(124) Acceptability of Using a Silicone Bbuffer for Management of Endometriosis-associated Deep Dyspareunia: A Pilot Randomized Control Trial
Authors: Macleod R , Parmar G , Zhang S , Orr N , Wahl K , Albert A , Brotto L , Flannigan R , Yong P 
Published: May 2023

Abstract

Introduction
Approximately 10% of reproductive-age females are affected by endometriosis, and of those, ~50% suffer from deep dyspareunia (DD). A portion of those with DD do not respond to medical and surgical treatments and therefore alternative management strategies are required.

Objective
We conducted a pilot randomized controlled trial (RCT) to assess the acceptability of a silicone buffer (Ohnut) for the management of endometriosis-associated DD.

Methods
This was a 1:1 waitlist-controlled pilot randomized control trial of a buffer that fits over the penis/penetrating object to limit the depth of penetration. Individuals with a surgical diagnosis of endometriosis aged 19-49 were recruited from a prospective data registry at a tertiary endometriosis centre who had a clinic visit between January 2018 and December 2020. Inclusion criteria were female-assigned at birth, DD score ≥ 4/10 (patient participants), and sexually active with a monogamous partner who consented to participate (partner participants). Exclusion criteria were superficial dyspareunia ≥ 4/10, prior use of a silicone buffer, intense anxiety around sexual activity, GAD-7≥15, and PHQ-9≥15. Participants were not blinded. The trial was 10 weeks. Over the first 4 weeks, participants (both intervention and control groups) continued their normal sexual activities and used a diary to record DD severity (0-10) during each penetrative vaginal sexual encounter. Over the following 6 weeks, the intervention group used the buffer during intercourse, while the control group continued normal sexual activities. Both groups continued to record DD severity until the conclusion of the study period. The intervention group then completed an acceptability questionnaire, of which an acceptability index score was calculated (0-1; 1 indicates more acceptability).

Results
Recruitment and data collection occurred between June and December 2021. 31 couples enrolled in the study and 17 couples completed primary data collection (control N=7; intervention N=10). All patient participants identified as cis-gender and the majority identified as heterosexual (94.1%) and white (94.1%). The mean buffer acceptability score for intervention was 0.78±0.06 for the patients (N=9) and for their partners (N=8) was 0.78±0.07. All of the patients and partners found that it was somewhat easy or very easy to handle the buffer. Five (55.5%) patients and five (62.5%) partners had somewhat more or much more sexual satisfaction when using the buffer compared to vaginal sex without using the buffer, two (22.2%) patients and three (37.5%) partners were neutral and 2 (22.2%) participants had less sexual satisfaction. The mean DD score from weeks 1-4 (i.e. normal sexual activities) for the control group was 4.5±2.0 and for the intervention group was 5.1±2.0. The mean DD score from weeks 5-10 (i.e. intervention period) was 4.2±2.1 for the control group and 2.4±2.0 for the intervention group that used the silicone buffer. No important adverse events were reported.

Conclusions
The Ohnut was acceptable among participants with endometriosis-associated DD and their partners. This pilot RCT suggested a reduction in the mean DD scores with the use of the buffer which should be substantiated in a definitive RCT.

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.