[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518068":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":49,"collaborators":20,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":20,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TTNS Treatment Arm","EXPERIMENTAL","Treatments Patient will complete 6 weeks of 30 minute treatment sessions (these can be done at home after the first teaching session) During treatments, patient may experience a tingling sensation in the foot\u002Fankle. Patient may have discomfort in the area when first adjusting to the correct amount of stimulation for patient.\n\nPatient will have a visit with your doctor after 6 weeks of treatment at Scottish Rite. If patient have a good response to the treatments, they may be extended for another 6 weeks.\n\nAfter treatments Bladder diary (completed at home, on paper over a 3-day period, recording catheterization volumes and amount of leakage by weighing pads\u002Fdiapers) Complete questionnaires on paper (about 10 minutes) Complete urodynamic testing at Children's Medical Center (approximately 45-60 minutes).",[13],"Device: Transcutaneous Tibial Nerve Stimulation (TTNS) treatment",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Transcutaneous Tibial Nerve Stimulation (TTNS) treatment","Spina Bifida pediatric patients with neurogenic bladder will be in Transcutaneous Tibial Nerve Stimulation (TTNS) treatment. Patient will complete 6 weeks of 30 minute treatment sessions (these can be done at home after the first teaching session)",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Richard Adams, MD","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Alexandra Carolan, MD","CONTACT","214-456-5632","alexandra.carlon@utsouthwestern.edu",{"name":32,"role":28,"phone":20,"phoneExt":20,"email":33},"Shreedhar Reddy","shreedhar.reddy@utsouthwestern.edu",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":20},"Scottish Rite for Children","RECRUITING","Dallas","Texas","75219","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-96.80667,32.78306,{"lat":47,"lon":46},{"type":24,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Richard Adams","Professor","100518068","transcutaneous-tibial-nerve-stimulation-ttns-treatment-in-spina-bifida-pediatric-patients-with-neurogenic-bladder-100518068",false,"NCT06025734","Transcutaneous Tibial Nerve Stimulation (TTNS) Treatment in Spina Bifida Pediatric Patients With Neurogenic Bladder","Effectiveness of Transcutaneous Tibial Nerve Stimulation in Pediatric Patients With Neurogenic Bladder Secondary to Spina Bifida","Inclusion Criteria:\n\n* Age 8-18\n* Patient at TSRH\n* Diagnosis of lumbosacral spina bifida (myelomeningocele, meningocele, lipoma of spinal cord, myelocystocele, diastematomyelia, fatty\u002Fthickened filum)\n* Incontinence refractory to compliant catheterization (compliance with catheterization as assessed by their treating provider)\n* Patient able and willing to undergo urodynamic testing without sedation\n* No surgical reconstruction with the exception of a single appendicovesicostomy (APV)\n* No Botox treatments within 1 year of enrollment\n* Patient willing and able to stop bladder medications (anticholinergics or beta agonists) 2 weeks prior to pre-intervention bladder diary, questionnaires and UDS\n* Patient lives close enough to TSRH and CMC to be willing to return for UDS, teaching, and clinic visits as detailed above\n* Patient\u002Ffamily speak English\n\nExclusion Criteria:\n\n* Ages \\\u003C8 or \\>18\n* Diagnosis not listed above\n* Patients that have received reconstructive surgeries (i.e. augmentation or bladder neck sling) with the exception for a single APV\n* Patient received Botox treatment within 1 year of enrollment\n* Patient unable or unwilling to stop bladder medications (anticholinergics or beta agonists)\n* Patients with high-risk bladders, as assessed by their treating provider (i.e. poorly compliant bladders with high end-fill pressures)\n* Non-English speaking\n* Patients who are pregnant\n* Patients who are suspected of being pregnant\n* Patients who are nursing","ALL","8 Years","18 Years",{"count":63,"type":64},12,"ESTIMATED","INTERVENTIONAL",[67],"NA","The purpose of this research study is to determine the effectiveness of a treatment called \"transcutaneous tibial nerve stimulation\" or \"TTNS\" in the treatment of urinary leakage for patients with spina bifida. This treatment involves electrical stimulation of a nerve by the ankle. Participants will complete urodynamic testing and questionnaires prior to the treatments. Participants will then complete 6 weekly treatments of TTNS. Participants will learn how to do the treatment in the clinic, and then can complete the treatments at home. For patients with a good response, the treatments may be continued for another 6 weeks, for a total of 6 weeks.",[70],"Spina Bifida",[72,73,74],"Pediatrics","Neurogenic bladder","TTNS","2026-02-09",{"date":77,"type":78},"2026-02-12","ACTUAL",{"date":80,"type":78},"2025-11-18",{"date":82,"type":64},"2028-12",{"name":5,"class":6},1]