Abstract

ABSTRACT Introduction During menopause, many women experience vaginal atrophy symptoms including vaginal dryness, burning, stinging, and dyspareunia. Revaree is a non-drug, hormone-free vaginal insert containing hyaluronic acid. Clinical evidence supports the use of hyaluronic acid to reduce vaginal dryness, vaginal itching and burning, and dyspareunia. Objective A national survey study was conducted to affirm results previously reported from controlled clinical trials and to investigate the trends of this product across multiple variables. This study gathered information on the real-world experiences of women, including the use of Revaree and its effect on symptom relief including vaginal dryness, quality of life, and satisfaction. Methods An optional, rolling online survey was emailed to patients who had been taking Revaree for time periods ranging from less than one month to more than one year. Survey data was collected from 3,080 patients between March 2019 and October 2021. A 5-point Likert scale was used to assess patient satisfaction. During the initial 9 months of enrollment, patients received no compensation. To increase enrollment, after the initial 9 months, patients were compensated with a $5 gift card for completing the survey. Results An analysis of survey findings showed that of patients taking Revaree (n=total applicable responses per question): 83% responded that Revaree reduced vaginal dryness (n=3,050); 73% responded that Revaree reduced vaginal burning (n=2,315); 77% responded that Revaree reduced vaginal irritation (n=2,644); 66% responded that Revaree reduced pain during sex (n=2,576); 69% responded that Revaree made sex more comfortable (n=2,617); 66% responded that Revaree improved intimacy with partners (n=2,617); and 72% responded that Revaree improved quality of life (n=2,933). Furthermore, 79% responded that Revaree is easy to insert (n=3,000); 69% responded that Revaree is non-messy (n=3,023); 80% responded that the insert formulation makes Revaree convenient to use (n=2,997); and 60% responded that Revaree makes everyday activities more comfortable (n=2,677). No differences in efficacy (e.g., improvements in vaginal dryness, vaginal burning, and vaginal irritation) were detected when the data were analyzed by user age (age range: 24 – 84). Additionally, no decrease in efficacy was detected with use over time. Of the 3,080 women, 58% reported that they first saw an improvement with Revaree within 2 weeks and 85% reported that they first saw an improvement with Revaree within 8 weeks. Overall, 79% of women reported satisfaction with Revaree (n=3,007); 92% of women would recommend Revaree to friends or family (n=3,079); and 96% plan to continue using Revaree (n=3,079). Conclusions This survey study demonstrated high levels of relief from vaginal atrophy symptoms across a wide age range with the use of Revaree. A majority of women saw great improvement in symptoms within the first month, with continued or higher levels of improvement with continued use. These findings confirm the objective findings of previously published randomized, controlled studies on Revaree's main ingredient, hyaluronic acid. Together, the results of this study support the use of Revaree to alleviate vaginal atrophy symptoms, enhance comfort during intimacy, and improve everyday quality of life. Disclosure Yes, this is sponsored by industry/sponsor: JDS Therapeutics Clarification Industry initiated, executed and funded study Any of the authors act as a consultant, employee or shareholder of an industry for: JDS Therapeutics

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