Acceptability, reliability, and validity of a vaginal insert for the self-assessment of endometriosis-associated deep dyspareunia: a cross-sectional study
Approximately half of people with endometriosis experience deep dyspareunia; however, there is no means of objective self-testing of endometriosis-associated deep dyspareunia.
Aim
The aim of this study was to assess the acceptability, test-retest reliability, and validity of a vaginal insert for a self-assessment of endometriosis-associated deep dyspareunia.
Methods
Participants were recruited from a tertiary endometriosis center. Inclusion criteria were: 19 to 49 years of age, self-reported deep dyspareunia of ≥4 of 10, and surgically confirmed endometriosis. Participants completed 2 self-assessments using the vaginal insert to self-assess tenderness at the right and left pelvic floor, bladder, cervix-uterus, and posterior cul-de-sac (vaginal fornix). The participants recorded tenderness at each pelvic site and completed a questionnaire regarding the acceptability of the vaginal insert to assess deep dyspareunia. Test-retest reliability was assessed by correlating the tenderness scores between the 2 assessment dates. Over a 4-week period, the participants also recorded deep dyspareunia severity at each penetrative vaginal sex encounter. Validity was assessed by correlating vaginal insert tenderness to deep dyspareunia severity, and also to tenderness reported on a prior gynecologic pelvic examination.
Outcomes
The main outcome measures were the acceptability index score, tenderness (0-10) at each pelvic site, and prospective deep dyspareunia scores (0-10) over 4 weeks.
Results
There were 19 participants (mean age 34 ± 7 years) who completed the study. The majority identified as female (94.7%), heterosexual (89.5%), and white (89.5%). The median acceptability index score was 0.72 (interquartile range, 0.66-0.81). For test-retest reliability, the intraclass correlation coefficients were 0.79 (P = .001) for the left pelvic floor, 0.82 (P < .001) for the right pelvic floor, 0.54 (P = .07) for the bladder, 0.89 (P < .001) for the cervix-uterus, and 0.77 (P = .003) for the cul-de-sac. The correlation between the highest self-assessed mean tenderness in each participant and self-reported deep dyspareunia over 4 weeks was r = 0.32, but correlations for each pelvic site varied significantly. Tenderness at each site on prior gynecologist pelvic exam was associated with higher self-assessed mean tenderness with the vaginal insert in each participant (effect sizes = 0.42-0.88).
Clinical Implications
The vaginal insert is acceptable and reliable for the objective self-assessment of endometriosis-associated deep dyspareunia, with initial evidence of validity.
Strengths and Limitations
A strength was the inclusion of participants who were avoiding sexual activity and a limitation was the small sample size.
Conclusion
Future studies with larger sample sizes are required to further establish the validity of the vaginal insert for the self-assessment of endometriosis-associated deep dyspareunia.
Rojas HE et al., 2026·Journal of women's health (2002)
To characterize differences between individuals with and without mid-cycle pain in a registry cohort with endometriosis. Prospective analysis of data from the Endometriosis Pelvic Pain Interdisciplinary Cohort Data Registry (Clinicaltrials.gov #NCT02911090) at a tertiary referral center in Western Canada. Three hundred forty-five individuals aged 18-49 years who: (1) had at least one episode of menstrual bleeding in the last 3 months, (2) attended a baseline initial visit, and (3) subsequently had surgery with histological confirmation of endometriosis between January 2018 and December 2023. Exclusion criteria included (1) previous hysterectomy; (2) hormonal suppressive therapy use in the last 3 months; and (3) missing data on mid-cycle pain, history of hormonal therapy use, or menstrual cycle regularity. N/A. Mid-cycle pain in the last month versus No mid-cycle pain in the last month. Of the 345 participants, 67% (n = 232) reported mid-cycle pain in the last month. Mid-cycle pain in the last month was significantly associated with higher mean Central Sensitization Inventory score (48 ± 17 versus 36 ± 16, p < 0.001) and more months of prior hormonal suppressive therapy use (58 [14-120] versus 26 [0-109], p = 0.012). Abnormal anatomy at the time of surgery (e.g., endometrioma, ovarian adhesions) was not associated with mid-cycle pain in the last month. In this endometriosis cohort at a tertiary referral center, most participants reported mid-cycle pain in the last month, which was associated with central sensitization but was not clearly related to endometriosis anatomical distortion.
Yong PJ et al., 2026·Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC
To provide health care professionals with an evidence-based approach to the management of endometriosis and its associated symptoms.
Women and gender-diverse individuals affected by endometriosis.
BENEFITS, HARMS, Timely and effective management of endometriosis has the potential to reduce pain, improve fertility and quality of life, and enhance long-term health outcomes. Early intervention may also help mitigate the financial and health system burdens associated with delayed diagnosis and treatment.
Published literature was retrieved through searches of PubMed, Ovid, Medline, Embase, Scopus, and the Cochrane Library from August 2010 through December 2025, using relevant MeSH heading and keywords. Results were restricted to systematic reviews, meta-analyses, randomized controlled trials/controlled clinical trials, observational studies, and clinical practice guidelines. Results were limited to English or French language materials. Evidence was supplemented with references from the 2010 Society of Obstetricians and Gynaecologists of Canada guideline No. 244.
The authors rated the quality of evidence and strength of recommendations using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. See online Appendix A (Tables A1 for definitions and A2 for interpretations of strong and conditional recommendations).
Health care providers involved in the care of individuals with endometriosis.
Early identification and management of endometriosis can significantly improve patient outcomes, reduce long-term health care costs and improve their quality of life.
RECOMMENDATIONS.
Predictive tools are lacking for pain-related outcomes after endometriosis surgery. The objective of this study was to develop and validate a machine learning-based clinical model to predict poor pain-related quality of life after endometriosis surgery. Registry data from a prospective longitudinal cohort at a tertiary referral center (2013-2020) was used for model development and validation. Participants underwent an index endometriosis surgery, and completed the pain subscale of the Endometriosis Health Profile-30 (EHP-30) at baseline and 1-2-year follow-up. The outcome was poor pain-related quality of life defined as EHP-30 pain subscale above the 75th percentile for North America, at 1 to 2 years postsurgery. Thirty-two preoperative factors were evaluated, with final models retaining the top 10 most important predictors. Elastic net logistic regression, random forest (RF) and multilayer perceptron neural network models were developed. Internal validation was performed using 500 bootstrap samples, and a held-out test cohort. The study included 650 488 in the training cohort and 162 in a held-out test cohort. The RF model exhibited the most consistent discrimination, measured by the area under the receiver operating characteristic curve, between the training cohort (0.768; 95% CI: 0.690-0.837) and test cohort (0.766; 95% CI: 0.676-0.863, Δ = -0.002). The RF model also demonstrated the best integrated calibration index (0.029) and highest net benefit. Final preoperative predictors for the RF model included baseline EHP-30 score, surgery type (conservative fertility-sparing vs hysterectomy), anxiety scores, depression scores, pain catastrophizing scale scores, abdominal wall pain, pelvic floor myalgia, smoking status, back pain, and race/ethnicity. We present the RF model as the Endometriosis Pain Index to aid preoperative counselling for endometriosis surgery.
Goodwin E et al., 2025·BMC women's health·Free full text on PubMed Central
Endometriosis is a chronic and inflammatory condition that often presents with chronic pelvic pain, dysmenorrhea, and dyspareunia, thus having important effects on quality of life. There are two proposed hypotheses to describe the known association between endometriosis and depression and anxiety: (1) the disease hypothesis, where the inflammatory nature of endometriosis is driving increased risk for depression and anxiety; and (2) the pain hypothesis, where it is the painful symptoms underlying the increased risk. We aimed to shed further light on these two hypotheses by assessing the risk for depression and/or anxiety in three groups of patients pathologically assessed for endometriosis: symptomatic endometriosis patients (Symp Endo), symptomatic patients with no pathological endometriosis diagnosis (Symp No Endo), and asymptomatic endometriosis patients (Asymp Endo).
This study included pathologically-confirmed endometriosis patients identified from the pathology records of Vancouver Coastal Health Authority between 2000 and 2008. These data were linked with population-based administrative health data for follow-up to 2017. Depression and anxiety were identified through diagnostics codes from health services use data and prescriptions for antidepressants. Bivariate analyses were performed to assess differences between groups. Cox proportional hazards models were run to generate hazard ratios for incident depression and/or anxiety between the groups.
There were 2729 people in Symp Endo, 585 in Symp No Endo, and 326 in Asymp Endo. Symp No Endo was more likely than Symp Endo to be visiting a physician for pelvic pain and to be taking prescription-level pain medications (p < 0.001). After adjusting for several covariates, Symp No Endo had a significantly higher risk of incident depression and/or anxiety (adjusted HR: 1.23, 95% CI: 1.06-1.41) compared to Symp Endo. There was no statistically significant difference in risk of depression and/or anxiety between Symp Endo and Asymp Endo (adjusted HR: 0.94, 95% CI: 0.76-1.17).
These results point toward the pain focused hypotheses as Symp No Endo patients were at higher risk for depression/anxiety than the Symp Endo group. However, the results also suggest the disease hypothesis is at play, because the Symp Endo and Asymp Endo groups were at the same level of risk for depression/anxiety.
Orr NL et al., 2018·The journal of sexual medicine
The etiology of endometriosis-associated deep dyspareunia may include direct endometriosis-specific factors (eg, stage or invasiveness of disease) and/or indirect contributors such as bladder/pelvic floor dysfunction (eg, related to myofascial mechanisms or nervous system sensitization).
This study aimed to determine whether bladder/pelvic floor tenderness and painful bladder syndrome were associated with severity of deep dyspareunia in women with endometriosis, regardless of Stage (I/II vs III/IV) or other endometriosis-specific factors.
Observational study from a prospective patient registry (January 2014 to December 2016) at a tertiary centre for endometriosis. Included were women aged 18 to 49 years who had surgical removal and histopathologic confirmation of endometriosis at the centre. Cases with Stage I/II vs Stage III/IV endometriosis were analyzed separately. Bivariate associations with the primary outcome (severity of deep dyspareunia) were tested for bladder/pelvic floor tenderness, painful bladder syndrome, as well as endometriosis-specific factors identified at the time of laparoscopic surgery (eg, deep infiltrating endometriosis) and demographic factors (eg, age). Multivariable ordinal logistic regression was carried out to adjust for factors associated with the primary outcome.
Primary outcome was severity of deep dyspareunia on an 11-point numeric rating scale, categorized as none/mild (0-3), moderate (4-6), and severe (7-10), from a preoperative self-reported questionnaire.
Overall, 411 women had surgically confirmed endometriosis: 263 had Stage I/II and 148 had Stage III/IV endometriosis. Among women with Stage I/II endometriosis, severity of deep dyspareunia was associated with both bladder/pelvic floor tenderness and painful bladder syndrome (AOR = 1.94, 95% CI: 1.11-3.38, P = .019 and AOR = 1.99, 95% CI: 1.15-3.44, P = .013, respectively), independent of endometriosis-specific factors or other factors associated with deep dyspareunia severity. Similar associations were found in women with Stage III/IV endometriosis (bladder/pelvic floor tenderness AOR =2.51, 95% CI: 1.25-5.02, P = .01, painful bladder syndrome: AOR = 1.90, 95% CI: 1.01-3.57, P = .048).
Myofascial or nervous system mechanisms may be important for deep dyspareunia in women with endometriosis, even in those with moderate-to-severe disease (Stage III/IV).
Strengths include the prospective registry, and histological confirmation of endometriosis and staging by experienced endometriosis surgeons. Limitations include assessment of only one pelvic floor muscle (levator ani).
In women with Stage I/II or Stage III/IV endometriosis, severity of deep dyspareunia was strongly associated with bladder/pelvic floor tenderness and painful bladder syndrome, independent of endometriosis-specific factors, which suggests the role of myofascial or sensitization pain mechanisms in some women with deep dyspareunia. Orr NL, Noga H, Williams C, et al. Deep Dyspareunia in Endometriosis: Role of the Bladder and Pelvic Floor. J Sex Med 2018;15:1158-1166.
Shum LK et al., 2018·Sexual medicine·Free full text on PubMed Central
Deep dyspareunia occurs in half of women with endometriosis, a condition present in 10% of reproductive-age women and associated with negative effects on sexual quality of life (SQoL). However, women with endometriosis can have other clinical factors (eg, superficial dyspareunia, other pelvic pains, and psychological or pain conditions) possibly affecting SQoL. To determine whether deep dyspareunia is associated with SQoL in women with endometriosis, independent of potential confounders. This study involved a prospective patient registry of women at a tertiary-level referral center for endometriosis and pelvic pain. Inclusion criteria were (i) referrals to the center recruited into the registry from January 2014 through December 2016 and (ii) subsequent surgery at the center with histologic confirmation of endometriosis. Exclusion criteria included menopausal status, age at least 50 years, never sexually active, or did not answer dyspareunia or SQoL questions. Bi-variable tests and multiple linear regression analysis were performed. SQoL measured by the 5-item sexual intercourse subscale of the Endometriosis Health Profile-30 (EHP-30) modular questionnaire (0-100%, with higher scores indicating worse SQoL). Consent rate for the prospective registry was 87%; 277 women met the study criteria (mean age = 34.2 ± 7.1 years). Most women had stage I to II endometriosis at time of surgery (64%), with the remaining having stage III to IV endometriosis. Through regression analysis, worse SQoL (higher EHP-30 sexual intercourse subscale score) was independently associated with: more severe deep dyspareunia (P < .0001), more severe superficial dyspareunia (P < .0001), increased depression (P < .001), higher pain catastrophizing (P = .04), bladder pain syndrome (P = .02), heterosexual orientation (P < .001), and new referral status (P = .02). In women with endometriosis at a tertiary referral center, more severe deep dyspareunia was associated with worse SQoL, independent of superficial dyspareunia, psychological comorbidities, and other potential confounders. Shum LK, Bedaiwy MA, Allaire C, et al. Deep Dyspareunia and Sexual Quality of Life in Women With Endometriosis. Sex Med 2018;6:224-233.
Endometriosis is a common chronic disease affecting 1 in 10 women of reproductive age, with half of women with endometriosis experiencing deep dyspareunia. A review of research studies on endometriosis indicates a need for a validated question or questionnaire for deep dyspareunia. Moreover, placebo-controlled randomized trials have yet to demonstrate a clear benefit for traditional treatments of endometriosis for the outcome of deep dyspareunia. The reason some patients might not respond to traditional treatments is the multifactorial nature of deep dyspareunia in endometriosis, which can include comorbid conditions (eg, interstitial cystitis and bladder pain syndrome) and central sensitization underlying genito-pelvic pain penetration disorder. In general, there is a lack of a framework that integrates these multifactorial causes to provide a standardized approach to deep dyspareunia in endometriosis.
To propose a clinical framework for deep dyspareunia based on a synthesis of pain mechanisms with genito-pelvic pain penetration disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
Narrative review after literature search with the terms (endometriosis AND dyspareunia) OR (dyspareunia AND deep) and after analysis of placebo-controlled randomized trials.
Deep dyspareunia presence or absence or deep dyspareunia severity on a numeric rating scale or visual analog scale.
Four types of deep dyspareunia are proposed in women with endometriosis: type I that is directly due to endometriosis; type II that is related to a comorbid condition; type III in which genito-pelvic pain penetration disorder is primary; and type IV that is secondary to a combination of types I to III.
Four types of deep dyspareunia in endometriosis are proposed, which can be used as a framework in research studies and in clinical practice. Research trials could phenotype or stratify patients by each type. The framework also could give rise to more personalized care for patients by targeting appropriate treatments to each deep dyspareunia type. Yong PJ. Deep Dyspareunia in Endometriosis: A Proposed Framework Based on Pain Mechanisms and Genito-Pelvic Pain Penetration Disorder. Sex Med Rev 2017;5:495-507.
Orr NL et al., 2020·The journal of sexual medicine
Deep dyspareunia, a common symptom in endometriosis, has previously been associated with bladder and/or pelvic floor tenderness (BPFT), which suggests a role for central nervous system sensitization. The Central Sensitization Inventory (CSI, 0-100) is a validated self-reported scale for patients with central sensitization.
The objective of this study was to phenotype deep dyspareunia using BPFT and the CSI.
The methods included cross-sectional analysis from a prospective registry from January 2018 to June 2018 at a tertiary center for endometriosis (ClinicalTrials.gov #NCT02911090). Included were women aged 18-50 years with endometriosis (previously surgically diagnosed, current visualized endometrioma on ultrasound, or current palpable or visualized nodule on ultrasound), who were newly or re-referred to the center. Severity of deep dyspareunia was self-reported using an 11-point numeric rating scale (0 = no pain; 10 = worst pain imaginable), categorized as no or low deep dyspareunia (0-4) and high deep dyspareunia (5-10). We identified the subgroup with high deep dyspareunia and presence of BPFT, where we hypothesized a central component of the sexual pain. This subgroup was compared with 2 other subgroups: no or low deep dyspareunia and high deep dyspareunia but no BPFT. The CSI was compared between the groups using analysis of variance, followed by post hoc testing (P < .05).
The main outcome measure was the CSI score ranging from 0 to 100.
Data from 163 women with endometriosis were analyzed. The mean age of this cohort was 36.4 ± 6.8 years, and the mean CSI score was 41.0 ± 18.6. 37 percent (61/163) had high deep dyspareunia and BPFT; 29% (47/163) had high deep dyspareunia and no BPFT; and 34% (55/163) had no or low deep dyspareunia. The CSI significantly differed between the 3 groups (analysis of variance: F = 22.4, P < .001). In post hoc testing, the CSI was higher in women with high deep dyspareunia and BPFT (51.3 ± 16.9), compared with women with no or low deep dyspareunia (30.9 ± 15.4, P < .001) and compared with women with high deep dyspareunia but no BPFT (39.4 ± 17.2, P = .001).
The CSI could be used to classify and phenotype patients with endometriosis-associated sexual pain.
Strengths include a prospective registry with integrated pain scores, validated questionnaires, and physical examination findings. Limitations include the lack of quantitative sensory testing for central sensitization.
In women with endometriosis, the subgroup with high deep dyspareunia and bladder and/or pelvic floor tenderness had a significantly higher score on the CSI than other subgroups, suggesting that this group may have a central component to their sexual pain. Orr NL, Wahl KJ,Noga H, et al. Phenotyping Sexual Pain in Endometriosis Using the Central Sensitization Inventory. J Sex Med 2020;17:761-770.
Sexual Health › Sexual Pain › Dyspareunia · Research Methods › Measurement and Statistics › Instrument Development and Validation · General Gynecology › Pelvic Pain › Chronic Pelvic Pain
Rebecca G K MacLeod, Gurkiran Parmar, Sandy Zhang, Catherine Allaire, Arianne Albert, Ryan Flannigan, Lori A Brotto, Kate Wahl
Becky MacLeod, R MacLeod, G Parmar, S Zhang, Cathy Allaire, Kate Allaire, C Allaire, A Albert, R Flannigan, L Brotto, Catherine Wahl, Katherine Wahl, Kathryn Wahl, K Wahl
PMID 38014766 38014766 DOI 10.1093/jsxmed/qdad133 10.1093/jsxmed/qdad133 MacLeod et al. 2023, MacLeod 2023
