[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100450751":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":40,"centralContacts":44,"locations":53,"responsibleParty":71,"collaborators":73,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":39,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":39,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":55,"whyStopped":39,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"4-Week Treatment with no Maintenance Period","ACTIVE_COMPARATOR","Treatment will be provided via self-administration of pulsed electromagnetic field (PEMF) therapy using the B. Body (full body mat) and B. Pad (targeted pelvic pad). The participant will lie the B. Body mat on any flat surface and lay on the mat with the smaller B. Pad placed directly over the pelvic area. The PEMF device (attached to the control unit) has been pre-programmed to deliver the same level of energy every time. Participants will be instructed to administer this home treatment twice a day (morning and evening) for 8-minute sessions over a 4-week period. After 4 weeks, participants will return the device and complete one set of electronic questionnaires during the last week of the month for the following 3 months.",[13],"Device: Pulsed Electromagnetic Field (PEMF) Device",{"label":15,"type":16,"description":17,"interventionNames":18},"4-Week Sham Treatment with no Maintenance Period","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 surface and lay on the mat with the smaller sham B. Pad placed directly over the pelvic area. The participant will be instructed to administer this sham treatment twice a day (morning and evening) for 8-minute sessions over a 4-week period. After 4 weeks, participants will return the sham device and complete one set of electronic questionnaires during the last week of the month for the following 3 months.",[19],"Device: Sham Pulsed Electromagnetic Field (PEMF) Device",{"label":21,"type":10,"description":22,"interventionNames":23},"4-Week Treatment with 1-Week-Per-Month Maintenance Period for an Additional 3 Months","Treatment will be provided via self-administration of pulsed electromagnetic field (PEMF) therapy using the B. Body (full body mat) and B. Pad (targeted pelvic pad). The participant will lie the B. Body mat on any flat surface and lay on the mat with the smaller B. Pad placed directly over the pelvic area. The PEMF device (attached to the control unit) has been pre-programmed to deliver the same level of energy every time. Participants will be instructed to administer this home treatment twice a day (morning and evening) for 8-minute sessions over a 4-week period. After 4 weeks, participants will keep the device and use it for 1 week (7 days) during the last week of the month for the following 3 months. Each participant in this group will be asked to complete a set of electronic questionnaires immediately following their week-long maintenance treatment during the last 3 months of the study.",[13],[25,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","Pulsed Electromagnetic Field (PEMF) Device","BEMER PEMF device consists of a B. Body (full body mat), B. Pad (targeted pelvic pad), and Control Unit which powers the device. Both B. Body and B. Pad must be plugged in simultaneously into the Control Unit and activated individually. B. Body must be placed on a flat surface (e.g. floor, bed, reclining chair, etc) for best results.",[21,9],[31,32,33,34],"BEMER PEMF","BEMER B. Body","BEMER B. Pad","BEMER Control Unit",{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Sham Pulsed Electromagnetic Field (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],null,[41],{"name":42,"affiliation":5,"role":43},"Stephen J Walker, PhD","PRINCIPAL_INVESTIGATOR",[45,49],{"name":42,"role":46,"phone":47,"phoneExt":39,"email":48},"CONTACT","336-713-7272","Stephen.J.Walker@advocatehealth.org",{"name":50,"role":46,"phone":51,"phoneExt":39,"email":52},"Kaylee A Ferrara, BS","336-713-1693","Kaylee.Ferrara@Advocatehealth.org",[54],{"facility":5,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"RECRUITING","Winston-Salem","North Carolina","27157","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-80.24422,36.09986,{"lat":65,"lon":64},[68,69],{"name":42,"role":46,"phone":47,"phoneExt":39,"email":48},{"name":70,"role":46,"phone":51,"phoneExt":39,"email":52},"Kaylee A Ferrarra, BS",{"type":72,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[74],{"name":75,"class":76},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100450751","investigation-of-pemf-therapy-for-female-patients-with-icbps-100450751",false,"NCT05149573","Investigation of PEMF Therapy for Female Patients With IC\u002FBPS","Investigation of Non-Invasive Pulsed Electromagnetic Field (PEMF) Therapy for Female Patients With Interstitial Cystitis\u002FBladder Pain Syndrome (IC\u002FBPS)","Inclusion Criteria:\n\n* Previously established clinical diagnosis of IC\u002FPS\n* Current numeric rating scale (NRS) score of ≥ 6\n* History of cystoscopy with hydrodistension with bladder capacity determination under anesthesia\n* No cognitive deficits\n\nExclusion Criteria:\n\n* History of bladder, ovarian, 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, multiple sclerosis, or stroke\n* Current placement of a pacemaker or metal prosthesis\n* Active urinary tract infection\n* BMI \\> 40\n* Residual urine of \\> 100cc\n* Current pregnant","FEMALE","18 Years","80 Years",{"count":88,"type":89},75,"ESTIMATED","INTERVENTIONAL",[92],"NA","The purpose of this study is to gather information about the safety and effectiveness of the non-pharmacological (non-drug), non-invasive treatment known as low-frequency pulsed electromagnetic field (PEMF) therapy. The study team will distribute the PEMF device to female adults with Interstitial Cystitis\u002FBladder Pain Syndrome (IC\u002FBPS) to measure its ability to decrease bladder and pelvic pain as well as other urinary symptoms associated with IC\u002FBPS. There are two sequential Aims in this study and subjects will be recruited to participate in only one Aim. In both Aims, data will be collected at baseline\u002Fenrollment, 4-weeks after using PEMF therapy, and 8, 12, and 16 weeks post-enrollment.",[95,96,97],"Interstitial Cystitis","Chronic Interstitial Cystitis","Bladder Pain Syndrome",[99,100,101,102,103,104,105,106],"interstitial cystitis","bladder pain syndrome","painful bladder syndrome","painful bladder","bladder pain","urinary urgency","urinary frequency","pulsed electromagnetic field","2026-05-06",{"date":109,"type":110},"2026-05-07","ACTUAL",{"date":112,"type":110},"2022-08-29",{"date":114,"type":89},"2027-02",{"name":5,"class":6},1]