[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637891":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":56,"collaborators":60,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":24,"enrollmentInfo":72,"targetDuration":24,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":42,"whyStopped":24,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University Hospital, Martin","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Electrical Stimulation + Active Contraction","ACTIVE_COMPARATOR","Home-based anal electrical stimulation combined with synchronized active voluntary anal sphincter contraction for 12 weeks",[13],"Device: Home-based anal electrical stimulator",{"label":15,"type":10,"description":16,"interventionNames":17},"Electrical Stimulation Alone","Home-based anal electrical stimulation alone without active voluntary sphincter contraction for 12 weeks.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Home-based anal electrical stimulator","Home-based anal electrical stimulation delivered using the NeuroTrac Continence device. Stimulation parameters include frequency 40 Hz, pulse width 250 µs, 5 seconds ON and 10 seconds OFF cycles, 1-second ramp-up, session duration 25 minutes, and patient-adjusted intensity up to the maximum tolerable level without pain.",[9,15],null,[26],{"name":27,"affiliation":28,"role":29},"Peter Liptak, MD, PhD","Clinic of Internal Medicine- Gastroenterology, University Hospital Martin, Jessenous Faculty of Medicine in Martin, Comenius University, Slovakia","STUDY_DIRECTOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":35},"Peter Liptak, MD, PHD","CONTACT","+421904820189","peter.liptak@gmail.com",{"name":37,"role":33,"phone":24,"phoneExt":24,"email":38},"Adam Lukac, MD","adamlukac99@gmail.com",[40],{"facility":41,"status":42,"city":43,"state":24,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Clinic of Internal Medicine- Gastroenterology, University Hospital Martin","RECRUITING","Martin","03601","Slovakia","SK",{"type":48,"coordinates":49},"Point",[50,51],18.92399,49.06651,{"lat":51,"lon":50},[54,55],{"name":27,"role":33,"phone":34,"phoneExt":24,"email":35},{"name":37,"role":33,"phone":24,"phoneExt":24,"email":38},{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Peter Liptak","Consultant Gastroenterologist and clinical researcher",[61],{"name":62,"class":6},"Comenius University","100637891","active-versus-passive-anal-sphincter-training-in-patients-with-fecal-incontinence-100637891",false,"NCT07604415","Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence","ACTIPAST","Inclusion Criteria:\n\n* Signed informed consent\n* Age ≥18 years\n* Diagnosis of fecal incontinence (urge, passive, or mixed type) with at least 1 episode of involuntary stool leakage requiring hygiene intervention or underwear change per month for ≥3 months\n* Vaizey (St. Mark's) Incontinence Score ≥8\n* Ability to understand study procedures and comply with the 12-week home intervention\n* Willingness to attend all study visits and assessments\n* Stable medical management for fecal incontinence for at least 4 weeks prior to enrollment\n\nExclusion Criteria:\n\n* Complete spinal cord injury above the conus medullaris\n* Active inflammatory bowel disease flare requiring systemic therapy or not in clinical remission\n* Rectal prolapse requiring surgical intervention\n* Severe symptomatic hemorrhoids interfering with anorectal assessments or device use\n* Active anal fissure or perianal fistula\n* Active colorectal cancer or history of colorectal cancer within 5 years\n* Colorectal surgery within the previous 6 months\n* Pregnancy or planned pregnancy during study participation\n* Implanted cardiac pacemaker or defibrillator\n* Other implanted electrical devices contraindicating electrical stimulation\n* Previous specialized pelvic floor physiotherapy, biofeedback therapy, EMG-guided rehabilitation, or anal electrical stimulation within 3 months prior to randomization\n* Cognitive impairment preventing understanding of study procedures or informed consent\n* Uncontrolled severe diarrhea (\\>5 liquid stools\u002Fday)\n* Anal stenosis preventing probe insertion\n* Severe anal sphincter defect (\\>120° on ultrasound) requiring surgical repair\n* Isolated severe rectal sensory dysfunction without significant sphincter dysfunction\n* Previous pelvic radiotherapy\n* Concurrent participation in another interventional clinical trial","ALL","18 Years",{"count":73,"type":74},24,"ESTIMATED","INTERVENTIONAL",[77],"NA","Fecal incontinence is a disabling condition that can substantially impair quality of life. This study evaluates whether home-based anal electrical stimulation combined with active voluntary anal sphincter contraction is superior to electrical stimulation alone in patients with fecal incontinence.\n\nThe study is a prospective, randomized, parallel-group, open-label controlled trial. Participants will be randomized in a 1:1 ratio to either electrical stimulation with synchronized active sphincter contraction or electrical stimulation alone. The primary outcome is the change in Vaizey\u002FSt. Mark's Incontinence Score from baseline to week 12. Secondary outcomes include fecal incontinence episodes, quality of life, anorectal manometry parameters, adherence, safety, and sustained response during follow-up.",[80],"Fecal Incontinence",[82,83,84],"fecal incontinence","anal stimulation","pelvic floor training","2026-05-22",{"date":87,"type":88},"2026-05-28","ACTUAL",{"date":90,"type":88},"2026-05-15",{"date":92,"type":74},"2029-05",{"name":5,"class":6},1]