(012) Vulvovaginal Atrophy (VVA) Treatment Compliance Correlates with Improved Outcome

Abstract

Abstract Introduction To effectively manage chronic conditions such as VVA, daily or semi-daily patient compliance to a treatment regimen is essential. Despite the fact that risk of cancer or cancer recurrence prevents many women from treating their VVA with hormone therapy, patient compliance to over-the-counter moisturizers and lubricants is relatively low: 40% of women find them completely unsatisfactory due to difficulty of use and lack of desired treatment outcome. As an alternative to current therapies, an at-home, easy-use therapeutic ultrasound device was developed with the potential to increase treatment compliance and help women successfully manage their VVA. This study aimed to optimize patient compliance by increasing ease of device use, minimizing therapy side effects, and tracking self-reported patient data electronically. Objectives To assess the correlation between patient-reported and objectively tracked actual compliance to therapy, as well as the association between treatment compliance and improvement in patient condition. Methods This randomized (1:1), double-blind, sham-controlled trial assessed the effectiveness of a daily, at-home ultrasound therapy, applied to the vaginal introitus for 8 min/day over the course of 12 weeks, on menopausal vaginal dryness in an ambulatory setting (Clinicaltrials.gov NCT00583-1). In 30 post- menopausal women (ages 48-70), device use compliance was collected via a self-reported electronic diary completed daily on a mobile phone. Objective compliance data were obtained from a logger installed in all devices, which recorded the duration and time the device was used every day. Participants self- assessed change (from baseline to 12 weeks) in VVA symptoms (vaginal dryness, soreness, irritation, dyspareunia) measured by the Vaginal Assessment Scale (VAS) with a 4-level response score ranging from none, mild, moderate, to severe. Healthcare providers evaluated change in vaginal tissue response (tissue elasticity, vaginal fluid, pH, mucosa, and vaginal moisture) assessed by the Vaginal Health Index (VHI) giving a numerical score (1-5) for each of the 5 parameters. Results After week-12 follow-up, participants in the operating group self-reported compliance (mean ± SE%) of 85.4 ± 5.4% and the device log objectively tracked compliance of 80.7 ± 7.2% (paired t-test, P=0.17). The sham group had self-reported compliance of 89.5 ± 2.1% and the device log compliance of 82.5 ± 5.2% (P=0.14). There was no significant difference (ANOVA) between operating and sham groups compliance for self-reported (P =0.46) or objective log data (P =0.83). With both operating and sham groups combined, there was a significant strong correlation (r=0.76, P<0.0001) between self-reported and device log compliance. Linear regression showed a significant positive dose-response between treatment and change in VHI score from baseline to week 12 (r=0.51, P=0.04). A smaller positive correlation was observed between treatment compliance and participants’ self-assessed change in VAS score (r=0.40, P=0.28). Conclusions Objective device use compliance was high (80.7-82.5%) across both groups assessed, indicating general participant desire to receive the therapy. In addition, participants with higher treatment rates had better scores in VHI, which indicated decreased VVA severity. For post-menopausal women, high adherence to the daily at-home ultrasound therapy proved efficacious in improving their condition of VVA and could offer a new therapeutic option. Disclosure Yes - Madorra. Industry funding only - investigator initiated and executed study – Yes.