[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"genito-pelvic-painpenetration-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:genito-pelvic-painpenetration-disorder":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":5},"100580670","vibrating-vs-traditional-therapy-for-treatment-of-entry-dyspareunia-100580670",false,"NCT06840314","VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia","VIBRENT- VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia","VIBRENT","Inclusion Criteria:\n\n* Assigned female at birth\n* Age ≥ 18 years old\n* Genito-pelvic pain\u002Fpenetration disorder (per ICD-10 diagnosis codes: F52.5 Vaginismus not due to a substance or known physiological condition, F52.6 Dyspareunia not due to a substance or known physiological condition, N94.1 Dyspareunia, N94.2 Vaginismus, N94.81 Vulvodynia)\n\nExclusion Criteria:\n\n* Current or prior use of a therapeutic vaginal device used to treat GPPPD\n* Unmanaged genitourinary syndrome of menopause\n* History of pelvic radiation\n* History of genital tract malignancy\n* History of female genital mutilation\n* History of prior surgery for prolapse or incontinence, including vaginal mesh or midurethral sling mesh\n* Silicone allergy","FEMALE","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this randomized controlled trial is to determine whether the use of a novel vibrating pelvic floor therapeutic device (\"Kiwi\") improves sexual function in sexually active women aged 18 and older with genito-pelvic pain and penetration disorder (GPPPD) more effectively than traditional vaginal dilators.\n\nThe main questions it aims to answer are:\n\n1. Does the use of the Kiwi device lead to higher sexual function scores compared to traditional vaginal dilators\n2. Does the Kiwi device improve sexual distress, pain, and overall symptom severity more effectively than traditional vaginal dilators?\n\nResearchers will compare the Kiwi vibrating device to traditional cylindrical vaginal dilators to assess whether the Kiwi device results in greater improvements in sexual function and symptom relief.\n\nParticipants will:\n\n* Be randomly assigned to use either the Kiwi device or traditional vaginal dilators.\n* Use the assigned device three times per week for 15 minutes per session over four weeks.\n* Complete surveys before and after the study, including assessments of sexual function, pain, and overall improvement.",[27,28,29,30,31,32],"Genito-Pelvic Pain\u002FPenetration Disorder","Dyspareunia","Vaginismus","Pelvic Pain","Vestibulodynia","Vulvodynia (Chronic Vulvar Pain)",[34,35,36,37,38,39,40,41,42],"genito-pelvic pain\u002Fpenetration disorder","dyspareunia","entry dyspareunia","vaginismus","pelvic pain","female sexual function","pain with sex","vulvodynia","vestibulodynia","RECRUITING","2025-05-16",{"date":46,"type":47},"2025-05-21","ACTUAL",{"date":49,"type":47},"2025-03-01",{"date":51,"type":21},"2026-03",{"name":53,"class":54},"Medstar Health Research Institute","OTHER"]