Endometriosis is a common condition in people assigned female at birth of childbearing age where tissue similar to the lining of the uterus grows outside the uterus. This condition affects about 10% of individuals assigned female at birth.

Deep dyspareunia, associated with endometriosis, causes pain during sex and impacts quality of life. The first step toward improving deep dyspareunia is reliably identifying and assessing it when it occurs.

That’s why a new study was aimed at evaluating a vaginal insert as a self-assessment tool for deep dyspareunia in people with endometriosis. The researchers hypothesized that the insert is acceptable to patients, reliable (consistent), and valid (accurate) in its results.

To test this hypothesis, they recruited participants from the Endometriosis and Pelvic Pain Interdisciplinary Cohort (EPPIC) registry to be part of this study evaluating the self-assessment tool for deep dyspareunia.

The inclusion criteria for participants were to be between 19 to 49 years old, be assigned female at birth, be in a monogamous sexual relationship, be either sexually active or not currently sexually active due to deep dyspareunia, have a self-reported deep dyspareunia score ≥4 out of 10, have a sexual partner willing to participate, and be willing to engage in penetrative sex at least once during the study period.

Participants used the vaginal insert for self-assessment, recording tenderness on an 11-point scale at five different pelvic sites over two weeks. They started by inserting the device into the vagina as deep as felt comfortable and placing the marker at the 12 o’clock position. Then they assessed the left pelvic floor (levator ani), right pelvic floor (levator ani), bladder, cervix/uterus, and posterior cul-de-sac (vaginal fornix).

The participants also gauged the depth of insertion by observing the number of dots (ranging from 0 to 5) visible on the device while inserted in the vagina. All the instructions for the vaginal insert were included in booklets that were distributed to the participants.

In the end, 19 individuals with endometriosis completed the study. The sample was mainly female (94.7%), heterosexual (89.5%), and white (89.5%), with a mean age of 34. The acceptability index score for the vaginal insert was 0.72, meaning that most of the participants found it easy to follow instructions and insert/remove the vaginal insert.

Test–retest reliability showed significant correlations for tenderness levels between the first and second assessments, indicating that the tool produced consistent results. Lastly, validity assessments demonstrated correlations between self-assessed tenderness and results from prior pelvic exams. Some participants expressed uncertainty about how to use the insert and suggested additional instructions for the self-assessment process.

Overall, this vaginal insert was found to be an acceptable, reliable, and valid tool for self-assessing dyspareunia related to endometriosis. What’s more, the participants appreciated the privacy and autonomy the insert allowed them.

Nevertheless, they expressed concerns about the accuracy of completing the assessment on their own, and over half stated that they preferred clinician assessment. Still, the results of this study suggest the potential benefits of integrating self-assessment into care, emphasizing the importance of clinician demonstration to address accuracy concerns and improve patient autonomy in gynecologic care.

References:

• MacLeod, R. G. K., Parmar, G., Zhang, S., Noga, H., Allaire, C., Albert, A., Flannigan, R., Brotto, L. A., Orr, N. L., & Wahl, K. (2024). Acceptability, reliability, and validity of a vaginal insert for the self-assessment of endometriosis-associated deep dyspareunia: A cross-sectional study. The Journal of Sexual Medicine, 21(1), 44–53. https://doi.org/10.1093/jsxmed/qdad133