[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539420":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":45,"responsibleParty":64,"collaborators":27,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":27,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":48,"whyStopped":27,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Centro de Atenção ao Assoalho Pélvico","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Radiofrequency group","EXPERIMENTAL","Once a week, for 8 weeks, patient will undergo monopolar non-ablative radiofrequency application by a trained researcher.",[13,14],"Device: nonablative radiofrequency","Device: Vaginal dilator",{"label":16,"type":17,"description":18,"interventionNames":19},"Sham group","ACTIVE_COMPARATOR","Once a week, for 8 weeks, patient will undergo monopolar non-ablative radiofrequency application by a trained researcher, but the radiofrequency device will not emit the radiofrequency wave.",[14,20],"Device: Sham nonablative radiofrequency",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DEVICE","nonablative radiofrequency","The active electrode from the nonablative radiofrequency will be applied to the urogenital- and uroanal trigone and the dispersive electrode will be attached to the back of the patient. The water-soluble gel will be applied to the active electrode and to the non-lubricated condom which will involve the electrode. There will be a gradual increase in temperature, monitored by a digital infrared thermometer, to reach temperature between 36°C and 38°C, keeping the movement for two minutes in each area, spending in total around 10 minutes.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Vaginal dilator","Both groups will use the vaginal dilator at the end of each session for 15 minutes and all patients will be advised to use it for 15 minutes daily in a home based treatment.",[9,16],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Sham nonablative radiofrequency","The active electrode from the nonablative radiofrequency will be applied to the urogenital- and uroanal trigone and the dispersive electrode will be attached to the back of the patient. The water-soluble gel will be applied to the active electrode and to the non-lubricated condom which will involve the active electrode. As the device will not deliver the radiofrequency wave, the gel will be heated so the patient has the feeling of the temperature change, keeping the movement for two minutes in each area, spending in total around 10 minutes.",[16],[37,42],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},"Tuffy Mamede, Post-graduation","CONTACT","+5571999673967","tuffy@tuffymamede.com",{"name":43,"role":39,"phone":27,"phoneExt":27,"email":44},"Patrícia Lordelo, Ph.D","pvslordelo@hotmail.com",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Centro de Atenção ao Assoalho Pelvico","RECRUITING","Salvador","Estado de Bahia","40.290-000","Brazil","BR",{"type":55,"coordinates":56},"Point",[57,58],-38.49096,-12.97563,{"lat":58,"lon":57},[61],{"name":62,"role":39,"phone":63,"phoneExt":27,"email":44},"Patricia V Lordelo, Phd","+5571988592400",{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Patricia Lordelo","Head of the CentroAAP","100539420","effects-of-non-ablative-radiofrequency-on-female-genito-pelvic-pain-disorder-100539420",false,"NCT06303609","Effects of Non-ablative Radiofrequency on Female Genito-pelvic Pain Disorder","Effects of Non-ablative Radiofrequency on Female Genito-pelvic Pain Disorder: Randomized Clinical Trial","Pelvic Pain","Inclusion Criteria:\n\n* Women with genito-pelvic pain disorder associated to penetration.\n\nExclusion Criteria:\n\n* Chronic degenerative disease\n* Cognitive impairment\n* Genital agenesis\n* History of vaginal cancer or genital radiotherapy\n* Pelvic or lumbosacral prostheses\n* Cardiac pacemakers\n* Pregnant women\n* Infections in the genital or systemic region\n* Any type of treatment for genito-pelvic pain disorder\n* Unstable relationship with the same partner\n* Partner with sexual complaints.","FEMALE","18 Years","45 Years",{"count":80,"type":81},56,"ESTIMATED","INTERVENTIONAL",[84],"NA","The goal of this randomized clinical trial is to verify the response of genito-pelvic pain disorders in women associated with inability to penetrate to the treatment with non-ablative radiofrequency. The main question it aims to answer is: Does non-ablative radiofrequency have a positive effect on the symptoms of genito-pelvic pain disorders associated with inability to penetrate? Before starting the intervention and at one week, one-, three- and six months after the end of the study, participants will be evaluated with 03 questionnaires (Female Sexual Function Index, Sexual Quality of Life and Perceived Stress Scale-10) and will score the visual analogue scale the level of pain with the penetration (from 0 to 10); participants will then undergo digital evaluation of the pelvic floor muscles, using vaginal dilators and electromyographic evaluation. After being randomized, participants will be divided into the Experimental Group and the Sham Group, being submitted to • the use of non-ablative radiofrequency in the anal and urogenital triangles, • the positioning of the vaginal dilator at the end of each session • and participants will be instructed to use the vaginal dilator at home daily. The researchers will compare the groups in relation to the ability to penetrate with reduced vaginal pain, sexual function, quality of sexual life and the correlation between pelvic muscle activity and perceived stress.",[74],[88,89,24,90],"genito-pelvic pain disorder","radiofrequency","women","2024-05-27",{"date":93,"type":94},"2024-05-29","ACTUAL",{"date":96,"type":94},"2024-04-20",{"date":98,"type":81},"2026-07-20",{"name":5,"class":6},1]