Clinical study: Vaginal ovules containing hyaluronic acid, polycarbophil and lactic acid for vulvovaginal symptoms such as burning, dryness, irritation, dysuria and dyspareunia
Gruppo FarmaImpresa is required, for regulatory reasons, to regularly follow a postmarketing surveillance system called postmarketing clinical follow-up (PMCF). The PMCF is a continuous and proactive process that aims to continuously evaluate the efficacy and safety of the medical device throughout its expected lifetime.
For Gruppo FarmaImpresa vaginal ovules containing hyaluronic acid, polycarbophil, and lactic acid, we conducted a study in which we collected 20 Vaginal Symptom Questionnaire (VSQ) questionnaires, after sample size assessment. These questionnaires were administered to women who had vulvovaginal symptoms such as burning, dryness, irritation, dysura, and dyspareunia and who used our product.
In order to obtain statistically significant and accurate results, we determined the sample size based on the expected effect as assessed through a review of the scientific literature. For data analysis, we used the paired t-test (The t-test is a parametric type of statistical test with the purpose of testing whether the mean value of a distribution deviates significantly from a certain reference value), using Cohen’s D (Effect size: a statistical measure of the size of an effect that can be related to the difference between groups or the association between variables) with a calculated value of 1.1 as the effect measure. According to Cohen’s D scale, this value indicates an extremely positive effect.
The suggested sample size for the study was 19 participants (initial 15 plus a dropout rate of 20 percent). The statistical parameters used for calculation were a significance level (α) of 0.05 and a power (1-β) of 0.8.
The scientifically validated VSQ questionnaire used in the study assesses the impact of vulvovaginal symptoms on patients’ quality of life (Erekson, 2013). It consists of 20 questions divided into 4 thematic areas: emotions, impact on daily life, symptoms and impact on the sexual sphere. Each positive answer to the questions corresponds to one point, for a total of 20 possible points. For each patient, we evaluated both the total score and the score for each area of the questionnaire.
The ovules treatment was performed according to the directions in the package insert: one ovule per day to be applied for 5-7 days, preferably in the evening.
The results of the study (Figure 1) showed that, following treatment, in 75% of the patients, the score obtained by means of the VSQ questionnaire was 0. This indicates that the treatment completely resolved the patients’ symptoms, emotional problems and impact on their lives.
In the case of patients 4 and 10, less improvement was observed than in the other study participants. However, statistical analysis of the data showed that the overall difference between the scores at time T1 and T0 was statistically significant.
In most cases (15 out of 20 patients), the score obtained at time T1 via the questionnaire was 0, indicating complete healing of symptoms and overall improvement in quality of life.
In Figure 2, we show the results by single question and topic area of the VSQ questionnaire (emotions, impact on daily life, impact on sexual sphere and symptoms) and how participants’ responses changed over time from baseline to follow-up.
In the evaluation of emotions, frustration and worry were the most present negative feelings, in both cases in 70% of participants at baseline and decreased to 13% at follow-up.
In the assessment of life impact, desire for intimacy was the most affected (70%), a parameter that decreased to 25% after treatment.
Regarding sex life, 80% of the women felt an impact on their sex life at baseline, after treatment the impact was 13%. Sixty percent also experienced pain during sex before using the egg, while after only 19% experienced this discomfort.
The main symptoms reported by patients included dryness of the vulva (60%), burning (60%) and irritation (65%). After treatment, only 6% of patients still reported vaginal dryness, 6% complained of irritation, and no patients complained of burning anymore.
In conclusion, the study showed a positive impact of our vaginal eggs on vulvovaginal symptoms and the lives of the patients involved, without recording any adverse events. The VSQ questionnaire proved to be a valuable tool to evaluate the efficacy of our product.
Finally, in the 20 patients involved in the study, a decrease in discomfort of more than 50% (as a minimum expected) was observed, with an efficacy of 89%. An excellent result considering that the improvement occurred following only one week of treatment.
We are proud to offer an innovative and safe solution to address vulvovaginal symptoms, improving women’s health and well-being. For more information about our vaginal ovules and partnership opportunities, please feel free to contact us.
