[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649952":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":37,"centralContacts":42,"locations":48,"responsibleParty":64,"collaborators":27,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":27,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":27,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":92,"whyStopped":27,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Pamukkale University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Active TTNS Group","EXPERIMENTAL","Pelvic floor muscle training (PFMT) plus active TTNS, delivered via Enraf Nonius Myomed 932, unilateral, 20 Hz, 200 microseconds pulse width, continuous mode; once weekly, 30 minutes per session, for 12 weeks (12 sessions total), plus a 12-week progressive home-based PFMT program.",[13,14],"Device: Active Transcutaneous Tibial Nerve Stimulation (TTNS)","Behavioral: Pelvic Floor Muscle Training (PFMT)",{"label":16,"type":17,"description":18,"interventionNames":19},"Sham TTNS Group","SHAM_COMPARATOR","Pelvic floor muscle training (PFMT) plus sham TTNS, using an identical device, electrode placement, session duration, frequency, and total duration; a four-electrode masking protocol is applied with brief initial sensory stimulation followed by gradual current reduction to zero. Same PFMT program as the active arm.",[20,14],"Device: Sham Transcutaneous Tibial Nerve Stimulation (TTNS)",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DEVICE","Active Transcutaneous Tibial Nerve Stimulation (TTNS)","Active TTNS delivered via Enraf Nonius Myomed 932 at 20 Hz, 200 microseconds pulse width, continuous mode; once weekly, 30 minutes per session, for 12 weeks.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Sham Transcutaneous Tibial Nerve Stimulation (TTNS)","Sham TTNS using the same device and electrode placement; brief initial sensory stimulation followed by gradual current reduction to zero, so no current is delivered during the session. Once weekly, 30 minutes per session, for 12 weeks.",[16],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"BEHAVIORAL","Pelvic Floor Muscle Training (PFMT)","A 12-week progressive home-based pelvic floor muscle training program with graded contraction\u002Frelaxation durations and postural progression.",[9,16],[38],{"name":39,"affiliation":40,"role":41},"Necmettin Yıldız, MD","Pamukkale University Faculty of Medicine","PRINCIPAL_INVESTIGATOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":27,"email":47},"Yusuf YOLCU, MD","CONTACT","+90 258 296 16 02","dr.yusufyolcu@gmail.com",[49],{"facility":50,"status":27,"city":51,"state":52,"zip":53,"country":54,"countryCode":27,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Pamukkale University Faculty of Medicine, Department of Physical Medicine and Rehabilitation","Pamukkale","Denizli","20160","Turkey (Türkiye)",{"type":56,"coordinates":57},"Point",[58,59],29.11729,37.91644,{"lat":59,"lon":58},[62,63],{"name":44,"role":45,"phone":46,"phoneExt":27,"email":47},{"name":39,"role":41,"phone":27,"phoneExt":27,"email":27},{"type":41,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Necmettin Yildiz","Professor","100649952","transcutaneous-tibial-nerve-stimulation-for-urinary-incontinence-after-radical-prostatectomy-100649952",false,"NCT07742176","Transcutaneous Tibial Nerve Stimulation for Urinary Incontinence After Radical Prostatectomy","Efficacy of Transcutaneous Tibial Nerve Stimulation in Patients With Urinary Incontinence After Radical Prostatectomy: A Randomized, Double-Blind, Sham-Controlled Clinical Trial","Inclusion Criteria:\n\n* Male patients aged 18-80 years\n* Urinary incontinence greater than 8 g on the 24-hour pad test after radical prostatectomy\n* Postoperative catheter removed, between 2 weeks and 1 year after surgery\n* Willing to complete study questionnaires and able to understand the procedures, benefits, and possible side effects\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* History of urinary incontinence prior to radical prostatectomy\n* History of conservative treatment after prostatectomy, including tibial nerve stimulation, magnetic stimulation, or electrical stimulation\n* Prolonged indwelling urethral catheterization (more than 15 days)\n* Anatomical\u002Fpost-traumatic malformations or active skin conditions at electrode sites preventing electrode application or stimulation\n* History of prior urological surgery\n* Inability to voluntarily contract pelvic floor muscles on digital rectal examination per ICS terminology\n* Currently receiving or having received radiotherapy\n* Urethral stricture or active urinary tract infection\n* Heart failure, pacemaker, or implanted defibrillator\n* History of transurethral resection of the prostate (TURP) for benign prostatic hyperplasia\n* Use of medications that may affect bladder function (antimuscarinics, duloxetine, tricyclic antidepressants, etc.)\n* History of neurogenic bladder or peripheral\u002Fcentral neurological pathology\n* Inability to attend treatment sessions regularly due to distance or physical limitations","MALE","18 Years","80 Years",{"count":78,"type":79},104,"ESTIMATED","INTERVENTIONAL",[82],"NA","Urinary incontinence (UI) after radical prostatectomy (RP) is a common postoperative complication that significantly affects quality of life. This study aims to evaluate the efficacy of active transcutaneous tibial nerve stimulation (TTNS), added to standard pelvic floor muscle training (PFMT), compared with sham TTNS, in patients with UI after RP. The study uses a randomized, double-blind, sham-controlled design. The primary outcome is incontinence severity measured by the 24-hour pad test. Secondary outcomes include voiding diary parameters, pelvic floor muscle strength (perineometry), quality of life, sexual function, and anxiety\u002Fdepression levels.",[85,86],"Urinary Incontinence (UI)","Prostatectomy",[88,89,90,91],"Radical prostatectomy","Urinary incontinence","Pelvic floor muscle training","Transcutaneous tibial nerve stimulation","NOT_YET_RECRUITING","2026-08-05",{"date":95,"type":96},"2026-08-06","ACTUAL",{"date":98,"type":79},"2026-08",{"date":100,"type":79},"2027-12",{"name":5,"class":6},1]