[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neurogenic-detrusor-overactivity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neurogenic-detrusor-overactivity":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100477020","phase-2-open-label-long-term-safety-efficacy-and-pharmacokinetics-study-of-vibegron-in-pediatric-subjects-2-years-to--18-years-of-age-with-ndo-and-on-cic-100477020",false,"NCT05491525","Open-label, Long-term Safety, Efficacy, and Pharmacokinetics Study of Vibegron in Pediatric Subjects 2 Years to \u003C 18 Years of Age With NDO and on CIC","A Phase 2\u002F3, Open-label, Baseline-controlled, Multicenter, Long-term Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Vibegron in Pediatric Subjects 2 Years to \u003C 18 Years of Age With Neurogenic Detrusor Overactivity (NDO) on Clean Intermittent Catheterization (CIC)","KANGUROO","Inclusion Criteria:\n\n* Male or female participants, age 2 years to \\\u003C 18 years and weighing at least 11 kg at the Screening Visit.\n* Participant has been diagnosed with NDO due to one of the following: spinal dysraphism, which includes spina bifida (eg, myelomeningocele, meningocele) and all forms of tethered cord; or acquired NDO from a spinal cord injury or spinal cord surgery, with the injury\u002Fsurgery having occurred at least 6 months prior to the Screening Visit; or acquired NDO due to transverse myelitis with diagnosis at least 12 months prior to the Screening Visit.\n* Participant undergoes CIC at least 3 times per 24 hours (with the last CIC performed prior to going to sleep for the night) for at least 4 weeks prior to the Screening Visit.\n\nExclusion Criteria:\n\n* Participant has cerebral palsy, uncontrolled epilepsy, diabetes insipidus, or Stage 2 hypertension\n* Participant has an active malignancy in the 12 months prior to the Screening Visit.\n* Participant has been administered intravesical botulinum toxin within 9 months prior to the Screening Visit and should remain off this therapy during the study.\n* Participant is taking digoxin or lithium within 10 days prior to Screening Visit or plans to start taking either during the study.\n* Participant currently uses or plans to use a baclofen pump during the study.\n* Participant has had urethral dilatation or urethral surgery in the 3 months prior to the Screening Visit.\n* Participant has undergone bladder augmentation surgery.\n* Participant has a known genitourinary condition (other than NDO) that may cause overactive contractions or incontinence (bladder exstrophy, urinary tract obstruction, urethral diverticulum or fistula) or bladder stones or another persistent urinary tract pathology that may cause symptoms.\n* Participant has an insufficient urethral sphincter, has had implantation of an artificial sphincter, has a surgically-treated underactive urethral sphincter, or, in the 6 months prior to the Screening Visit, has undergone pelvic gender reassignment surgery.\n* Participant has one of the following gastrointestinal problems: partial or complete obstruction, decreased motility such as paralytic ileus, risk of gastric retention, or malabsorption syndrome of any form.\n* Participant has acute fecal impaction or, within the 3 months prior to the Screening Visit, had fecal impaction that required hospitalization or ambulatory surgical treatment.\n* Participant had a urinary indwelling catheter in the 4 weeks prior to the Screening Visit.\n* Participant has moderate to severe dilating vesicoureteral reflux (Grade IV to V) or severe renal failure.\n* Participant started electrostimulation\u002Fneuromodulation therapy in the 4 weeks before the Screening Visit, or is expected to start this therapy during the study period.\n* Participant has participated in another clinical trial and\u002For has taken an investigational drug within 4 weeks prior to the Screening Visit.\n* Participant is unable, or parent\u002Fcaregiver is not willing, to washout any medication for the management of NDO.\n* Participant is a female of childbearing potential who is unwilling or unable to use a highly effective method of contraception for the duration of the study.\n* Female participants who are currently breastfeeding or plan to breastfeed any time from the Screening Visit until 28 days after the final study drug administration.","ALL","2 Years","17 Years",{"count":21,"type":22},71,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE2","PHASE3","The purpose of this study is to evaluate the safety, efficacy, and PK of Vibegron in pediatric participants with NDO who are regularly using CIC",[29],"Neurogenic Detrusor Overactivity",[29,31,32,33,34,35,36,37,38,39,40],"Vibegron","Clean Intermittent Catheterization","Beta-3 Adrenergic Receptor Agonist","Maximum Cystometric Capacity","Spinal Dysraphism","Spina Bifida","Myelomeningocele","Meningocele","Spinal cord injury","Transverse myelitis","RECRUITING","2026-06-10",{"date":44,"type":45},"2026-06-15","ACTUAL",{"date":47,"type":45},"2022-10-12",{"date":49,"type":22},"2030-09",{"name":51,"class":52},"Urovant Sciences GmbH","INDUSTRY",38,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100561909","phase-1-dose-escalation-study-of-eg110a-administered-by-intradetrusor-injections-to-adults-with-neurogenic-detrusor-overactivity-related-incontinence-following-spinal-cord-injury-who-regularly-perform-clean-intermittent-catheterization-100561909","NCT06596291","Dose Escalation Study of EG110A, Administered by Intradetrusor Injections to Adults With Neurogenic Detrusor Overactivity-related Incontinence Following Spinal Cord Injury Who Regularly Perform Clean Intermittent Catheterization","First-In-Human Phase 1b\u002F2a Dose Escalation Study of EG110A, Administered by Intradetrusor Injections to Adult Participants With Neurogenic Detrusor Overactivity-related Incontinence Following Spinal Cord Injury Who Regularly Perform Clean Intermittent Catheterization","Main Inclusion Criteria:\n\n1. Participant has stable supra-sacral traumatic SCI with American Spinal Injury Association (ASIA) Impairment Scale grade A, B, C, D or E which occurred at least 12 months before Screening.\n2. Participant has UI due to urodynamically-confirmed NDO for at least 3 months prior to Screening.\n3. Participant has:\n\n   1. been treated for NDO for at least 3 months prior to Screening with an adequate course of oral pharmacotherapy(ies) and\u002For has had intolerable side-effects and\u002For exhibited an inadequate response in the opinion of the investigator and participant, i.e., at least 8 UI episodes in a week despite consistent use of the therapy. Participant does not wish to proceed to BoNT\u002FA treatment, and their next step would be surgical intervention.\n\n      OR\n   2. had an inadequate response to BoNT\u002FA treatment in the opinion of the investigator and participant, i.e., at least 8 UI episodes in a week, and the last BoNT\u002FA treatment for their NDO was at least 6 months prior to screening. Treatment with BoNT\u002FA was not started more than 7 years ago, and their next step would be surgical intervention.\n\nMain Exclusion Criteria:\n\n1. Participant has previous or current tumor or malignancy affecting the spinal column or spinal cord, or any other nonstable cause of SCI.\n2. Participant with active oral or genital herpes lesion. If the participant has an active oral or genital herpes infection this needs to be treated and healed first. The participant may be rescreened once the lesion has fully healed (at least 4 weeks after the lesion has healed).\n3. Participant had cancer therapy or radiotherapy ≤ 4 weeks prior to Screening and has toxicities\u002FAEs attributable to previously administered cancer therapies that have not resolved or stabilized.","18 Years","75 Years",{"count":64,"type":22},16,[66,25],"PHASE1","This is a first-in-human, Phase 1b\u002F2a, open-label, dose-escalation study of a single treatment course consisting of multiple intradetrusor injections of EG110A in male and female adult participants with Neurogenic Detrusor Overactivity (NDO)-related incontinence following Spinal Cord Injury (SCI), who have persistent incontinence after standard of care therapy and who perform Clear Intermittent Catheterization (CIC) on a regular basis.",[29,69],"Spinal Cord Injuries","2026-02-03",{"date":72,"type":45},"2026-02-05",{"date":74,"type":45},"2025-01-08",{"date":76,"type":22},"2027-06",{"name":78,"class":52},"EG 427",4,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":106},"100555679","improving-pelvic-rehabilitation-using-epidural-stimulation-after-spinal-cord-injury-100555679","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.",{"count":88,"type":22},20,[90],"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.",[69,93,94,95,29],"Neuromodulation","Neurogenic Bladder","Neurogenic Bowel","2025-03-13",{"date":98,"type":45},"2025-03-14",{"date":100,"type":45},"2024-10-14",{"date":102,"type":22},"2027-11-01",{"name":104,"class":105},"University College, London","OTHER",1]