[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100205612":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":32,"responsibleParty":50,"collaborators":18,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":18,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":18,"studyType":65,"phases":66,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":35,"whyStopped":18,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Autologous Muscle Fiber Fragments","EXPERIMENTAL","Autologous Muscle Fiber Fragments administered via a single,direct injection into the bladder neck sphincter region",[13],"Other: Autologous Muscle Fiber Fragments",[15],{"type":6,"name":9,"description":16,"armGroupLabels":17,"otherNames":18},"Autologous muscle fiber fragments administered via a single direct injection into the bladder neck sphincter region",[9],null,[20],{"name":21,"affiliation":22,"role":23},"Gopal Badlani, MD","Wake Forest School of Medicine, Dept. of Urology","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Mary-Clare Day, RN, BSN","CONTACT","336-713-1343","mday@wakehealth.edu",{"name":21,"role":27,"phone":18,"phoneExt":18,"email":31},"gbadlani@wakehealth.edu",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Wake Forest Urology Clinic","RECRUITING","Winston-Salem","North Carolina","27103","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-80.24422,36.09986,{"lat":45,"lon":44},[48,49],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},{"name":21,"role":23,"phone":18,"phoneExt":18,"email":18},{"type":51,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100205612","phase-1-muscle-fiber-fragment-treatment-for-urinary-incontinence-100205612",false,"NCT01953263","Muscle Fiber Fragment Treatment for Urinary Incontinence","A Phase 1 Study of Human Muscle Fiber Fragment (MFF) Treatment for Urinary Incontinence","Inclusion Criteria:\n\n* Adult female patients who are not pregnant or lactating\u002Fbreast-feeding and must be either not sexually active, surgically sterilized, or must be practicing an effective method of birth control as determined by the investigator\n* Patients between the ages of 18 and 75 years\n* Patients with positive diagnosis of urinary incontinence due to sphincter insufficiency caused by acquired (e.g., stress urinary incontinence) and\u002For congenital conditions.\n* Patients with cystometric capacity of bladder \\> 100 ml\n* Patients with normal renal function\n* Patients with a history of primary incontinence\n\nExclusion Criteria:\n\n* Patients with a history of hypercontractile bladder, non-compliant bladder, hydronephrosis or neurogenic bladder\n* Patients with an active urinary tract infection as evidenced by positive urine culture\n* Patients who are taking medication that affect urination such as prescription drugs, over-the-counter drugs, or dietary supplements, including herbal supplements and those taken with teas\n* Patients requiring concomitant use of or treatment with immunosuppressive agents\n* Patients with a history of systemic conditions, including but not limited to HIV, diabetes and chronic liver disease (including Hepatitis B or C), that the Investigator believes may jeopardize the safety of the patient to participate in the study\n* Patients with evidence or diagnosis of any primary muscle disease or coagulation disorder (including concomitant anti-coagulation therapy)\n* Patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this study\n* Patients who have been treated with any cellular therapy within 12 months prior to enrollment in this study\n* Patients with urinary incontinence other than the categories being investigated\n* Patients with significant (\\>grade 2) pelvic organ prolapse\n* Patients with vaginal prolapse beyond introitus\n* Patients with neurological disorders\n* Patients with abnormal bladder capacity (i.e., less than 100 cc)\n* Patients with abnormal urologic conditions, including post-void residual, urethral stricture and bladder neck contracture, spastic bladder, vesicoureteral reflux, bladder stones, bladder tumors, hydronephrosis, other renal impairment","FEMALE","18 Years","75 Years",{"count":63,"type":64},10,"ESTIMATED","INTERVENTIONAL",[67,68],"PHASE1","PHASE2","This study is designed to evaluate the safety of autologous muscle fiber fragments for the treatment of urinary incontinence due to incompetent outlet (bladder neck\u002Furethra).",[71],"Urinary Incontinence",[73],"urinary incontinence, muscle fibers","2026-04-22",{"date":76,"type":77},"2026-04-23","ACTUAL",{"date":79,"type":18},"2016-01",{"date":81,"type":64},"2028-12",{"name":83,"class":6},"Wake Forest University",1]