Ensaio clínico randomizado com o uso de laser de CO2 fracionado e estrogênio vaginal no tratamento da síndrome genito urinária em mulheres pós menopausa

Detalhes bibliográficos
Autor(a) principal: Dutra, Paula Fernanda Santos Pallone [UNIFESP]
Data de Publicação: 2020
Tipo de documento: Dissertação
Idioma: por
Título da fonte: Repositório Institucional da UNIFESP
Texto Completo: https://sucupira.capes.gov.br/sucupira/public/consultas/coleta/trabalhoConclusao/viewTrabalhoConclusao.jsf?popup=true&id_trabalho=9989771
https://hdl.handle.net/11600/64819
Resumo: Introduction: Genitourinary syndrome (SGU) is a chronic and progressive disease common in postmenopausal women and defines a set of symptoms and signs associated with estrogen deficit in Organs genitourinary organs. It is estimated that SGU affects about 50% of post-menopausal women, negatively impacting quality of life. Among the most common symptoms we can mention vaginal dryness, pain on intercourse, vulvovaginal itching and urinary infections. Topical estrogen therapy is the treatment of choice and the most effective for SGU. However, some women have specific contraindications for hormonal therapy or, even, do not respond to the topical dose used for treatment. In this context, the evaluation of new alternative non- hormonal treatments will allow a peculiar group of women to have access to the treatment of symptoms resulting from vulvovaginal atrophy. Objectives: To compare the effectiveness of using fractional CO2 laser and vaginal topical estriol in genitourinary syndrome. Subjects and Methods: A randomized clinical trial was carried out, involving 25 postmenopausal women, selected, between February 2017 and February 2018. It included women, between 50 and 65 years old, with at least 1 year of amenorrhea and FSH above 40 IU / L, being followed up at the Ambulatory of Pathology of the Lower Genital Tract and Colposcopy - UNIFESP and that met the inclusion criteria of the work. The women were randomly randomized into two groups, with 13 women in the laser group and 12 women in the group that would use vaginal estrogen therapy. Subjective evaluation was performed through physical examination and colposcopy, analysis of the cell maturation index and sexual function before and after the treatments proposed for each group and histomorphometric analysis of the vaginal epithelium. Statistical analysis was performed using: Shapiro-Wilk to verify the assumption of Normality of the numerical information; t-Student for independent samples when comparing groups (estrogen, laser), according to numerical information with Normal distribution; Chi-square or Fisher's exact test when comparing groups (estrogen, laser), according to marital status and education; Mann- Whitney in the comparison of groups (estrogen, laser), according to age at the beginning of menopause and analysis of variance (ANOVA) with repeated measures in the comparison of epithelial thickness, Female Sexual Quotient (QSF), number of deep, intermediate and superficial (FROST) and maturation index between groups (estrogen, laser) and times (initial, final); in addition to multiple Bonferroni 12 comparisons when needed. In all conclusions obtained through inferential analyzes, an alpha significance level of 5% was used and statistical analyzes were performed using the statistical programs IBM-SPSS Statistics version 24 and R version 3.6.3. Results: The evaluation through physical examination showed an important improvement in trophic aspects in both groups. Regarding cell maturation, there was a tendency for the estrogen group to increase when compared to laser. Sexual function, assessed using the Female Sexual Quotient (QSF), showed a significant increase over time, both in the estrogen group (p <0.001) and in the laser group (p <0.001). In histological analysis, both fractional CO2 laser (p <0.001) and estrogen therapy (p = 0.001), showed a significant increase in the thickness of the vaginal epithelium at the end of treatment. Conclusion: CO2 fractional laser can be considered an effective method for the treatment of vulvovaginal atrophy similarity to standard estrogen treatment.
id UFSP_ae22858e4c17ef6ab1b367d173d6fa77
oai_identifier_str oai:repositorio.unifesp.br/:11600/64819
network_acronym_str UFSP
network_name_str Repositório Institucional da UNIFESP
repository_id_str 3465
spelling Ensaio clínico randomizado com o uso de laser de CO2 fracionado e estrogênio vaginal no tratamento da síndrome genito urinária em mulheres pós menopausaCO2 LaserGenitourinary SyndromeVulvovaginal AtrophyDyspareuniaEstriolLaser Fracionado De CO2DispareuniaSíndrome GenitourináriaEstriolIntroduction: Genitourinary syndrome (SGU) is a chronic and progressive disease common in postmenopausal women and defines a set of symptoms and signs associated with estrogen deficit in Organs genitourinary organs. It is estimated that SGU affects about 50% of post-menopausal women, negatively impacting quality of life. Among the most common symptoms we can mention vaginal dryness, pain on intercourse, vulvovaginal itching and urinary infections. Topical estrogen therapy is the treatment of choice and the most effective for SGU. However, some women have specific contraindications for hormonal therapy or, even, do not respond to the topical dose used for treatment. In this context, the evaluation of new alternative non- hormonal treatments will allow a peculiar group of women to have access to the treatment of symptoms resulting from vulvovaginal atrophy. Objectives: To compare the effectiveness of using fractional CO2 laser and vaginal topical estriol in genitourinary syndrome. Subjects and Methods: A randomized clinical trial was carried out, involving 25 postmenopausal women, selected, between February 2017 and February 2018. It included women, between 50 and 65 years old, with at least 1 year of amenorrhea and FSH above 40 IU / L, being followed up at the Ambulatory of Pathology of the Lower Genital Tract and Colposcopy - UNIFESP and that met the inclusion criteria of the work. The women were randomly randomized into two groups, with 13 women in the laser group and 12 women in the group that would use vaginal estrogen therapy. Subjective evaluation was performed through physical examination and colposcopy, analysis of the cell maturation index and sexual function before and after the treatments proposed for each group and histomorphometric analysis of the vaginal epithelium. Statistical analysis was performed using: Shapiro-Wilk to verify the assumption of Normality of the numerical information; t-Student for independent samples when comparing groups (estrogen, laser), according to numerical information with Normal distribution; Chi-square or Fisher's exact test when comparing groups (estrogen, laser), according to marital status and education; Mann- Whitney in the comparison of groups (estrogen, laser), according to age at the beginning of menopause and analysis of variance (ANOVA) with repeated measures in the comparison of epithelial thickness, Female Sexual Quotient (QSF), number of deep, intermediate and superficial (FROST) and maturation index between groups (estrogen, laser) and times (initial, final); in addition to multiple Bonferroni 12 comparisons when needed. In all conclusions obtained through inferential analyzes, an alpha significance level of 5% was used and statistical analyzes were performed using the statistical programs IBM-SPSS Statistics version 24 and R version 3.6.3. Results: The evaluation through physical examination showed an important improvement in trophic aspects in both groups. Regarding cell maturation, there was a tendency for the estrogen group to increase when compared to laser. Sexual function, assessed using the Female Sexual Quotient (QSF), showed a significant increase over time, both in the estrogen group (p <0.001) and in the laser group (p <0.001). In histological analysis, both fractional CO2 laser (p <0.001) and estrogen therapy (p = 0.001), showed a significant increase in the thickness of the vaginal epithelium at the end of treatment. Conclusion: CO2 fractional laser can be considered an effective method for the treatment of vulvovaginal atrophy similarity to standard estrogen treatment.Introdução: A Síndrome genitourinária (SGU) é uma doença crônica e progressiva comum em mulheres na pós menopausa e define um conjunto de sintomas e sinais associados ao déficit de estrogênios nos órgãos genito-urinários. Estima-se que a SGU afeta cerca de 50% das mulheres na pós menopausa, impactando negativamente na qualidade de vida. Entre os sintomas mais comuns podemos citar secura vaginal, dor ao coito, prurido vulvovaginal e infecções urinárias. A estrogenioterapia tópica é o tratamento de escolha e mais eficaz para a SGU. Entretanto, algumas mulheres possuem contraindicações específicas para a terapêutica hormonal ou, ainda, não apresentam resposta a dose tópica utilizada para o tratamento. Neste contexto, a avaliação de novos tratamentos não-hormonais alternativos permitirá que um grupo peculiar de mulheres tenha acesso ao tratamento dos sintomas decorrentes da atrofia vulvovaginal. Objetivos: Comparar a eficácia do uso do laser de CO2 fracionado com o estriol tópico vaginal na síndrome genitourinária. Sujeitos e Métodos: Foi realizado ensaio clínico, randomizado, envolvendo 25 mulheres na pós menopausa, selecionadas, entre Fevereiro de 2017 e Fevereiro de 2018. Incluiu-se mulheres, entre 50 e 65 anos, com pelo menos um ano de amenorreia e FSH acima de 40 UI/L, em seguimento no Ambulatório de Patologia do Trato genital Inferior e Colposcopia – UNIFESP e que atendiam aos critérios de inclusão do trabalho. As mulheres foram randomizadas aleatoriamente em dois grupos, sendo que no grupo laser foram alocadas 13 mulheres e no grupo que usaria estrogenioterapia vaginal foram alocadas 12 mulheres. Foi realizado avaliação subjetiva através do exame físico e colposcopia, análise do índice maturação celular e da função sexual antes e após os tratamentos propostos para cada grupo e análise histomorfométrica do epitélio vaginal. A análise estatística foi realizada usando-se :Shapiro-Wilk na verificação da suposição de Normalidade das informações numéricas; t-Student para amostras independentes na comparação dos grupos (estrógeno, laser), segundo as informações numéricas com distribuição Normal; Qui-Quadrado ou Exato de Fisher na comparação dos grupos (estrógeno, laser), segundo estado civil e escolaridade; Mann-Whitney na comparação dos grupos (estrógeno, laser), segundo idade no início da menopausa e análise de variância (ANOVA) com medidas repetidas na comparação da espessura do epitélio, Quociente Sexual Feminino (QSF), quantidade de células profundas, intermediárias 10 e superficiais (FROST) e índice de maturação entre grupos (estrógeno, laser) e tempos (inicial, final); além da comparações múltiplas de Bonferroni quando necessária. Em todas as conclusões obtidas através das análises inferenciais foi utilizado o nível de significância alfa igual a 5% e as análises estatísticas foram realizadas com os programas estatísticos IBM-SPSS Statistics versão 24 e R versão 3.6.3. Resultados: A avaliação por meio do exame físico, demonstrou importante melhora dos aspectos tróficos em ambos os grupos. Em relação a maturação celular, houve uma tendência do grupo estrógeno apresentar aumento desta quando comparado ao laser. A função sexual, avaliada através do Quociente Sexual Feminino (QSF), apresentou aumento significativo com o tempo, tanto no grupo estrógeno (p<0,001), quanto no grupo laser (p<0,001). Na análise histológica tanto o laser fracionado de CO2 (p<0,001) como a estrogenioterapia (p=0,001), apresentaram aumento significativo da espessura do epitélio vaginal ao fim do tratamento. Conclusão: O laser fracionado de CO2 pode ser considerado um método eficaz para o tratamento da atrofia vulvovaginal, semelhante ao tratamento padrão com estrogênio.Dados abertos - Sucupira - Teses e dissertações (2020)Universidade Federal de São Paulo (UNIFESP)Speck, Neila Maria De Gois [UNIFESP]Universidade Federal de São PauloDutra, Paula Fernanda Santos Pallone [UNIFESP]2022-07-22T17:29:06Z2022-07-22T17:29:06Z2020-08-27info:eu-repo/semantics/masterThesisinfo:eu-repo/semantics/publishedVersion60 p.application/pdfhttps://sucupira.capes.gov.br/sucupira/public/consultas/coleta/trabalhoConclusao/viewTrabalhoConclusao.jsf?popup=true&id_trabalho=9989771PAULA FERNANDA SANTOS PALLONE DUTRA.pdfhttps://hdl.handle.net/11600/64819porinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UNIFESPinstname:Universidade Federal de São Paulo (UNIFESP)instacron:UNIFESP2024-07-27T03:48:22Zoai:repositorio.unifesp.br/:11600/64819Repositório InstitucionalPUBhttp://www.repositorio.unifesp.br/oai/requestbiblioteca.csp@unifesp.bropendoar:34652024-07-27T03:48:22Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP)false
dc.title.none.fl_str_mv Ensaio clínico randomizado com o uso de laser de CO2 fracionado e estrogênio vaginal no tratamento da síndrome genito urinária em mulheres pós menopausa
title Ensaio clínico randomizado com o uso de laser de CO2 fracionado e estrogênio vaginal no tratamento da síndrome genito urinária em mulheres pós menopausa
spellingShingle Ensaio clínico randomizado com o uso de laser de CO2 fracionado e estrogênio vaginal no tratamento da síndrome genito urinária em mulheres pós menopausa
Dutra, Paula Fernanda Santos Pallone [UNIFESP]
CO2 Laser
Genitourinary Syndrome
Vulvovaginal Atrophy
Dyspareunia
Estriol
Laser Fracionado De CO2
Dispareunia
Síndrome Genitourinária
Estriol
title_short Ensaio clínico randomizado com o uso de laser de CO2 fracionado e estrogênio vaginal no tratamento da síndrome genito urinária em mulheres pós menopausa
title_full Ensaio clínico randomizado com o uso de laser de CO2 fracionado e estrogênio vaginal no tratamento da síndrome genito urinária em mulheres pós menopausa
title_fullStr Ensaio clínico randomizado com o uso de laser de CO2 fracionado e estrogênio vaginal no tratamento da síndrome genito urinária em mulheres pós menopausa
title_full_unstemmed Ensaio clínico randomizado com o uso de laser de CO2 fracionado e estrogênio vaginal no tratamento da síndrome genito urinária em mulheres pós menopausa
title_sort Ensaio clínico randomizado com o uso de laser de CO2 fracionado e estrogênio vaginal no tratamento da síndrome genito urinária em mulheres pós menopausa
author Dutra, Paula Fernanda Santos Pallone [UNIFESP]
author_facet Dutra, Paula Fernanda Santos Pallone [UNIFESP]
author_role author
dc.contributor.none.fl_str_mv Speck, Neila Maria De Gois [UNIFESP]
Universidade Federal de São Paulo
dc.contributor.author.fl_str_mv Dutra, Paula Fernanda Santos Pallone [UNIFESP]
dc.subject.por.fl_str_mv CO2 Laser
Genitourinary Syndrome
Vulvovaginal Atrophy
Dyspareunia
Estriol
Laser Fracionado De CO2
Dispareunia
Síndrome Genitourinária
Estriol
topic CO2 Laser
Genitourinary Syndrome
Vulvovaginal Atrophy
Dyspareunia
Estriol
Laser Fracionado De CO2
Dispareunia
Síndrome Genitourinária
Estriol
description Introduction: Genitourinary syndrome (SGU) is a chronic and progressive disease common in postmenopausal women and defines a set of symptoms and signs associated with estrogen deficit in Organs genitourinary organs. It is estimated that SGU affects about 50% of post-menopausal women, negatively impacting quality of life. Among the most common symptoms we can mention vaginal dryness, pain on intercourse, vulvovaginal itching and urinary infections. Topical estrogen therapy is the treatment of choice and the most effective for SGU. However, some women have specific contraindications for hormonal therapy or, even, do not respond to the topical dose used for treatment. In this context, the evaluation of new alternative non- hormonal treatments will allow a peculiar group of women to have access to the treatment of symptoms resulting from vulvovaginal atrophy. Objectives: To compare the effectiveness of using fractional CO2 laser and vaginal topical estriol in genitourinary syndrome. Subjects and Methods: A randomized clinical trial was carried out, involving 25 postmenopausal women, selected, between February 2017 and February 2018. It included women, between 50 and 65 years old, with at least 1 year of amenorrhea and FSH above 40 IU / L, being followed up at the Ambulatory of Pathology of the Lower Genital Tract and Colposcopy - UNIFESP and that met the inclusion criteria of the work. The women were randomly randomized into two groups, with 13 women in the laser group and 12 women in the group that would use vaginal estrogen therapy. Subjective evaluation was performed through physical examination and colposcopy, analysis of the cell maturation index and sexual function before and after the treatments proposed for each group and histomorphometric analysis of the vaginal epithelium. Statistical analysis was performed using: Shapiro-Wilk to verify the assumption of Normality of the numerical information; t-Student for independent samples when comparing groups (estrogen, laser), according to numerical information with Normal distribution; Chi-square or Fisher's exact test when comparing groups (estrogen, laser), according to marital status and education; Mann- Whitney in the comparison of groups (estrogen, laser), according to age at the beginning of menopause and analysis of variance (ANOVA) with repeated measures in the comparison of epithelial thickness, Female Sexual Quotient (QSF), number of deep, intermediate and superficial (FROST) and maturation index between groups (estrogen, laser) and times (initial, final); in addition to multiple Bonferroni 12 comparisons when needed. In all conclusions obtained through inferential analyzes, an alpha significance level of 5% was used and statistical analyzes were performed using the statistical programs IBM-SPSS Statistics version 24 and R version 3.6.3. Results: The evaluation through physical examination showed an important improvement in trophic aspects in both groups. Regarding cell maturation, there was a tendency for the estrogen group to increase when compared to laser. Sexual function, assessed using the Female Sexual Quotient (QSF), showed a significant increase over time, both in the estrogen group (p <0.001) and in the laser group (p <0.001). In histological analysis, both fractional CO2 laser (p <0.001) and estrogen therapy (p = 0.001), showed a significant increase in the thickness of the vaginal epithelium at the end of treatment. Conclusion: CO2 fractional laser can be considered an effective method for the treatment of vulvovaginal atrophy similarity to standard estrogen treatment.
publishDate 2020
dc.date.none.fl_str_mv 2020-08-27
2022-07-22T17:29:06Z
2022-07-22T17:29:06Z
dc.type.driver.fl_str_mv info:eu-repo/semantics/masterThesis
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
format masterThesis
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://sucupira.capes.gov.br/sucupira/public/consultas/coleta/trabalhoConclusao/viewTrabalhoConclusao.jsf?popup=true&id_trabalho=9989771
PAULA FERNANDA SANTOS PALLONE DUTRA.pdf
https://hdl.handle.net/11600/64819
url https://sucupira.capes.gov.br/sucupira/public/consultas/coleta/trabalhoConclusao/viewTrabalhoConclusao.jsf?popup=true&id_trabalho=9989771
https://hdl.handle.net/11600/64819
identifier_str_mv PAULA FERNANDA SANTOS PALLONE DUTRA.pdf
dc.language.iso.fl_str_mv por
language por
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 60 p.
application/pdf
dc.publisher.none.fl_str_mv Universidade Federal de São Paulo (UNIFESP)
publisher.none.fl_str_mv Universidade Federal de São Paulo (UNIFESP)
dc.source.none.fl_str_mv reponame:Repositório Institucional da UNIFESP
instname:Universidade Federal de São Paulo (UNIFESP)
instacron:UNIFESP
instname_str Universidade Federal de São Paulo (UNIFESP)
instacron_str UNIFESP
institution UNIFESP
reponame_str Repositório Institucional da UNIFESP
collection Repositório Institucional da UNIFESP
repository.name.fl_str_mv Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP)
repository.mail.fl_str_mv biblioteca.csp@unifesp.br
_version_ 1814268457036808192