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Effect of fractional microablative radiofrequency and pelvic floor muscle training in the treatment of women with of vaginal laxity: randomized clinical trial

Grant number: 19/26723-5
Support Opportunities:Scholarships in Brazil - Doctorate
Effective date (Start): July 01, 2020
Effective date (End): August 23, 2023
Field of knowledge:Health Sciences - Medicine
Principal Investigator:Luiz Gustavo Oliveira Brito
Grantee:Glaucia Miranda Varella Pereira
Host Institution: Faculdade de Ciências Médicas (FCM). Universidade Estadual de Campinas (UNICAMP). Campinas , SP, Brazil
Associated scholarship(s):21/13700-7 - Predictors of vaginal laxity and sexual function in a multiethnic population: a cross-sectional study, BE.EP.DR

Abstract

Vaginal laxity is defined as a complaint of excessive vaginal flaccidity. It presents prevalence of 24% and seems to be associated with young age, vaginal deliveries, prolapse symptoms, and objective prolapse, being, therefore, a somatic dysfunction rather than psychogenic. To date, no clinical trial has been developed to evaluate the role of pelvic floor muscle training and radiofrequency in vaginal looseness. Objectives: To compare the effect of fractional microablative radiofrequency (RF) and pelvic floor muscle training (TMAP) in women complaining of vaginal laxity. Methodology: Clinical, randomized, prospective, controlled, parallel and non-blind study. Premenopausal women aged e 18 years, vaginal delivery, with complaints of vaginal laxity will be included. Participants will be divided into two treatment groups: 1 - radiofrequency and 2 - pelvic floor muscle training, with reevaluation in 90 and 180 days. To characterize the research participants, a descriptive analysis of the data will be made. Inferential statistical analysis will be performed from the following statistical tests: Kolmogorov-Smirnov, Variance Analysis, Wilcoxon and Mann-Whitney Test, Pearson or Spearman Test, Chi-square test and Fisher's exact test. Statistical analyses will be performed by the SPSS (Statistical Package for the Social Sciences), adopting a significance level of 5% (p <0.05). Data will also be evaluated by analysis of variance for repeated measurements (ANOVA). If the numerical variables do not present normal distribution, they will be transformed into ranks or stations. (AU)

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Scientific publications (14)
(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)
DE ALBUQUERQUE COELHO, SUELENE COSTA; PEREIRA, GLAUCIA MIRANDA VARELLA; BRITO, LUIZ GUSTAVO OLIVEIRA; JULIATO, CASSIA RAQUEL TEATIN. Cross sectional study on assessment of ring pessary cleaning and removal every six months: adverse events and complications. INTERNATIONAL UROGYNECOLOGY JOURNAL, . (19/26723-5)
BRITO, LUIZ GUSTAVO OLIVEIRA; PEREIRA, GLAUCIA MIRANDA VARELLA; MOALLI, PAMELA; SHYNLOVA, OKSANA; MANONAI, JITTIMA; WEINTRAUB, ADI YEHUDA; DEPREST, JAN; BORTOLINI, MARIA AUGUSTA T.. Age and/or postmenopausal status as risk factors for pelvic organ prolapse development: systematic review with meta-analysis. INTERNATIONAL UROGYNECOLOGY JOURNAL, v. 33, n. 1, . (19/26723-5)
VARELLA PEREIRA, GLAUCIA MIRANDA; TEATIN JULIATO, CASSIA RAQUEL; MARTINS DE ALMEIDA, CRISTIANE; VALENTE, ISABELLA SALVETTI; DE ANDRADE, KLEBER CURSINO; OLIVEIRA BRITO, LUIZ GUSTAVO. Measurement of the vaginal wall thickness by transabdominal and transvaginal ultrasound of women with vaginal laxity: a cross-sectional study. INTERNATIONAL UROGYNECOLOGY JOURNAL, v. 33, n. 12, p. 10-pg., . (19/26723-5)
FREDERICE, CLAUDIA PIGNATTI; OLIVEIRA BRITO, LUIZ GUSTAVO; VARELLA PEREIRA, GLAUCIA MIRANDA; BARBOSA LUNARDI, ANNA LYGIA; TEATIN JULIATO, CASSIA RAQUEL. Interventional treatment for myofascial pelvic floor pain in women: systematic review with meta-analysis. INTERNATIONAL UROGYNECOLOGY JOURNAL, . (19/26723-5)
VARELLA PEREIRA, GLAUCIA MIRANDA; TEATIN JULIATO, CASSIA RAQUEL; DE ALMEIDA, CRISTIANE MARTINS; DE ANDRADE, KLEBER CURSINO; FANTE, JULIA FERREIRA; MARTINHO, NATALIA; JALES, RODRIGO MENEZES; PINTO E SILVA, MARCELA PONZIO; OLIVEIRA BRITO, LUIZ GUSTAVO. ffect of radiofrequency and pelvic floor muscle training in the treatment of women with vaginal laxity: A study protoco. PLoS One, v. 16, n. 11, . (19/26723-5)
PEREIRA, GLAUCIA MIRANDA VARELLA; PIMENTEL, VERONICA MARIA; SURITA, FERNANDA GARANHANI; SILVA, AMANDA DANTAS; BRITO, LUIZ GUSTAVO OLIVEIRA. Perceived racism or racial discrimination and the risk of adverse obstetric outcomes: a systematic review. São Paulo Medical Journal, v. 140, n. 5, p. 14-pg., . (19/26723-5)
PEREIRA, GLAUCIA MIRANDA VARELLA; DE ARAUJO, CAMILA CARVALHO; JULIATO, CASSIA RAQUEL TEATIN; BRITO, LUIZ GUSTAVO OLIVEIRA. Incarcerated Ring Pessary Repair under Local Anesthesia. JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY, v. 28, n. 6, p. 2-pg., . (19/26723-5)
FREDERICE, CLAUDIA PIGNATTI; OLIVEIRA BRITO, LUIZ GUSTAVO; VARELLA PEREIRA, GLAUCIA MIRANDA; BARBOSA LUNARDI, ANNA LYGIA; TEATIN JULIATO, CASSIA RAQUEL. Interventional treatment for myofascial pelvic floor pain in women: systematic review with meta-analysis. INTERNATIONAL UROGYNECOLOGY JOURNAL, v. 32, n. 5, p. 10-pg., . (19/26723-5)
RAFAEL COELHO DE ALBUQUERQUE; GLÁUCIA MIRANDA VARELLA PEREIRA; ADRIANA GOMES LUZ; MARINA AUGUSTO NÓBREGA; GIULIANE JESUS LAJOS; LUIZ GUSTAVO OLIVEIRA BRITO. Risk factors for mediolateral episiotomy at a tertiary hospital: a cross-sectional study. Revista da Associação Médica Brasileira, v. 68, n. 4, p. 463-469, . (19/26723-5)
VARELLA PEREIRA, GLAUCIA MIRANDA; TEATIN JULIATO, CASSIA RAQUEL; YELA GOMES, DANIELA ANGERAME; BELTRAMINI, TAIS DE SOUZA; DE CASTRO MONTEIRO, MARILENE VALE; OLIVEIRA BRITO, LUIZ GUSTAVO. Cross-cultural adaptation and validation of the Brazilian Portuguese version of the Female Sexual Distress Scale-Revised questionnaire for women with vaginal laxity. INTERNATIONAL UROGYNECOLOGY JOURNAL, v. N/A, p. 8-pg., . (19/26723-5)
DE ALBUQUERQUE COELHO, SUELENE COSTA; PEREIRA, GLAUCIA MIRANDA VARELLA; BRITO, LUIZ GUSTAVO OLIVEIRA; JULIATO, CASSIA RAQUEL TEATIN. Cross sectional study on assessment of ring pessary cleaning and removal every six months: adverse events and complications. INTERNATIONAL UROGYNECOLOGY JOURNAL, v. 33, n. 2, p. 397-403, . (19/26723-5)
D'ALMEIDA LUCAS MACHARET, DEBORA VIANNA; MENDES, LEONARDO NOGUEIRA; SANTOS DE OLIVEIRA, WALTER CARLOS; VARELLA PEREIRA, GLAUCIA MIRANDA; DE CASTRO MONTEIRO, MARILENE VALE. Patient Acceptance of Telemedicine in Urogynecology Consultations - A Cross-Sectional Study Performed at a Brazilian Public Institution. Revista Brasileira de Ginecologia e Obstetrícia, v. 44, n. 08, p. 6-pg., . (19/26723-5)
D'ALMEIDA LUCAS MACHARET, DEBORA VIANNA; MENDES, LEONARDO NOGUEIRA; VARELLA PEREIRA, GLAUCIA MIRANDA; DE CASTRO MONTEIRO, MARILENE VALE. Implementing telemedicine in urogynecology: A feasibility study. INTERNATIONAL UROGYNECOLOGY JOURNAL, v. N/A, p. 7-pg., . (19/26723-5)
FITZ, FATIMA FANI; BORTOLINI, MARIA AUGUSTA TEZELLI; PEREIRA, GLAUCIA MIRANDA VARELLA; SALERNO, GISELA ROSA FRANCO; CASTRO, RODRIGO AQUINO. PEOPLE: Lifestyle and comorbidities as risk factors for pelvic organ prolapse-a systematic review and meta-analysis PEOPLE: PElvic Organ Prolapse Lifestyle comorbiditiEs. INTERNATIONAL UROGYNECOLOGY JOURNAL, v. 34, n. 9, p. 26-pg., . (19/26723-5)

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