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Microablative fractional radiofrequency for the genitourinary syndrome of menopause: protocol of randomised controlled trial.
BMJ Open. 2021 07 05; 11(7):e046372.BO

Abstract

INTRODUCTION

Menopause is a physiological and progressive phenomenon secondary to decreased ovarian follicular reserve. These changes have consequences: vaginal dryness, dyspareunia, discomfort, burning and irritation, vulvovaginal pruritus, dysuria and increased frequency of genitourinary infections. The therapy more suitable for vaginal symptoms in postmenopause yet is the use of a topical hormone. However, the prescription of topical oestrogens should also be avoided in women with a history of breast cancer, oestrogen-sensitive tumours and thromboembolism, emphasising the necessity of alternative treatments. Recently, physical methods, such as laser and radiofrequency (RF), in their non-ablative, ablative and microablative forms have been used in the vaginal mucosa to promote neocolagenesis and neoelastogenesis. This randomised study aims to compare the efficiency of microablative fractional RF (MAFRF) treatment with vaginal oestrogens and no treatment.

METHODS AND ANALYSES

This randomised, controlled clinical intervention trial with an open label design comparing the treatment of MAFRF with vaginal oestrogens and no treatment. Four important moments were considered to evaluate treatment results (T0, T1, T2 and T3). The primary outcome includes vulvovaginal atrophy (vaginal pain, burning, itching, dryness, dyspareunia and dysuria), and the secondary outcomes will be sexual function, vaginal health (epithelial integrity, vaginal elasticity, moisture, fluid volume and vaginal pH) and quality of life.

ETHICS AND DISSEMINATION

Due to the nature of the study, we obtained approval from the ethics committee. All participants must sign an informed consent form before randomisation. The results of this study will be published in peer-reviewed journals. The data collected will also be available in a public repository of data.

TRIAL REGISTRATION NUMBER

RBR-94DX93.

Authors+Show Affiliations

Health Sciences Postgraduate Program, Federal University of Rio Grande do Norte, Natal, Brazil.Department of Clinical Analysis and Toxicology, Federal University of Rio Grande do Norte, Natal, Brazil.Health Sciences Postgraduate Program, Federal University of Rio Grande do Norte, Natal, Brazil.Health Sciences Postgraduate Program, Federal University of Rio Grande do Norte, Natal, Brazil.Department of Clinical Analysis and Toxicology, Federal University of Rio Grande do Norte, Natal, Brazil.Health Sciences Postgraduate Program, Federal University of Rio Grande do Norte, Natal, Brazil anakatherine_ufrnet@yahoo.com.br. Department of Obstetrics and Gynaecology, Federal University of Rio Grande do Norte, Natal, Brazil.

Pub Type(s)

Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

34226218

Citation

Sarmento, Ayane Cristine Alves, et al. "Microablative Fractional Radiofrequency for the Genitourinary Syndrome of Menopause: Protocol of Randomised Controlled Trial." BMJ Open, vol. 11, no. 7, 2021, pp. e046372.
Sarmento ACA, Fernandes FS, Costa APF, et al. Microablative fractional radiofrequency for the genitourinary syndrome of menopause: protocol of randomised controlled trial. BMJ Open. 2021;11(7):e046372.
Sarmento, A. C. A., Fernandes, F. S., Costa, A. P. F., Medeiros, K. S., Crispim, J. C., & Gonçalves, A. K. (2021). Microablative fractional radiofrequency for the genitourinary syndrome of menopause: protocol of randomised controlled trial. BMJ Open, 11(7), e046372. https://doi.org/10.1136/bmjopen-2020-046372
Sarmento ACA, et al. Microablative Fractional Radiofrequency for the Genitourinary Syndrome of Menopause: Protocol of Randomised Controlled Trial. BMJ Open. 2021 07 5;11(7):e046372. PubMed PMID: 34226218.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Microablative fractional radiofrequency for the genitourinary syndrome of menopause: protocol of randomised controlled trial. AU - Sarmento,Ayane Cristine Alves, AU - Fernandes,Fabíola S, AU - Costa,Ana Paula Ferreira, AU - Medeiros,Kleyton Santos, AU - Crispim,Janaina Cristina, AU - Gonçalves,Ana Katherine, Y1 - 2021/07/05/ PY - 2021/7/6/entrez PY - 2021/7/7/pubmed PY - 2021/8/5/medline KW - gynaecology KW - sexual dysfunction KW - sexual medicine SP - e046372 EP - e046372 JF - BMJ open JO - BMJ Open VL - 11 IS - 7 N2 - INTRODUCTION: Menopause is a physiological and progressive phenomenon secondary to decreased ovarian follicular reserve. These changes have consequences: vaginal dryness, dyspareunia, discomfort, burning and irritation, vulvovaginal pruritus, dysuria and increased frequency of genitourinary infections. The therapy more suitable for vaginal symptoms in postmenopause yet is the use of a topical hormone. However, the prescription of topical oestrogens should also be avoided in women with a history of breast cancer, oestrogen-sensitive tumours and thromboembolism, emphasising the necessity of alternative treatments. Recently, physical methods, such as laser and radiofrequency (RF), in their non-ablative, ablative and microablative forms have been used in the vaginal mucosa to promote neocolagenesis and neoelastogenesis. This randomised study aims to compare the efficiency of microablative fractional RF (MAFRF) treatment with vaginal oestrogens and no treatment. METHODS AND ANALYSES: This randomised, controlled clinical intervention trial with an open label design comparing the treatment of MAFRF with vaginal oestrogens and no treatment. Four important moments were considered to evaluate treatment results (T0, T1, T2 and T3). The primary outcome includes vulvovaginal atrophy (vaginal pain, burning, itching, dryness, dyspareunia and dysuria), and the secondary outcomes will be sexual function, vaginal health (epithelial integrity, vaginal elasticity, moisture, fluid volume and vaginal pH) and quality of life. ETHICS AND DISSEMINATION: Due to the nature of the study, we obtained approval from the ethics committee. All participants must sign an informed consent form before randomisation. The results of this study will be published in peer-reviewed journals. The data collected will also be available in a public repository of data. TRIAL REGISTRATION NUMBER: RBR-94DX93. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/34226218/Microablative_fractional_radiofrequency_for_the_genitourinary_syndrome_of_menopause:_protocol_of_randomised_controlled_trial_ L2 - https://bmjopen.bmj.com/lookup/pmidlookup?view=long&pmid=34226218 DB - PRIME DP - Unbound Medicine ER -