Improvement In Dyspareunia Research Articles

Psychological modalities for the treatment of localized provoked vulvodynia: a scoping review of literature from 2010 to 2023.

Localized provoked vulvodynia is a common sexual health condition for which there is a lack of consensus on effective management, even though it can have a significant negative impact on psychological wellbeing, sexual functioning, and quality of life for women and their partners. To map the research landscape related to the effectiveness/efficacy of psychological treatments for localized provoked vulvodynia, identify gaps, and make recommendations for future research. We used Arksey and O'Malley's approach to conducting a scoping review to identify, organize, and summarize research published between 2010 and 2023 that investigated the efficacy or effectiveness of interventions in the management of localized provoked vulvodynia. Inclusion and exclusion criteria and the search strategy were developed by subject experts in collaboration with a health sciences librarian. A PubMed search used controlled vocabulary and keyword terms relating to vulvodynia, which were then translated into other databases. Studies not published in English or French were excluded. We did not consider other subsets of vulvodynia.Articles were uploaded to Covidence, duplicates removed, and titles and abstracts screened. The remaining articles were subject to a 2-person, independent full-text review followed by a hand search of eligible articles. All intervention studies were included regardless of the study design. Study details were reported narratively and analyzed. Of the 88 included articles published between January 2010 and March 2023, 15 reported on the efficacy/effectiveness of psychological treatments for localized provoked vulvodynia, including group educational seminars, cognitive behavioral therapy, acceptance and commitment therapy, and somatocognitive therapy. Cognitive behavioral therapy was the most common form of psychological treatment studied (n = 7) with interventions for both individuals and couples. Education about the condition and the therapeutic process was a component of many interventions. Psychological therapies may be of some benefit, but only 1 RCT evaluating the efficacy of acceptance and commitment therapy appeared adequately powered to demonstrate improvement in dyspareunia. Studies sampled homogenous patient populations, primarily consisting of White, urban-dwelling, educated, partnered, heterosexual cis-women. Evidence of efficacy/effectiveness, drawn mainly from small studies, is promising and highlights opportunities for more robust studies with heterogeneous populations, more research on the role of education in treatment success, and greater attention to assessing patient-driven outcomes in partnered and unpartnered women.

Clash of the Titans: the first multi-center retrospective comparative study between da Vinci and Hugo™ RAS surgical systems for the treatment of deep endometriosis

Background The proliferation of several robotic platforms presents an opportunity to pinpoint the most suitable system for specific procedures and patient profiles. This study aims to explore differences in complications and functional outcomes among patients undergoing deep endometriosis excision with the da Vinci surgical system compared to the Hugo™ RAS system. Method This is a retrospective, multicenter cohort study. Patients were categorized based on the surgical system used: the Da Vinci system and the Hugo™ RAS system. Perioperative complications, functional outcomes (via validated questionnaire: BFLUTS, KESS, GIQLI), and pain symptoms both before and after surgery were compared between the two groups. Results A total of six postoperative complications were reported: four in the Da Vinci system group (20%) and two in the Hugo™ RAS system group (12.5%). No difference in the mean operative time (p = 0.647), median estimated blood loss (p = 0.179), and hospital stay (p < 0.0001) was found between the two groups. A significant difference was reported in questionnaire score changes and dyspareunia severity in the da Vinci system arm. Conclusions Both robotic systems offer comparable performances in terms of intraoperative complications, although there was a higher incidence of postoperative complications in patients who underwent surgery with the Da Vinci system. Moreover, there was an improvement in dyspareunia, urinary, and gastrointestinal function in the same group.

Addressing vulvodynia in a chronic pelvic pain unit, does it make any difference?

Vulvodynia is a chronic painful entity that poses diagnostic and therapeutic challenges. The aim of this work was to describe the characteristics of women affected by vulvodynia and to estimate the effectiveness of currently available therapeutic options. A retrospective observational study has been carried out with a sample of 50 women who presented vulvodynia at a chronic pelvic pain unit between 2019 and 2021. The mean age at diagnosis was 38.44 years. Mean delay to diagnosis was 29.82 months. According to the classification currently used, vulvodynia was mainly localized, provoked, intermittent, and immediate. Most of the women also reported dyspareunia with mean baseline pain and dyspareunia according to the Visual Analog Scale (VAS) of 4 and 8, respectively. Among the therapeutic options used, neuromodulatory drugs have shown to be effective in symptom control and improving quality of life both at 6 and 12 months. At 24 months improvement in dyspareunia was not statistically significant, probably due to the small sample size due to losses in the follow-up. Non-pharmacological treatments such as physical therapy and cognitive behavioral therapy may also play a role in symptom improvement. Most of the available evidence is based on retrospective studies. Quality randomized clinical trials are necessary to better test the efficacy of treatments, especially neuromodulatory drugs.

Is Hysteroscopic Metroplasty Advisable for U2bC2V1 Malformation?

A complete uterine septum, with a double cervix and vaginal septum, is a complex and rare congenital genital tract anomaly. The diagnosis is difficult and often challenging, requiring complex imaging investigations and diagnostic hysteroscopy. The benefit of hysteroscopic metroplasty for this uterine malformation is still the subject of dispute. However, the potential benefits of obtaining pregnancies and reducing the rate of abortions make this surgical method a desirable one. We present a series of three cases with U2bC2V1 malformation that were diagnosed via magnetic resonance imaging (MRI), in which hysteroscopic removal of the uterine septum and resection of the longitudinal vaginal septum were performed, with the preservation of the two cervixes. All patients became pregnant after the hysteroscopic intervention and reported an improvement in dyspareunia and dysmenorrhea.

(134) EFFECTIVE TREATMENT OF MENOPAUSAL HOT FLASHES IMPROVES DOWNSTREAM FEMALE SEXUAL COMPLAINT

Abstract Introduction Approximately 75% of women aged between 45 years and 55 years suffer from symptoms of menopause. Untreated hot flashes have many downstream effects including but not limited to fatigue, low energy, memory complaints, lowered libido, sexual dysfunction and may even be linked to increased cardiovascular disease. While the gold standard for effective treatment is hormonal therapy, many women (especially those with a family history of breast cancer) may decline their use due to concerns regarding efficacy and safety. Lack of sensitivity training and level of comfort to disclose menopausal symptoms is often a significant barrier to effective treatment. Dose optimization, close surveillance of efficacy of hormone utilization is essential to maintain patient compliance. Objective Menopausal hot flashes are associated with a variety of downstream sexual complaints including lowered libido. This retrospective study was done to assess if optimal treatment of hot flashes with hormones and over the counter products would have a downstream effect on concurrent reported sexual complaints. Methods A retrospective review of a random convenience sample was conducted to assess women who presented with complaints of hot flashes. Concurrent associated symptoms were also reported. Treatment interventions and symptom resolution was evaluated. Data was collected and stored in private HIPPA protected database. Results A random convenience sample (n=56) from the HerMD centers (Cincinnati and Kentucky) was assessed for women (mean age 51.3; range 30-73) who presented with complaints of hot flashes. Associated symptoms included: brain fog/memory complaints (66%); sleep disturbances including insomnia (59%), decreased libido (49%), weight management concerns (38%), vaginal dryness (31%) and dyspareunia (14%). A family history of breast cancer was present in 18% of the sample. Treatment included: behavioral intervention counseling (100%), over the counter supplements n=2, (3.5%) and systemic hormonal therapy n=54 (96.5%) and over the counter recommendations (100%). All patients (100%) with a family history of breast cancer received hormonal therapy. Overall, 96% of patients responded to their intervention with self-reported improvement in hot flashes, and improvement in dyspareunia, vaginal dryness and improved libido at scheduled follow up visits. Patients had multiple office/telehealth visits to ensure dose optimization, efficacy of symptom resolution and ensure no treatment emergent adverse effects. There were n=3 (5%) reported adverse effects (minimal vaginal spotting) yet no patients discontinued treatment Conclusions Hot flashes are associated with a variety of sexual complaints including but not limited to decreased libido (49%), vaginal dryness (31%) and dyspareunia (14%). Optimal treatment of hot flashes will have downstream efficacy with FSD complaints. At HerMD, HCP have internal continuing menopausal medical education which includes standardized clinical algorithms, bibliotherapy, article data base, 1-1 didactic education/supervision and preceptorships with national menopausal experts. Systemic hormones will help with vaginal dryness and dyspareunia. HerMD advocates close clinical surveillance with treatment efficacy and safety review which allows for interventions to be modified henceforth allow for outcome optimization and enhance compliance. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Michael Krychman is a consultant for exeltis pharmaceuticals, Astellas, Uberlube and CEEK.

Effect and acceptability of jasmine compound essential oil for premenopausal breast cancer survivors suffering from genitourinary syndrome of menopause: A prospective interventional study.

1063 Background: Genitourinary syndrome of menopause (GSM) includes dyspareunia, vaginal dryness, vaginal burning, urinary urgency, and recurrent urinary tract infections. Breast cancer survivors (BCSs) exhibit more severe symptoms of GSM than healthy aging women, especially premenopausal BCSs in sexually active lifetime. GSM detrimentally impacts their quality of life and contributes to the premature cessation of endocrine therapy for breast disease. This study aims to explore the efficacy and safety of Jasmine compound essential oil in the treatment of GSM in premenopausal breast cancer women. Methods: Premenopausal sextually-active women with hormone receptor (HR) positive stage I to III BC taking ovarian function suppression (OFS) treatment and endocrine therapy with self-reported vaginal dryness, dyspareunia, or decreased libido were enrolled to the 12 weeks topically applied Jasmine compound essential oil trial. E2 and FSH was measured at baseline and weeks 12. A series of validated sexual quality-of-life questionnaires were completed at baseline, and subsequently at weeks 4, 8, and 12. The primary endpoint is the improvement in sexual pain evaluated based on the Female Sexual Function Index scale (FSFI). Acceptability was measured by patient preference and reported intention to continue using the products. Gynecologic examinations and metagenomic profiling of the vaginal microbiota were conducted at baseline and post-treatment for patients in an exploratory cohort. Results: Overall, 96 BCSs signed consent (mean [range] age, 45 [32-55] years) and 89 completed 12 weeks of treatment. E2 and FSH were maintained within the postmenopausal range without significant fluctuations during the treatment. Topically applied Jasmine compound essential oil resulted in significant improvements in dyspareunia, vaginal dryness, irritation and quality of life over time (all P&lt; 0.001). Both BCSs and their sexual partners reported being satisfied with the essential oil treatment and the adherence rate reached 95% (SD 10). In the 20-patient exploratory cohort, there were improvements in vaginal pH (baseline mean 6.07 compared with 12-week mean 4.68[ P&lt;.001]), and vaginal maturation index (45.3 compared with 52.1[ P&lt;.001]). We also observed a positive influence on the vaginal microbiota after intervention. In patients with elevated baseline abundance of Lactobacillus in the vaginal microbiome, there was a more pronounced improvement in scale scores following essential oil access. Conversely, a high baseline abundance of Escherichia coli may be considered a detrimental factor associated with less benefit from essential oil. Conclusions: Jasmine compound essential oil could relieve vaginal symptoms and improve vaginal health in breast cancer survivors who have experienced menopause after cancer treatment.

Could tranexamic acid be a suitable alternative to cryotherapy for symptomatic cervical ectopy? Results from a randomized clinical trial.

Cervical ectropion occurs due to the eversion of the endocervix that exposes glandular cells to the vaginal milieu. The aim of the present study was to evaluate and compare the clinical efficacy of effervescent vaginal tablets of tranexamic acid and cryotherapy in women with symptomatic cervical ectopy. The current randomized clinical trial was conducted on 92 samples of women with cervical erosive ectropion from March 20, 2022 to August 27, 2022. Participants were divided into two groups; the intervention group (n = 46) was treated with a 400 mg effervescent vaginal tablet of tranexamic acid and the control group (n = 46) underwent cryotherapy. All the patients were requested to visit weekly in the first month and then monthly for the next 3 months, and the outcomes encompass improvement of symptoms (leukorrhea, dyspareunia, pelvic pain, post-coital bleeding, and suprapubic pain) and cervical erosive ectropion view were monitored based on repeated examinations. In this study, no statistically significant difference was observed in cure rate of symptoms between study groups (P value > 0.05). Women in both the tranexamic acid and cryotherapy groups reported significant improvements in dyspareunia (34 [75%] vs 31 [67%]), pelvic pain (34 [75%] vs 34 [74%]), post-coital bleeding (37 [81%] vs 31 [67%]), leukorrhea (36 [78%] vs 36 [78%]), suprapubic pain (32 [71%] vs 33 [73%]) disappearance of cervical ectropion tranexamic acid (40 [86%], vs 39 [84%]). Our findings highlighted the equal effect of tranexamic acid and cryotherapy for treating cervical ectropion. Due to the ease of use, availability, and fewer side effects of tranexamic acid, it can be a suitable alternative to cryotherapy. IRCT20220115053719N1. The name of the registry: Iranian Registry of Clinical Trials. URL of registration: https://en.irct.ir/trial/61483.

O-027 Efficacy results from a phase 3, randomized, placebo-controlled trial testing two doses of linzagolix in women with endometriosis-associated pain

Abstract Study question Does once-daily linzagolix for up to 6 months reduce the pain symptoms in women with endometriosis? Summary answer Once-daily oral use of the GnRH agonist linzagolix alone or in combination with combined hormonal add-back therapy (ABT) for 24 weeks improved endometriosis-associated pain symptoms. What is known already Linzagolix is an oral GnRH antagonist under development to treat endometriosis-associated pain (EAP). In the EDELWEISS 3 study linzagolix 200mg+ABT met its co-primary endpoints at 3 months by reducing dysmenorrhea (DYS) and non-menstrual pelvic pain (NMPP) in a clinically meaningful fashion along with a stable or decreased use of analgesics. Linzagolix 75mg significantly reduced DYS but not NMPP. Secondary endpoints were DYS, NMPP, overall pelvic pain, dyschezia, and dyspareunia at 6 months assessed with a numeric and/or verbal rating scale (NRS and/or VRS), and interference of pain with daily activities assessed with the Endometriosis-Health-Profile-30 (EHP-30) pain domain. Study design, size, duration EDELWEISS 3 was a randomized, double-blind, placebo-controlled Phase 3 study, investigating efficacy and safety of linzagolix 75mg and linzagolix 200mg with ABT (1mg estradiol/0.5mg norethindrone acetate) for up to 24 weeks in women with moderate to severe EAP. To qualify, subject had to demonstrate over 2 menstrual cycles at least moderate DYS and NMPP for ≥2 days each and at least moderate overall pelvic pain for ≥5 days. Participants/materials, setting, methods Eligible women with moderate to severe EAP were equally randomized to once daily oral: placebo, linzagolix 75mg or linzagolix 200mg+ABT. Efficacy assessments included DYS, NMPP, dyspareunia (assessed with a 4-point VRS), overall pelvic pain and dyschezia (assessed with an 11-point NRS), and interference of pain with daily activities (assessed with the EHP-30 pain domain). The co-primary endpoint was a responder analysis at Month 3. We present secondary endpoints at Month 6. Main results and the role of chance Participants (n = 484) had a mean age of 35 years, a BMI of 24kg/m2 with 99% of subjects being White. At Month 6, compared to placebo significant improvements in DYS and NMPP (VRS) were observed in the 200mg+ABT group, with an estimated mean change from baseline (CfB) of -1.83 (95%CI: 1.96, 1.70; difference with placebo p &amp;lt; 0.001) and 0.92 (95%CI: 1.03, 0.82; p = 0.002), respectively. For the 75mg group, the mean CfB was 1.10 (95%CI: 1.23; 0.97; p &amp;lt; 0.001) and 0.84 (95%CI: 0.95; 0.73; p = 0.048), respectively. For overall pelvic pain (NRS), marked improvements were observed with an estimated mean CfB of 3.39 (95%CI: 3.74, 3.03; p &amp;lt; 0.001) for 200mg+ABT and 2.84 (95%CI: 3.20, 2.48; p = 0.024) for 75mg. Similarly, dyschezia (NRS) was significantly improved for both groups with a mean CfB of 1.99 (95%CI: 2.29, 1.70; p = 0.012) for 200mg+ABT and -1.98 (95%CI: 2.28, 1.69; p = 0.015) for 75mg. Both doses offered a marked, statistically significant improvement in the interference of pain with daily activities as measured on the EHP-30 Pain Dimension, with an estimated mean CfB of 35.60 (95%CI: 38.73, 32.48; p &amp;lt; 0.001) and -27.37 (95%CI: 30.50, 24.25; p = 0.001) for the 200mg+ABT and 75mg group, respectively. Both doses did not provide significant improvements in dyspareunia. Limitations, reasons for caution We report data of the EDELWEISS 3 study for up to Month 6. An extension study of this trial will provide more information on the sustained effect and potential symptom recurrence after stopping treatment. Wider implications of the findings The linzagolix 200mg+ABT group provided substantial improvement in endometriosis-associated pain symptoms. The 75mg dose was less effective but demonstrated still marked improvements. There exists an substantial need for different treatment regimens in women suffering from endometriosis. Trial registration number NCT03992846

A discrete-choice experiment study of physicians’ prioritization of attributes of medical treatments for endometriosis-associated pain

ABSTRACT Background Physicians’ preferences for attributes of medical treatments for endometriosis-associated pain have not previously been quantified. Methods US obstetrician-gynecologists completed an online discrete-choice experiment survey. In a series of questions, physicians chose a medical treatment for a hypothetical patient with endometriosis experiencing severe, persistent dysmenorrhea, nonmenstrual pelvic pain, and/or dyspareunia. Each question presented two hypothetical medical treatments for endometriosis-associated pain, defined by seven attributes with varying levels. Preferences weights and conditional relative importance (CRI) were calculated using a random-parameters logit model. Results Respondents (N = 250) had an average age of 53 years; 36% were female. The most important attribute, conditional on the attributes and levels evaluated, was risk of moderate-to-severe hot flashes (CRI, 3.34). In descending order of importance, the CRIs of the other attributes were 2.13 for improvement in nonmenstrual pelvic pain, 2.04 for improvement in dyspareunia, 1.88 for improvement in dysmenorrhea, 1.16 for risk of pregnancy-related complications if pregnancy occurs during treatment, 0.62 for increased risk of bone fracture later in life, and 0.48 for mode of administration. Conclusions In addition to valuing pain reduction, respondents prioritized avoiding moderate-to-severe hot flashes, followed by less common and less immediate risks of pregnancy-related complications and bone fracture.

Reproductive and postsurgical outcomes of infertile women with deep infiltrating endometriosis

BackgroundThis study aimed to summarize and analyze clinical characteristics and reproductive outcomes in postoperative deep infiltrating endometriosis (DIE).MethodsThis retrospective cohort study included 55 reproductive-aged patients who were diagnosed with DIE, wished to conceive and underwent resection surgery at the Obstetrics and Gynecology Hospital, Fudan University, from January 2009–June 2017. Those with any plausible infertility factor or abnormalities in the partner’s semen analysis were excluded. Patient characteristics, preoperative symptoms, infertility history, intraoperative findings and reproductive outcomes were followed up and recorded. Risk factors for reproductive outcomes were identified for women who became pregnant versus those who did not by univariate logistic regression. Additionally, pre- and postoperative endometriosis health profile questionnaire-30 (EHP-30), Knowles–Eccersley–Scott Symptom questionnaire (KESS), Cox Menstrual Symptom Scale (CMSS) and Female Sexual Function Index (FSFI) scores were used to evaluate the effect of DIE surgery on quality of life.ResultsThe average age was 30.22 ± 3.62 years, with no difference between the pregnancy and nonpregnancy groups. The average follow-up time was 26.57 ± 14.51 months. There were 34 pregnancies (61.82%): 24 (70.59%) conceived spontaneously and 10 (29.41%) by in vitro fertilization (IVF). Twenty-eight patients (82.35%) had term deliveries. The interval between operation and pregnancy was 10.33 ± 5.6 (1–26) months. Univariate analysis showed that a lower endometriosis fertility index (EFI) score (EFI < 8) was a risk factor for infertility (OR: 3.17 (1.15–10.14), p = .044). For patients with incomplete surgery, postoperative gonadotropin-releasing hormone agonist (GnRHa) administration improved the pregnancy rate (p < 0.05). Regarding quality of life, there was significant improvement (p < 0.05) in the postoperative EHP-30, KESS and CMSS scores compared with preoperative scores in both groups. Although there was no obvious difference in FSFI scores, significant improvement in dyspareunia was observed (p < 0.05).ConclusionsOverall, the postoperative pregnancy rate of DIE patients was 61.82%. Surgical management of DIE for patients with complaints of pain and with pregnancy intentions was feasible and effective. Long-term expectant treatment should not be advised for patients with lower EFI scores (EFI < 8), and postoperative IVF–ET may be a good choice. More cases should be enrolled for further study, and randomized studies are required.

Effects of Breastfeeding on Endometriosis-Related Pain: A Prospective Observational Study.

Endometriosis is a gynecological estrogen-dependent disease whose commonest pain symptoms are dysmenorrhea, dyspareunia, and acyclic chronic pelvic pain (CPP). Hormonal changes occurring during breastfeeding seem to reduce pain and disease recurrence. The aim of this observational prospective study was to assess the effect of breastfeeding on pain and endometriotic lesions in patients with endometriosis and to evaluate a possible correlation between the duration of breastfeeding, postpartum amenorrhea, and pain. Out of 156 pregnant women with endometriosis enrolled, 123 who breastfed were included in the study and were monitored for 2 years after delivery; 96/123 exclusively breastfed for at least 1 month. Mode of delivery, type and duration of breastfeeding, intensity of pain symptoms, and lesion size before pregnancy and during the 24-month follow-up were analyzed. All patients experienced a significant reduction in dysmenorrhea proportional to the duration of breastfeeding. CPP was significantly reduced only in women who exclusively breastfed. No significant improvement in dyspareunia was observed. Ovarian endometriomas were significantly reduced. Therefore, breastfeeding, particularly if exclusive, may cause improvement in dysmenorrhea and CPP proportional to the duration of breastfeeding, as well as a reduction in the size of ovarian endometriomas.

Fractional CO2 laser treatment as adjunctive therapy to topical steroids for managing vulvar lichen sclerosus

ObjectivesUncontrolled vulvar lichen sclerosus (VLS) is often associated with distressful symptoms of genital itch, irritation, and pain and can lead to a pathological process including anatomical changes, scarring, and an elevated risk of cancer in the genital area. First‐line topical corticosteroid as monotherapy is frequently not adequate to fully suppress disease activity and control symptoms. This study evaluated the efficacy of fractional CO2 laser treatments as adjunctive therapy where recalcitrant VLS had been improved, but not adequately controlled, with topical corticosteroid treatment. Outcomes were evaluated up to 12 months after a series of CO2 laser treatments delivered via a fractional handpiece.Materials and MethodsWomen with a diagnosis of VLS supported by histologic findings on biopsy and/or clinical signs on physical examination received up to five monthly laser treatments. Subjects maintained existing topical corticosteroid and any exogenous hormone treatment during the study. Investigators assessed severity (0 = not present, 1 = mild, 2 = moderate, or 3 = severe) of clinical signs and architectural changes present before adjunctive study interventions and at follow‐up visits. Subjects reported the presence of clinical symptoms and impact on quality of life on 4‐ or 5‐point Likert scales. The validated Female Sexual Function Index (FSFI) was used to assess changes in sexual function. Four subjects were biopsied before adjunctive laser treatment and at follow‐up.ResultsTwelve females, 11 postmenopausal, with a mean age of 57 ± 10 years received three to five monthly CO2 laser treatments. Significant improvement in all prominent clinical signs and architectural changes were reported at the 3‐ and 6‐month follow‐ups after the treatment series. Significant improvement was maintained at the 12‐month follow‐up, with 89% of subjects showing at least one‐point improvement in elasticity compared to baseline; 86% in lichenification; 88% in sclerosis; and 80% in whitening and parchment‐like skin. Labial fusion and the extent of disease improved in 50% of patients. Ulcerations present in three subjects at baseline resolved after treatment. Subjects reported 86% improvement in dyspareunia and 83% in skin tearing. Quality of life improved significantly after treatment (p < 0.01). The 6‐month follow‐up FSFI showed significant improvement in sexual function compared to baseline (p < 0.05), with a mean point improvement of 4.5. Histology findings after treatment showed some positive improvement, as a decrease in dermal hyalinized zone thickness. There were no treatment complications or adverse events related to the treatment.ConclusionsFractional CO2 laser treatment outcomes showed improvement in predominant clinical signs and architectural changes in VLS recalcitrant to topical corticosteroid treatment. Adjunctive laser treatment relieved symptoms and improved quality of life as well as sexual function. Fractional CO2 laser treatment may provide an advanced treatment modality for the management of recalcitrant VLS with improved patient care and sustainable outcomes. Further study in a larger population and with CO2 laser treatment to both vulvar tissue and the vaginal canal should be explored.

A DISCRETE CHOICE EXPERIMENT STUDY OF PHYSICIANS’ PReferences FOR TREATMENTS FOR ENDOMETRIOSIS-ASSOCIATED PAIN

To quantify physicians’ preferences for attributes of medical treatments for endometriosis-associated pain. Obstetricians and gynecologists who treated at least 2 patients with moderate-to-severe endometriosis-associated pain per month in the United States completed an online discrete-choice experiment survey. In a series of treatment-choice questions, physicians were asked to choose the medical treatment they would recommend for a hypothetical patient who is still menstruating, has surgically confirmed endometriosis, and has severe dysmenorrhea, nonmenstrual pelvic pain, and/or dyspareunia that persists despite nonsteroidal anti-inflammatory medications and oral contraceptive pills. Each treatment-choice question contained a pair of hypothetical medical treatments for endometriosis-associated pain characterized by 7 clinically relevant attributes with varying levels: improvement in dysmenorrhea, improvement in nonmenstrual pelvic pain (both from severe to moderate, mild, or no pain), improvement in dyspareunia (from severe to moderate or mild pain, or no improvement), mode of administration (daily oral or monthly injection), risk of pregnancy-related complications if pregnancy occurs during treatment (unknown, 0%, 2%, 7%), increased risk of bone fracture later in life (unknown, 0%, 2%, 5%, 10%), and risk of moderate to severe hot flashes (0%, 30%, 50%, 65%, 85%). A mixed logit model was used to quantify preferences, which were then used to calculate the conditional relative importance (CRI) of each attribute as the difference between the largest and smallest preference weights for that attribute’s levels. Larger values correspond to greater relative importance. Two hundred and fifty physicians completed the survey. Average respondent age was 53 years, 36% were female, and 72% were both obstetricians and gynecologists. The most important treatment attribute (conditional on the attributes and levels included in the survey) was risk of moderate to severe hot flashes (CRI: 3.34). The relative importance of the remaining attributes in decreasing order of importance is improvement in nonmenstrual pelvic pain (CRI: 2.13), improvement in dyspareunia (CRI: 2.04), improvement in dysmenorrhea (CRI: 1.88), risk of pregnancy-related complications if pregnancy occurs during treatment (CRI: 1.16), increased risk of bone fracture later in life (CRI: 0.62), and mode of administration (CRI: 0.48). Oral treatments were preferred to injections. Most physicians (n = 152; 61%) would prescribe add-back hormonal therapy in addition to the preferred treatment to mitigate vasomotor symptoms. In exchange for pain relief, physicians treating women with severe endometriosis-associated pain have relatively lower tolerance for treatment-related risks of moderate to severe hot flashes than less common and less immediate risks of pregnancy-related complications and bone fracture.

Improvement in dyspareunia after vaginal mesh removal measured by a validated questionnaire.

The objective was to examine the effect of the surgical removal of vaginally placed prolapse and incontinence mesh on sexual function. We hypothesize that patients with painful complications of mesh will experience improvement in dyspareunia and sexual function after mesh removal. The eligible cohort consisted of 133 women who presented with a new onset of pain attributed to mesh-augmented incontinence or prolapse surgery and who elected to undergo mesh removal between 1 August 2012 and 1 July 2013. Sexual function symptoms were assessed before and after mesh removal surgery using the Pelvic Organ Prolapse and Urinary Incontinence Sexual Function Questionnaire short form (PISQ-12). Multivariate analysis was performed to identify predictors of improvement in dyspareunia. Ninety-four patients undergoing mesh removal completed a pre-operative questionnaire, 63 of whom also completed a post-operative questionnaire. After mesh removal, there was a nearly 50% reduction in the proportion of women reporting always experiencing post-operative pain with intercourse among those experiencing pre-operative pain. There was a statistically significant quantitative improvement in pain with intercourse after mesh removal based on mean change score of PISQ-12 question 5 "How often do you experience pain with intercourse?". In multivariate analysis, only history of vaginal delivery was associated with symptom improvement. Removal of transvaginal prolapse mesh is associated with improvement in self-reported dyspareunia based on a standardized question on a validated instrument in a small cohort of women. Although larger studies are needed to confirm the relationship between mesh-augmented surgeries and post-procedural dyspareunia, these data suggest that consideration of mesh removal is a reasonable step for patients with painful intercourse attributed to mesh-augmented prolapse and incontinence surgeries.

Horizontal versus vertical plication of the rectovaginal septum in transperineal repair of anterior rectocele: a pilot randomized clinical trial.

Anterior rectocele is usually an asymptomatic condition in many women, yet it can be associated with obstructed defaecation syndrome (ODS). Transperineal repair of rectocele (TPR) has been followed by variable rates of improvement in ODS. The present pilot randomized clinical trial aimed to evaluate the outcome of TPR with vertical plication (VP) of the rectovaginal septum compared to horizontal plication (HP). Adult women with anterior rectocele were recruited to the study and were randomly allocated to one of two equal groups. The first group underwent TPR with VP of the rectovaginal septum and the second group underwent TPR with HP. The main outcome measures were improvement in ODS, recurrence of rectocele, complications and dyspareunia. The trial included 40 female patients with anterior rectocele. There was no significant difference between the two groups regarding the postoperative Wexner score. Complete cure and significant improvement in ODS symptoms were comparable after the two techniques. The reduction in rectocele size after HP was significantly greater than after VP (1.7 vs. 2.6, P<0.0001). Significant improvement in dyspareunia was recorded after HP (P=0.001) but not after VP (P=0.1). There was no significant difference between the two groups with regard to operating time, complications and recurrence. VP and HP of the rectovaginal septum in TPR were associated with a comparable improvement in ODS symptoms and similar complication rates. HP was followed by a greater reduction in the rectocele size and greater improvement in dyspareunia than VP.

Clinically Meaningful Reduction in Dyspareunia Is Associated With Significant Improvements in Health-Related Quality of Life Among Women With Moderate to Severe Pain Associated With Endometriosis: A Pooled Analysis of Two Phase III Trials of Elagolix

BackgroundDyspareunia experienced by women diagnosed with endometriosis is associated with a decreased health-related quality of life (HRQoL). AimWe evaluated the relationship of clinically meaningful improvements in dyspareunia with HRQoL changes among women with endometriosis. MethodsThis was a post hoc analysis of pooled data from the phase III ELARIS-I and ELARIS-II clinical trials. Women aged 18–49 years with moderate to severe endometriosis-associated pain were randomized to placebo, elagolix 150 mg once daily, or elagolix 200 mg twice daily. HRQoL was measured using the validated Endometriosis Health Profile-30 questionnaire (EHP-30), consisting of 5 core domains and a sexual intercourse modular domain. Dyspareunia was ranked 0–3 (none, mild, moderate, or severe) or not applicable using a daily eDiary and averaged monthly. A woman with a clinically meaningful dyspareunia response (dyspareunia responder) was defined as a woman with a reduction from the baseline in dyspareunia score greater than or equal to a predetermined cutoff while maintaining stable/decreased analgesic use. OutcomesDyspareunia response impact on EHP-30 scores was determined at 3 and 6 months using multivariate linear regression controlling for age, baseline EHP-30 scores, and dysmenorrhea and non-menstrual pelvic pain symptom severity. ResultsAnalysis included 1,368 women with a mean age of 32.2 years. Dyspareunia responders had significant improvements vs non-responders in all adjusted mean EHP-30 domain scores at months 3 and 6 (control and powerlessness: −17.8 and −18.5; emotional well-being: −10.0 and −10.4; pain: −15.3 and −15.7; self-image: −11.4 and −12.8; social support: −14.3 and −14.0; and sexual intercourse: −18.1 and −19.7; all P < .0001). Clinical ImplicationsDyspareunia improvements are associated with both personal and psychological benefits. Strengths & LimitationsThis study involved a large sample of women from a well-defined patient population to provide statistical power in evaluating the results. As such, the findings may not be generalizable in a real-world setting. Although the perception of dyspareunia and its severity and the associated effect on HRQoL was subjective, the use of a large patient sample was used to minimize potential issues with this limitation. ConclusionClinically meaningful responses in dyspareunia are associated with improvements across multiple HRQoL domains among women with endometriosis.Agarwal SK, Soliman AM, Pokrzywinski RM, et al. Clinically Meaningful Reduction in Dyspareunia Is Associated with Significant Improvements in Health-Related Quality of Life Among Women with Moderate to Severe Pain Associated with Endometriosis: A Pooled Analysis of Two Phase III Trials of Elagolix. J Sex Med 2020;17:2427–2433.

106: Pelvic floor symptoms following onabotulinumtoxinA trigger point injections for myofascial pelvic pain: Analysis of secondary outcomes

Myofascial pelvic pain is a complex condition that is often associated with other pelvic floor symptoms. While pelvic floor physical therapy is considered first line therapy, pelvic floor injection of onabotulinumtoxinA is usually reserved for refractory myofascial pain. We set out to determine the effect of onabotulinumtoxinA point injections on pelvic floor symptoms compared to placebo. A double-blind, randomized, placebo-controlled trial in women with myofascial pelvic pain was conducted at a single institution. Participants were randomly allocated to a pelvic floor injection of 200 units of onabotulinumtoxinA or 20 mL of saline. All participants started 8 weeks of pelvic floor physical therapy at 4 weeks. Participants followed up at 2, 4, and 12 weeks after injection for assessment of pain. In addition to validated questionnaires, data was collected on presence of specific pelvic floor symptoms, including constipation, pain with defecation, dyspareunia, and dysmenorrhea. At each follow up, subjects indicated whether each symptom was present, and designated it as new, better, same or worse compared to the previous visit. Among subjects who were symptomatic at baseline, symptoms categorized as none or better were considered improved, whereas symptoms categorized as unchanged or worse were considered not improved. Sixty women were enrolled and randomized. One participant in the placebo group was lost to follow-up. Of the 59 subjects, 39 (66%) reported constipation, 28 (48%) reported pain with defecation, 35 (59%) reported dyspareunia, and 21 (36%) reported dysmenorrhea at baseline. Among subjects with constipation, 27% of intervention and 34% of control group reported improvement at 12 weeks. Among subjects with pain with defecation, 23% of intervention and 28% of control group reported improvement. Among subjects with dyspareunia, 27% of intervention and 17% of control group reported improvement. Lastly, among subjects with dysmenorrhea, 13% of intervention and 10% of control group reported improvement at 12 weeks. In our study, participants who received onobotulinumA experienced overall similar responses as placebo in specific pain symptoms from baseline to 12 weeks. There may be a trend toward improvement in dyspareunia but the number of subjects was too small. Pelvic floor physical therapy, which is considered to be first line therapy for myofascial pain, may help regardless of intervention. Our findings suggest that onabotulinumtoxinA should be reserved for women with myofascial pain with symptoms that have not previously responded to physical therapy. Future studies should evaluate other factors such as duration of pain, comorbidities and other pain conditions as factors in response to therapy.

Long-term Outcome of Synthetic Mesh Use in Iranian Women with Genital Prolapse.

To evaluate the long-term outcome of synthetic mesh use in the treatment of women with Pelvic organ prolapse (POP). We evaluated the outcome of synthetic mesh implantation by vaginal surgery method in 153 women (mean age of 53.66±9.31 years) with POP grade >2 in the anterior compartment. Demographic findings, baseline symptoms as well as subjective and objective outcome were recorded during the follow-up period of 36.89±11.33 months. Results: POP relapse occurred in 3.3% indicative of 96.7% anatomical success rate. Patients' common baseline findings were frequency (72.5%), stress and urge incontinence (59.5% and 47.7%). Subjective outcome were vaginal pain (13.7%), dyspareunia (9.2%) and tension feeling (8.5%), while objective outcomes were mesh exposure (3.9%), urge incontinence (11.1%) and vaginal infection (1.3%). Stress incontinence was completely treated following surgery. There was significant improvement in dyspareunia, vaginal pain, urge and stress incontinence (all p < 0.001) and fecal incontinence (p = 0.02). After surgery, 88.42% were satisfied of the surgery outcome. POP surgery with synthetic mesh has acceptable results, considerable improvement in symptoms and high rate of satisfaction during follow-up; however, side effects are not uncommon but tolerable.

Elagolix reduced dyspareunia and improved health-related quality of life in premenopausal women with endometriosis-associated pain

Objectives: The objective was to evaluate the effects of elagolix on dyspareunia in women with endometriosis-associated pain. Methods: Data were pooled from two similar, randomized, double-blind, placebo-controlled, 6-month phase 3 studies (Elaris Endometriosis-I and Elaris Endometriosis-II) of elagolix at two doses (150 mg QD and 200 mg BID) in women with endometriosis-associated pain. In this post hoc analysis, dyspareunia responders were defined as having a clinically meaningful decrease from baseline in the dyspareunia score and decreased or stable use of rescue analgesic agents, as recorded in a daily electronic diary. Sexual relationship was assessed using the 30-item Endometriosis Health Profile questionnaire sexual relationship module. Results: A total of 1384 women reported ⩾1 day of sexual activity at baseline (35 days prior to and including day 1 of treatment). Of these 1384 women, 1297 (94%) reported ⩾1 day of any dyspareunia (mild, moderate, or severe), of which 51% reported ⩾1 day of severe dyspareunia. Among sexually active women who reported any dyspareunia at baseline, both elagolix doses led to improvements in dyspareunia. Women in the 200-mg BID group showed more months at which the dyspareunia response rates were statistically significantly greater than placebo, particularly in a subgroup of women with severe dyspareunia at baseline. Compared to placebo, both elagolix doses led to statistically significantly greater improvements in the mean 30-item Endometriosis Health Profile sexual relationship module score. Conclusion: Up to 6 months of elagolix treatment improved dyspareunia in women with endometriosis-associated pain in a dose-dependent manner, with 200-mg BID dose showing the most significant improvements in dyspareunia and quality of sexual relationships compared with placebo.

Ulipristal acetate on quality of life and sexual function of women with uterine fibromatosis

To evaluate quality of life and sexual function of childbearing-age women, affected by uterine fibromatosis undergoing medical treatment with ulipristal acetate. The data obtained by filling the questionnaires European Quality of Life Five-Dimension Scale and modified Female Sexual Function Index, were analyzed to assess UPA usefulness in improving QoL and sexual activity. A total of 139 patients affected by uterine fibromatosis undergoing conservative ulipristal acetate treatment were enrolled in this prospective observational cohort study. Seventy-one women (average age 46.5 years) answered the questionnaires: QoL and sexuality were evaluated before and after ulipristal acetate treatment. 59 patients (83.1%) had an improvement of QoL and general health state, with a reduction of VAS score after ulipristal acetate treatment. EQ-5D-5L showed a statistically significant improvement of usual act impairment, mobility, discomfort, anxiety/depression (p < .0005). There was no difference in personal care management after therapy. Modified FSFI showed a statistically significant improvement (p < .0001) of sexual satisfaction and sexual life. A not statistically significant improvement in dyspareunia was also highlighted. This study provides a clear picture about QoL impact on women and confirms the effectiveness of the ulipristal acetate in improving different aspects of daily and sexual life of patients undergoing medical treatment.