[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-tone-pelvic-floor-dysfunction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-tone-pelvic-floor-dysfunction":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":46},"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",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":71,"leadSponsor":73,"locationsCount":46},"100624035","phase-2-comparing-adjuvant-treatments-for-high-tone-pelvic-floor-dysfunction-100624035","NCT07404397","Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction","Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction: a Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Self-reported moderate to severe chronic pelvic pain for \\>6 months duration at time of screening visit. Moderate to severe chronic pain is defined as \\>4 on 0-10 (worst daily pain) for \\>14 days per month. Pelvic pain is defined as pain perceived to be located in the anatomic pelvis.\n* Diagnosis of high tone pelvic floor dysfunction (HTPFD), defined as \\>12\u002F60 summative pelvic floor tenderness score on standardized pelvic examination by chronic pelvic pain specialist (MD or NP) within the past year\n* Referred to pelvic floor physical therapy (PFPT) by their chronic pelvic pain specialist for management of HTPFD\n* Willing to undergo a 12-session course of PFPT for HTPFD, including internal\u002Fvaginal tissue manipulation per standardized protocol\n* Willing to delay start of PFPT until Phase 2 of the trial\n* Willing to be randomized to either daily use of cyclobenzaprine or use of vibrating pelvic floor muscle massage wand for total of 18 weeks\n* Willing to undergo standardized pelvic floor myofascial exam three times over the study period (baseline, end of Phase 1, end of Phase 2)\n* Willing to undergo quantitative sensory testing (QST) two times over the study period (baseline, end of Phase 1)\n* Willing to undergo blood draw two times over the study period (baseline, end of Phase 1)\n* Ability to read and speak English to allow for written informed consent, phenotyping, and patient-reported outcome measures\n* No plans for pregnancy within the next 12 months\n\nExclusion Criteria:\n\n* Hypersensitivity or allergy to cyclobenzaprine or any component of cyclobenzaprine\n* Underwent PFPT within 6 months of screening date\n* Pregnancy at any point during study period (self-reported home urine pregnancy test or serum b-Hcg test, positive urine pregnancy test at baseline, post-Phase 1, or post-Phase 2 study visits).\n* Currently breastfeeding at time of screening visit\n* Scheduled for or are planning moderate\u002Fmajor gynecologic surgery (including hysterectomy, excision of endometriosis, ovarian cystectomy\u002Foopherectomy, myomectomy) within the following 6 months of screening date\n* Current (at time of screening visit) diagnosis of postural orthostatic tachycardia syndrome\n* Current significant neurologic or musculoskeletal conditions that would preclude participation in PFPT (cerebral palsy, severe hip\u002Fback osteoarthritis that would prevent lithotomy position during sessions)\n* Unwilling to avoid or stop baseline use of cyclobenzaprine and other muscle relaxants (including methocarbamol, tizanidine, baclofen, carisoprodol, metaxalone)\n* Current use of tricyclic antidepressants\n* Current use of monoamine oxidase inhibitor\n* Current use of vaginally delivered benzodiazepine such as diazepam (more than once per month) and unwilling to stop use of vaginally delivered benzodiazepine for the duration of this study\n* Current diagnosis of hyperthyroidism\n* Current diagnosis of moderate or severe hepatic impairment\n* Myocardial infarction within prior 12 months\n* Current diagnosis of congestive heart failure\n* Current cardiac pacemaker in place\n* Current diagnosis of closed angle glaucoma\n* Current major psychiatric condition (including psychosis or suicidal ideation within past year)","65 Years",{"count":56,"type":21},60,[58,59],"PHASE2","PHASE3","The researchers are comparing two treatments for high tone pelvic floor dysfunction (HTPFD) in conjunction with pelvic floor physical therapy (PFPT). The goal of this study is to find out which of two extra treatments works better for people with HTPFD when they also do regular PFPT. First, the researchers will compare a muscle relaxant medicine (cyclobenzaprine IR) to using a vibrating pelvic floor massage wand. Everyone in the study will also do pelvic floor physical therapy. The researchers want to see how these treatments affect pain, sexual health, physical ability, and overall quality of life.",[29],[63,64,65],"pelvic floor physical therapy","cyclobenzaprine","vibrating pelvic floor massage wand","RECRUITING","2026-02-18",{"date":69,"type":38},"2026-02-20",{"date":67,"type":38},{"date":72,"type":21},"2026-12",{"name":74,"class":45},"University of Michigan"]