(123) Evaluation of a Vaginal Insert for Self-assessment of Endometriosis-associated Deep Dyspareunia

Abstract

Abstract Introduction Among individuals with endometriosis, approximately 50% experience deep dyspareunia. There is a validated test to evaluate superficial dyspareunia (tampon test); however, no such test exists for deep dyspareunia. Thus, we conducted a pilot study to evaluate the use of a vaginal insert for self-assessment of deep dyspareunia. Objective To report test-retest reliability and validity of using a vaginal insert for self-assessment of deep dyspareunia in individuals with endometriosis. Methods This was a prospective cohort study embedded within a pilot RCT. Individuals with a surgical diagnosis of endometriosis aged 19-49, who had a clinic visit between January 2018 and December 2020 were recruited from a prospective data registry at a tertiary endometriosis and pelvic pain centre. Inclusion criteria were assigned female at birth, sexually active or not sexually active due to pain, monogamous partner who consents to participate, and deep dyspareunia score ≥ 4/10. Exclusion criteria were superficial dyspareunia ≥ 4/10, prior use of the intervention under investigation in the RCT, intense fear or anxiety around sexual activity, and severe levels of anxiety or depression on validated screening measures. Participants used the vaginal insert to self-assess tenderness at two time points, one week apart, using a numeric rating scale (0-10) at the right and left pelvic floor, bladder, cervix-uterus, and posterior cul-de-sac. Participants also used a daily diary to record deep dyspareunia severity (0-10) during intercourse over a four-week period. Test-retest reliability was evaluated by correlating tenderness scores between the two time points. Validity was assessed by correlating the vaginal insert tenderness scores with deep dyspareunia scores. Results Nineteen participants completed the study. The average age was 34 ± 7 years, and the majority of participants identified as female (n=18; 94.7%), heterosexual (n=17; 89.5%) and white (n=17;89.5%). Intraclass correlation coefficients for each site showed good test-retest reliability: left pelvic floor 0.79 (p = 0.001), right pelvic floor 0.82 (p < 0.001), bladder 0.54 (p = 0.07), cervix-uterus was 0.89 (p < 0.001), and the cul-de-sac 0.77 (p = 0.003). The strongest correlation between tenderness using the vaginal insert and deep dyspareunia scores was at the cervix-uterus (r=0.35); however, no statistically significant correlations were identified at any of the pelvic sites. Conclusions We found a strong correlation of tenderness scores between assessment dates (test-retest reliability), indicating that the vaginal insert may be a reliable method of assessing deep dyspareunia. A future study with larger sample size will be needed to study the correlations between tenderness assessed with the vaginal insert and prospective deep dyspareunia scores for evaluation of validity. Self-assessment of deep dyspareunia using a vaginal insert shows promise, and may support trauma-informed practice and the collection of ecologically valid data. Disclosure Yes, this is sponsored by industry/sponsor: OhNut Wearable - provided a discount on the silicon buffer used in the trial; ISSWSH Grant. Clarification: No industry support in study design or execution.