Intravaginal non-ablative radiofrequency treatment for Genitourinary Syndrome of Menopause: preliminary results of a randomized clinical trial

Costa T1, Pinheiro C1, Brasil C1, Gomes T1, Lemos A1, Ferreira R1, Sodre P1, Pires J2, Teles A1, Alvares C1, Barros D3, Brim R1, Marianno A1, Silva L1, Pitiá A1, Baqueiro P1, Araújo E1, Fontes A1, Passos R4, Torrieri C5, Lordelo P1

Research Type

Clinical

Abstract Category

Conservative Management

Abstract 472
ePoster 7
Scientific Open Discussion Session 32
On-Demand
Conservative Treatment Clinical Trial New Devices
1. Escola Bahiana de Medicina e Saúde Pública, Centro de Atenção ao Assoalho Pélvico, Instituto Patricia Lordelo, 2. Centro Universitário Estácio do Ceará, Faculdade IDE, 3. Escola Bahiana de Medicina e Saúde Pública, Centro de Atenção ao Assoalho Pélvico, Instituto Patricia Lordelo, Hospital Santa Izabel, 4. União Metropolitana para o Desenvolvimento da Educação e Cultura - UNIME, 5. CT Clinical
Presenter
T

Teresa Alencar Costa

Links

Abstract

Hypothesis / aims of study
Genitourinary Syndrome of Menopause (GSM) is defined as a set of signs and symptoms, involving tissues changes in the labia majora and minora, clitoris, vagina, urethra and bladder, which can affect up to 50% of menopausal women. (1) Non-ablative radiofrequency (RF) is a diathermic technique that favors collagen production and stimulates tissues remodeling.  Based on this knowledge, it is hypothesized that RF may assist in the reduction of GSM’s symptoms. Thus, the aim of this original trial is to verify safeness, cytologic changes and the impact on sexual function and urinary symptoms of non-ablative RF treatment in women with GSM.
Study design, materials and methods
: This is a randomized blind clinical trial. Menopausal women with one or more symptoms of GSM, up to 65 years old, with vaginal pH ≥ 5, negative Pap smears screening for malignancy in the last 12 months, or previous three negatives, were included. Women with pacemakers, who were on or off hormone therapy for less than 6 months, hemophiliacs, using anticoagulants / vasodilators, unable to answer the research instruments, with metal in the pelvic region, with active vaginal infections, and cancer history were excluded. After consent, an anamnesis was performed, as the vaginal pH measurement, Vaginal Maturation Index (VMI) and application of the questionnaires Female Sexual Function Index (FSFI) and International Consultation on Incontinence Questionnaire (ICIQ-SF). For the sample calculation, the standard deviation (SD) of 8 was adopted for control group (CG) and 16, for radiofrequency group (RG). The difference estimate was considered 10, a power of 80% and a significance level of 5%, requiring 52 patients, 26 for each group. Considering a 10% loss of the sample, the study predicts a total of 58 women. The randomization was made by a secretary, who was not part of the research, ensuring allocation secrecy, through a random table, by separating it into two groups: CG, where pelvic floor muscle training (PFMT) was offered and radiofrequency turned off, with heated gel; and RG, where PFMT was offered plus intravaginal non-ablative monopolar RF, with a temperature of 40oC, for 2 minutes on the anterior wall and more 2 minutes on the posterior wall
The RF was used in the form of capacitive electrical transfer, monopolar configuration, with Capenergy device, C500 model, which has two electrodes: an intracavitary active, placed in the vaginal canal with condom. Both groups performed 5 sessions, with an interval of seven days. Vaginal pH, VMI and the questionnaires were reassessed one week and 3 months after treatment. Side effects such as erythema, ulcer, fistulas, burns, blisters and / or bleeding were assessed weekly and in the two reevaluations. Inferential analyses were performed using Statistical Package for Social Sciences, version 14.0. This research was approved by Research Ethics Committee and the patients signed the Informed Consent Form.
Results
The sample consisted of 30 women, 18 women in the RG and 12 in the CG. One patient in the CG was excluded from the analysis because she reported having started hormone therapy during the intervention. There were no statistical differences in the clinical and sociodemographic variable between groups. The mean age in the CG was 56.2 and in the RG was 57.4 (p: 0.495). The most prevalent symptom in the sample was vaginal dryness (100% of the sample, in both groups). In table 1, it is observed that there was no significant difference in the intragroup analysis in vaginal pH (p: 0.270 in CG and p: 0.301 in RG) and in the VMI (p: 0.368 no GC e p: 0.771 no GR). Still in table 1, it is observed that there was an improvement in urinary symptoms assessed by ICIQ-SF in RG, in the intragroup analysis (p: 0.042 no GR e p: 0.097 no GC). There was no difference in the intergroup analysis. Regarding sexual function, there was an improvement in the overall score (p:0.019) and in the domains of desire, arousal, lubrication and pain (p<0.05 for them all) in the RG (table 2). In the intergroup analysis, only the arousal domain showed difference (p: 0.043). There were no side effects reports
Interpretation of results
Results showed a positive impact in sexual function and urinary symptoms after non-ablative RF treatment, in RG, corroborating with data found in the literature. (2) One innovative characteristic of the present study was the cytologic analysis to verify clinical response to non-ablative RF in women with GSM, which, to our knowledge, is pioneer in the available scientific literature. There was no difference in relation to VMI and vaginal pH.
Concluding message
Intravaginal non-ablative RF treatment had no side effects, with positive results in sexual function and urinary symptoms. There was no improvement in the VMI and vaginal pH.
Figure 1 Table 1
Figure 2 Table 2
References
  1. Am EF. Genitourinary syndrome of menopause. 2017;46(7):481–4.
  2. Vicariotto F, De Seta F, Faoro V, Raichi M. Dynamic quadripolar radiofrequency treatment of vaginal laxity/menopausal vulvo-vaginal atrophy: 12-month efficacy and safety. Minerva Ginecol. 2017;69(4):342–9.
Disclosures
Funding No funding received Clinical Trial Yes Registration Number Clinical Trial, NCT03506594 RCT Yes Subjects Human Ethics Committee Bahiana School's Research and Ethics Committee Helsinki Yes Informed Consent Yes
05/12/2021 22:41:06