[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556977":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":24,"locations":25,"responsibleParty":49,"collaborators":24,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":24,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":61,"minAge":62,"maxAge":24,"enrollmentInfo":63,"targetDuration":24,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":27,"whyStopped":24,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Medical College of Wisconsin","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"fatigability of various striated continence muscles healthy adults","ACTIVE_COMPARATOR","Device: anorectal manometry\u002Fvaginal manometry (female) with and without applying c-RED Participants will do repetitive anal contraction and sustained contraction without device and with device in a random order. For contraction with the device, three different resistance level will be applied as described previously.\n\nFor isometric contraction, the annal balloon of the device will be inflated to internal pressure of 500mmHg, which is noncompressible. Participants will repeat the repetitive contraction and sustained contraction.",[13],"Device: continence muscles resistance device",{"label":15,"type":10,"description":16,"interventionNames":17},"contribution of continence muscles motor function enhancement in improving fecal incontinence","Device: anorectal manometry\u002Fvaginal manometry (female) with c-RED Patients will then be assigned to one of the exercise protocols for 6 weeks. Protocol 1: 20 Kegel like repetitive short contractions against a progressively increased intra-vaginal resistance Protocol 2: 40 Kegel like repetitive short contractions against a progressively increased intra-vaginal resistance Protocol 3: 20 Kegel like repetitive short contractions against a progressively increased intra-anal resistance Protocol 4: 40 Kegel like repetitive short contractions against a progressively increased intra-anal resistance Protocol 5: 20 Kegel like repetitive short contractions without device Protocol 6: 40 Kegel like repetitive short contractions without device Protocol 7: 20 Kegel like repetitive short contractions against the non-compressible balloon as previously mentioned Protocol 8:40 Kegel like repetitive short contractions against the non-compressible balloon as previously mentioned",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","continence muscles resistance device","The c-RED consists of a noncompliant cylindrical balloon (intra-anal balloon) that is connected to a small compliant balloon (external balloon) by a 2 mm diameter tube and a stopcock to allow for air to be filled and sealed in the system. The system is prefilled with air to determine the amount of air needed for a given internal pressure, or desired resistance of the intra-anal balloon. This is determined using a sphygmomanometer gauge in a sealed system.",[15,9],null,[26],{"facility":5,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"RECRUITING","Milwaukee","Wisconsin","53086","United States","US",{"type":34,"coordinates":35},"Point",[36,37],-87.90647,43.0389,{"lat":37,"lon":36},[40,45],{"name":41,"role":42,"phone":43,"phoneExt":24,"email":44},"Ling Mei, MD","CONTACT","4148059694","lmei@mcw.edu",{"name":46,"role":42,"phone":47,"phoneExt":24,"email":48},"Mark Kern","4148053826","mkern@mcw.edu",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Ling Mei MD, MPH","Associate Professor","100556977","mechanisms-of-improving-fecal-continence-muscles-motor-function-100556977",false,"NCT06532123","Mechanisms of Improving Fecal Continence Muscles Motor Function","Mechanisms of Improving Fecal Continence Muscles Motor Function in Health and Disease","Inclusion Criteria:\n\n* Healthy volunteers without past or present history of fecal incontinence\n* Patients age 18 years and older with reduced anal resting and or squeeze pressure, reflecting weakness of the anal sphincters who can perform the study\n\nExclusion Criteria:\n\n* Any one less than 18 years old\n* Neurological disorders like dementia, cerebrovascular diseases\n* Muscle diseases like muscular dystrophy, myopathies\n* Inflammatory bowel disease or celiac disease\n* Neuro-muscular junction disorders\u002Fmyasthenia gravis, Eaton-Lambert syndrome\n* Organ prolapse, large rectocele(\\>2cm), rectal intussusception\n* Hip dysplasia or recent hip surgery and immobile patients.\n* Patients with complete normal anal resting and squeeze pressure\n* Impaired rectal evacuation (dyssynergy defecation)\n* Fecal incontinence completely due to loss of rectal sensation\n* Subjects unable to contract their external anal sphincter at all",true,"ALL","18 Years",{"count":64,"type":65},340,"ESTIMATED","INTERVENTIONAL",[68],"NA","The investigators hypothesize that different continence muscles have different fatigue characteristics and fatigue induced by resisted contractions will result in significant increase in contractility of the continence muscles and improvement of fecal incontinence severity.",[71],"Fecal Incontinence",[73],"fecal incontinence","2025-10-21",{"date":76,"type":77},"2025-10-23","ACTUAL",{"date":79,"type":77},"2025-07-15",{"date":81,"type":65},"2030-03-01",{"name":5,"class":6},1]