Effect of radiofrequency and pelvic floor muscle training in the treatment of women with vaginal laxity: A study protocol.

Autor: Pereira GMV; Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, Campinas, Brazil., Juliato CRT; Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, Campinas, Brazil., de Almeida CM; Centro de Atenção Integral à Saúde da Mulher (CAISM)-Hospital da Mulher Professor Dr. José Aristodemo Pinotti-UNICAMP, Campinas, Brazil., de Andrade KC; Centro de Atenção Integral à Saúde da Mulher (CAISM)-Hospital da Mulher Professor Dr. José Aristodemo Pinotti-UNICAMP, Campinas, Brazil., Fante JF; Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, Campinas, Brazil., Martinho N; Centro Universitário das Faculdades Associadas de Ensino-UNIFAE, São João da Boa Vista, Brazil.; Centro Regional Universitário de Espírito Santo do Pinhal-UNIPINHAL, Santo do Pinhal, Brazil., Jales RM; Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, Campinas, Brazil., Pinto E Silva MP; Centro de Atenção Integral à Saúde da Mulher (CAISM)-Hospital da Mulher Professor Dr. José Aristodemo Pinotti-UNICAMP, Campinas, Brazil., Brito LGO; Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, Campinas, Brazil.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2021 Nov 09; Vol. 16 (11), pp. e0259650. Date of Electronic Publication: 2021 Nov 09 (Print Publication: 2021).
DOI: 10.1371/journal.pone.0259650
Abstrakt: Background: 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.
Methods/design: 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).
Expected Results: 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.
Trial Registration: Registry: RBR-2zdvfp-Registro Brasileiro de Ensaios Clínicos-REBEC (19/02/2020).
Competing Interests: The authors declare no competing Interests.
Databáze: MEDLINE
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