Ohnut vs waitlist control for the self-management of endometriosis-associated deep dyspareunia: a pilot randomized controlled trial

Abstract

Background:Deepdyspareunia affects 50% of people with endometriosis. The Ohnutis aset of interlocking ringsthat fitover thepenis/insertive object. One or more rings can be used to limit insertion depth and reduce deep dyspareunia. Aim: We conducted a pilot, parallel, open-label randomized controlled trial (RCT) to investigate the feasibility of the study design and the acceptability and preliminary efficacy of the Ohnut. Method: Participants were recruited from a tertiary center for endometriosis. Eligibility criteria were surgically confirmed endometriosis, age 19-49 years, monogamous sexual relationship with a partner willing to participate in the study, and no comorbid superficial dyspareunia, anxiety, or depression. Couples were randomized into an intervention group or a waitlist control group using a 1:1 allocation ratio. All couples had sex as normal during weeks 1 to 4 (baseline period), and couples in the intervention group used the Ohnut with sex during weeks 5 to 10 (intervention period) while controls had sex as normal. Patient participants used daily diaries to record sexual activity and deep dyspareunia score (0-10) for the 10-week study. Intervention group participants completed an acceptability questionnaire at the end of the study. Outcomes:TheprimaryoutcomeswerefeasibilityofthestudyandacceptabilityoftheOhnut.Wealsoassesseddifferencesindeepdyspareunia scores in the participants who used the Ohnut compared to the control participants who did not. Results:Werecruitedapproximately5couplespermonthofactiverecruitment.Of864potentiallyeligibleparticipants,wesuccessfullycontacted 44.7% (n=386), of whom 8.0% (n=31) consented, 64.8% (n=250) were ineligible, and 27.2% (n=105) declined. Thirty-one couples were randomly assigned to the intervention or control group, and 17 couples completed the study. Intervention group couples used the Ohnut for an averageof72.4%(32.7%)ofsexualencountersduringtheinterventionperiod.ThemeanacceptabilityindexscorefortheOhnutwas0.83(0.078) among patients and 0.83(0.049) among partners (index between 0 and 1). After controlling for baseline deep dyspareunia, there was a significant difference in the intervention period mean deep dyspareunia scores between the control and intervention group (4.69(2.44) vs 2.46(1.82), P = .012). Clinical Implications: We identified preliminary evidence for the acceptability and efficacy of the Ohnut among both patients and partners, suggesting that the Ohnut may be a useful stand-alone or adjuvant management tool for endometriosis-associated deep dyspareunia. Strengths and Limitations:Strengths of this study were the "real-world"use of the Ohnut and data collection from both patients and partners. Limitations of the study design included the strict eligibility criteria that affected feasibility and generalizability. Conclusion:This pilot RCT indicated that the Ohnut may be an acceptable and effective intervention to reduce endometriosis-associated deep dyspareunia. We identified opportunities to improve design for a larger RCT.