness (mean change -0.1N/mm, 95% CI -0.2 to -0.1, Cohen's d effect size 0.59), as well as significant improvements in flexibility (mean change 9.0mm, 95% CI 5.8-12.2, Cohen's d effect size 1.08), coordination (mean change 3 rapid contractions, 95% CI 2-4, Cohen's d effect size 0.85) and endurance (mean change 683%*s, 95% CI 388-978, Cohen's d effect size 0.90). CONCLUSION: Our findings suggest significant improvements in pelvic floor morphometry and muscle function after a multimodal physiotherapy treatment in gynaecological cancer survivors with dyspareunia. These effects may represent key treatment mechanisms to reduce dyspareunia, supporting the rationale for multimodal physiotherapy in this population. CLINICAL TRIAL REGISTRATION NUMBER (CLINICALTRIALS.GOV): NCT03935698.

Improvements following multimodal pelvic floor physical therapy in gynecological cancer survivors suffering from pain during sexual intercourse: Results from a one-year follow-up mixed-method study.

BACKGROUND: A large proportion of gynecological cancer survivors suffer from pain during sexual intercourse, also known as dyspareunia. Following a multimodal pelvic floor physical therapy (PFPT) treatment, a reduction in pain and improvement in psychosexual outcomes were found in the short term, but no study thus far has examined whether these changes are sustained over time. PURPOSE: To examine the improvements in pain, sexual functioning, sexual distress, body image concerns, pain anxiety, pain catastrophizing, painful intercourse self-efficacy, depressive symptoms and pelvic floor disorder symptoms in gynecological cancer survivors with dyspareunia after PFPT, and to explore women's perceptions of treatment effects at one-year follow-up. METHODS: This mixed-method study included 31 gynecological cancer survivors affected by dyspareunia. The women completed a 12-week PFPT treatment comprising education, manual therapy and pelvic floor muscle exercises. Quantitative data were collected using validated questionnaires at baseline, post-treatment and one-year follow-up. As for qualitative data, semi-structured interviews were conducted at one-year follow-up to better understand women's perception and experience of treatment effects. RESULTS: Significant improvements were found from baseline to one-year follow-up on all quantitative outcomes (P ≤ 0.028). Moreover, no changes were found from post-treatment to one-year follow-up, supporting that the improvements were sustained at follow-up. Qualitative data highlighted that reduction in pain, improvement in sexual functioning and reduction in urinary symptoms were the most meaningful effects perceived by participants. Women expressed that these effects resulted from positive biological, psychological and social changes attributable to multimodal PFPT. Adherence was also perceived to influence treatment outcomes. CONCLUSIONS: Findings suggest that the short-term improvements following multimodal PFPT are sustained and meaningful for gynecological cancer survivors with dyspareunia one year after treatment.

Microablative fractional radiofrequency for the genitourinary syndrome of menopause: protocol of randomised controlled trial.

INTRODUCTION: Menopause is a physiological and progressive phenomenon secondary to decreased ovarian follicular reserve. These changes have consequences: vaginal dryness, dyspareunia, discomfort, burning and irritation, vulvovaginal pruritus, dysuria and increased frequency of genitourinary infections. The therapy more suitable for vaginal symptoms in postmenopause yet is the use of a topical hormone. However, the prescription of topical oestrogens should also be avoided in women with a history of breast cancer, oestrogen-sensitive tumours and thromboembolism, emphasising the necessity of alternative treatments. Recently, physical methods, such as laser and radiofrequency (RF), in their non-ablative, ablative and microablative forms have been used in the vaginal mucosa to promote neocolagenesis and neoelastogenesis. This randomised study aims to compare the efficiency of microablative fractional RF (MAFRF) treatment with vaginal oestrogens and no treatment. METHODS AND ANALYSES: This randomised, controlled clinical intervention trial with an open label design comparing the treatment of MAFRF with vaginal oestrogens and no treatment. Four important moments were considered to evaluate treatment results (T0, T1, T2 and T3). The primary outcome includes vulvovaginal atrophy (vaginal pain, burning, itching, dryness, dyspareunia and dysuria), and the secondary outcomes will be sexual function, vaginal health (epithelial integrity, vaginal elasticity, moisture, fluid volume and vaginal pH) and quality of life. ETHICS AND DISSEMINATION: Due to the nature of the study, we obtained approval from the ethics committee. All participants must sign an informed consent form before randomisation. The results of this study will be published in peer-reviewed journals. The data collected will also be available in a public repository of data. TRIAL REGISTRATION NUMBER: RBR-94DX93.

Female Genital Cutting: An Evidence-based Review for the OBGYN of Long-term Sequelae and Management Options.

Female genital cutting (FGC) is a persisting global practice that increases patients' risk for experiencing long-term health sequelae. Existing meta-analysis evidence strongly supports an association between FGC and the development of long-term dyspareunia, urinary tract infections, and sexual dysfunction as well as increased risk obstetrically of prolonged labor, cesarean section, perineal lacerations, and episiotomy. Surgical defibulation is recommended in patients with type III FGC to decrease obstetric and gynecologic morbidity. Existing evidence does not seem to definitively support clitoral reconstructive surgery. More research is needed to study conservative treatment and management approaches to long-term sequelae of FGC.

A Prospective Single-Arm Study Evaluating the Effects of a Multimodal Physical Therapy Intervention on Psychosexual Outcomes in Women With Dyspareunia After Gynecologic Cancer.

BACKGROUND: Dyspareunia affects most women after treatment for gynecologic malignancies. However, to date, evidence-based interventions remain limited and no study has examined the effects of multimodal physical therapy on psychosexual outcomes in these patients. AIM: To assess the effects of multimodal physical therapy on psychosexual outcomes including sexual distress, body image concerns, pain anxiety, pain catastrophizing, pain self-efficacy and depressive symptoms in women with dyspareunia after treatment for gynecologic malignancies. METHODS: Thirty-one gynecologic cancer survivors with dyspareunia enrolled in this prospective single-arm interventional study. The participants undertook 12 weekly sessions of physical therapy incorporating education, pelvic floor muscle exercises with biofeedback, manual therapy and home exercises. Outcome measures were evaluated pre- and post-treatment. Paired t-tests were conducted to investigate the changes from pre-treatment (P-value Ë‚ 0.05) while effect sizes (Cohen's d) were calculated to measure the magnitude of the change. MAIN OUTCOME MEASURES: Sexual distress (Female Sexual Distress Scale-Revised), body image concerns (Body Image Scale), pain anxiety (Pain Anxiety Symptoms Scale), pain catastrophizing (Pain Catastrophizing Scale), pain self-efficacy (Painful Intercourse Self-Efficacy Scale) and depressive symptoms (Beck Depression Inventory-II). RESULTS: Significant changes were found from pre- to post-treatment for all psychosexual outcomes. Women reported reductions in sexual distress (P Ë‚ 0.001, d = 1.108), body image concerns (P Ë‚ 0.001, d = 0.829), pain anxiety (P Ë‚ 0.001, d = 0.980), pain catastrophizing (P Ë‚ 0.001, d = 0.968) and depression symptoms (P = 0.002, d = 0.636) with an increase in pain self-efficacy (P Ë‚ 0.001, d ≥ 0.938) following the intervention. CLINICAL IMPLICATIONS: The results suggest that multimodal physical therapy significantly improves sexual distress, body image concerns, pain anxiety, pain catastrophizing, pain self-efficacy and depressive symptoms in our sample of women with dyspareunia after treatment for gynecologic malignancies. The medium to large effect sizes obtained with the high proportion of women presenting meaningful changes according to the known minimal clinically important difference or clinical cut-off underlines the significance of these effects. STRENGTHS & LIMITATIONS: The current study used validated questionnaires to assess the psychosexual outcomes of a well-designed physical therapy intervention using multiple modalities to address the multifaceted aspect of dyspareunia in cancer survivors. This study did not include a control group, which may limit drawing definitive conclusions. CONCLUSION: Findings showed that multimodal physical therapy yielded significant improvements in psychosexual outcomes in gynecologic cancer survivors with dyspareunia. A randomized controlled trial is indicated to confirm these results. Cyr M-P, Dumoulin C, Bessette P, et al. A Prospective Single-Arm Study Evaluating the Effects of a Multimodal Physical Therapy Intervention on Psychosexual Outcomes in Women With Dyspareunia After Gynecologic Cancer. J Sex Med 2021;18:946-954.

[Management of endometriosis pain : Stage-based treatment strategies and clinical experience]. / Endometrioseschmerz beherrschen : Stufenschema und klinische Erfahrungen.

BACKGROUND: Endometriosis is associated with various types of intense pain. In addition to nociceptive pain, there is also a nociplastic reaction with central sensitization. Atypical symptoms such as acyclic lower abdominal pain, radiating pain, non-specific bladder and intestinal complaints or even depression are frequent as are classic cyclical complaints such as severe dysmenorrhea, cyclical lower abdominal pain, dyspareunia, dysuria and dyschezia. In cases of a diverse range of symptoms, patients often consult not just gynecologists but specialists from other disciplines (e.g., internal medicine, gastroenterology, orthopedics, pain therapy, psychology). AIMS: Overview about the pathophysiology and complexity of the disease and the resulting treatment options. A multimodal interdisciplinary concept might be able to take into consideration all aspects of the complex disease. METHODS: Interdisciplinary concepts should be involved in the treatment of endometriosis patients along with hormonal and surgical therapy, which are generally under the supervision of a gynecologist. Pain management, dietary changes, psychological support, as well as physiotherapy should be included. The present article is intended to provide an overview of possible treatment strategies for chronic, symptomatic endometriosis. CONCLUSION: The use of multimodal treatment strategies regarding the complex pathophysiological aspects of this disease might be helpful in significantly improving the quality of life of endometriosis patients.

Benefits of a Multidisciplinary Women's Sexual Health Clinic in the Management of Sexual and Menopausal Symptoms After Pelvic Radiotherapy.

OBJECTIVE: The objective of this study was to examine patterns of care and outcomes of female cancer patients treated for sexual and menopausal symptoms following pelvic radiotherapy (PRT) at our institution's multidisciplinary Sexuality, Intimacy, and Menopause (SIMS) Program. MATERIALS AND METHODS: We performed a retrospective review of 69 female patients who received PRT for gynecologic or gastrointestinal malignancies and were referred for SIMS Program intervention. Indications for referral and treatment patterns were summarized. Preintervention and postintervention, patients were screened at follow-up visits, and symptoms were recorded. Statistics were performed using Stata 13.1. RESULTS: Cancer types included cervical (53.6%), endometrial (31.9%), anorectal (5.8%), and vulvar/vaginal (8.7%). The median age was 48 years (interquartile range: 38 to 58 y). Patients were educated on vaginal lubricants, moisturizers, and dilator therapy both before and after PRT. Reasons for SIMS referral included persistent menopausal symptoms (50.7%), dyspareunia (40.6%), vaginal dryness (37.7%), decreased libido (17.4%), intimacy concerns (17.4%), and/or physical examination alterations (27.5%). SIMS interventions included vaginal estrogen (77.3%), nonhormonal climacteric interventions (53%), systemic hormone therapy (31.8%), dehydroepiandrosterone (4.6%), testosterone cream (4.6%), and/or psychological pharmacotherapy or counseling (13.6%). With a median follow-up of 36 months (interquartile range: 18 to 58 mo), sexual symptoms improved or were stable in 83.6%, while menopausal symptoms improved or were stable in 80.5%. CONCLUSIONS: This study highlights the importance of multidisciplinary care in improving the sexual and menopausal symptoms of women after PRT. Future work examining the impact of intervention timing with respect to PRT and measures of patient satisfaction is warranted.

The genitourinary syndrome of menopause.

ABSTRACT: Genitourinary syndrome of menopause (GSM) refers to a collection of symptoms resulting from diminished hormonal, primarily estrogenic stimulation to the vulvovaginal or lower urinary tract and may affect up to 50% of postmenopausal women. Symptoms, which are typically progressive and unlikely to resolve spontaneously, may include, but are not limited to, vulvovaginal dryness, burning or irritation, dyspareunia, or urinary symptoms of urgency, dysuria or recurrent urinary tract infection. These symptoms are typically progressive and unlikely to resolve spontaneously. Diagnosis is clinical. Telemedicine may play a role in diagnosis, initiation of treatment, and follow-up of women with GSM. Effective treatments include moisturizers and lubricants, local hormonal therapy with estrogen or dehydroepiandrosterone, and oral selective estrogen receptor agonists. Laser or radiofrequency procedures, although currently utilized, are being studied to comprehensively understand their overall effectiveness and safety. Additionally, the influence and effect of the vaginal microbiome, as well as potential of treatment via its manipulation, is being studied. We performed a literature search of PubMed, Google Scholar, and Ovid with search terms of vulvovaginal atrophy and GSM and reviewed major US Society Guidelines to create this narrative review of this topic. The literature suggests that healthcare providers can make a significant impact of the health and quality of life of women by being proactive about discussing and providing interventions for GSM. A systematic approach with consideration of current guidelines and attention to developing protocols for interventions should be employed.

Video Summary:http://links.lww.com/MENO/A702 .

"Two wavelengths endovaginal laser system": Clinical evaluation of a new device for mild SUI and vaginal atrophy treatment.

Menopause is the condition when a woman no longer manifests menstrual periods. Genitourinary syndrome (GSM) is the acronym to describe possible symptoms of this condition. Vaginal dryness can be a particular problem for women entering menopause, it can make the intercourse painful and may cause the increase in the need to urinate. Aim of this study is to evaluate the efficacy of combined fractional CO2 (10 500 nm) ablative and 1540 nm nonablative lasers on these symptoms. About 40 postmenopausal nonestrogenized women with moderate to severe vaginal atrophy referring symptoms related to GSM were recruited. A treatment cycle included three laser applications (every 4 weeks), was performed. Time points of the study were baseline (T1), week 4 (T2), week 8 (T3), and week 12 (T4).. Results evaluation was done with a modified female sexual function index (FSFI) and a modified stress urinary incontinence (SUI) scale. A significant improvement both of FSFI total score and each individual FSFI domain score was observed. No undesired side effects or short-term or long-term complications were shown. This study shows that the "two wavelengths endovaginal laser treatment" is a safe and effective technique to treat signs and symptoms related to GSM syndrome. For the treatment of women with severe urogenital symptoms who do not benefit from lifestyle changes, vaginal moisturizers, or local estrogen therapy, clinicians should consider the use of vaginal fractional laser treatment.

Subspecialty care for peripartum pelvic floor disorders.

Obstetrical perineal and anal sphincter lacerations can be associated with considerable sequelae. The diagnosis of short-term bowel, bladder, and healing problems can be delayed if patients are not seen until the traditional postpartum visit at 4 to 6 weeks. Specialized peripartum clinics create a unique opportunity to collaborate with obstetrical specialists to provide early, individualized care for patients experiencing a variety of pelvic floor issues during pregnancy and in the postpartum period. Although implementation of these clinics requires thoughtful planning and partnering with care providers at all levels in the obstetrics care system, many of the necessary resources are available in routine gynecologic practice. Using a multidisciplinary approach with pelvic floor physical therapists, nurses, advanced practice providers, and other specialists is important for the success of this service line and enhances the level of care provided. Overall, these clinics provide a structured means by which pregnant and postpartum women with pelvic floor symptoms can receive specialized counseling and treatment.

A cost-effectiveness analysis of vaginal carbon dioxide laser therapy compared with standard medical therapies for genitourinary syndrome of menopause-associated dyspareunia.

BACKGROUND: Topical vaginal estrogen therapy is considered the gold standard treatment for genitourinary syndrome of menopause-associated dyspareunia, but early investigations of energy-based devices show promise for patients with contraindications or those who are refractory to vaginal estrogen cream therapy. Although evaluating safety, efficacy, and long-term outcomes for novel technologies is critically important when new technologies become available to treat unmet healthcare needs, evaluation of the costs of these new technologies compared with existing therapies is also critically important but often understudied. OBJECTIVE: We sought to perform a cost-effectiveness analysis of 3 therapies for genitourinary syndrome of menopause, including vaginal estrogen therapy, oral ospemifene therapy, and vaginal CO2 laser therapy and determine if vaginal laser therapy is a cost-effective treatment strategy for dyspareunia associated with genitourinary syndrome of menopause. STUDY DESIGN: An institutional review board-exempt cost-effectiveness analysis was performed by constructing a decision tree using decision analysis software (TreeAge Pro; TreeAge Software, Inc, Williamstown, MA) using integrated empirical data from the published literature. Tornado plots and 1-way and 2-way sensitivity analyses were performed to assess how changes in the model's input parameters altered the overall outcome of the cost-effectiveness analysis model. RESULTS: All 3 treatment methods were found to be cost-effective below the willingness-to-pay threshold of $50,000.00 per quality-adjusted life year for moderate dyspareunia. The incremental cost-effectiveness ratio for vaginal CO2 laser therapy was $16,372.01 and the incremental cost-effectiveness ratio for ospemifene therapy was $5711.14. Although all 3 treatment strategies were on the efficient frontier, vaginal CO2 laser therapy was the optimal treatment strategy with the highest effectiveness. In a 1-way sensitivity analysis of treatment adherence, vaginal CO2 laser therapy was no longer cost-effective when the adherence fell below 38.8%. Vaginal estrogen cream and ospemifene therapies remained cost-effective treatment strategies at all ranges of adherence. When varying the adherence to 100% for all strategies, oral ospemifene therapy was "dominated" by both vaginal CO2 laser therapy and vaginal estrogen cream therapy. In a 2-way sensitivity analysis of vaginal CO2 laser therapy adherence and vaginal CO2 laser therapy cost, vaginal CO2 laser therapy still remained the optimal treatment strategy at 200% of its current cost ($5554.00) when the adherence was >55%. When the cost fell to 20% of its current cost ($555.40), it was the optimal treatment strategy at all adherence values above 29%. CONCLUSION: This study showed that vaginal fractional CO2 laser therapy is a cost-effective treatment strategy for dyspareunia associated with GSM, as are both vaginal estrogen and oral ospemifene therapies. In our model, vaginal CO2 laser therapy is the optimal cost-effective treatment strategy, and insurance coverage should be considered for this treatment option if it is proven to be safe and effective in FDA trials.