[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583127":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":72,"collaborators":74,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":26,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":26,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":99,"whyStopped":26,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Mahidol University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention (fractional bipolar radiofrequency therapy)","ACTIVE_COMPARATOR","A single treatment with intravaginal device for fractional bipolar radiofrequency therapy. Using the EmpowerRF platform with the Morpheus8V applicator, RF energy was applied via 24 microneedles, to release the radiofrequency energy to the vaginal mucosa",[13],"Device: Fractional bipolar radiofrequency",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham group","SHAM_COMPARATOR","The sham group will receive treatment with a specialized sham device that mimics the treatment group's equipment. There are no differences in the design of the tip device, the auditory signal (beeping), or the pulse count display.",[19],"Device: Sham device",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Fractional bipolar radiofrequency","The treatment group will receive a single treatment of intravaginal fractional bipolar radiofrequency therapy.",[9],null,{"type":22,"name":28,"description":17,"armGroupLabels":29,"otherNames":26},"Sham device",[15],[31],{"name":32,"affiliation":33,"role":34},"Suthanud Premchit, MD","Ramathibodi Hospital","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","(66)+954575848","dai_suthanud@hotmail.com",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},"Orawee Chinthakanan, Assoc.Prof.","(66)+19522215","orawee.chi@mahidol.edu",[45],{"facility":46,"status":26,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Faculty of Medicine Ramathibodi Hospital, Mahidol University","Ratchathewi","Bangkok","10400","Thailand","TH",{"type":53,"coordinates":54},"Point",[55,56],100.53358,13.759,{"lat":56,"lon":55},[59,62,63,66,68,70],{"name":60,"role":37,"phone":61,"phoneExt":26,"email":26},"Female Pelvic Medicine and Reconstructive Surgery Division, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Obstetrics & Gynecology","66+2012175",{"name":32,"role":34,"phone":26,"phoneExt":26,"email":26},{"name":64,"role":65,"phone":26,"phoneExt":26,"email":26},"Assoc.Prof. Orawee Chinthakanan, MD, MPH","SUB_INVESTIGATOR",{"name":67,"role":65,"phone":26,"phoneExt":26,"email":26},"Assist. Prof.Komkrit Komkrit, MD",{"name":69,"role":65,"phone":26,"phoneExt":26,"email":26},"Assist. Prof. Rujira Wattanayingcharoenchai, MD, M.Sc.",{"name":71,"role":65,"phone":26,"phoneExt":26,"email":26},"Prof. Jittima Manonai, MD, MHM",{"type":73,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[75],{"name":76,"class":77},"InMode MD Ltd.","INDUSTRY","100583127","fractional-bipolar-radiofrequency-therapy-vs-sham-for-treatment-of-vaginal-laxity-in-premenopausal-women-100583127",false,"NCT06872281","Fractional Bipolar Radiofrequency Therapy VS Sham for Treatment of Vaginal Laxity in Premenopausal Women","A Randomized Controlled Trial Comparing Fractional Bipolar Radiofrequency Therapy VS Sham for Treatment of Vaginal Laxity in Premenopausal Women","Inclusion Criteria:\n\n* Premenopausal women\n* Age 20-55 years\n* Reported symptoms of vaginal looseness with a score of at least 1 on The Vaginal Laxity Questionnaire (VLQ)\n* Sexually active (≥1 time\u002Fmonth)\n* Willing to undergo vaginal energy-based treatment and attend follow-up visits 3 months after treatment\n\nExclusion Criteria:\n\n* \\- Presence of sexually transmitted diseases or active genital lesions\n* Currently pregnant or planning for conception during study period\n* Pelvic organ prolapse (POP ≥ Stage II)\n* Previous treatment for vaginal laxity with modalities other than pelvic floor muscle training\n* Currently using intrauterine devices for contraception\n* Presence of any active electrical implant such as pacemaker, internal defibrillator\n* Current condition of genital cancer","FEMALE","20 Years","55 Years",{"count":89,"type":90},56,"ESTIMATED","INTERVENTIONAL",[93],"NA","Knowledge gap: Lack of randomized controlled trials evaluating the efficacy of fractional bipolar radiofrequency therapy compared to a sham treatment for vaginal laxity in premenopausal women.\n\nPrimary outcomes\n\n* Subjective outcomes: The Vaginal Laxity Questionnaire (VLQ) Secondary outcomes\n* Subjective outcomes\n\n  * The Thai version of the Female Sexual Function Index (FSFI) will be administered to evaluate sexual function.\n  * The Thai version of the Female Genital Self-Image Scale (FGSIS)\n  * The International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS), validated in Thai\n  * The Patient Global Impression of Improvement (PGI-I)\n  * Patients will report any side effects or adverse events experienced during the study.\n* Objective outcomes - Vaginal wall thickness will be assessed using 3D transvaginal ultrasound imaging, following the standardized protocol established in previous studies.\n\nPICO:\n\nP (Population): Premenopausal women with clinically diagnosed vaginal laxity who are sexually active.\n\nI (Intervention): Fractional bipolar radiofrequency therapy (single treatment)\n\nC (Comparison): Sham treatment (placebo).\n\nO (Outcomes):\n\n* Primary Outcome: Improvement in vaginal laxity as assessed by the Vaginal Laxity Questionnaire (VLQ).\n* Secondary Outcomes: Patient satisfaction with treatment (measured by the Patient Global Impression of Improvement - PGI-I)., Changes in sexual function (assessed using the Thai version of the Female Sexual Function Index - FSFI).\n\nPerception of genital self-image (evaluated using the Thai version of the Female Genital Self-Image Scale - FGSIS)., Evaluation of vaginal symptoms (using the International Consultation on Incontinence Questionnaire-Vaginal Symptoms - ICIQ-VS), Objective assessment of vaginal wall thickness through 3D transvaginal ultrasound, Recording of any side effects or adverse events associated with the treatment.\n\nStudy Design:\n\nA double-blind, randomized controlled trial (RCT) conducted at the Female Pelvic Medicine and Reconstructive Surgery clinic in Ramathibodi Hospital.",[96],"Vaginal Laxity",[98],"fractional bipolar radiofrequency therapy","NOT_YET_RECRUITING","2025-03-12",{"date":102,"type":103},"2025-03-17","ACTUAL",{"date":105,"type":90},"2025-04-01",{"date":107,"type":90},"2025-11-30",{"name":5,"class":6},1]