Clinical efficacy of dynamic quadripolar radiofrequency therapy in postmenopausal women with vulvovaginal atrophy

Background: Vulvovaginal atrophy (VVA) is a chronic progressive disease that affects the female genital organs and lower urinary tract. This condition is associated with hypoestrogenia as a result of menopause, but can also develop in patients suffering from breast cancer after adjuvant hormonal therapy. Given the high prevalence of VVA and the expected increase in its incidence, and due to the increase in the mean age of women, it is easy to understand its significant social impact. VVA causes unpleasant disorders such as vaginal dryness, itching, burning, and dyspareunia, and requires ongoing treatment – when the therapy is stopped, the symptoms usually reappear. Currently available treatments include vaginal lubricants and moisturizers, vaginal estrogens and dehydroepiandrosterone (DHEA), and systemic hormone therapy. However, since these treatments have contraindications, lack of efficacy, and poor adherence to treatment, search for innovative, effective, and safe treatments is critical.

Objective. Evaluation of the efficacy and safety of dynamic quadripolar radiofrequency (DQRF™) therapy in the treatment of VVA in postmenopausal women.

Methods. The study included 180 women. The mean age of the patients was 52±4.3 years. All patients underwent a course of treatment: group 1 – the impact of DQRF^TM on the vagina and vulva, 4 procedures with an interval of 2 weeks; group 2 – DQRF™ in the mode of radioporation with estriol cream 0.5 mg, 4 procedures with an interval of 2 weeks; group 3 - local hormonal therapy with estriol cream 0.5 mg according to the scheme for 8 weeks. Evaluation of the effectiveness of treatment was carried out by measuring the vaginal pH, assessing the index of vaginal health, FSFI, VSQ questionnaires. In all groups, satisfaction with the appearance of the vulva was assessed according to VAS. For the clinical data of patients in each of the groups, the parameters were compared after treatment with a zero time point using paired and unpaired Mann-Whitney test. Comparison of changes in clinical parameters of the group 1 and 2 with the control group at each time point was made using the Mann-Whitney test.

Results. Analysis of the results of the study revealed a significant decrease in the severity of VVA symptoms one month after treatment in all groups. In the group 1, an increase in the mean vaginal health index in 40 (67%) women from 21.3 to 23.1 points (P<0.001), a decrease in the mean vaginal pH in 39 (65%) women from 6.8 to 4.9 (P<0.001), an increase in mean values of satisfaction with the appearance of the vulva in 48 (80%) patients according to VAS from 6.5 to 9.2 (P<0.001) were observed. In the group 2, there was an increase in the mean index of vaginal health in 50 (87%) women from 18.1 to 24.1 points (P<0.001), a decrease in the mean vaginal pH in 49 (85%) women from 7.0 to 4.5 (P<0.001), an increase in mean values of satisfaction with the appearance of the vulva in 48 (83%) patients according to VAS from 5.5 to 9.0 (P<0.001). Analysis of the results of the group 3 revealed an increase in the mean vaginal health index in 56 (90%) women from 19.1 to 24.5 points (P<0.001), a decrease in the mean vaginal pH in 53 (87%) women from 7.0 to 4.3 (P<0.001), an increase in mean values of satisfaction with the appearance of the vulva in 12 (20%) patients according to VAS from 5.5 to 7.0 (P<0.001).

Conclusion. The article confirms the safety and efficacy of DQRF™ procedures within 12 months of follow-up after the end of treatment sessions. Vaginal health index, vaginal pH, satisfaction with vulvar appearance, and female sexual function index (FSFI) were shown to improve rapidly to near normal levels. It has been shown that it is necessary to undergo a new course of DQRF™ therapy 6–9 months after the previous cycle, and not 9–12 months after, as previously suggested. This algorithm provides maintaining the level of women’s health indicators and quality of life at a high level. This work has shown that it is possible to use only DQRF™ procedures without the use of local hormonal therapy with comparable, and sometimes even superior results. This may be especially true for patients who have had cancer and/or cardiovascular diseases, as well as for patients who refuse hormonal treatment.