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Effect of radiofrequency and pelvic floor muscle training in the treatment of women with vaginal laxity: A study protocol
Vaginal laxity is an underreported condition that negatively affects women's sexual function and their relationships. Evidence-based studies are needed to better understand this complaint and to discuss its treatment options. Thus, we present a study protocol to compare the effect of radiofrequ...
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Published in: | PloS one 2021-11, Vol.16 (11), p.e0259650 |
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creator | Pereira, Gláucia Miranda Varella Juliato, Cássia Raquel Teatin de Almeida, Cristiane Martins de Andrade, Kleber Cursino Fante, Júlia Ferreira Martinho, Natália Jales, Rodrigo Menezes Pinto E Silva, Marcela Ponzio Brito, Luiz Gustavo Oliveira |
description | Vaginal laxity is an underreported condition that negatively affects women's sexual function and their relationships. Evidence-based studies are needed to better understand this complaint and to discuss its treatment options. Thus, we present a study protocol to compare the effect of radiofrequency and pelvic floor muscle training in the treatment of women with complaints of vaginal laxity.
This is a prospective, parallel-group, two-arm, randomized clinical trial (Registry: RBR-2zdvfp-REBEC). Participants will be randomly assigned to one of the two groups of intervention (Radiofrequency or Pelvic Floor Muscle Training). The study will be performed in the Urogynecology outpatient clinic and in the physiotherapy outpatient clinic at the State University of Campinas-UNICAMP and will include women aged ≥ 18 years and with self-reported complaints of vaginal laxity. Participants will be assessed at baseline (pre-intervention period) and will be followed up in two periods: first follow-up (30 days after intervention) and second follow-up (six months after intervention).
The results of this randomized clinical trial will have a positive impact on the participants' quality of life, as well as add value to the development of treatment options for women with complaints of vaginal laxity.
Registry: RBR-2zdvfp-Registro Brasileiro de Ensaios Clínicos-REBEC (19/02/2020). |
doi_str_mv | 10.1371/journal.pone.0259650 |
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This is a prospective, parallel-group, two-arm, randomized clinical trial (Registry: RBR-2zdvfp-REBEC). Participants will be randomly assigned to one of the two groups of intervention (Radiofrequency or Pelvic Floor Muscle Training). The study will be performed in the Urogynecology outpatient clinic and in the physiotherapy outpatient clinic at the State University of Campinas-UNICAMP and will include women aged ≥ 18 years and with self-reported complaints of vaginal laxity. Participants will be assessed at baseline (pre-intervention period) and will be followed up in two periods: first follow-up (30 days after intervention) and second follow-up (six months after intervention).
The results of this randomized clinical trial will have a positive impact on the participants' quality of life, as well as add value to the development of treatment options for women with complaints of vaginal laxity.
Registry: RBR-2zdvfp-Registro Brasileiro de Ensaios Clínicos-REBEC (19/02/2020).</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0259650</identifier><identifier>PMID: 34752494</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Adult ; Biology and Life Sciences ; Care and treatment ; Childbirth & labor ; Clinical trials ; Demographic aspects ; Diagnosis ; Exercise Therapy - methods ; Female ; Gynecology ; Health aspects ; Hospitals ; Humans ; Intervention ; Medicine and Health Sciences ; Middle Aged ; Muscle function ; Muscles ; Obstetrics ; Pathophysiology ; Pelvic Floor - physiopathology ; Pelvis ; Physical therapy ; Postpartum period ; Pregnancy ; Prospective Studies ; Quality of Life ; Questionnaires ; Radio frequency ; Radiofrequency Therapy - methods ; Research and Analysis Methods ; Sexual disorders ; Sexual intercourse ; Study Protocol ; Training ; Trauma ; Treatment Outcome ; Vagina ; Vagina - physiopathology ; Women ; Womens health</subject><ispartof>PloS one, 2021-11, Vol.16 (11), p.e0259650</ispartof><rights>COPYRIGHT 2021 Public Library of Science</rights><rights>2021 Pereira et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2021 Pereira et al 2021 Pereira et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-7118421257f7a13a2650d2c6da5358cf812cf3def6fc83707325a03c7af15cc23</citedby><cites>FETCH-LOGICAL-c692t-7118421257f7a13a2650d2c6da5358cf812cf3def6fc83707325a03c7af15cc23</cites><orcidid>0000-0002-7364-4718</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/2595527257/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/2595527257?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,25753,27924,27925,37012,37013,44590,53791,53793,75126</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34752494$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Blasco, Jose María</contributor><creatorcontrib>Pereira, Gláucia Miranda Varella</creatorcontrib><creatorcontrib>Juliato, Cássia Raquel Teatin</creatorcontrib><creatorcontrib>de Almeida, Cristiane Martins</creatorcontrib><creatorcontrib>de Andrade, Kleber Cursino</creatorcontrib><creatorcontrib>Fante, Júlia Ferreira</creatorcontrib><creatorcontrib>Martinho, Natália</creatorcontrib><creatorcontrib>Jales, Rodrigo Menezes</creatorcontrib><creatorcontrib>Pinto E Silva, Marcela Ponzio</creatorcontrib><creatorcontrib>Brito, Luiz Gustavo Oliveira</creatorcontrib><title>Effect of radiofrequency and pelvic floor muscle training in the treatment of women with vaginal laxity: A study protocol</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>Vaginal laxity is an underreported condition that negatively affects women's sexual function and their relationships. Evidence-based studies are needed to better understand this complaint and to discuss its treatment options. Thus, we present a study protocol to compare the effect of radiofrequency and pelvic floor muscle training in the treatment of women with complaints of vaginal laxity.
This is a prospective, parallel-group, two-arm, randomized clinical trial (Registry: RBR-2zdvfp-REBEC). Participants will be randomly assigned to one of the two groups of intervention (Radiofrequency or Pelvic Floor Muscle Training). The study will be performed in the Urogynecology outpatient clinic and in the physiotherapy outpatient clinic at the State University of Campinas-UNICAMP and will include women aged ≥ 18 years and with self-reported complaints of vaginal laxity. Participants will be assessed at baseline (pre-intervention period) and will be followed up in two periods: first follow-up (30 days after intervention) and second follow-up (six months after intervention).
The results of this randomized clinical trial will have a positive impact on the participants' quality of life, as well as add value to the development of treatment options for women with complaints of vaginal laxity.
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Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Pereira, Gláucia Miranda Varella</au><au>Juliato, Cássia Raquel Teatin</au><au>de Almeida, Cristiane Martins</au><au>de Andrade, Kleber Cursino</au><au>Fante, Júlia Ferreira</au><au>Martinho, Natália</au><au>Jales, Rodrigo Menezes</au><au>Pinto E Silva, Marcela Ponzio</au><au>Brito, Luiz Gustavo Oliveira</au><au>Blasco, Jose María</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of radiofrequency and pelvic floor muscle training in the treatment of women with vaginal laxity: A study protocol</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2021-11-09</date><risdate>2021</risdate><volume>16</volume><issue>11</issue><spage>e0259650</spage><pages>e0259650-</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Vaginal laxity is an underreported condition that negatively affects women's sexual function and their relationships. Evidence-based studies are needed to better understand this complaint and to discuss its treatment options. Thus, we present a study protocol to compare the effect of radiofrequency and pelvic floor muscle training in the treatment of women with complaints of vaginal laxity.
This is a prospective, parallel-group, two-arm, randomized clinical trial (Registry: RBR-2zdvfp-REBEC). Participants will be randomly assigned to one of the two groups of intervention (Radiofrequency or Pelvic Floor Muscle Training). The study will be performed in the Urogynecology outpatient clinic and in the physiotherapy outpatient clinic at the State University of Campinas-UNICAMP and will include women aged ≥ 18 years and with self-reported complaints of vaginal laxity. Participants will be assessed at baseline (pre-intervention period) and will be followed up in two periods: first follow-up (30 days after intervention) and second follow-up (six months after intervention).
The results of this randomized clinical trial will have a positive impact on the participants' quality of life, as well as add value to the development of treatment options for women with complaints of vaginal laxity.
Registry: RBR-2zdvfp-Registro Brasileiro de Ensaios Clínicos-REBEC (19/02/2020).</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>34752494</pmid><doi>10.1371/journal.pone.0259650</doi><tpages>e0259650</tpages><orcidid>https://orcid.org/0000-0002-7364-4718</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | Adult Biology and Life Sciences Care and treatment Childbirth & labor Clinical trials Demographic aspects Diagnosis Exercise Therapy - methods Female Gynecology Health aspects Hospitals Humans Intervention Medicine and Health Sciences Middle Aged Muscle function Muscles Obstetrics Pathophysiology Pelvic Floor - physiopathology Pelvis Physical therapy Postpartum period Pregnancy Prospective Studies Quality of Life Questionnaires Radio frequency Radiofrequency Therapy - methods Research and Analysis Methods Sexual disorders Sexual intercourse Study Protocol Training Trauma Treatment Outcome Vagina Vagina - physiopathology Women Womens health |
title | Effect of radiofrequency and pelvic floor muscle training in the treatment of women with vaginal laxity: A study protocol |
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