Measurement properties of sexual function assessment questionnaires in women with endometriosis: A systematic review following COSMIN guidelines.

INTRODUCTION: Sexual function of patients with endometriosis should be assessed by patient-reported outcome measures (PROMs) that present high reliability and validity. The objective was to study the PROMs used to assess sexual function for patients with endometriosis to improve their selection for research and clinical practice. MATERIAL AND METHODS: We performed a systematic literature review from January 2000 to September 2023. All studies including women with confirmed endometriosis and assessing sexual quality of life or sexual function or sexual distress were retrieved. Different properties of PROMs used for sexual dysfunction were assessed according to the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) recommendations. Properties evaluated were: structural validity, internal consistency, cross-cultural validity, reliability, measurement error, criterion validity, construct validity, and responsiveness. This literature review was registered on Prospero as 2018 CRD42018102278. RESULTS: Seventy-four articles with evaluation of sexual function were included. Of the 25 PROMs assessing sexual function, the Female Sexual Function Index (FSFI) was the most frequently used (34/74 [45.9%] items), followed by the Female Sexual Distress Scale (9/74 [12.2%] items) and the Sexual Activity Questionnaire (SAQ) (8/74 [10.8%] items). The most commonly used measurement properties were "hypothesis testing" and "responsiveness". The PROMs with a high level of evidence for these two measurement properties were the FSFI, the SAQ, the Short Sexual Functioning Scale, the Sexual Satisfaction Scale for Women, Sexual Quality of Life-Female, the Brief Profile of Female Sexual Function, and the Sexual Health Outcomes in Women Questionnaire. The FSFI questionnaire appeared to be more relevant for evaluating medical treatment, and the SAQ for evaluating surgical treatment. Only one instrument was specific to endometriosis (the Subjective Impact of Dyspareunia Inventory [SIDI]). CONCLUSIONS: In this systematic literature review of sexual function assessment questionnaires in endometriosis, the FSFI and the SAQ questionnaires emerged as having the best measurement properties according to the COSMIN criteria. The FSFI questionnaire appears to be suited for evaluating medical treatment, and the SAQ for surgical treatment. The SIDI is the only specific questionnaire, but its responsiveness remains to be defined.

Do high-dose progestins impair sexual function in women treated for endometriosis? A prospective observational longitudinal study.

INTRODUCTION: High-dose progestins are used as an effective therapy for painful symptoms of endometriosis but their impact on sexual function has been poorly studied. The study aims to assess the impact of high-dose progestin on sexual function among women treated for endometriosis. MATERIAL AND METHODS: In this bicenter prospective observational study, women with endometriosis who received medical or surgical treatment for endometriosis and who were sexually active were included. They completed the Sexual Activity Questionnaire (SAQ, a validated tool) before (T0) and 12 months after (T1) endometriosis treatment. We classified patients into two groups according to whether they were using high-dose progestins at T1: a high-dose progestin group and a control group. The main outcome was sexual function measured by the SAQ score (from 0 to 30) at T1. The secondary outcomes were each individual SAQ item, the dyspareunia 100-mm visual analog scale (VAS) and the quality of life assessed with EuroQoL Group 5D Index (EQ-5D) at T1. We also assessed the change in dyspareunia VAS and quality of life between T0 and T1. The Ethics Committee of Ile-de-France (Act 2004-806, 9 August 2004) approved the study. RESULTS: Among 214 women included, 25 (12%) were exposed to high-dose progestins at T1. The SAQ score of women exposed to high-dose progestins was significantly lower compared with the control group, with or without adjustment for covariates (15.5 ± 6.3 vs 18.3 ± 6.2, P = .03, adjusted effect size -0.44 [95% CI -0.86 to -0.02], P = .04). High-dose progestin intake at T1 was associated with a lower subscore on two SAQ items: pleasure (1.8 ± 0.8 vs 2.2 ± 0.9, P = .02), and satisfaction with frequency of intercourse (1.2 ± 1.2 vs 1.8 ± 1.1, P = .02). In the overall population, dyspareunia VAS and quality of life assessed by EQ-5D improved between T0 and T1 (45 ± 29 at T0 vs 28 ± 29 at T1, P < .001; 0.78 ± 0.14 at T0 vs 0.86 ± 0.14 at T1, P < .001, respectively). At T1, the groups did not differ significantly for dyspareunia VAS (effect size 0.36 [95% CI -0.06 to 0.78], P = .10) and quality of life (EQ-5D, effect size 0.02 [95% CI -0.40 to 0.44], P = .91). CONCLUSION: In this observational study, high-dose progestins impair the sexual function of women treated for endometriosis even though they improved dyspareunia.

Systematic Nerve Sparing during Surgery for Deep-infiltrating Posterior Endometriosis Improves Immediate Postoperative Urinary Outcomes.

STUDY OBJECTIVE: Evaluate the feasibility and risk-benefit ratio of systematic nerve sparing by complete dissection of the inferior hypogastric nerves and afferent pelvic splanchnic nerves during surgery for deep-infiltrating endometriosis (DIE) on the basis of complication rates and postoperative bladder morbidity. DESIGN: Observational before (2012-2014)-and-after (2015-2017) study based on a prospectively completed database of all patients treated medically or surgically for endometriosis. SETTING: Unicentric study at the Centre Hospitalier Intercommunal de Poissy-St-Germain-en-Laye. PATIENTS: This study included patients undergoing laparoscopic surgery for DIE (pouch of Douglas resection with or without colpectomy or bilateral uterosacral ligament resection), with complete excision of all identifiable endometriotic lesions, with or without an associated digestive procedure, between 2012 and 2017. The exclusion criteria included prior history of surgery for DIE or colorectal DIE excision, unilateral uterosacral ligament resection, and bladder endometriotic lesions. INTERVENTIONS: For the patients in group 1 (2012-2014, n = 56), partial dissection of the pelvic nerves was carried out only if they were macroscopically caught in endometriotic lesions, without dissection of the pelvic splanchnic nerves. The patients in group 2 (2015-2017, n = 65) systematically underwent nerve sparing during DIE surgery, with dissection of the inferior hypogastric nerves and pelvic splanchnic nerves. MEASUREMENTS AND MAIN RESULTS: Both groups were comparable in terms of patient age, parity, body mass index, and previous abdominal surgery. The operating times were similar in both groups (228 ± 105 minutes in group 2 vs 219 ± 71 minutes in group 1), as were intra- and postoperative complication rates. Time to voiding was significantly longer in the patients in group 1 (p <.01), with 7 (12.9%) patients requiring self-catheterization in this group compared with no patients (0%) in group 2. The duration of self-catheterization for the 7 patients in group 1 was 28, 21, 3, 60, 21, 1 (stopped by the patient), and 28 days, respectively. Uroflowmetry on postoperative day 10 was abnormal in 5/25 patients in group 1 compared with 1/33 in group 2 (p = .031). CONCLUSION: Systematic and complete nerve sparing, including pelvic splanchnic nerve dissection, during surgery for posterior DIE improves immediate postoperative urinary outcomes, reducing the need for self-catheterization without increasing operating time or complication rates.

[Impact of the diastasis of the rectus abdominis muscles on the pelvic-perineal symptoms: Review of the literature]. / Impact du diastasis des muscles droits de l'abdomen sur les symptômes pelvi-périnéaux : revue de la littérature.

INTRODUCTION: The diastasis of the rectus abdominis muscles is common during pregnancy and post-partum. OBJECTIVE: To determine the prevalence of this pathology, methods of diagnosis, association with pelvic-perineal disorders and therapies that may be proposed. METHODS: Review of Pubmed, Medline, Embase and Cochrane literature using the following words and MeSH: diastasis, diastasis and pregnancy, diastasis of the rectus abdominis muscle, increase of the inter-recti distance. RESULTS: Among the 124 articles found, 61 were selected. Ultrasound seems to be the exam of choice both in terms of feasibility and reproducibility for the diagnosis of this pathology (intra-class correlation coefficients (ICC) high 0.81 to 0.94). The risk factors identified vary from one study to another: heavy load bearing (OR=2.18 (95 % CI 1.05 to 4.52) P=0.04), weight gain. Studies are discordant regarding the association between diastasis and low back pain (RR=1.39 (95 % CI 0.91-2.14), P=0.17), urinary incontinence (RR=0.86 (95 % CI 0.55-1.33) P>0.65) and prolapse (OR=2.25 (95 % CI 1.51-3.37) P<0.001), but the diastasis seems to play a role in the alteration of the quality of life for these patients. CONCLUSION: Knowledge about risk factors, consequences of diastasis and management is still limited today. It is therefore necessary to establish prospective studies on larger numbers in order to improve knowledge on the diastasis of the rectus abdominis muscles.

Neonatal outcome of very preterm twins: policy of planned vaginal or cesarean delivery.

OBJECTIVE: The objective of the study was to compare neonatal mortality and morbidity in very preterm twins with the first twin in cephalic presentation in hospitals with a policy of planned vaginal delivery (PVD) and those with a policy of planned cesarean delivery (PCD). STUDY DESIGN: Women with preterm cephalic first twins delivered after preterm labor and/or premature preterm rupture of membranes from 26(0/7) to 31(6/7) weeks of gestation were identified from the databases of 6 perinatal centers and classified as PVD or PCD according to the center's management policy from 1999 to 2010. Severe neonatal morbidity was defined as any of the following: intraventricular hemorrhage grades 3-4, periventricular leukomalacia, necrotizing enterocolitis, bronchopulmonary dysplasia, and hospital death. The independent effect of the planned mode of delivery, defined by the center's management policy, was tested and quantified with a 2-level multivariable logistic regression. RESULTS: The PVD group included 248 women, and the PCD group 63. Maternal characteristics did not differ between the 2 groups. The rate of vaginal delivery was 85.9% (213 of 248) vs 20.6% (13 of 63) (P < .001), and the rate of cesarean delivery for the second twin was 1.6% (4 of 248) vs 4.8% (3 of 63) (P = .13) for PVD and PCD. PVD had no independent effect on either newborn hospital mortality or severe neonatal composite morbidity. CONCLUSION: A policy of planned vaginal delivery of very preterm twins with the first twin in cephalic presentation does not increase either severe neonatal morbidity or mortality.

Nomogram to predict pregnancy rate after ICSI-IVF cycle in patients with endometriosis.

BACKGROUND: Although several scoring systems have been published to evaluate the pregnancy rate after ICSI-IVF in infertile patients, none of them are applicable for patients with deep infiltrating endometriosis (DIE) nor can they evaluate the chances of pregnancy for individual patients. The aim of this study was to develop a nomogram based on an association of patients' characteristics to predict the clinical pregnancy rate in patients with endometriosis. METHODS: This prospective longitudinal study was conducted from January 2007 to June 2010. The nomogram was built from a training cohort of 94 consecutive patients (141 ICSI-IVF cycles) and tested on an independent validation cohort of 48 patients (83 ICSI-IVF cycles). DIE was confirmed in all participants. RESULTS: The pregnancy rate (per patient) in women with and without DIE was 58 and 83%, respectively (P = 0.03). Increased patient age (P = 0.04), serum anti-Mullerian hormone (AMH) level ≤ 1 ng/ml (P = 0.03) and increased number of ICSI-IVF cycles (P = 0.03) were associated with a decreased clinical pregnancy rate. The presence of DIE was the strongest determinant factor of the clinical pregnancy rate in our model [odds ratio = 0.26, 95% confidence interval (CI): 0.07-0.9 (P = 0.006)], which also included patient age, serum AMH level and number of attempts at ICSI-IVF. The nomogram showed an area under the curve (AUC) of 0.76 for the training cohort (95% CI: 0.7-0.8) and was well calibrated. The AUC for the validation cohort was 0.68 (95% CI: 0.6-0.75) and calibration was good. CONCLUSIONS: Our nomogram provides realistic and precise information about ICSI-IVF success and can be used to guide couples and practitioners.

Patient-Reported Outcome Measures in Endometriosis.

Patient Reported Outcome Measures (PROM) evoke measurements that allow capturing patients' perspectives on their condition. In endometriosis care, physicians' understanding of the effect of the disease and the treatment on patients is often poor. The use of PROMs in endometriosis clinical practice can facilitate patient-provider communication and the implementation of patient-centered care, improve patients' quality of life, as well as provide a tool for patients' self-management of the disease. Today, PROMs are extensively used in research and clinical trials, however they are barely used in clinical practice. The development of digital tools facilitating capturing PROMs can contribute to their use by physicians in routine endometriosis care. However, all PROMs are not adapted to be used in routine care in the context of endometriosis. The objective of this study was to present a catalogue of available PROMs for routine endometriosis care and evaluate them according to selected criteria. To do so, we explored the different PROMs currently in the literature. Consequently, 48 PROM were identified as tools used to evaluate various dimensions of the impact of endometriosis on patients. The selected PROMs were evaluated for their potential to be used as a standard in clinical practice in endometriosis. The selected catalogue of PROMs is the starting point for the integration of digital tools to capture PROMs and the development of patient-centered dashboards to be used by patients and clinicians in endometriosis care and self-management to improve care processes, patient satisfaction, quality of life, and outcomes.

The ENDOPAIN 4D Questionnaire: A New Validated Tool for Assessing Pain in Endometriosis.

OBJECTIVES: To study the measurement properties, the responsiveness and the minimal clinically important difference of the ENDOPAIN-4D: a new questionnaire for assessing pain in endometriosis. METHODS: A prospective, observational, multicentre study was conducted including all women ≥18 years consulting for symptomatic proven endometriosis between 1 January 2017 and 30 June 2018 and volunteering to participate. Each patient had to answer a new self-administered patient-reported outcome (PRO) questionnaires (the ENDOPAIN-4D) at inclusion (T0) and 12 months after medical or surgical treatment (T1). Criteria defined by COSMIN were used to validate the questionnaire's measurement properties. The minimal clinically important difference was estimated by the anchor-based method. RESULTS: The study included 199 women. The ENDOPAIN-4D score had a four dimensional structure with good internal consistency (measured by Cronbach α): (I) pain-related disability (α = 0.79), (II) painful bowel symptoms (α = 0.80), (III) dyspareunia (α = 0.83), and (IV) painful urinary tract symptoms (α = 0.77). They produced four subscores that can be summed to obtain a single score (α = 0.61). The ENDOPAIN-4D total score ranged from 0 to 94.00 (mean ± SD: 46.7 ± 22). The total score was significantly correlated with the PROs used in endometriosis. Sensitivity to change was good with large effect sizes (ES) (mean of the differences: 36.3 p = 1.8 10-7, ES 0.76). The minimal clinically important difference of the global score was determined to be 10.9. CONCLUSIONS: The ENDOPAIN-4D questionnaire is easy to use, valid, and effective in assessing patient reported pain symptoms in women treated for endometriosis. This new instrument can be used as the primary outcome for future clinical trials and as a tool for routine patient follow-up.

Diastasis of the rectus abdominis muscles in postpartum: Concordance of patient and clinician evaluations, prevalence, associated pelvic floor symptoms and quality of life.

OBJECTIVES: The main objective was to assess the reliability of the patient's measurement of diastasis. The secondary aims were the estimation postpartum diastasis prevalence, of diastasis-associated pelvic floor symptoms and quality of life immediately after childbirth and at 3-6 months postpartum. STUDY DESIGN: Using a prospective observational design, women who gave birth in a French university hospital were eligible. After a learning phase, both clinician and patient conducted a clinical evaluation of diastasis. Then, patients were asked to complete the HerQLes, the FPFQ and a general questionnaire. Three to 6 months later, patients completed the same questionnaires online and performed a clinical evaluation of diastasis at home, as learned previously. RESULTS: Of 253 patients included in the study, 139 (54.9 %) completed the questionnaires at 3-6 months of follow-up. There was good correlation between clinician and patient evaluations of diastasis (kappa coefficient 0.76 [95 % CI, 0.5-0.7]). Immediately after childbirth, 210 (83 %) of the women presented diastasis including 116/210 (55 %) cases of severe diastasis and 51 (42 %) of those had persistent diastasis at 3-6 months of follow-up. Cesarean section (p = 0.05) and multiparity (p = 0.04) were factors of persistent diastasis. Severe diastasis had a significant impact on quality of life (HerQLes score) at birth (p = 0.001) and at 3-6 months (p = 0.01), but no effect on pelvic floor symptoms according the FPFQ. The occurrence and severity of diastasis did not significantly impact lumbar or pubic symphysis pain. Furthermore, the aesthetic discomfort felt by patients was significantly increased by the presence of diastasis on a numerical scale at 3-6 months (p = 0.03). CONCLUSION: Good agreement between clinician and patient evaluations of postpartum diastasis indicated that the evaluation method is reliable. Persistent diastasis was associated with impaired quality of life.

First follow-up of art pregnancies in the context of the COVID-19 outbreak.

OBJECTIVE: The aims of this study were to follow up the monitoring, health and anxiety from women who became pregnant after an embryo transfer or a intrauterine insemination during the COVID-19 epidemic in France STUDY DESIGN: This is a single centre, retrospective study from December 2019 to March 2020 based on a phone call interview using a specific questionnaire sheet specially developed for this study. Questionnaires from 104 pregnant women were completed and descriptive data are then analyzed. RESULTS: Women with ongoing pregnancies (n = 88) did not change their physician visits. The COVID-19 outbreak has created no or few additional stresses for 77 % of pregnant women since the lockdown started. We report a miscarriage rate of 14.4 % (n = 15) and documented 10 patients (11.3 %) who had symptoms related to COVID-19. No severe symptoms and no hospitalization in intensive care unit were identified. CONCLUSION: The epidemic context did not disrupt the medical monitoring of pregnancies and we did not recover an increased rate of miscarriage after ART. None of the patients who had COVID-related symptoms presented with severe clinical manifestations. Surprisingly, pregnant women were psychologically able to experience the lockdown.

Pregnancy Rate after First Intra Cytoplasmic Sperm Injection- In Vitro Fertilisation Cycle in Patients with Endometrioma with or without Deep Infiltrating Endometriosis.

BACKGROUND: To evaluate the impact of the association of endometrioma with or without deep infiltrating endometriosis (DIE) after a first intra cytoplasmic sperm injection- in vitro fertilization (ICSI-IVF) cycle on pregnancy rate. MATERIALS AND METHODS: In this retrospective study, women with endometrioma who underwent a first ICSI-IVF cycle from January 2007 to June 2010 were reviewed for pregnancy rate. The main outcome measure was the clinical pregnancy rate. A multiple logistic regression (MLR) was performed; including all variables that were correlated to the conception rate. Only independent factors of pregnancy rate were included in a Recursive Partitioning (RP) model. RESULTS: The study population consisted of 104 patients (37 without DIE and 67 patients with associated DIE). Using multivariable analysis, a lower pregnancy rate was associated with the presence of DIE (OR=0.24 (95% CI: 0.085-0.7); p=0.009) and the use of ICSI (OR=0.23 (95% CI: 0.07-0.8); p=0.02). A higher pregnancy rate was associated with an anti-mullerian hormone (AMH) serum level over 1 ng/ml (OR=4.3 (95% CI: 1.1-19); p=0.049). A RP was built to predict pregnancy rate with good calibration [ROC AUC (95% CI) of 0.70 (0.65-0.75)]. CONCLUSION: Our data support that DIE associated with endometrioma in infertile patients has a negative impact on pregnancy rate after first ICSI-IVF cycle. Furthermore, our predictive model gives couples better information about the likelihood of conceiving.

Deep infiltrating endometriosis is a determinant factor of cumulative pregnancy rate after intracytoplasmic sperm injection/in vitro fertilization cycles in patients with endometriomas.

OBJECTIVE: To evaluate the cumulative pregnancy rate (CPR) per patient after in vitro fertilization/intracytoplasmic sperm injection (IVF-ICSI) cycles in patients with endometriomas and to evaluate the determinant factors of CPR per patient. DESIGN: Retrospective study from January 2007 to October 2008. SETTING: Tertiary care university hospital. PATIENT(S): 103 patients who had undergone IVF treatment, comprising isolated endometriomas (n = 30) and endometriomas with associated deep infiltrating endometriosis (DIE) (n = 73). INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Clinical pregnancy rate after IVF-ICSI cycle. RESULT(S): The total number of cycles was 162, and the median number of cycles per patient was 1 (1 to 5). Fifty-eight women (56.3%) became pregnant. The total number of endometriomas and size of the largest endometrioma and bilateral endometriomas had no impact on the CPR per patient. Using multivariable analysis, the associated DIE and antimüllerian hormone serum level (≤ 1 ng/mL) were independent factors associated with a decrease in the pregnancy rate per patient. Overall, the CPR per patient was 73.7%, and it increased until the third cycle with no benefit for additional cycles. The CPR per patient for women with isolated endometriomas and women with endometriomas and associated DIE was 82.5% and 69.4%, respectively. CONCLUSION(S): Associated DIE has a negative impact on assisted reproduction results in patients with endometriomas. Moreover, our data show that after three IVF-ICSI cycles the CPR per patient is not improved and that surgery should be considered.