SEXUAL FUNCTION OF WOMEN WITH GENITOURINARY SYNDROME OF MENOPAUSE UNDERGOING NON-ABLATIVE RADIOFREQUENCY: A RANDOMIZED SINGLE-BLIND CLINICAL TRIAL

Ferreira M1, Mamede T1, Brasil C2, Oliveira C3, Godoy P4, Pavie M5, Ramos A1, Mamede C6, Amaral L1, Alencar A7, Santos J7, Rocha F5, Rocha K4, Sodré D8, Lemos A2, Cerqueira M2, Teles A8, Lordelo C7, Alencar T1, Vilas Boas A1, Lordelo P1

Research Type

Clinical

Abstract Category

Conservative Management

Abstract 20
Interventional Studies
Scientific Podium Short Oral Session 2
Wednesday 23rd October 2024
09:22 - 09:30
Hall N105
Conservative Treatment Physiotherapy Clinical Trial Sexual Dysfunction Female
1. Escola Bahiana de Medicina e Saúde Pública - EBMSP; Instituto Patricia Lordelo – IPL, 2. Escola Bahiana de Medicina e Saúde Pública - EBMSP; União Metropolitana de Educação e Cultura - UNIME; Instituto Patricia Lordelo – IPL, 3. Escola Bahiana de Medicina e Saúde Pública - EBMSP; Universidade do Estado da Bahia - UNEB; Instituto Patricia Lordelo - IPL, 4. Universidade do Estado da Bahia - UNEB; Instituto Patricia Lordelo – IPL, 5. Universidade Salvador - UNIFACS; Instituto Patricia Lordelo – IPL, 6. Escola Bahiana de Medicina e Saúde Pública - EBMSP; Universidade do Estado da Bahia - UNEB; Instituto Patricia Lordelo – IPL, 7. Universidade Federal da Bahia - UFBA; Instituto Patricia Lordelo – IPL, 8. Instituto Patricia Lordelo – IPL
Presenter
Links

Abstract

Hypothesis / aims of study
Genitourinary Syndrome of Menopause (GSM) is defined as a set of signs and symptoms resulting from estrogen deficiency, having a direct impact on women's health. GSM symptomatology includes: vaginal dryness, vaginal discharge, itching, pain and/or discomfort during sexual intercourse, vaginal bleeding associated with sexual intercourse and/or unusual discharge, and urinary symptoms such as increased urinary frequency, dysuria, urinary incontinence, and recurrent urinary infections [1]. Hormonal therapy and non-hormonal therapy are commonly used for treating GSM. It is important to note that hormonal therapy has some contraindications, such as breast cancer, endometrial cancer and deep vein thrombosis [2]. For women who cannot or do not want to undergo hormonal therapy, treatment with Non-Ablative Radiofrequency (NARF) is an alternative. NARF acts by generating tissue heating, which promotes an inflammatory cascade, resulting in neocollagenesis and elastogenesis, providing micro-remodeling[1]. This study aims to evaluate sexual function in women with Genitourinary Syndrome of Menopause undergoing Non-Ablative Radiofrequency treatment.
Study design, materials and methods
This is a randomized single-blinded clinical trial. Were included 60 women up to 65 years of age with established menopause (at least 12 months since the last menstrual period or a bilateral oophorectomy) who presented one or more of the clinical signs and symptoms of GSM, and with vaginal pH ≥ 5 and predominance of basal epithelial cells cytology. Were excluded: women in use of pacemaker, hormone replacement therapy up to six months prior to the study, pregnant women, hemophiliacs, patients using vasodilators and/or anticoagulants, women with cognitive impairment or psychiatric illness, chronic degenerative neurological diseases, with metal prosthesis in the pelvic region, with diagnosis of vaginal infections, and those who didn’t sign the Free and Informed Consent Form (FICF). Once accepting informed consent, the participants were asked to complete self-administered questionnaires: Sociocultural Questionnaire (Table 1), Female Sexual Function Index (FSFI), Sexual Quotient – ​​Female Version (SQ-F), Female Genital Self- Image Scale-7 (FGSIS-7), and Visual Analogic Scale (VAS). A secretary, who is not part of the study, carried out the randomization using a random table generated on the website www.random.org and ensured that the allocation concealment of participants into two groups: Intervention Group (IG) and Kinesiotherapy Group (KG). In the IG, non-ablative radiofrequency (RF) with a Capenergy brand device, model C500 (Barcelona, Spain), was used keeping the temperature in 40°C. When the temperature was reached, the active electrode was maintained for 2 minutes on the anterior vaginal wall and 2 minutes on the posterior vaginal wall, totalizing 4 minutes. Immediately after the application of NARF, the physiotherapist performed a pelvic floor muscle training with the patient. The participants were then instructed to perform the same exercises at home, twice a day. For the KG the treatment protocol was the same, however, in this group, the NARF was turned off and warmed gel was applied. The treatment consisted of five NARF sessions, once a week. The entire evaluation protocol was applied before and immediately after the five treatment sessions, being carried out by the same initial evaluators. To create the database, descriptive and analytical analysis, the Statistical Package for Social Sciences (SPSS) software, version 22.0 for MAC, was used. Paired Student's t was used for paired analyses. The independent Student's t test was used to compare independent data. The significance level adopted was 5%. The sample calculation was performed using the WINPEPI calculator. The data to evaluate the clinical efficacy of radiofrequency in the treatment of vulvovaginal atrophy were extracted from the study by Yaralizadeh[3].
Results
Sixty patients were treated, with 30 in each group. The intergroup analysis indicates no significant difference between the IG and KG groups in all variables studied (table 2). However, intragroup analysis shows a significant difference in IG FSFI (p<0.01), SQ-F (p<0.01), and in vaginal dryness and pain during sexual intercourse assessed by VAS (p<0.01). The KG also indicated a statistical difference in SQ-F (p=0.032), in vaginal dryness by VAS (p<0.01) and pain during sexual activity also by VAS (p=0.015).
Interpretation of results
Although NARF did not demonstrate statistical superiority in relation to the kinesiotherapy group, this study shows the importance of a well-performed approach by health professionals in a group of women who, due to age-related hormonal changes, are susceptible to presenting sexual dysfunctions. NARF, in addition to showing already known aesthetic benefits, seems to be promising as sexual dysfunction improvement therapy due to tissue rejuvenation, which favors better nutrition, increasing sensitivity and pelvic floor awareness. The heat caused by diathermic resources such as NARF also influences muscle tone, resulting in reduced muscle tension, and facilitating vaginal penetration. The benefits of NARF become even more interesting because it gives the women the opportunity to have the benefits in the perineal tissue without undergoing hormone replacement therapy, which can cause unwanted responses. It is important to notice that these potential benefits were acquired within only five weekly applications. It is believed that more applications can expand the effects of NARF.
Concluding message
NARF showed no improvement in the analyzed variables when compared to the KG. However, some data suggest that NARF treatment seems to be promising as a therapeutic option to improve sexual function in women with GSM.
Figure 1 Table 1: Research Groups Sociodemographic data
Figure 2 Table 2: Intra and intergroup comparisons of the Female Sexual Function Index (FSFI), the Visual Analogue Scale (VAS), the Sexual Quotient – female version (SQ-F), and Female Genital Self-Image Scale (FGSIS-7) at baseline and one week after 5 sessi
References
  1. Stachowicz AM, Hoover ML, Karram MM. Utilidade clínica da energia de radiofrequência para disfunção geniturinária feminina: passado, presente e futuro. Int Urogynecol J. 2021;32:1345–1350.
  2. Sarmento ACA, Costa AP, Lírio J, Eleutério J, Jr Baptista P V, Gonçalves AK. Efficacy of Hormonal and Nonhormonal Approaches to Vaginal Atrophy and Sexual Dysfunctions in Postmenopausal Women: A Systematic Review. Rev Bras Ginecol Obstet. 2022;44(10), 986–994.
  3. Yaralizadeh M, Abedi P, Najar S, Namjoyan F, Saki A. Effect of Foeniculum vulgare (fennel) vaginal cream on vaginal atrophyin postmenopausal women: A double-blind Randomized placebo-controlled trial. Maturitas. 2016;84:75-80.
Disclosures
Funding National Council for Scientific and Technological Development - CNPq Clinical Trial Yes Registration Number NCT03506594 RCT Yes Subjects Human Ethics Committee Escola Bahiana de Medicina e Saúde Publica - FBDC Helsinki Yes Informed Consent Yes
Citation

Continence 12S (2024) 101362
DOI: 10.1016/j.cont.2024.101362

11/12/2024 16:14:40