[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595904":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":52,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":20,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":20,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":83,"whyStopped":20,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","Participants will be instructed to use the Hyivy Floora Pelvic Rehabilitation Vaginal Dilator at least three times per week for a total of 12-weeks. Each session consists of 10 minutes of heat and 10 minutes of dilation.",[13],"Device: Floora Pelvic Rehabilitation Vaginal Dilator",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Floora Pelvic Rehabilitation Vaginal Dilator","The Floora Pelvic Rehabilitation Vaginal Dilator, created by Hyivy Health Inc, is a multi-therapy hand held ergonomic intravaginal wand device that is designed to be used in the comfort of the user's home. The Floora has two main therapeutic functions, controllable dilation and thermal therapy. It is the first vaginal dilator that performs auto-dilation using one or two air chambers inflated from the device surface by an internal pump, eliminating the need for reinsertion. The device is equipped with biosensors that measure the pressure from the vaginal canal which allows this device to provide a gradual and gentle stretch to the pelvic floor muscles. The thermal therapy is achieved through an electrical circuit, changing the temperature of the device in small increments. Users are able to force-stop and change the temperature and dilation settings during a session.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Stephen J Walker, PhD","Wake Forest Institute for Regenerative Medicine","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Kaylee Ferrara, MA","CONTACT","336-713-1693","kaylee.ferrara@advocatehealth.org",[33],{"facility":34,"status":20,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Atrium Health Wake Forest Baptist Urology","Winston-Salem","North Carolina","27103","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-80.24422,36.09986,{"lat":44,"lon":43},[47,49],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":48},"kferrara@wakehealth.edu",{"name":50,"role":51,"phone":20,"phoneExt":20,"email":20},"Amr El Haraki, MD","SUB_INVESTIGATOR",{"type":53,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[55],{"name":56,"class":57},"Hyivy Health Inc","INDUSTRY","100595904","evaluation-of-hyivy-floora-in-managing-interstitial-cystitisbladder-pain-syndromehigh-tone-pelvic-floor-dysfunction-100595904",false,"NCT07038512","Evaluation of Hyivy Floora in Managing Interstitial Cystitis\u002FBladder Pain Syndrome\u002FHigh-tone Pelvic Floor Dysfunction","Evaluation of the Hyivy Floora Pelvic Rehabilitation Vaginal Dilator in Managing Interstitial Cystitis\u002F Bladder Pain Syndrome and High-tone Pelvic Floor Dysfunction","Inclusion Criteria:\n\n* Biological Female\n* Previously established clinical diagnosis of Interstitial Cystitis\u002F Bladder Pain Syndrome (IC\u002FBPS)\n* Diagnosed with High-tone Pelvic Floor Dysfunction (HTPFD)\n* Current pelvic pain score of 5 or greater on an 11-point Likert Scale\n* Must be willing and able to insert intravaginal device\n* No cognitive deficits\n* Agrees not to commence any new treatments for HTPFD or IC\u002FBPS (medical or physical therapy) during the 12-week intervention period\n\nExclusion Criteria:\n\n* History of a spinal cord injury\n* Currently pregnant or lactating\n* Allergy to device materials\n* Active vaginal infection (e.g. vulvovaginal candidiasis, trichomonas, vaginitis, bacterial vaginosis, STIs, etc.)\n* Have open wounds, cuts, or open sores present in the vaginal or pelvic area\n* Recent pelvic or abdominal surgery within the last 3 months\n* Currently under the care of a pelvic floor physical therapist or pelvic floor physiotherapist\n* History of Neurogenic bladder\n* History of bladder, uterine, ovarian or vaginal cancer\n* History of radiation cystitis\n* Any pelvic floor\u002Fbladder Botox use within 6 months of enrollment and no future plans for Botox injections during the study period.\n* Any other medical condition or clinical finding giving reasonable suspicion of a disease or condition that contraindicates the use of the Floora, at the discretion of the Investigator","FEMALE","18 Years","80 Years",{"count":69,"type":70},10,"ESTIMATED","INTERVENTIONAL",[73],"NA","The purpose of this study is to test the safety and effectiveness of the Floora Pelvic Rehabilitation Vaginal Dilator in females with Interstitial Cystitis\u002F Bladder pain Syndrome (IC\u002FBPS) and High-tome Pelvic Floor Dysfunction (HTPFD). After enrollment, participants will be given a Floora device and will be instructed to use the device at least three times per week for 12-weeks in the comfort of their home. Each session consists of 10 minutes of heat and 10 minutes of dilation. All participants will be required to attend 3 in-person clinic visits and there will be two follow-up phone-calls throughout the 16-week trial period.",[76,77,78],"Interstitial Cystitis\u002FPainful Bladder Syndrome","Interstitial Cystitis, Chronic","High Tone Pelvic Floor Dysfunction",[80,81,82],"bladder and pelvic pain","lower urinary tract symptoms","sexual function","NOT_YET_RECRUITING","2026-06-24",{"date":86,"type":87},"2026-06-26","ACTUAL",{"date":89,"type":70},"2026-08",{"date":91,"type":70},"2027-01",{"name":5,"class":6},1]