[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555679":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":51,"collaborators":53,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":20,"enrollmentInfo":65,"targetDuration":20,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":20,"overallStatus":39,"whyStopped":20,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"University College, London","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","Implantation of Epidural Spinal Cord Stimulation to target bladder and bowel function. Applied in combination with Pelvic Floor Muscle Training.",[13],"Device: Epidural Spinal Cord Stimulation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Epidural Spinal Cord Stimulation","Epidural Spinal Cord Stimulation Mapping and Pelvic Floor Muscle Training",[9],null,[22],{"name":23,"affiliation":24,"role":25},"David Baxter, MD","National Health Service, United Kingdom","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Lynsey Duffell, PhD","CONTACT","0208 385 3787","l.duffell@ucl.ac.uk",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Hannah Houliston, PhD","02039470291","hannah.houliston@nhs.net",[37],{"facility":38,"status":39,"city":40,"state":20,"zip":20,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Royal National Orthopaedic Hospital","RECRUITING","Stanmore","United Kingdom","UK",{"type":44,"coordinates":45},"Point",[46,47],-0.31667,51.61667,{"lat":47,"lon":46},[50],{"name":33,"role":29,"phone":20,"phoneExt":20,"email":35},{"type":52,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[54],{"name":55,"class":6},"Royal National Orthopaedic Hospital NHS Trust","100555679","improving-pelvic-rehabilitation-using-epidural-stimulation-after-spinal-cord-injury-100555679",false,"NCT06515223","Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury","ImPRESS","Inclusion Criteria:\n\n* Spinal Cord Injury (supra-sacral)\n* AIS A-D\n* \\>18 years;\n* SCI sustained \\>12 months ago;\n* Neurogenic detrusor overactivity (NDO) confirmed on urodynamics;\n* Responsive to dorsal genital nerve stimulation\n* Willing and able to provide informed consent\n* Stable medical, physical and psychological condition as considered by the investigators\n* Able to understand and interact with the study team in English\n* Sufficient upper limb function to operate the device\n* Suitably optimised bladder and bowel routine\n\nExclusion Criteria:\n\n* Transected cord or SCI related to a neurodegenerative disease\n* Any device or metal work in situ that would exclude the patient from having eSCS implanted\n* Intra-detrusor botulinum toxin injections within the last 6 months\n* Previous surgical intervention on bladder sphincters\n* Any diseases and conditions that would exclude the patient from eSCS and\u002For surgery, for example, degenerative spinal pathology, syrinx and\u002For tumor.\n* Recurrent urinary tract infection refractory to antibiotics\n* Women who are pregnant or intending to become pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding, or lack of safe contraception for women of childbearing capacity.\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders or dementia of the participant\n* Participation in another study with investigational drug within the 30 days preceding and during the present study\n* Enrolment of the investigator, his\u002Fher family members, employees, and other dependent persons.","ALL","18 Years",{"count":66,"type":67},20,"ESTIMATED","INTERVENTIONAL",[70],"NA","The investigators will recruit up to 20 volunteers with chronic, supra-sacral SCI. Following screening, eligible participants will enter 'Phase I', they will complete baseline outcome measures and then have the epidural spinal cord stimulator (eSCS) implanted with either percutaneous or paddle electrodes. Preoperative and intraoperative testing will determine exact location of electrodes.\n\nMapping and optimisation of stimulation parameters will be performed simultaneously with urodynamic investigations of bladder function, and anorectal physiology investigations of bowel function. The acute effects of eSCS to suppress bladder overactivity, facilitate voiding, prevent unwanted reflex sphincter activity, and pelvic floor function will guide development of eSCS programmes for use at home.\n\nIn 'Phase II', participants will use eSCS at home for 12-weeks. Participants will also be taught how to perform bladder and pelvic floor muscle training (PFMT) in combination with eSCS.\n\nOutcome measures assessing bladder, bowel, sexual function, quality of life, motor function and spasticity will be captured prior to and following the 12-week intervention, and at 3 and 6 month follow up.",[73,74,75,76,77],"Spinal Cord Injuries","Neuromodulation","Neurogenic Bladder","Neurogenic Bowel","Neurogenic Detrusor Overactivity","2025-03-13",{"date":80,"type":81},"2025-03-14","ACTUAL",{"date":83,"type":81},"2024-10-14",{"date":85,"type":67},"2027-11-01",{"name":5,"class":6},1]