[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561415":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":32,"locations":37,"responsibleParty":52,"collaborators":24,"id":55,"slug":24,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":24,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":24,"enrollmentInfo":63,"targetDuration":24,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":40,"whyStopped":24,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care","ACTIVE_COMPARATOR","Standard of care. Perioperative education for information related to prostatectomy and pelvic floor exercise training. Patient were advice to perform pelvic floor exercise at least 30 times per day",[13],"Other: Standard of care",{"label":15,"type":16,"description":17,"interventionNames":18},"EM Chair","EXPERIMENTAL","Patients who randomised to intervention group (Arm A) will receive HIFEM assisted (BTL EMsella) pelvic floor muscle training for total 6 sessions (2 session per week, 30 minutes per session with modulated intensity) plus standard of care. The intervention will be started within 2 weeks after Foley Catheter removed. Patients will attend follow up for training and at 1, 3 and 6 month post-operatively.",[19],"Device: EM Chair",[21,25],{"type":22,"name":15,"description":17,"armGroupLabels":23,"otherNames":24},"DEVICE",[15],null,{"type":6,"name":26,"description":11,"armGroupLabels":27,"otherNames":24},"Standard of care",[9],[29],{"name":30,"affiliation":5,"role":31},"Chi Fai NG, MD","PRINCIPAL_INVESTIGATOR",[33],{"name":30,"role":34,"phone":35,"phoneExt":24,"email":36},"CONTACT","35052625","ngcf@surgery.cuhk.edu.hk",[38],{"facility":39,"status":40,"city":41,"state":24,"zip":24,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Prince of Wales Hospital","RECRUITING","Shatin","Hong Kong",{"type":44,"coordinates":45},"Point",[46,47],114.18333,22.38333,{"lat":47,"lon":46},[50],{"name":30,"role":34,"phone":51,"phoneExt":24,"email":36},"3505 2625",{"type":31,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Chi Fai NG","Professor","100561415",false,"NCT06589869","Effect of High-Intensity Focused Electromagnetic (HIFEM) Technology in the Treatment of SUI in Chinese Men Undergone Robotic Radical Prostatectomy","To Investigate the Effect of High-Intensity Focused Electromagnetic (HIFEM) Technology in the Treatment of Stress Urinary Incontinence Compared With Standard of Care in Chinese Men Who Had Undergone Robotic Radical Prostatectomy","Inclusion Criteria:\n\n* Undergone robotic radical prostatectomy\n* Able to carry out 1-hour pad test\n* Voluntary participation and signing of the informed consent form\n\nExclusion Criteria:\n\n* Pre-existing stress urinary incontinence\n* Post-void residual urine greater than 200ml\n* Active urinary tract infection\n* Urethral or bladder fistula\n* History of pelvic irradiation\n* Neurological condition (Spinal cord problems, stroke with poor neurological recovery, epilepsy, Parkinson disease, multiple sclerosis)\n* Previous surgery for SUI\n* Concurrent medication with diuretics, serotonin-norepinephrine reuptake inhibitors or any other medication known to worsen incontinence\n* Condition contraindicated for electromagnetic therapy i.e. Arrhythmia, on a pacemaker or implanted metallic device; Coagulopathy or on anticoagulant","MALE","18 Months",{"count":64,"type":65},184,"ESTIMATED","INTERVENTIONAL",[68],"NA","This is a prospective, randomized trial to evaluate the efficacy and safety of High-Intensity Focused Electromagnetic (HIFEM) Technology in the treatment of stress urinary incontinence compared with standard of care in Chinese men who had undergone robotic radical prostatectomy.",[71,72],"Urinary Incontinence , Stress","Prostatectomy",[74,75],"stress urinary incontinence","prostatectomy","2024-09-10",{"date":78,"type":79},"2024-09-19","ACTUAL",{"date":81,"type":79},"2022-07-29",{"date":83,"type":65},"2026-06",{"name":5,"class":6},1]