[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100372766":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":45,"responsibleParty":63,"collaborators":26,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":26,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"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 treatment subjects will be asked to sit on the center of the Emsella chair. The height of the chair will be adjusted until the participant's feet are on the floor. 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 then be decreased slightly and stay unchanged for the remainder of the treatment time. The treatment threshold should be increased with every treatment until the subject reaches 100%.",[13],"Device: BTL Emsella",{"label":15,"type":16,"description":17,"interventionNames":18},"Emsella Sham Treatment","SHAM_COMPARATOR","Sham subjects will be positioned on the device in the same manner as the active treatment group. The sham treatment will be provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below therapeutic level (\\\u003C10% power).",[19],"Device: Sham BTL Emsella",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","BTL Emsella","The Emsella Chair is a novel high-intensity focused electromagnetic (HIFEM) technology for the treatment of SUI, in addition to other 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 stimlulation 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":17,"armGroupLabels":29,"otherNames":26},"Sham BTL Emsella",[15],[31],{"name":32,"affiliation":33,"role":34},"Kenneth Peters, MD","Corewell Health William Beaumont University Hospital","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Julie Swanson, RN","CONTACT","248-551-3551","Julie.Swanson2@corewellhealth.org",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Jennifer Giordano, RN","248-551-3517","Jennifer.Giordano@corewellhealth.org",[46],{"facility":33,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Royal Oak","Michigan","48073","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-83.14465,42.48948,{"lat":57,"lon":56},[60,61,62],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},{"name":32,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Kenneth M Peters, MD","Director and Chair of the Department of Urology","100372766","btl-emsella-chair-versus-sham-for-the-treatment-of-stress-urinary-incontinence-100372766",false,"NCT04133675","BTL Emsella Chair Versus Sham for the Treatment of Stress Urinary Incontinence","A Single-Blind, Randomized Study of the BTL EmsellaTM Chair Versus Sham for the Treatment of Stress Urinary Incontinence","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. Females and males, 18 to 80 years of age, inclusive, at screening\n3. Positive Cough or Bladder Stress Test at screening\n4. Subject agrees not to start any new treatment (medication or otherwise) during the treatment and follow-up periods.\n\n6\\. Subject agrees to maintain a stable dose of any medication known to affect lower urinary tract function, including but not limited to anticholinergics, tricyclic antidepressants, beta-3 adrenergic agonist, or α-adrenergic blockers, throughout the treatment and follow-up periods.\n\nFor Females Only:\n\n* Subject agrees to discontinue use of bladder support devices, including but not limited to vaginal pessary, during the screening, treatment, and follow-up periods.\n* 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\nFor Males Only:\n\n\\- Subject must be ≥ 4 months post radical prostatectomy\n\nExclusion Criteria:\n\n1. Pelvic floor physical therapy, including muscle training and\u002For electrostimulation, in a clinical setting within 30 days prior to screening\n2. Subject is morbidly obese (defined as body mass index 40 or greater)\n3. Pulmonary insufficiency, defined as difficulty breathing and fatigue, especially during exercise; chest pain, such as squeezing, pressure or 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 lower extremities\n5. Implanted cardiac pacemaker or metal in the body, including, but not limited to drug pumps, neurostimulators, electronic implants, copper intrauterine devices (IUDs), and\u002For defibrillators\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. Treatment with urethral bulking agents within the 6 months prior to the Screening Visit\n11. Subject is currently receiving treatment for a malignant tumor that would interfere with study participation.\n12. Subject has used the BTL EMSELLA device previously\n13. Subject has urinary incontinence of neurogenic etiology, such as multiple sclerosis, spina bifida, Parkinson's, spinal cord injury, diabetic neuropathy etc.\n14. Clinically confirmed urinary tract infection, requiring treatment as determined by the investigator, at the Screening Visit\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\n18. History of surgery with insertion of vaginal mesh for SUI\n19. Vaginal prolapse beyond the introitus\n20. Vaginal rejuvenation treatment, including laser treatments and radiofrequency therapy, within the 6 months prior to the Screening Visit\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","80 Years",{"count":77,"type":78},110,"ESTIMATED","INTERVENTIONAL",[81],"NA","Stress urinary incontinence (SUI) is a condition that affects both men and women. SUI is the involuntary leakage of urine caused by an increase in intra-abdominal pressure from activities such as exercise, coughing, laughing, or sneezing. It can significantly affect quality of life as patients avoid activities or behaviors that cause leakage. This clinical trial will compare the efficacy of the Emsella chair to sham and determine if electromagnetic technology is effective in the treatment of SUI.",[84],"Stress Urinary Incontinence",[86,87],"urinary incontinence","urine leakage","2025-12-05",{"date":90,"type":91},"2025-12-11","ACTUAL",{"date":93,"type":91},"2019-12-18",{"date":95,"type":78},"2028-12",{"name":5,"class":6},1]