Intravaginal Non-Ablative Radiofrequency In The Treatment Of Genitourinary Syndrome Of Menopausesymptoms: A Phase I Clinical Trial

Abstract

Background: Genitourinary Syndrome of Menopause (GSM) involves vaginal dryness, dyspareunia, itching, burning, pain, and also symptoms in urinary organs. Non-ablative radiofrequency (RF) is a type of current with electromagnetic waves with the thermal effect that generates an acute inflammatory process with consequent neocolagenesis and neoelastogenesis. We aimed to describe the clinical response, cytological changes, and adverse effects of applying nonablative RF in patients with GSM and to assess sexual and urinary function after treatment. Methods: This is a pilot study with 11 women diagnosed with GSM with established menopause. Patients with hormone replacement initiation less than six months, who used a pacemaker or had metals in the pelvic region, were excluded. Subjective measures (Visual Numerical Scale-VNS of symptoms, Vaginal Health Index-VHI) and objective measures (Vaginal Maturation Index-VMI and vaginal pH) were used. Sexual function was assessed by the FSFI, and the ICIQ-SF measured the impact on urinary function. A Likert scale measured the degree of satisfaction with the treatment. Five sessions of monopolar non-ablative RF (41 °C) were performed with an interval of one week between each application. The entire evaluation was performed before treatment (T0), one month (T1), and three months (T2) after treatment. Adverse effects were assessed weekly. Results: There was a reduction in symptoms after treatment in most patients (T1/T2, respectively): vaginal dryness 90.9%/81.8%, dyspareunia 83.3%/66.7, vaginal laxity 100%/100%, pruritus 100%/100%, burning 75%/87.5%, pain 75%/75%, and in VHI 90.9%/81.9%. Most patients did not show changes in VMI (54.5%) and pH (63.6%) at T1, but there was an improvement in VMI in most patients (54.5%) at T2. Nine patients were satisfied and two were very satisfied at T1. The treatment was well tolerated and no adverse effects were observed. There was an improvement in sexual function in 72.7% and in urinary function in 66.7% in T1 and 83.3% in T2. Conclusion: Intravaginal RF reduced the clinical signs and symptoms of GSM and women reported satisfaction with treatment. The technique showed no adverse effects and there were positive effects on sexual and urinary function. Trial registration: This research was registered at clinicaltrial.gov (NCT03506594) and complete registration date (first date posted) April 24, 2018.