[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625161":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":68,"collaborators":26,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":26,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":98,"whyStopped":26,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University of Castilla-La Mancha","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Bipolar Radiofrequency","EXPERIMENTAL","Participants assigned to the active intervention group will receive six weekly sessions of bipolar radiofrequency therapy delivered according to a standardized protocol including external and intracavitary application.",[13],"Device: Active bipolar radiofrequency therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Procedure","SHAM_COMPARATOR","Participants assigned to the sham comparator group will undergo six weekly sessions replicating the structure and duration of the active protocol but without delivery of therapeutic radiofrequency energy.",[19],"Device: Sham radiofrequency procedure",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Active bipolar radiofrequency therapy","Bipolar radiofrequency will be delivered using a non-ablative medical device for vulvovaginal tissue remodeling. Participants will receive six weekly sessions lasting approximately 40 minutes each. Each session will include three phases: an initial 5-minute external application using a capacitive electrode applied to the perineal and vulvar areas with gradual thermal increase to a comfortable sensation (approximately 4-5\u002F10); a 10-minute intracavitary phase using a bipolar electrode with controlled temperature maintained between 41-43°C and systematic rotation for uniform energy distribution; and a final 5-minute external capacitive application replicating the first phase.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham radiofrequency procedure","The sham procedure will replicate the structure, duration, electrode placement, and anatomical application sites of the active intervention. Participants will undergo six weekly sessions lasting approximately 40 minutes, including an initial 5-minute external application to the perineal and vulvar areas, a 10-minute intracavitary electrode placement, and a final 5-minute external application. However, no therapeutic radiofrequency energy or thermal increase will be delivered.",[15],[32],{"name":33,"affiliation":5,"role":34},"ASUNCIÓN FERRI-MORALES, PT, MSc","STUDY_DIRECTOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"CLAUDIA QUEZADA-BASCUÑÁN, PT, MSc","CONTACT","+34652575842","claudia.quezada@uclm.es",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"ASUNCIÓN FERRI-MORALES, PT, PhD","+34 600 320 518","Asuncion.ferri@uclm.es",[46],{"facility":5,"status":26,"city":47,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Toledo","45071","Spain","ES",{"type":52,"coordinates":53},"Point",[54,55],-4.02263,39.8581,{"lat":55,"lon":54},[58,60,62,65,66],{"name":59,"role":38,"phone":39,"phoneExt":26,"email":40},"Claudia Quezada-Bascuñán, PT, MSc",{"name":26,"role":38,"phone":61,"phoneExt":26,"email":40},"CLAUDIA",{"name":63,"role":64,"phone":26,"phoneExt":26,"email":26},"CLAUDIA QUEZADA BASCUÑÁN, PT, MSc","PRINCIPAL_INVESTIGATOR",{"name":42,"role":64,"phone":26,"phoneExt":26,"email":26},{"name":67,"role":64,"phone":26,"phoneExt":26,"email":26},"CRISTINA LIRIO-ROMERO, PT, PhD",{"type":69,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100625161","bipolar-radiofrequency-for-genitourinary-syndrome-of-menopause-100625161",false,"NCT07419035","Bipolar Radiofrequency for Genitourinary Syndrome of Menopause","Efficacy of Bipolar Radiofrequency for Genitourinary Syndrome of Menopause in Postmenopausal Women: A Randomized, Sham-Controlled Clinical Trial","BRF-GSM","Inclusion Criteria:\n\n* Women aged 40 to 65 years\n* Postmenopausal status\n* Presence of at least one symptom of genitourinary syndrome of menopause (e.g., vaginal dryness, irritation, pruritus, urinary symptoms, or dyspareunia)\n* Sexual activity at least once per month\n* Ability to understand and complete study questionnaires\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Active vaginal infection\n* Neurological, neoplastic, or sexually transmitted diseases\n* Diagnosis of vulvodynia or vaginismus\n* Pelvic organ prolapse stage II or higher\n* Pelviperineal hypoesthesia\n* Presence of pacemaker or other electronic implantable devices\n* Use of estrogen hormonal therapy within the previous 3 months\n* History of pelvic radiotherapy\n* Pelvic surgery within the previous 6 months\n* Active anticoagulant therapy\n* Previous vaginal laser or ablative vaginal rejuvenation procedures within the previous 6 months\n* Cognitive impairment preventing completion of questionnaires","FEMALE","40 Years","65 Years",{"count":82,"type":83},40,"ESTIMATED","INTERVENTIONAL",[86],"NA","This randomized, sham-controlled clinical trial aims to evaluate the efficacy and safety of bipolar radiofrequency in the treatment of genitourinary syndrome of menopause (GSM) in postmenopausal women. Participants will be randomly assigned to receive either active bipolar radiofrequency treatment or a sham procedure.\n\nThe primary objective is to determine whether bipolar radiofrequency improves vaginal and sexual function. Secondary objectives include assessment of pain with vaginal penetration, vaginal lubrication and tissue distensibility, patient-reported vulvovaginal symptom severity, and treatment safety and tolerability.",[89],"Genitourinary Syndrome of Menopause (GSM)",[91,92,93,94,95,96,97],"bipolar radiofrequency","menopause","sexual function","dyspareunia","vaginal atrophy","postmenopausal women","radiofrequency therapy","NOT_YET_RECRUITING","2026-02-11",{"date":101,"type":102},"2026-02-18","ACTUAL",{"date":104,"type":83},"2026-03-15",{"date":106,"type":83},"2026-09-30",{"name":5,"class":6},1]