Background: A growing body of evidence illustrates the benefits experienced by women with vulvo-vaginal atrophy/genitourinary syndrome of menopause (VVA/ GSM) undergoing vaginal rejuvenation with the very recent low-energy Dynamic Quadripolar RadioFrequency (DQRF™) technology. Twelve-month follow-up data describe significant improvement from both a clinical (relief of VVA/GSM symptoms) and psychological perspective (women’s self-esteem and satisfaction from sexual life and couple relationship). The proprietary Ultra-Pulsed Radioporation (UPR™) technology is intended to associate the anti-atrophic benefits of both the DQRF™ technology and any topical agent with anti-atrophic properties. UPR™ acts by opening aqueous channels in cell membranes and further modulating DQRF™ performance. UPR™ helps any active principle with useful properties to penetrate the deep layers of vulvar skin and vaginal mucosa. Topical hyaluronic acid (HA) is increasingly used, based on solid biological rationale, to help slow and reverse the menopause-related loss of elasticity and volume of vulvo-vaginal tissues. This pilot study was designed to verify if the novel UPR™ technology, applied to a test anti-atrophic topical agent like HA in combination with standard DQRF procedures, could indeed enhance the already established anti-atrophic efficacy of the DQRF™ technology.
Methods: Prospective, randomised, open-label study; two parallel groups of 30 women with evidence of vaginal atrophy and dryness and other postmenopausal VVA/ GSM symptoms. Radiofrequency treatment schedule in both the Dynamic Quadripolar RadioFrequency (“DQRF™”) and Dynamic Quadripolar RadioFrequency/ Ultra-Pulsed Radioporation (“DQRF™ + UPR™”) study arms: five 15-min sessions every 14-16 days following application of either standard or UPR coupling gel. Operative temperatures in target tissues during procedure: 42°C (range 40-43°C). Self-administered evaluation tools (before and at the end of the treatment sessions): 10-cm visual analogue scales (VAS) for VVA/GSM symptoms (vaginal dryness, itching and burning, dyspareunia, dysuria/incontinence), 13-item Female Sexual Distress Scale-Revised (FSDS-R) questionnaire (multi-perspective assessment of the woman’s personal distress related to sexual dysfunction), Sexual Satisfaction Questionnaire (SSQ) (sexual gratification.) Non-parametric statistical analysis (Wilcoxon Signed Rank and McNemar tests).
Results: On average, all the assessed parameters (VAS symptom scores, FSDS-R and SSQ scores related to the sexual sphere) underwent statistically significant or highly significant improvements in both the “DQRF™ + UPR™” active group and “DQRF™” controls over the about two months of the treatment program. The observed improvements, though always very strong, were somewhat less impressive for at least some parameters in the control “DQRF™” group compared with the active “DQRF™ + UPR™” treatment group. That was distinctively the case for vaginal itching, dyspareunia and dysuria/incontinence among VVA/GSM symptoms (“DQRF™ + UPR™” vs. “DQRF™” VAS scores: −۶۰٫۹% vs. −۴۹٫۲%, −۶۳٫۸% vs. −۵۰٫۵%, and −۵۹٫۳% vs. -44.9%, respectively), and for sexual satisfaction from intercourse activity (“DQRF™ + UPR™” vs. “DQRF™” SSQ scores: + 96.4% vs. + 85.8%, p <0.05).
Discussion: The novel UPR™ technology was devised to modify the performance of the DQRF™ EVA™ device to facilitate the deep penetration of any topical active principle that has demonstrated to have a favourable impact on the atrophy of female post-menopausal intimate tissues. The idea behind the UPR™ concept was to enhance the established rejuvenation effect of the DQRF™ technology thanks to the synergy between the biological effect of the radiofrequency treatment and that of the topical active principle. In the current short-term pilot study, low-molecular weight HA was chosen as the model topical active principle to test the UPR™ concept. This short-term pilot study confirmed the high vaginal rejuvenation efficacy over a short time of the established DQRF™ technology in post-menopausal women. Moreover, the study suggested that the novel UPR™ technology is likely to further enhance the DQRF™ clinical benefits. Long-term studies are warranted to confirm these preliminary encouraging results.
Keywords: electroporation, post-menopausal atrophy, radiofrequency, urinary incontinence, vaginal rejuvenation