[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07534696":3,"trial-entities:NCT07534696":95,"trial-summary:NCT07534696":98},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":36,"secondary_outcomes":47,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":14,"eligibility_criteria":54,"std_ages":68,"locations":71,"central_contacts":81,"overall_officials":82,"references":83,"see_also_links":91},"NCT07534696","IRB #26-0324","Evaluation of Non-Invasive Pelvic Floor Neuromuscular Stimulation for Urinary Incontinence After Prostatectomy","ENROLLING_BY_INVITATION","2026-12-31","2026-05","2026-05-27","2026-05-20","University of California, Los Angeles","OTHER",false,"Urinary incontinence is a common complication following prostatectomy and affects a substantial proportion of patients. Despite advances in surgical technique, many patients experience persistent symptoms that negatively impact quality of life. Current management strategies include pelvic floor muscle training, biofeedback and physical therapy, and surgical options. However, these approaches may be limited by adherence, access, and invasiveness, leaving a subset of patients with ongoing symptoms despite standard care.\n\nNon-invasive pelvic floor neuromuscular stimulation has emerged as a potential adjunct for pelvic floor rehabilitation by inducing supramaximal muscle contractions and enhancing neuromuscular activation without requiring active patient effort. Preliminary studies suggest that high-intensity electromagnetic stimulation may improve patient-reported continence outcomes and pad usage in women as well as men following radical prostatectomy, though existing data are limited by small sample sizes and short follow-up durations. Additionally, no clinical studies exist evaluating outcomes in men following prostatectomy prior to established stress incontinence.\n\nGiven these limitations, further evaluation is needed to assess the feasibility, tolerability, and short-term effectiveness of this intervention in a post-prostatectomy population.","This prospective study aims to evaluate feasibility, safety, and patient-reported continence outcomes associated with non-invasive pelvic floor neuromuscular stimulation in men with urinary incontinence following prostatectomy. Findings may inform future clinical implementation and guide the design of larger, controlled trials.",[18,19],"Urinary Incontinence","Prostatectomy",[21,22],"Neuromuscular stimulation","HIFEM","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},37,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DEVICE","Non-invasive pelvic floor neuromuscular stimulation","Participants will complete an 8-week intervention (12 sessions total), with outcomes assessed at baseline, end of treatment, and follow-up within three months of starting the intervention.",[33],[37,41,44],{"measure":38,"description":39,"timeFrame":40},"Change in EPIC questionnaire score","The Expanded Prostate Cancer Index Composite (EPIC) is a validated questionnaire assessing urinary, bowel, sexual, and hormonal outcomes.","From enrollment to 3 months after initiation of treatment",{"measure":42,"description":43,"timeFrame":40},"Change in ICIQ-UI questionnaire score","The International Consultation on Incontinence Questionnaire Urinary Incontinence (ICIQ-UI) short form is a validated questionnaire assessing urinary incontinence.",{"measure":45,"description":46,"timeFrame":40},"Continence","Continence is measured by number of pads used per 24 hours, with continence defined as less than one pad used per day.",[48],{"measure":49,"description":50,"timeFrame":40},"Treatment failure","Treatment failure is defined as requiring procedural or surgical intervention for urinary incontinence following prostatectomy.","MALE","18 Years",null,{"inclusion":55,"exclusion":59,"raw_text":67},[56,57,58],"Men aged 18 years or older","Undergoing or underwent prostatectomy at UCLA","Able to provide informed consent",[60,61,62,63,64,65,66],"Cardiac pacemaker, implanted defibrillator, or other contraindicated metallic or electronic implants","Active urinary tract infection","Hematuria of unknown origin","Untreated bladder outlet obstruction","Neurologic conditions affecting bladder function (e.g., multiple sclerosis, Parkinson disease, spinal cord injury)","Active fever or systemic inflammatory condition at the time of treatment","Any condition deemed by the investigator to make participation unsafe","Inclusion Criteria:\n\n* Men aged 18 years or older\n* Undergoing or underwent prostatectomy at UCLA\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Cardiac pacemaker, implanted defibrillator, or other contraindicated metallic or electronic implants\n* Active urinary tract infection\n* Hematuria of unknown origin\n* Untreated bladder outlet obstruction\n* Neurologic conditions affecting bladder function (e.g., multiple sclerosis, Parkinson disease, spinal cord injury)\n* Active fever or systemic inflammatory condition at the time of treatment\n* Any condition deemed by the investigator to make participation unsafe",[69,70],"ADULT","OLDER_ADULT",[72],{"facility":73,"city":74,"state":75,"zip":76,"country":77,"geoPoint":78},"UCLA The Men's Clinic","Santa Monica","California","90403","United States",{"lat":79,"lon":80},34.01949,-118.49138,[],[],[84,88],{"pmid":85,"type":86,"citation":87},"40909763","BACKGROUND","Tosun H, Akinsal EC, Bas U, Sonmez G, Baydilli N, Demirci D. Evaluating the Efficacy of High-Intensity Focused Electromagnetic (HIFEM) Therapy for Postprostatectomy Incontinence in Men. Ther Clin Risk Manag. 2025 Aug 30;21:1309-1315. doi: 10.2147\u002FTCRM.S534674. eCollection 2025.",{"pmid":89,"type":86,"citation":90},"31172580","Samuels JB, Pezzella A, Berenholz J, Alinsod R. Safety and Efficacy of a Non-Invasive High-Intensity Focused Electromagnetic Field (HIFEM) Device for Treatment of Urinary Incontinence and Enhancement of Quality of Life. Lasers Surg Med. 2019 Nov;51(9):760-766. doi: 10.1002\u002Flsm.23106. Epub 2019 Jun 7.",[92],{"label":93,"url":94},"Device used for non-invasive pelvic floor neuromuscular stimulation","https:\u002F\u002Faesthetic.zimmerusa.com\u002Fpf-toner-pro\u002F",{"nct_id":4,"conditions":96,"biomarkers":97},[18],[],{"nct_id":4,"found":99,"summary":100,"prompt_version":110},true,{"design":101,"status":102,"heading":103,"summary":104,"follow_up":105,"word_count":106,"commitments":107,"compensation":108,"drugs_mentioned":109},"This is an interventional study with a planned enrollment of 37 men. It is not specified if it is randomized or blinded.","completed","Non-Invasive Pelvic Floor Neuromuscular Stimulation for Urinary Incontinence After Prostatectomy","This study is looking at a treatment called non-invasive pelvic floor neuromuscular stimulation for men who experience urinary incontinence (leaking urine) after prostatectomy (surgery to remove the prostate). This treatment uses a device to help strengthen pelvic floor muscles without needing active effort from you. The study aims to see if this treatment is safe and effective in improving continence. Researchers will measure changes in your symptoms using questionnaires. You may be able to join if you are a man aged 18 or older, have had a prostatectomy at UCLA, and do not have certain medical conditions like a pacemaker or active urinary tract infection. The study plans to enroll 37 participants, but its current status is unclear.","Your continence and questionnaire scores will be measured up to 3 months after starting the treatment.",118,"Participants will complete an 8-week intervention with 12 sessions total. Outcomes will be assessed at the beginning, end of treatment, and within three months of starting the intervention.","Not stated in the trial record.",[33],"v2"]