JMIR Publications

ABSTRACT

Background:

Endometriosis-associated deep dyspareunia is associated with reduced sexual quality of life, lower self-esteem, and impaired sexual function.

Objective:

The primary objective is to assess the acceptability of a buffer worn over the penis or penetrating object to reduce endometriosis-associated deep dyspareunia and the feasibility of a definitive randomized controlled trial (RCT). The secondary objective is to obtain effectiveness estimates of the buffer. An embedded sub-study seeks to explore the acceptability and preliminary validity and reliability of a vaginal insert for self-assessment of deep dyspareunia.

Methods:

This is an investigator-initiated, 2-arm RCT. We will recruit 40 patient participants with diagnosed endometriosis between the ages of 19-49 and their sexual partners. The participating couples will be randomized in a 1:1 ratio into the experimental arm or the waitlist control arm. The study period is 10 weeks, during which time all participants will record deep dyspareunia severity following each episode of sexual intercourse. In weeks 1-4, all patient participants will record deep dyspareunia. In weeks 5-10, participants in the experimental arm will use the buffer during vaginal penetration; participants in the waitlist control arm will continue having vaginal penetration as usual. Participants will complete questionnaires assessing measures of anxiety, depression and sexual function at baseline, at 4 weeks, and at 10 weeks. In the sub-study, patient participants will self-assess dyspareunia using a vaginal insert on two occasions, at least 1 week apart. The primary outcomes of acceptability and feasibility of the buffer will be assessed with descriptive statistics, and the secondary outcome of PLR effectiveness will be assessed using an ANCOVA-based approach. Acceptability of the vaginal insert will be assessed, as well as convergent validity and test-retest reliability through correlation to dyspareunia assessed by clinical exam.

Results:

This pilot will provide initial data on the acceptability and effectiveness of the buffer and feasibility of the study methodology.

Conclusions:

This study will provide preliminary evidence for the self-assessment and management of endometriosis-associated deep dyspareunia. The randomized design is a strength of this study. One limitation is that definitive estimates of effectiveness of the buffer and validity for the vaginal insert will not be possible because this is a pilot trial. The findings will inform the decision to proceed to a definitive randomized controlled trial. Clinical Trial: ClinicalTrials.gov: NCT04370444; https://clinicaltrials.gov/ct2/show/NCT04370444