[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"interstitial-cystitispainful-bladder-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:interstitial-cystitispainful-bladder-syndrome":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"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":19,"type":20},10,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28],"Interstitial Cystitis\u002FPainful Bladder Syndrome","Interstitial Cystitis, Chronic","High Tone Pelvic Floor Dysfunction",[30,31,32],"bladder and pelvic pain","lower urinary tract symptoms","sexual function","NOT_YET_RECRUITING","2026-06-24",{"date":36,"type":37},"2026-06-26","ACTUAL",{"date":39,"type":20},"2026-08",{"date":41,"type":20},"2027-01",{"name":43,"class":44},"Wake Forest University Health Sciences","OTHER",""]