[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517123":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":37,"centralContacts":41,"locations":51,"responsibleParty":67,"collaborators":45,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":45,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":45,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":100,"whyStopped":45,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"6-week Pulsed Electromagnetic Field treatment with intravesical bupivacaine\u002Fheparin instillations","ACTIVE_COMPARATOR","Participants will be instructed to self-administer pulsed electromagnetic field therapy (PEMF) devices immediately following each intravesical bupivacaine\u002Fheparin instillation, while they are holding the instillation solution in their bladder. PEMF therapy will be self-administered using the B. Body (full body mat) and B. Pad (targeted pelvic pad). The participant will lie the B. Body mat on any flat dry surface and lay on the mat with the smaller B. Pad placed directly over the pelvic area. The PEMF device (attached to the control B. Box) has been pre-programmed to deliver the same energy level every time. Participants will be instructed to administer this home treatment in conjunction with their self-administered bladder instillations of bupivacaine\u002Fheparin for 8-minute sessions, three times a week over a 6 week period. At the mid way point (3 weeks) and after completion (6 weeks) participants will complete the online questionnaires. At 6 weeks the PEMF device is returned.",[13],"Device: Pulsed Electromagnetic Field (PEMF) Device",{"label":15,"type":16,"description":17,"interventionNames":18},"6-week Sham Treatment with intravesical bupivacaine\u002Fheparin instillations","SHAM_COMPARATOR","Participants will be provided with a sham B. Body and B. Pad that appears identical to the active pulsed electromagnetic field (PEMF) device. The participant will lie the sham B- Body mat on any flat dry surface and lay on the mat with with the smaller sham B. Pad placed directly over the pelvic area. The participant will be instructed to administer this sham treatment immediately following each intravesical bupivacaine\u002Fheparin instillation, while they are holding the instillation solution in their bladder. Participants will be instructed to administer this sham treatment in conjunction with their self-administered bladder instillations of bupivacaine\u002Fheparin for 8-minute sessions, three times a week over a 6 week period. At the mid way point (3 weeks) and after completion (6 weeks) participants will complete the online questionnaires. At 6 weeks the sham PEMF device is returned.",[19],"Device: Sham Pulsed Electromagnetic Feild (PEMF) Device",[21,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Pulsed Electromagnetic Field (PEMF) Device","Pulsed Electromagnetic Field (PEMF) Device BEMER Device consist of a total body mat (B. BODY) plus a targeted pelvic mat (B.PAD), and a Control Unit which powers the device and logs usage. Both B.BODY and B.PAD must be plugged into the Control Unit simultaneously and activated individually. B. Body must be placed on a flat surface (i.e. bed, floor, reclining chair etc.) for best results.",[9],[27,28,29,30],"BEMER PEMF","BEMER B. BODY","BEMER B. PAD","BEMER Control Unit",{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Sham Pulsed Electromagnetic Feild (PEMF) Device","The sham PEMF device appears identical to the BEMER PEMF device, with all of the same components and accessories, but does not emit a pulsed electromagnetic field.",[15],[36],"BEMER Sham Device",[38],{"name":39,"affiliation":5,"role":40},"Stephen J Walker, PhD","PRINCIPAL_INVESTIGATOR",[42,47],{"name":39,"role":43,"phone":44,"phoneExt":45,"email":46},"CONTACT","336-713-7272",null,"swalker@wakehealth.edu",{"name":48,"role":43,"phone":49,"phoneExt":45,"email":50},"Kaylee A Ferrara, BS","336-713-1693","Kaylee.Ferrara@Advocatehealth.org",[52],{"facility":5,"status":45,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Winston-Salem","North Carolina","27157","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-80.24422,36.09986,{"lat":62,"lon":61},[65,66],{"name":39,"role":43,"phone":44,"phoneExt":45,"email":46},{"name":48,"role":43,"phone":49,"phoneExt":45,"email":50},{"type":68,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100517123","efficacy-of-pulsed-electromagnetic-field-and-heparinbupivacaine-instillations-100517123",false,"NCT06013449","Efficacy of Pulsed Electromagnetic Field and Heparin\u002FBupivacaine Instillations","Investigation of the Effect of Simultaneous Pulsed Electromagnetic Field (PEMF) and Intravesical Heparin - Bupivacaine Cocktail Instillation for the Symptomatic Treatment of Interstitial Cystitis\u002FBladder Pain Syndrome (IC\u002FBPS)","Inclusion Criteria:\n\n* Previously established clinical diagnosis of Interstitial Cystitis\u002FBladder Pain Syndrome (IC\u002FBPS)\n* Current Numeric Rating Scale (NRS) greater than or equal to 5\n* History of cystoscopy with hydrodistension with bladder capacity determination under anesthesia\n* No contraindications to the instillation solution\n* No cognitive deficits\n\nExclusion Criteria:\n\n* History of bladder, ovarian or vaginal cancer\n* History of urethral diverticulum\n* History of radiation cystitis\n* History of spinal cord injury or spina bifida\n* History of Parkinson's Disease\n* History of Multiple Sclerosis (MS)\n* History of Stroke\n* History of genital herpes\n* History of or current cyclophosphamide treatment\n* Current placement of a pacemaker or metal prothesis\n* Active urinary tract infection\n* BMI \\>40\n* Residual urine of \\>100 cc\n* Currently pregnant","FEMALE","18 Years","80 Years",{"count":80,"type":81},20,"ESTIMATED","INTERVENTIONAL",[84],"NA","The objective of this study is to test the idea that Pulsed Electromagnetic Field (PEMF) therapy will serve as a safe therapeutic modality that can effectively be administered simultaneously with bladder instillations of a bupivacaine-heparin cocktail to improve the chronic pain and\u002For associated symptoms of Interstitial Cystitis\u002FBladder Pain Syndrome (IC\u002FBPS) patients. The study team will distribute the PEMF device to female adults with IC\u002FBPS who have been prescribed bladder instillations of bupivacaine-heparin to see if PEMF therapy in conjunction with bladder instillations of heparin and bupivacaine may be more effective in reducing pain levels and symptomatology of IC\u002FBPS than instillations alone.",[87,88,89],"Interstitial Cystitis","Chronic Interstitial Cystitis","Bladder Pain Syndrome",[91,92,93,94,95,96,97,98,99],"interstitial cystitis","bladder pain syndrome","painful bladder","chronic pelvic pain","urinary urgency","urinary frequency","pulsed electromagnetic field","PEMF","bladder instillation","NOT_YET_RECRUITING","2026-03-30",{"date":103,"type":104},"2026-03-31","ACTUAL",{"date":106,"type":81},"2026-09",{"date":108,"type":81},"2027-12",{"name":5,"class":6},1]