(091) Preferred Physical Characteristics of Lidocaine Film for Women with Vestibulodynia
Authors: Ogbansiegbe J , Rowland C , Mihas P , Benhabbour R , Carey E 
Published: May 2023

Abstract

Introduction
Vestibulodynia (VBD) is the most common cause of sexual pain in the United States, affecting up to 28% of reproductive-aged women during their lifetime. First-line treatment for VBD includes topical lidocaine therapy prior to vulvovaginal manipulation (tampon use, intercourse, tight clothing) to reduce symptoms. Limitations of topical therapy include messy application, inability to apply to the affected area, and transfer of drugs affecting the sexual partner. The purpose of this study was to describe the physical characteristics of a vulvar film designed for insertional sexual pain in women with VBD to optimize the device design.

Objective
This study explored individuals’ preferred physical characteristics of lidocaine film for women with Vestibulodynia.

Methods
Participants completed a blend of demographic and sexual history questionnaires followed by focus group discussions. Participants were eligible if they were 1) heterosexual female, 2) aged 18 to 51 years, 3) able and willing to provide written informed consent 4) have vulvodynia, vestibulodynia, or dyspareunia. Women who reported no episodes or attempts of vaginal intercourse in the prior 18 months were excluded. A total of six semi-structured 60-minute focus group discussions with 3-4 participants each, were audio-recorded, transcribed verbatim, and coded for content. All focus groups had participants of varying socioeconomic status, marital status, age, and racial/ethnic background. Women visually examined a new film technology designed for application to the vulvar vestibule prior to penetration. The device is a U-shaped, thin, and flexible short-acting lidocaine 5% film. The strip is clear, smooth, and has a nonslip texture. To apply the film, an easy-to-remove backing is peeled and applied to the vestibule for 5 minutes. After 5 minutes, lidocaine drug delivery into the vulvar tissue is complete and film is removed, preventing drug release onto partner during intercourse like current topical lidocaine therapy. This study was approved by the University of North Carolina Institutional Review Board.

Results
Twenty women participated in the focus group portion of the study. Across all groups, the mean age for the participants was 33.3 years, most women were educated with at least some college (93%), white (78.6%), married (75%), and had income greater than $100,000 (50%). Across all groups, 75% of women were interested in trying the commercial device. A major common physical theme that emerged across all groups was the desire for ease and accuracy of use, with an interest in multiple sizes or custom sizes. One group of women desired an additional wing-like vaginal flap to deliver lidocaine beyond the hymenal ring and one group of women desired round/oval shape to reach the upper vestibule. Across all groups, women were interested in the film being loaded with other acceptable medications or in combination with lidocaine.

Conclusions
Additional research and provider education efforts are needed to better communicate about and treat vulvodynia symptoms provoked by penetrative intercourse. Efforts to support and connect patients with symptoms should be considered. Vulvar films may be an acceptable treatment for vulvar pain provoked by penetrative intercourse.

Disclosure
No