Towards comprehensive management of symptomatic endometriosis: beyond the dichotomy of medical versus surgical treatment.

Except when surgery is the only option because of organ damage, the presence of suspicious lesions, or the desire to conceive, women with endometriosis-associated pain often face a choice between medical and surgical treatment. In theory, the description of the potential benefits and potential harms of the two alternatives should be standardized, unbiased, and based on strong evidence, enabling the patient to make an informed decision. However, doctor's opinion, intellectual competing interests, local availability of specific services and (mis)information obtained from social media, and online support groups can influence the type of advice given and affect patients' choices. This is compounded by the paucity of robust data from randomized controlled trials, and the anxiety of distressed women who are eager to do anything to alleviate their disabling symptoms. Vulnerable patients are more likely to accept the suggestions of their healthcare provider, which can lead to unbalanced and physician-centred decisions, whether in favour of either medical or surgical treatment. In general, treatments should be symptom-orientated rather than lesion-orientated. Medical and surgical modalities appear to be similarly effective in reducing pain symptoms, with medications generally more successful for severe dysmenorrhoea and surgery more successful for severe deep dyspareunia caused by fibrotic lesions infiltrating the posterior compartment. Oestrogen-progestogen combinations and progestogen monotherapies are generally safe and well tolerated, provided there are no major contraindications. About three-quarters of patients with superficial peritoneal and ovarian endometriosis and two-thirds of those with infiltrating fibrotic lesions are ultimately satisfied with their medical treatment although the remainder may experience side effects, which may result in non-compliance. Surgery for superficial and ovarian endometriosis is usually safe. When fibrotic infiltrating lesions are present, morbidity varies greatly depending on the skill of the individual surgeon, the need for advanced procedures, such as bowel resection and ureteral reimplantation, and the availability of expert colorectal surgeons and urologists working together in a multidisciplinary approach. The generalizability of published results is adequate for medical treatment but very limited for surgery. Moreover, on the one hand, hormonal drugs induce disease remission but do not cure endometriosis, and symptom relapse is expected when the drugs are discontinued; on the other hand, the same drugs should be used after lesion excision, which also does not cure endometriosis, to prevent an overall cumulative symptom and lesion recurrence rate of 10% per postoperative year. Therefore, the real choice may not be between medical treatment and surgery, but between medical treatment alone and surgery plus postoperative medical treatment. The experience of pain in women with endometriosis is a complex phenomenon that is not exclusively based on nociception, although the role of peripheral and central sensitization is not fully understood. In addition, trauma, and especially sexual trauma, and pelvic floor disorders can cause or contribute to symptoms in many individuals with chronic pelvic pain, and healthcare providers should never take for granted that diagnosed or suspected endometriosis is always the real, or the sole, origin of the referred complaints. Alternative treatment modalities are available that can help address most of the additional causes contributing to symptoms. Pain management in women with endometriosis may be more than a choice between medical and surgical treatment and may require comprehensive care by a multidisciplinary team including psychologists, sexologists, physiotherapists, dieticians, and pain therapists. An often missing factor in successful treatment is empathy on the part of healthcare providers. Being heard and understood, receiving simple and clear explanations and honest communication about uncertainties, being invited to share medical decisions after receiving detailed and impartial information, and being reassured that a team member will be available should a major problem arise, can greatly increase trust in doctors and transform a lonely and frustrating experience into a guided and supported journey, during which coping with this chronic disease is gradually learned and eventually accepted. Within this broader scenario, patient-centred medicine is the priority, and whether or when to resort to surgery or choose the medical option remains the prerogative of each individual woman.

Two-year efficacy and safety of relugolix combination therapy in women with endometriosis-associated pain: SPIRIT open-label extension study.

STUDY QUESTION: What is the efficacy and safety of long-term treatment (up to 2 years) with relugolix combination therapy (CT) in women with moderate to severe endometriosis-associated pain? SUMMARY ANSWER: For up to 2 years, treatment with relugolix CT improved menstrual and non-menstrual pain, dyspareunia, and function in women with endometriosis; after an initial decline of <1%, the mean bone mineral density (BMD) remained stable with continued treatment. WHAT IS KNOWN ALREADY: Endometriosis is a chronic condition characterized by symptoms of dysmenorrhea, non-menstrual pelvic pain (NMPP), and dyspareunia, which have a substantial impact on the lives of affected women, their partners, and families. SPIRIT 1 and 2 were phase 3, randomized, double-blind, placebo-controlled studies of once-daily relugolix CT (relugolix 40 mg, oestradiol 1 mg, norethisterone acetate 0.5 mg) in premenopausal women (age 18-50 years) with endometriosis and moderate-to-severe dysmenorrhea and NMPP. These trials demonstrated a significant improvement of dysmenorrhea, NMPP, and dyspareunia in women treated with relugolix CT, with minimal decline (<1%) in BMD versus placebo at 24 weeks. STUDY DESIGN, SIZE, DURATION: Patients participating in this open-label, single-arm, long-term extension (LTE) study of the 24-week SPIRIT pivotal studies (SPIRIT 1 and 2) received up to an additional 80 weeks of once-daily oral relugolix CT treatment between May 2018 and January 2023. PARTICIPANTS/MATERIALS, SETTING, METHODS: Premenopausal women with confirmed endometriosis and moderate to severe dysmenorrhea and NMPP who completed the 24-week pivotal studies (SPIRIT 1 and 2 trials; Giudice et al., 2022) and who met all entry criteria were eligible to enrol. Two-year results were analysed by treatment group based on original randomization in pivotal studies: relugolix CT, delayed relugolix CT (relugolix 40 mg monotherapy for 12 weeks, followed by relugolix CT), or placebo→relugolix CT (placebo for 24 weeks followed by relugolix CT). The primary endpoints of the LTE study were the proportion of dysmenorrhea and NMPP responders at Week 52 and Week 104/end-of-treatment (EOT). A responder was a participant who achieved a predefined, clinically meaningful reduction from baseline in Numerical Rating Scale (NRS) scores (0 = no pain, 10 = worst pain imaginable) for the specific pain type with no increase in analgesic use. The predefined clinically meaningful threshold for dysmenorrhea was 2.8 points and for NMPP was 2.1 points. Secondary efficacy endpoints included change from baseline in Endometriosis Health Profile-30 (EHP-30) pain domain scores, a measure of the effects of endometriosis-associated pain on daily activities (function), NRS scores for dysmenorrhea, NMPP, dyspareunia, and overall pelvic pain, and analgesic/opioid use. Safety endpoints included adverse events and changes in BMD. MAIN RESULTS AND THE ROLE OF CHANCE: Of 1261 randomized patients, 1044 completed the pivotal studies, 802 enrolled in the LTE, 681 completed 52 weeks of treatment, and 501 completed 104 weeks of treatment. Demographics and baseline characteristics of the extension population were consistent with those of the original randomized population. Among patients randomized to relugolix CT at pivotal study baseline who continued in the LTE (N = 277), sustained improvements in endometriosis-associated pain were demonstrated through 104 weeks. The proportion of responders at Week 104/EOT for dysmenorrhea and NMPP was 84.8% and 75.8%, respectively. Decreases in dyspareunia and improvement in function assessed by EHP-30 pain domain were also sustained over 2 years. At Week 104/EOT, 91% of patients were opioid-free and 75% of patients were analgesic-free. Relugolix CT over 104 weeks was well tolerated with a safety profile consistent with that observed over the first 24 weeks. After initial least squares mean BMD loss <1% at Week 24, BMD plateaued at Week 36 and was sustained for the duration of 104 weeks of treatment. Efficacy and safety results were generally consistent in women in the placebo→relugolix CT and delayed relugolix CT groups. LIMITATIONS, REASONS FOR CAUTION: The study was conducted as an open-label study without a control group over the 80 weeks of the extension period. Of the 802 patients who were enrolled in this LTE study, 681 patients (84.9%) and 501 patients (62.5%) of patients completed 52 and 104 weeks of treatment, respectively. In addition, there currently are no comparative data to other hormonal medications. Finally, a third (37.4%) of the study population terminated participation early. WIDER IMPLICATIONS OF THE FINDINGS: In conclusion, relugolix CT offers an additional option to help address an important unmet clinical need for effective, safe, and well-tolerated medical treatments for endometriosis that can be used longer-term, reducing the need for opioids and improving quality of life. The findings from this study may help support the care of women with endometriosis seeking longer-term effective medical management of their symptoms. STUDY FUNDING/COMPETING INTEREST(S): This study was funded by Myovant Sciences GmbH (now Sumitomo Pharma Switzerland GmbH). C.M.B. reports fees from Myovant, grants from Bayer Healthcare, fees from ObsEva, and Chair of ESHRE Endometriosis Guideline Group (all funds went to the University of Oxford); N.P.J. reports personal fees from Myovant Sciences, during the conduct of the study, personal fees from Guerbet, personal fees from Organon, personal fees from Roche Diagnostics; S.A.-S. reports personal fees from Myovant Sciences, personal fees from Bayer, personal fees from Abbvie, personal fees from UpToDate; J.S.P., and R.B.W. are employees and shareholders of Myovant Sciences; J.C.A.F. and S.J.I. are shareholders of Myovant Sciences (but at time of publicaion are no longer employess of Myovant Sciences); M.S.A. and K.W. have no conflicts to declare; V.M. is a consultant to Myovant; L.C.G. reports personal fees from Myovant Sciences, Inc and Bayer. The authors did not receive compensation for manuscript writing, review, and revision. TRIAL REGISTRATION NUMBER: NCT03654274.

An evaluation of sexual function and health-related quality of life following laparoscopic surgery in individuals living with endometriosis.

STUDY QUESTION: What is the relationship between sexual function, health-related quality of life (HRQoL), and laparoscopic surgery in individuals living with endometriosis? SUMMARY ANSWER: A higher number of laparoscopic surgeries is significantly associated with poorer HRQoL and greater levels of sexual dysfunction in individuals with endometriosis. WHAT IS KNOWN ALREADY: Prior research indicates that endometriosis is associated with lowered HRQoL and sexual function and that these outcomes are influenced by endometriosis-related symptom profiles, medical, and surgical management. A limited number of studies have examined changes in sexual function in individuals with endometriosis following laparoscopic surgery or following repeated surgeries. STUDY DESIGN, SIZE, DURATION: A cross-sectional community-based online survey was used to examine the relationships between sexual function, HRQoL, and laparoscopic surgery (n = 210). PARTICIPANTS/MATERIALS, SETTING, METHODS: Individuals with a self-reported diagnosis of endometriosis were recruited via online advertising through social media and gynaecology clinics. Endometriosis-specific data (e.g. diagnostic delay, symptom experience) was collected in addition to engagement with laparoscopic surgery, level of HRQoL (EuroQol-5 Dimension: EQ-5D-5L), and sexual function (Female Sexual Function Index: FSFI). Bivariate correlational analyses and hierarchical multiple regression were used to determine the associations between the variables of interest. MAIN RESULTS AND THE ROLE OF CHANCE: Individuals with endometriosis have substantially poorer HRQoL in comparison to Australian normative samples, with greater levels of endometriosis-related symptom burden, distress, and pain significantly associated with lower levels of HRQoL. The mean FSFI score was suggestive of clinically significant female sexual dysfunction, with the lowest level of function noted in the domain of sexual pain and the highest level of function noted in the sexual satisfaction domain. A greater number of laparoscopic surgeries was significantly associated with poorer overall HRQoL and greater levels of sexual dysfunction. LIMITATIONS, REASONS FOR CAUTION: The cross-sectional nature of the data precludes direct findings of causality and further longitudinal research is recommended. The information pertaining to engagement in laparoscopic surgery was self-report in nature and was not medically verified. WIDER IMPLICATIONS OF THE FINDINGS: The study's findings highlight the pervasive impact of endometriosis on all domains of living, emphasizing the need to extend treatment planning beyond that of physical pain management alone. Early referral for assessment and management of sexual wellbeing is recommended prior to, and post-surgical intervention, with a focus on maintaining post-surgical changes, potentially reducing the need for multiple surgeries. STUDY FUNDING, COMPETING INTEREST(S): The study was not associated with research funding. Author CN reports grant funding from the Australian Government and Medical Research Future Fund (MRFF) and was a previous employee of CSL Vifor (formerly Vifor Pharma Pty Ltd). TRIAL REGISTRATION NUMBER: N/A.

Screening women in young adulthood for disabling dysmenorrhoea: a nationwide cross-sectional study from the CONSTANCES cohort.

RESEARCH QUESTION: How do different warning indicators help to identify disabling dysmenorrhoea among women in young adulthood? DESIGN: A nationwide cross-sectional study of women aged 18-25 years from the CONSTANCES cohort was constructed. Disability was assessed with the Global Activity Limitation Indicator question 'For the past 6 months, have you been limited in routine activities?Yes, severely limited/Yes, limited/ No, not limited'. Dysmenorrhoea pain intensity and other chronic pelvic pain symptoms (dyspareunia and non-menstrual pain) were evaluated according to questions from a specific questionnaire. Probability of disability was estimated using a logistic prediction model according to dysmenorrhoea intensity, other indicators of pelvic pain symptoms and other obvious covariates. The results of the predictive model of disabling dysmenorrhoea were presented on a nomogram. RESULTS: Among 6377 women, the rate of disability was estimated at 7.5%. Increased intensity of dysmenorrhoea (odds ratio [OR] 1.08, 95% confidence interval [CI] 1.04-1.13), increased frequency of dyspareunia (from OR 1.69, 95% CI 1.33-2.14 up to OR 3.41, 95% CI 2.16-5.38) non-menstrual chronic pelvic pain (OR 1.75, 95% CI 1.40-2.19), body mass index over 25 kg/m2 (OR 1.45, 95% CI 1.17-1.80) and non-use of the hormonal contraceptive pill (OR 1.29, 95% CI 1.05-1.59) were significantly associated with disability. According to the nomogram, a predicted probability of 15% or more could be chosen as a threshold. This represents almost 4.6% of young women in this sample being classified at risk of disabling dysmenorrhoea. CONCLUSIONS: Dysmenorrhoea pain intensity and associated pelvic pain symptoms are warning indicators that can be measured to help screen young women who may suffer from disabling dysmenorrhoea.

Efficacy, tolerability, and bone density outcomes of elagolix with add-back therapy for endometriosis-associated pain: twelve months of an ongoing randomized phase 3 trial.

BACKGROUND: Elagolix, an approved oral treatment for endometriosis-associated pain, has been associated with hypoestrogenic effects when used as monotherapy. Hormonal add-back therapy has the potential to mitigate these effects. OBJECTIVE: To evaluate efficacy, tolerability, and bone density outcomes of elagolix 200 mg twice daily with 1 mg estradiol/0.5 mg norethindrone acetate (add-back) therapy once daily compared with placebo in premenopausal women with moderate-to-severe endometriosis-associated pain. STUDY DESIGN: This ongoing, 48-month, phase 3 study consists of a 12-month double-blind period, with randomization 4:1:2 to elagolix 200 mg twice daily with add-back therapy, elagolix 200 mg twice daily monotherapy for 6 months followed by elagolix with add-back therapy, or placebo. The coprimary endpoints were proportion of patients with clinical improvement (termed "responders") in dysmenorrhea and nonmenstrual pelvic pain at month 6. We report 12-month results on efficacy of elagolix with add-back therapy vs placebo in reducing dysmenorrhea, nonmenstrual pelvic pain, dyspareunia, and fatigue. Tolerability assessments include adverse events and change from baseline in bone mineral density. RESULTS: A total of 679 patients were randomized to elagolix with add-back therapy (n=389), elagolix monotherapy (n=97), or placebo (n=193). Compared with patients randomized to placebo, a significantly greater proportion of patients randomized to elagolix with add-back therapy responded with clinical improvement in dysmenorrhea (62.8% vs 23.7%; P≤.001) and nonmenstrual pelvic pain (51.3% vs 36.8%; P≤.001) at 6 months. Compared with placebo, elagolix with add-back therapy produced significantly greater improvement from baseline in 7 hierarchically ranked secondary endpoints including dysmenorrhea (months 12, 6, 3), nonmenstrual pelvic pain (months 12, 6, 3), and fatigue (months 6) (all P<.01). Overall, the incidence of adverse events was 73.8% with elagolix plus add-back therapy and 66.8% with placebo. The rate of severe and serious adverse events did not meaningfully differ between treatment groups. Study drug discontinuations associated with adverse events were low in patients receiving elagolix with add-back therapy (12.6%) and those receiving placebo (9.8%). Patients randomized to elagolix monotherapy exhibited decreases from baseline in bone mineral density of -2.43% (lumbar spine), -1.54% (total hip), and -1.78% (femoral neck) at month 6. When add-back therapy was added to elagolix at month 6, the change from baseline in bone mineral density remained in a similar range of -1.58% to -1.83% at month 12. However, patients who received elagolix plus add-back therapy from baseline exhibited little change from baseline in bone mineral density (<1% change) at months 6 and 12. CONCLUSION: Compared with placebo, elagolix with add-back therapy resulted in significant, clinically meaningful improvement in dysmenorrhea, nonmenstrual pelvic pain, and fatigue at 6 months that continued until month 12 for both dysmenorrhea and nonmenstrual pelvic pain. Elagolix with add-back therapy was generally well tolerated. Loss of bone mineral density at 12 months was greater in patients who received elagolix with add-back therapy than those who received placebo. However, the change in bone mineral density with elagolix plus add-back therapy was <1% and was attenuated compared with bone loss observed with elagolix monotherapy.

Effectiveness of non-pharmacological conservative therapies for chronic pelvic pain in women: a systematic review and meta-analysis.

OBJECTIVE: To evaluate the effectiveness of non-pharmacological, conservative therapies for women with chronic pelvic pain (CPP). DATA SOURCES: A systematic search of electronic databases (Amed, CINAHL, PsycINFO, SportDiscuss, Medline, PubMed, Embase, and Cochrane Central Register of Controlled Trials) was performed in January 2023, and updated in December 2023. STUDY ELIGIBILITY CRITERIA: Randomized controlled trials (RCTs) comparing a non-pharmacological, conservative therapy to inert (e.g., placebo, usual care) or non-conservative (e.g., surgical, pharmacological) treatment were included. Conservative therapies of interest to this review were: multimodal physical therapy, predominantly psychological approaches, acupuncture, and other tissue-based monotherapies (e.g., electrophysical agents, manual stretching). STUDY APPRAISAL AND SYNTHESIS METHODS: All study data were aggregated, and analyses of the included studies were performed. Effects on pain; sexual measures; psychological and physical function; health-related quality of life; symptom severity/bother; pelvic floor muscle function and morphometry; perceived improvement; and adverse events were analyzed. Meta-analyses (random effects model) were conducted using post-intervention scores for data that included similar interventions and outcomes. Standardized mean differences (SMD) were calculated. A narrative summary of findings that could not be included in the meta-analysis is provided. The quality of the evidence was assessed with the PEDro scale and the certainty of evidence with Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) criteria. RESULTS: Of 5776 retrieved studies, 38 RCTs including 2168 women (mean age 35.1±8.6) were included. Meta-analyses revealed that multimodal physical therapy resulted in lower pain intensity compared to inert or non-conservative treatments in both the short (SMD -1.69, 95% CI -2.54,-0.85; high certainty) and intermediate-terms (SMD -1.82, 95% CI -3.13, -0.52; moderate certainty), while predominantly psychological approaches resulted in no difference in pain intensity (SMD -0.18, 95% CI -0.56, 0.20; moderate certainty) and a slight difference in sexual function (SMD -0.28, 95% CI -0.52,-0.04; moderate certainty). The level of evidence regarding the meta-analysis of the effects of acupuncture on pain intensity (SMD 1.08, 95% CI -1.38, 3.54, non-statistically significant results in favor of control treatment) precluded any statement of certainty. A limited number of trials investigated individual tissue-based monotherapies, providing a restricted body of evidence. CONCLUSIONS: This systematic review with meta-analysis revealed that multimodal physical therapy is effective in women with CPP with a high certainty of evidence.

Sexual function, quality of life, anxiety, and depression in women of reproductive age using hormonal, nonhormonal, and no contraceptive methods.

BACKGROUND: Hormonal contraceptive use has been related to adverse effects, including impacts on sexual function and sexual satisfaction, although the difference in the effects on sexual function with the use of hormonal vs nonhormonal contraceptive methods remains controversial. AIM: In this study we sought to compare the prevalence of dyspareunia, sexual function, sexual satisfaction, quality of life, anxiety, and depression between women using hormonal, nonhormonal, or no contraceptive methods and to compare these outcomes between the most frequently used contraceptive methods. METHODS: This cross-sectional study included sexually active women of reproductive age who were stratified into 3 groups: women using hormonal, nonhormonal, or no contraceptive methods. Based on the use of questionnaires administered to the study participants, we compared sexual function in the 3 groups and more specifically among users of oral contraceptives, copper and hormonal intrauterine devices, and barrier methods. OUTCOMES: Participants completed 4 questionnaires to assess sexual function (Female Sexual Function Index), sexual satisfaction (Sexual Quotient-Feminine Version), quality of life (12-item Medical Outcomes Short Form Health Survey), and anxiety and depression (Hospital Anxiety and Depression Scale). RESULTS: This study included 315 women classified into 3 groups on the basis of contraceptive use: 161 in the hormonal contraceptives group (median [interquartile range] age, 24 [23-28] years), 97 in the nonhormonal contraceptives group (age 26 [23-30] years), and 57 in the no contraceptive methods group (age 28 [24-35] years). Dyspareunia prevalence showed no difference between the groups. In the quality of life domain, compared with women in the nonhormonal contraceptive group, women in the hormonal contraceptive group were younger and had lower sexual function satisfaction, reduced arousal, and heightened pain (P < .05), as well as higher anxiety and depression levels (P = .03, for both), increased pain (P = .01), and poorer overall health (P = .01). No difference was found between these groups in other quality of life domains. Regarding contraceptive methods, women using copper intrauterine devices had better sexual function, including higher rates of arousal and lower anxiety, than women using oral contraceptives (P < .05). CLINICAL IMPLICATIONS: The results of this study highlight worse sexual function and sexual satisfaction and higher levels of anxiety and depression in women using hormonal contraceptive methods than in women using nonhormonal methods. STRENGTHS AND LIMITATIONS: The findings of this study strengthen the evidence of differences in sexual function between women using oral contraceptives and those using copper intrauterine devices. Sexual function was also compared among users of oral contraceptives, copper and hormonal intrauterine devices, and barrier methods. However, less frequently used contraceptive methods, such as hormonal injections and vaginal rings, could not be compared in this sample. CONCLUSION: Women using hormonal contraceptive methods were younger, had lower sexual function and satisfaction, and experienced higher anxiety and depression levels than women using nonhormonal contraceptive methods.

A Comprehensive Evaluation of Sexual Life in Women After Laparoscopic Sacrocolpopexy using PISQ-IR.

INTRODUCTION AND HYPOTHESIS: Although laparoscopic sacrocolpopexy is a recommended procedure for sexually active women, its full impact on sexual life remains underexplored. This study is aimed at comprehensively assessing changes in the quality of sexual life and the prevalence of dyspareunia in women 1 year after laparoscopic sacrocolpopexy. METHODS: This prospective observational study enrolled women undergoing laparoscopic sacrocolpopexy for pelvic organ prolapse stage≥ 2. Included were women with a completed Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA Revised (PISQ-IR) questionnaire before and at 1 year after surgery. Individual domains of the PISQ-IR were compared separately. Dyspareunia, single summary PISQ-IR and PISQ-12 scores were additionally compared in sexually active women. Statistical analyses included paired signed rank, Wilcoxon, Median, Chi-squared, and Fisher tests (p < 0.05). RESULTS: Between February 2015 and December 2019, a total of 333 women were included. Mean age was 61.0 ± 11.2 and 141 (42%) reported being sexually active at baseline. At 12 months postoperatively, sexual activity was preserved in 110 (78%) of these women and an additional 26 women (14%) became sexually active. Both single-summary PISQ-IR (3.4 vs 3.6, p < 0.01) and PISQ-12 (36.0 vs 38.1, p < 0.01) scores increased significantly. The only variable that was associated with deteriorated scores postoperatively was a higher BMI. Individual domain analyses revealed significant improvement in condition-specific and condition-impact domains, except for the desire domain, which deteriorated. Prevalence of dyspareunia decreased post-surgery from 21.8% to 16.4%, p < 0.05. Newly sexually active women were older, had shorter vaginal length preoperatively, but lower PISQ-IR scores postoperatively than sexually inactive women pre- and postoperatively. Women ceasing sexual activity were older and had lower preoperative PISQ-IR scores than sexually active women pre- and postoperatively. CONCLUSIONS: Although the overall rate of sexually active women and sexual desire declined 12 months after sacrocolpopexy, overall sexual function scores improved and the prevalence of dyspareunia decreased.

Postpartum perineal pain and its association with sub-classified second-degree tears and perineal trauma-A follow-up of a randomized controlled trial.

INTRODUCTION: Postnatal perineal pain is prevalent following childbirth and can impact women both physically and emotionally. The aim of the study was to study the effect of collegial midwifery assistance on perineal pain and pain medication 1 month after birth and to investigate the associations between the type of tear and perineal pain, satisfaction with healing, and resumption of intercourse. MATERIAL AND METHODS: A follow-up questionnaire was sent 1 month postpartum to women with a first spontaneous vaginal birth participating in a randomized controlled trial (Oneplus trial). Data were collected from December 2019 to May 2020. Differences in perineal pain between women attended by one or two midwives were analyzed according to intention-to-treat using bivariate analyses. Associations between the type of tear and perineal pain, satisfaction with healing, and resumption of sexual intercourse were investigated using univariable and multivariable logistic regression. The category no tear/first-degree tear was compared separately to each of the other tear categories. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT03770962. RESULTS: Out of 2233 women, 1762 responded within 30-60 days postpartum. Of women in the no tear/first-degree tear category, 27.7% reported perineal pain during the past week, in contrast to women with OASI, where 64.2% reported perineal pain. Women with OASI experienced the highest odds of perineal pain (aOR 4.51, 95% CI 2.72-7.47) compared to those with no tear/first-degree tear, followed by women with major second-degree tears (aOR 1.87, 95% CI 1.45-2.41), women with an episiotomy (aOR 1.78, 95% CI 1.11-2.87), and those with minor second-degree tears (aOR 1.43, 95% CI 1.06-1.94). Women with episiotomy reported the highest odds ratios for dissatisfaction with tear healing (aOR 3.48, 95% CI 1.92-6.31). No significant differences in perineal pain and pain medication were observed between women allocated to collegial midwifery assistance and those allocated to standard care. CONCLUSIONS: Women with OASI reported the highest odds of perineal pain 30-60 days after birth compared to women with no tear or first-degree tear, followed by women with major second-degree tears. Women subjected to an episiotomy reported highest odds ratios of dissatisfaction with tear healing.

Prevalence of chronic pelvic pain and associated factors among indigenous women of reproductive age in Ecuador.

BACKGROUND: Chronic pelvic pain is a common disease that affects approximately 4% of women of reproductive age in developed countries. This number is estimated to be higher in developing countries, with a significant negative personal and socioeconomic impact on women. The lack of data on this condition in several countries, particularly those in development and in socially and biologically vulnerable populations such as the indigenous, makes it difficult to guide public policies. OBJECTIVES: To evaluate the prevalence of chronic pelvic pain (dysmenorrhea, dyspareunia, non-cyclical pain) and identify which variables are independently associated with the presence of the condition in indigenous women from Otavalo-Ecuador. DESIGN: A cross-sectional study was carried out including a sample of 2429 women of reproductive age between 14 and 49 years old, obtained from April 2022 to March 2023. A directed questionnaire was used, collected by bilingual interviewers (Kichwa and Spanish) belonging to the community itself; the number of patients was selected by random sampling proportional to the number of women estimated by sample calculation. Data are presented as case prevalence, odds ratio, and 95% confidence interval, with p < 0.05. RESULTS: The prevalence of primary dysmenorrhea, non-cyclic pelvic pain, and dyspareunia was, respectively, 26.6%, 8.9%, and 3.9%.all forms of chronic pain were independently associated with each other. Additionally, dysmenorrhoea was independently associated with hypertension, intestinal symptoms, miscegenation, long cycles, previous pregnancy, use of contraceptives and pear body shape. Pain in other sites, late menarche, exercise, and pear body shape were associated with non-cyclic pelvic pain. And, urinary symptoms, previous pregnancy loss, miscegenation, and pear body shape were associated with dyspareunia. CONCLUSION: The prevalence of primary dysmenorrhea and non-cyclical chronic pelvic pain was notably high, in contrast with the frequency of reported dyspareunia. Briefly, our results suggest an association between dysmenorrhoea and conditions related to inflammatory and/or systemic metabolic disorders, including a potential causal relationship with other manifestations of pelvic pain, and between non-cyclical pelvic pain and signs/symptoms suggesting central sensitization. The report of dyspareunia may be influenced by local cultural values and beliefs.

Prospective, multicenter, uncontrolled study on the effectiveness and safety of a hyaluronic acid water-based vaginal lubricant in alleviating vaginal dryness and dyspareunia.

BACKGROUND: Vaginal dryness (VD) represents a significant concern affecting women across diverse life stages, encompassing both pre- and postmenopausal women at any age. Dyspareunia, defined by genital pain that can be experienced before, during, or after intercourse, is often associated with vaginal dryness. AIM: This study aimed to evaluate the effectiveness and safety of a water-based vaginal lubricant with hyaluronic acid to reduce sexual discomfort associated with vaginal dryness. METHODS: A prospective, multicenter, uncontrolled clinical investigation was conducted over a three-month period in women aged 18 years or older experiencing pain or difficulty during sexual intercourse for whom the use of a vaginal lubricant was recommended. RESULTS: Significant improvements were observed in the FSFI scores, indicating enhanced sexual function (p < .001). Vaginal dryness symptoms, including irritation, dryness, itching, and dyspareunia, significantly decreased after product use (p < .001). CLINICAL IMPLICATIONS: This study contributes to the limited scientific knowledge on the application of lubricants in the context of symptoms associated with VD. STRENGTHS & LIMITATIONS: In addition to the short study period, inherent limitations of the study design, and lack of placebo control, it is pertinent to acknowledge that some of the pros used in this study were not based on validated questionnaires. However, as far as we know, this study is the only one that analyzes well-being and sexual pleasure as results using a lubricant formulated with hyaluronic acid. CONCLUSION: This tested vaginal lubricant with hyaluronic acid has demonstrated efficacy in improving vaginal dryness and female sexual function, particularly in reducing pain and improving lubrication during sexual intercourse, and showed a favorable safety profile, with minimal and transient adverse events.

Comparative study of postpartum sexual function: Second-degree tears versus episiotomy outcomes.

PURPOSE: The effects of episiotomy and second-degree tears on postpartum sexual function are key areas of enquiry in women's health research. Episiotomy and second-degree tears are common procedures and injuries that occur during childbirth. Understanding their impact on post-childbirth sexuality is crucial to women's overall well-being. This study aimed to examine the relationship between episiotomy, second-degree tears, and post childbirth sexuality. METHODS: A cross-sectional design was employed, including 83 women who gave birth to Cáceres in 2017. Participants were evaluated based on sociodemographic and sexual health factors. RESULTS: No significant differences were found in dyspareunia or sexual function between women who underwent episiotomies and those with second-degree tears. However, women who underwent episiotomies waited longer before resuming sexual activity after childbirth. Factors such as age, number of previous births, employment status, educational level, and breastfeeding status affected the timing and frequency of postpartum sexual activity. CONCLUSION: Dyspareunia negatively affects various aspects of sexual function. When comparing episiotomy and second-degree tears, their impacts on postpartum sexual function were similar. However, episiotomy delays the resumption of sexual activity. Sociodemographic factors significantly influence postpartum sexual health. These findings highlight the importance of individualised interventions and support for new mothers during the postpartum period to address potential sexual health concerns.

[Sex therapy and support for women and couples]. / Sexothérapie et accompagnement de la femme et du couple.

Sexuality is shaped by experience and by what has been passed down. Body image and sex influence desire and pleasure. In the case of endometriosis, suffering and pain can lead to shame and guilt. Encouraging people to talk to each other helps to create a free eroticism that resembles the couple.

Effects of Pelvic Floor Muscle Physiotherapy on Urinary, Bowel, and Sexual Functions in Women with Deep Infiltrating Endometriosis: A Randomized Controlled Trial.

Background and Objectives: Endometriosis is a chronic and recurrent disease defined as the presence and proliferation of endometrial glands and stroma outside the uterine cavity. It affects up to 6-10% of women of reproductive age and can be classified into superficial, ovarian, and deep infiltrating endometriosis (DIE). Deep infiltrating endometriosis can be associated with pain symptoms and pelvic floor muscle hypertone. Moreover, it may be responsible of bowel, urinary, and sexual dysfunctions with impairment of women's quality of life. Few studies have investigated the role of physiotherapy in women with DIE. Here, we aimed first to evaluate the effects of pelvic floor physiotherapy (PFP) on urinary, bowel, and sexual functions. Secondly, we aimed to evaluate the effects of ultrasound visual feedback during PFP on pelvic floor and subjective modifications in the frequency of sexual intercourse. Materials and Methods: This randomized controlled trial was conducted between June 2018 and December 2019 at our tertiary center. Nulliparous women with DIE and superficial dyspareunia were enrolled. At first examination, levator hiatal area (LHA) assessed with 3D/4D transperineal ultrasound, pain symptoms, urinary, bowel, and sexual functions were evaluated. Then, women were randomly assigned to no intervention (control group) or treatment with five individual sessions of PFP (experimental group), and after four months women underwent a second examination. Urinary, bowel, and sexual functions were assessed with validated questionnaires at first and second examinations. In particular, the Bristol Female Lower Urinary Tract Symptoms questionnaire was used to evaluate urinary symptoms, the Knowles-Eccersley-Scott-Symptom questionnaire to assess the presence of constipation, and the Female Sexual Function Index to investigate sexual function. Study outcomes were the comparisons among groups in terms of differences in actual changes in median of questionnaire scores between first and second examinations. Results: Thirty women (17 in the experimental group and 13 in the control group) completed the study. No significant differences were found between the two groups regarding urinary, bowel, and sexual functions, although women in the experimental group showed a tendency towards an improvement in constipation symptoms. Conclusion: In women with DIE, PFP does not appear to affect urinary, bowel, and sexual functions. Therefore, despite the improvement in superficial dyspareunia, chronic pelvic pain, and PFM relaxation with high treatment satisfaction, women should be informed about the unclear impact of PFP on urinary, bowel, and sexual functions. Larger studies are necessary to further investigate the impact of PFP on these functions.

Efficacy of Ethanol Sclerotherapy Versus Laparoscopic Excision in the Treatment of Ovarian Endometrioma.

Objective: The purpose of this study was to examine the recurrence rates of ovarian endometrioma, dysmenorrhea, dyspareunia, and related complications between sclerotherapy and laparoscopic ovarian cystectomy in individuals aged 25 to 38. Methods: Eighty-eight women participated in this retrospective, single-center study between January 2020 and February 2022. Patients received either laparoscopy or sclerotherapy, depending on the opinion of the pertinent physician. In this study, the following parameters were retrospectively analyzed in follow-up visits 2, 6 and 12 months after sclerotherapy and laparoscopy: dysmenorrhea and dyspareunia by visual analog scale, complications following the intervention, and serial pelvic sonograms for endometrioma cyst recurrence. Moreover, serum Anti-Müllerian hormone (AMH) level before and 6 months after sclerotherapy/surgery were analyzed. The collected data were then analyzed using R software. Results: The results demonstrate the efficiency of both sclerotherapy and laparoscopic techniques in reducing endometrioma-related dysmenorrhea and dyspareunia over a 12-month period. There was no statistically significant difference in the occurrence of complications and recurrence rate between these two therapies, and both are equally beneficial. Also, the rate of AMH decline after laparoscopy was higher than sclerotherapy; however there was not a statistically significant change in serum level of AMH in laparoscopy compared to the sclerotherapy after 6 months. Conclusion: Considering all the data, it appears that sclerotherapy, with its lower cost, shorter hospital stay, and quicker return to activities, can be a laparoscopic alternative to endometrioma cyst removal. More studies are required.

The effect of antioxidant supplementation on dysmenorrhea and endometriosis-associated painful symptoms: a systematic review and meta-analysis of randomized clinical trials.

This study aimed to review randomized controlled trials (RCTs) investigating the effects of dietary antioxidant supplements on the severity of endometriosis-related pain symptoms. The PubMed/Medline, Scopus, and Web of Science databases were searched until April 2022. Additionally, we manually searched the reference lists. Endpoints were summarized as standardized mean difference (SMD) with 95% confidence intervals (CIs) in a random-effects model. The I2 statistic was used to assess heterogeneity. Ten RCTs were included in this meta-analysis. Overall, 10 studies were related to dysmenorrhea, four to dyspareunia, and four to pelvic pain. Antioxidants significantly reduced dysmenorrhea (SMD, -0.48; 95% CI, -0.82 to -0.13; I2=75.14%). In a subgroup analysis, a significant reduction of dysmenorrhea was observed only in a subset of trials that administered vitamin D (SMD, -0.59; 95% CI, -1.13 to -0.06; I2=69.59%) and melatonin (SMD, -1.40; 95% CI, -2.47 to -0.32; I2=79.15%). Meta-analysis results also suggested that antioxidant supplementation significantly improved pelvic pain (SMD, -1.51; 95% CI, -2.74 to -0.29; I2=93.96%), although they seem not to have a significant beneficial impact on the severity of dyspareunia. Dietary antioxidant supplementation seems to beneficially impact the severity of endometriosis-related dysmenorrhea (with an emphasis on vitamin D and melatonin) and pelvic pain. However, due to the relatively small sample size and high heterogeneity, the findings should be interpreted cautiously, and the importance of further well-designed clinical studies cannot be overstated.

Migraine among women with endometriosis: a hospital-based case-control study in Bangladesh.

BACKGROUND: Endometriosis is a disease among women of reproductive age, which causes several health problems, such as dysmenorrhea, dyspareunia, and subfertility. In addition, it increases psychological stress and often results in marital disharmony. Similarly, migraine is more frequent among this group of women. Several studies have shown an association between endometriosis and migraine among groups of populations completely different from Bangladesh. OBJECTIVE: This study aimed to identify the association between endometriosis and migraine among the Bangladeshi population. STUDY DESIGN: This nonrandomized case-control study was conducted with cases of endometriosis and controls without endometriosis who were confirmed by laparoscopy or laparotomy. Among the study participants, cases of migraine in 1 group of respondents who were already diagnosed as patients of migraine were identified, and the others with complaints of headaches were further confirmed by a medicine specialist. Patients were recruited from the Department of Obstetrics and Gynecology at the Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders General Hospital and Ibrahim Medical College. The study was approved by the ethical review committee of the Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders General Hospital. Multivariate logistic regression was used to identify the association between endometriosis and migraine using odds ratios and 95% confidence intervals. RESULTS: Of 1496 patients who underwent laparoscopy or laparotomy during the study period, the frequency of endometriosis was found to be 12.7%. A total of 190 patients with confirmed endometriosis cases and an equal number of controls without endometriosis were enrolled, maintaining the age distribution of the controls similar to that of the cases. Compared with controls, the distribution of age, body mass index, education, and marital status of the patients with endometriosis were similar. The average ages of respondents were 30.6 years in both the case and control groups. Regarding occupation, cases included more students than controls (12% vs 0%, respectively). The odds of suffering from dysmenorrhea and dyspareunia among the cases were 3.3 (95% confidence interval, 2.66-4.15; P<.001) and 9.5 (95% confidence interval, 5.3-17.9; P<.001) times higher than that of controls, respectively. In addition, the odds of menstrual irregularity was 60% lower among the cases than among controls (odds ratio, 0.4; 95% confidence interval, 0.24-0.64; P<.001). No significant difference was observed in having primary subfertility and secondary subfertility among the 2 groups of respondents. Univariate regression analysis showed that patients with endometriosis have 6.13 times higher odds (95% confidence interval, 2.50-18.40; P<.001) of having a migraine and 2.00 times higher odds (95% confidence interval, 1.2-3.2; P=.01) of having a headache than controls. Furthermore, the age- and body mass index-adjusted multivariate model showed that patients with endometriosis have 5.4 times higher odds of having migraine than patients without endometriosis (95% confidence interval, 2.11-16.4; P<.001). In addition, the higher the age of reproductive-age women, the higher the odds of having migraine. A 1-year increase in age increases the odds of having migraine by 23% (odds ratio, 1.23; 95% confidence interval, 1.13-1.16; P<.001). CONCLUSION: Our results support the association between endometriosis and migraine among the Bangladeshi population, which is similar to relevant studies conducted in other geographic locations. The groups of physicians who treat patients suffering from the 2 diseases, endometriosis and migraine, should keep this interrelationship in mind to ensure a better quality of life for the patient.

Presentation and Management of Postpartum Granulation Tissue: A Single-Institution Retrospective Study.

INTRODUCTION: Although the development of postpartum granulation tissue (PPGT) is an expected phase of healing of perineal and vaginal lacerations, the persistence of this tissue can result in delayed wound healing, pain, bleeding, and discharge. There is a paucity of information on the efficacy of the treatments used for pathologic PPGT. The objective of this study was to describe characteristics associated with the development of PPGT and the treatment methods currently used for management. METHODS: This was a retrospective cohort study of 140 patients diagnosed with PPGT within one year of birth from 2012 through 2022 within a single health care system. Patients were identified by International Classification of Diseases and Current Procedural Terminology codes. Demographics, birth characteristics, symptoms, and treatment information were obtained and assessed in frequencies and means. Treatments were compared with 95% CIs and P values. Time to resolution was assessed by the number of weeks and the number of visits. RESULTS: It was the first vaginal birth for 129 (92%) patients in the study cohort. The majority (84.3%) of patients presented with pain. Almost half of all patients (45%) were diagnosed after 6 weeks postpartum. 30.0% of patients were initially treated conservatively. 76.4% of patients were treated with silver nitrate, and 33.6% had an excisional procedure. Successful conservative management had the lowest average number of visits to resolution with 1.39 visits (95% CI, 1.15-1.69), followed by silver nitrate alone with 1.95 visits (95% CI, 1.73-2.19), and excision with or without silver nitrate with 2.40 visits (95% CI, 2.07-2.78). Conservative management was unsuccessful 45% of the time, requiring additional treatment with silver nitrate or excision. 30% of patients treated with silver nitrate or excision continued to report pain even after the resolution of granulation tissue upon examination. CONCLUSION: PPGT is commonly associated with first vaginal births, often presents beyond 6 weeks postpartum, and frequently requires treatment.

Rare Broad Ligament Cavernous Hemangioma Mimicking Advanced Endometriosis: A Case Report.

Cavernous hemangioma within the female genital tract is an extremely rare pathology, characterized by irregular vascular spaces containing blood or thrombus. We present a unique case of a 42-year-old primiparous woman who presented with typical endometriosis symptoms such as dysmenorrhea, dyspareunia, and heavy menstrual bleeding. The patient also experienced complex postpartum symptoms, which were misdiagnosed as cholecystitis and retained placental products. Imaging studies suggested deep infiltrative endometriosis with extraovarian endometriotic lesions. Surgical exploration revealed a hemangioma within the right anterior broad ligament alongside peritoneal endometriosis lesions. The hemangioma itself expresses estrogen and progesterone receptors in stromal cells. The presence of steroid hormone receptors strongly suggests symptom alleviation during the menstrual cycle and the postpartum period. The coexistence of cavernous hemangioma and endometriosis in the broad ligament, previously unreported, and symptomatic overlap between the two conditions complicates diagnosis and management, emphasizing the need for comprehensive evaluation integrating clinical symptoms and imaging findings.