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RESEARCH PRODUCT

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

Cássia Raquel Teatin JuliatoLuiz Gustavo Oliveira BritoGlaucia Miranda Varella PereiraRodrigo Menezes JalesNatalia MartinhoCristiane Martins De AlmeidaKleber Cursino De AndradeJúlia Ferreira FanteMarcela Ponzio Pinto E Silva

subject

Muscle PhysiologyMuscle FunctionsPhysiologyRadio WavesMaternal HealthAmbulatory Care Facilitieslaw.inventionUrogynecologyStudy ProtocolLabor and DeliveryRandomized controlled trialQuality of lifelawMedicine and Health SciencesOutpatient clinicRegistriesMultidisciplinaryQRObstetrics and Gynecologymedicine.anatomical_structureVaginaMedicineMuscle Contractionmedicine.medical_specialtyDrug Research and DevelopmentUrologyScienceSurgical and Invasive Medical ProceduresResearch and Analysis MethodsPelvic Floor MuscleIntervention (counseling)medicineClinical TrialsOutpatient ClinicsPharmacologyIncontinencebusiness.industryBiology and Life SciencesPelvic FloorRandomized Controlled TrialsHealth CareHealth Care FacilitiesPhysical therapyQuality of LifeBirthWomen's HealthSelf ReportClinical MedicineSexual functionbusiness

description

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).

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8577744/?tool=EBI