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

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