[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100429512":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":64,"collaborators":26,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":26,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Corewell Health East","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Emsella Chair Active Treatment","ACTIVE_COMPARATOR","Active subjects will be asked to sit on the center of the device and the height will be adjusted until the subject's feet are on the floor. The active treatments are individualized, since some subjects will be more sensitive than others. The Emsella chair will be turned on and the setting gradually increased to the subject's sensory threshold; the maximum sensation the subject can tolerate. The setting will be decreased slightly and stay unchanged for the reminder of the treatment. The treatment threshold should be increased with every treatment until the subject reaches 100%.",[13],"Device: BTL Emsella Chair",{"label":15,"type":16,"description":17,"interventionNames":18},"Emsella Chair Sham Treatment","PLACEBO_COMPARATOR","Sham treatment subjects will be positioned on the device in the same manner. The sham treatment will provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below the therapeutic level (less than 10% power).",[19],"Device: Sham BTL Emsella Chair",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","BTL Emsella Chair","The Emsella Chair is a novel high-intensity focused electromagnetic (HIFEM) technology for the treatment of pelvic floor related disorders. HIFEM technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercises over 28 minutes. The treatment paradigm consists of 3 different phases. The phases consist of an intense stimulation of the pelvic floor muscles (PFM), which consists of stimulation and relaxation. The repetition of the phases and focused electromagnetic energy delivery leads to pelvic floor stimulation, adaptation, and remodelation.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham BTL Emsella Chair","The sham treatment will provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below therapeutic level (less than 10%) power.",[15],[32],{"name":33,"affiliation":34,"role":35},"Kenneth Peters, MD","Corewell Health William Beaumont University Hospital","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Danielle Tenney","CONTACT","248-551-3565","Danielle.Tenney@corewellhealth.org",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Jennifer Giordano, BSN","248-551-3517","Jennifer.Giordano@corewellhealth.org",[47],{"facility":34,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Royal Oak","Michigan","48073","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-83.14465,42.48948,{"lat":58,"lon":57},[61,62,63],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"type":35,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Kenneth M Peters, MD","Director and Chair of the Department of Urology","100429512","btl-emsella-chair-versus-sham-for-the-treatment-of-overactive-bladder-100429512",false,"NCT04873037","BTL Emsella Chair Versus Sham for the Treatment of Overactive Bladder","A Single-Blind, Randomized Study of the BTL EmsellaTM Chair Versus Sham for the Treatment of Overactive Bladder","EmsellaOAB","Inclusion Criteria:\n\n1. Able to read, understand, and provide written, dated, informed consent prior to screening, and be likely to comply with study protocol, including independently complete study questionnaires and communicate with study personnel about AEs and other clinically important information.\n2. Women and men ≥ 18 years of age\n3. Self-reported bladder symptoms present ≥ 3 months\n4. Self-reported failed conservative care of behavioral modifications and\u002For oral medications\n5. On a stable dose of antimuscarinics\u002Fbeta-3 agonists for ≥ 4 weeks, and willing to remain on the medication for the duration of the study OR discontinued antimuscarinics\u002Fbeta-3 agonists for ≥ 2 weeks\n6. Ambulatory and able to use a toilet independently, without difficulty\n7. Subject agrees not to start any new treatment for OAB (medication or otherwise) during the treatment and follow-up periods.\n\n   For Females Only:\n8. If of child-bearing age and female, agree to practice approved birth-control methods (oral contraceptives, condom barrier, injection, diaphragm or cervical cap, vaginal contraceptive ring, IUD, implantable contraceptive, surgical sterilization (bilateral tubal ligation), vasectomized partner(s))\n\nExclusion Criteria:\n\n1. Botox® use in bladder or pelvic floor muscles in the past year\n2. Subject weighs greater than 330 pounds\n3. Pulmonary insufficiency, defined as difficulty breathing and fatigue, especially during exercise; chest pain, such as squeezing, pressure of tightness; the sensation of rapid or irregular heartbeat (palpitations); swelling of the legs or feet; dizziness or fainting; and\u002For bluish discoloration of the nails and\u002For lips (cyanosis)\n4. Any condition that causes a lack of normal skin sensation to the pelvis, buttocks, and thighs, at the discretion of the investigator.\n5. Major metal implants such as: metal plates, screws, joint replacements, implanted cardiac pacemakers, drug pumps, neurostimulators, electronic implants, copper intrauterine devices, defibrillators, and metal implants in the pelvic area. Patients with other metal implants will be evaluated by the investigator for inclusion in the study.\n6. Subject has a piercing between the waist and knees and is not willing to remove it before each treatment\n7. Active urethral diverticula\n8. Known vesicoureteral reflux\n9. Currently healing from surgical procedures where muscle contraction may disrupt the healing process\n10. Subject is currently receiving treatment for a malignant tumor that would interfere with study participation. Skin cancers are permitted.\n11. Subject has used the BTL EMSELLA device previously\n12. Subject has urinary incontinence of neurogenic etiology, such as multiple sclerosis, spina bifida, Parkinson's, spinal cord injury, diabetic neuropathy, neurogenic bladder etc.\n13. Current urinary tract infection. If a subject has a confirmed symptomatic UTI at screening, per investigator's clinical judgment, they will be deferred from screening until treatment is completed, and may resume once symptoms have resolved\n14. Current use of neuromodulation therapy, including interstim and PTNS, for bladder symptoms within 3 months of screening visit (if past sacral\u002Fpudendal implant, must be explanted)\n15. Currently participating in an investigational study that may impact study results or previously received an investigational drug or treatment within 30 days of the Screening Visit\n16. Current or history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results interpretation\n\n    For Females Only:\n17. Pregnant, or planning to become pregnant, at screening or anytime throughout the study period\n\n    * Note: For the sake of preserving scientific integrity, one or more of the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.","ALL","18 Years",{"count":78,"type":79},166,"ESTIMATED","INTERVENTIONAL",[82],"NA","The purpose of this clinical trial is to compare the Emsella Chair therapy to Sham and to determine whether electromagnetic technology is effective in the treatment of overactive bladder (OAB). Currently there are no other studies utilizing the Emsella Chair for the treatment of OAB. Eligible subjects will receive 2 treatments per week for a total of 4 weeks.",[85,86,87,88],"Overactive Bladder Syndrome","Overactive Bladder","Urinary Frequency","Urinary Urgency",[86],"2025-12-05",{"date":92,"type":93},"2025-12-11","ACTUAL",{"date":95,"type":93},"2021-11-22",{"date":97,"type":79},"2028-12",{"name":5,"class":6},1]