[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643857":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":51,"collaborators":20,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":20,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":20,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":76,"whyStopped":20,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Genital Nerve Stimulation","EXPERIMENTAL","Study participants will don the device at the beginning of the experiment session. An initial clinical urodynamics test will be performed to confirm that the participant has neurogenic bladder. The investigators will select stimulation parameters that effectively inhibit reflexive bladder contractions. Serial cystometrograms will then be conducted. Each fill will be conducted either 1) without stimulation (control runs) or 2) with stimulation.",[13],"Device: Noninvasive electrical stimulation device to improve bladder control",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Noninvasive electrical stimulation device to improve bladder control","Genital nerve stimulation (GNS) will be applied using a wearable, transcutaneous neurostimulator and sleeve electrode that targets the genital nerve reflex pathway for the treatment of neurogenic bladder associated with spinal cord injury.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Dennis Bourbeau, PhD","Louis Stokes VA Medical Center, Cleveland, OH","PRINCIPAL_INVESTIGATOR",[27],{"name":23,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","(216) 791-3800","4845","Dennis.Bourbeau@va.gov",[33],{"facility":24,"status":20,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Cleveland","Ohio","44106-1702","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-81.69541,41.4995,{"lat":43,"lon":42},[46,50],{"name":47,"role":28,"phone":29,"phoneExt":48,"email":49},"Curtis J Donskey, MD","4788","curtis.donskey@va.gov",{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":52,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100643857","phase-1-device-for-bladder-control-for-men-with-sci-100643857",false,"NCT07668063","Device for Bladder Control for Men With SCI","Noninvasive Electrical Stimulation Device to Improve Bladder Control for Men With Spinal Core Injury","Inclusion Criteria:\n\n* Suprasacral SCI\n* Neurologically stable\n* Skeletally mature\n* Presence of reflex bladder contractions\n* At least 12 months post SCI\n\nExclusion Criteria:\n\n* Active sepsis\n* Open pressure sores on or around pelvis\n* Bleeding diathesis\n* Significant urethral trauma, erosion, or stricture\n* Indwelling catheter for over 1 year AND bladder capacity less than 100 mL\n* Significant history of autonomic dysreflexia","MALE","18 Years",{"count":63,"type":64},12,"ESTIMATED","INTERVENTIONAL",[67,68],"PHASE1","PHASE2","Urinary incontinence, bladder frequency, and bladder urgency are significant medical problems for people with overactive bladder (OAB) or neurogenic bladder overactivity (NDO). Affected individuals typically experience reflex bladder contractions in response to bladder filling at low volumes, resulting in urinary incontinence and decreased bladder capacity. This project will advance a new device for administering noninvasive electrical stimulation in order to improve bladder control.",[71],"Neurogenic Bladder",[73,74,75],"Neurogenic detrusor overactivity","Spinal cord injury","Genital nerve stimulation","NOT_YET_RECRUITING","2026-06-18",{"date":79,"type":80},"2026-06-25","ACTUAL",{"date":82,"type":64},"2028-06-01",{"date":84,"type":64},"2029-12-31",{"name":5,"class":6},1]