[{"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":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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"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":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Interstitial Cystitis\u002FPainful Bladder Syndrome","Interstitial Cystitis, Chronic","High Tone Pelvic Floor Dysfunction",[31,32,33],"bladder and pelvic pain","lower urinary tract symptoms","sexual function","NOT_YET_RECRUITING","2026-06-24",{"date":37,"type":38},"2026-06-26","ACTUAL",{"date":40,"type":21},"2026-08",{"date":42,"type":21},"2027-01",{"name":44,"class":45},"Wake Forest University Health Sciences","OTHER"]