[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spina-bifida\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spina-bifida":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,45,84,110,143,175,198,223,250,278,309,339,359,395,419,445,464,486,510,540,567],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100615280","establishing-the-preliminary-utility-of-a-novel-pediatric-manual-mobile-standing-wheelchair-100615280",false,"NCT07290556","Establishing the Preliminary Utility of a Novel Pediatric Manual Mobile Standing Wheelchair","Inclusion Criteria:\n\n* 8 - 17 years old\n* Primarily use a manual wheelchair for daily mobility\n* Are actively enrolled in a standing program\n* Fit the height and weight requirements of the PedMMSWC\n* Can follow simple verbal instructions\n* Are able to speak and read in English\n\nExclusion Criteria:\n\n* Have insufficient trunk control to maneuver in seated and standing positions\n* Have lower limb contracture which would preclude standing\n* Have had orthopedic surgery within the last twelve months\n* Have pressure injuries at the location where the PedMMSWC interfaces\n* Have insufficient fine motor skills to independently initiate the sit-to-stand function\n* Have a history of uncontrolled seizures or cardiovascular conditions that would make participation unsafe","ALL","8 Years","17 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"NA","To establish the preliminary utility of a novel pediatric manual mobile standing wheelchair (PedMMSWC).",[26],"Spina Bifida",[28,29,30,31],"Spinal Bifida","Wheelchair","Pediatric","Standing","RECRUITING","2026-06-19",{"date":35,"type":36},"2026-06-24","ACTUAL",{"date":38,"type":36},"2026-06-18",{"date":40,"type":20},"2027-08-25",{"name":42,"class":43},"Optimal Mobility, Inc","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":15,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":64,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100643017","early-phase-1-coupled-gentamicin-lactobacillus-rhamnosus-in-nlutd-100643017","NCT07643974","Coupled Gentamicin-Lactobacillus Rhamnosus in NLUTD","Effect of Dose Timing of Coupled Intravesical Gentamicin and Lactobacillus Rhamnosus LGG on Success and Length of Colonization in Men and Women With SCI\u002FD and NLUTD","Inclusion Criteria:\n\n* Neurologic diagnosis\n* ≥18 years old\n* Neurogenic bladder for at least 6 months\n* No USQNB-IC A, B1, or B2 symptoms\n* No currently diagnosed UTI (within 24 hours of initiating instillations)\n* Community dwelling (not in acute hospital setting)\n\nExclusion Criteria:\n\n* Known genitourinary pathology beyond NLUTD (i.e. kidney stones, bladder stones, vesicoureteral reflux, etc.)\n* Use of prophylactic antibiotics or any antibiotics within 2 weeks of beginning instillations\n* Instillation of intravesical agents other than saline bladder wash\n* Immunodeficiency\n* Psychologic or psychiatric conditions influencing the ability to follow instructions\n* Allergy to ampicillin, daptomycin, gentamicin\u002Fgentamycin, or probiotics\n* Participation in another study which could confound results","18 Years",{"count":54,"type":20},48,[56],"EARLY_PHASE1","The main objective of the proposed research study is to determine in men and women with spinal cord injury\u002Fdisease and neurogenic bladder whether the dose of coupled gentamicin \\& Lactobacillus rhamnosus GG affects the recolonization of the bladder, and whether the rate of success differs by sex. Secondary objectives include determining whether that recolonization lasts 7, 14, or 28 days; and safety of the coupled gentamicin \\& Lactobacillus instillations.",[59,60,61,62,26,63],"Spinal Cord Injury","Neurogenic Bladder (NB)","Neurogenic Lower Urinary Tract Dysfunction","Multiple Sclerosis","Urinary Tract Infection(UTI)",[65,66,67,68,69,70,71],"gentamicin","gentamycin","lactobacillus","spinal cord injury","spinal cord disease","urinary tract infection","neurogenic bladder","NOT_YET_RECRUITING","2026-06-08",{"date":75,"type":36},"2026-06-12",{"date":77,"type":20},"2026-06",{"date":79,"type":20},"2027-09",{"name":81,"class":82},"Medstar Health Research Institute","OTHER",2,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":15,"minAge":91,"maxAge":17,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":44},"100640427","tscs-in-children-with-spina-bifida-100640427","NCT07615686","tSCS in Children With Spina Bifida","Transcutaneous Spinal Cord Stimulation to Improve Strength and Gait in Children With Spina Bifida","Inclusion Criteria:\n\n* Diagnosed myelomeningocele confirmed by a neurosurgeon or neurologist\n* Some difficulty ambulating, but able to ambulate at least a short distance (10 meters) with devices and\u002For assistance.\n* Between the ages of 4 and 17 years of age.\n* Documented neurogenic bladder dysfunction\n* On a stable bladder management regimen at least 4-6 weeks prior to the enrollment in the trial\n\nExclusion Criteria:\n\n* Severe behavioral or cognitive impairments that preclude participation in the study, in the opinion of the investigator.\n* Has an active surgery planned for impairments from spina bifida (e.g. tethered cord syndrome surgery or orthopedic surgery) or has had surgery in the last 6 months.\n* Is pregnant. Pregnancy will be assessed via verbal report.\n* Open wounds at the thoracic or lumbar spine that precludes transcutaneous stimulation.\n* Implanted or attached electronic device in any location of the body (e.g. pacemakers, baclofen pumps, or implanted insulin pumps)\n* Symptomatic urinary tract infection, urinary tract infection for which they are currently receiving treatment, scheduled urological surgery, or inability to perform or receive catheterization.","4 Years",{"count":93,"type":20},20,[23],"A single-center, open-label, investigational pilot trial to explore potential effects of transcutaneous spinal cord stimulation on leg muscle strength and walking in children with myelomeningocele.",[26,97],"Myelomeningocele",[99,100],"spina bifida","myelomeningocele","2026-05-22",{"date":103,"type":36},"2026-05-29",{"date":105,"type":20},"2026-06-10",{"date":107,"type":20},"2029-03-10",{"name":109,"class":82},"Bailey Petersen",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":15,"minAge":118,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":142},"100622953","bowel-continence-across-the-lifespan-in-people-with-spina-bifida-100622953","NCT07390318","Bowel Continence Across the Lifespan in People With Spina Bifida","Comparing Antegrade Versus Retrograde Enemas To Improve Bowel Continence Across the Lifespan in People With Spina Bifida","BCALS","Inclusion Criteria:\n\n* Minimum age 5 years old\n* Myelomeningocele diagnosis\n* Starting a retrograde or antegrade enema program (or switching from one enema program to the other)\n* English or Spanish speaking\u002Fliterate\n\nExclusion Criteria:\n\n\\- Other types of spinal dysraphism (e.g., lipomyelomeningocele, fatty filum)","5 Years",{"count":120,"type":20},943,"OBSERVATIONAL","The goal of this observational study is to learn how different enema programs affect bowel control in children and adults with spina bifida. An enema program involves putting liquid into the large intestine (colon) to help someone poop. The main questions it aims to answer are:\n\n1. How well do different enema programs prevent bowel accidents?\n2. How do these enema programs affect independence, bowel symptoms, and quality of life?\n\nResearchers will compare two types of enema programs to see which works better and is easier for participants to manage.\n\nParticipants starting a new enema program will answer online survey questions at 3 different timepoints over the course of 1 year.",[26,124,125],"Neurogenic Bowel","Bowel Incontinence",[127,128,129,130,131,132],"retrograde enema","antegrade enema","bowel management program","bowel continence program","self-management","quality of life","2026-04-17",{"date":135,"type":36},"2026-04-21",{"date":137,"type":36},"2026-04-01",{"date":139,"type":20},"2030-05-01",{"name":141,"class":82},"David Chu",24,{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":15,"minAge":151,"maxAge":17,"enrollmentInfo":152,"targetDuration":4,"studyType":21,"phases":154,"briefSummary":156,"conditions":157,"keywords":158,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":174},"100595020","phase-3-efficacy-of-intravesical-oxybutynin-in-children-with-neurogenic-bladder-dysfunction-100595020","NCT07027020","Efficacy of Intravesical Oxybutynin in Children With Neurogenic Bladder Dysfunction","Efficacy of Intravesical Oxybutynin in Children With Neurogenic Bladder Dysfunction: A Randomized, Prospective Controlled Multi-center Trial","POXIPEN","Inclusion Criteria:\n\n* Person affiliated to or beneficiary of a social security plan\n* In failure of treatment with one or more anticholinergics defined by a response considered insufficient by the investigator after at least 4 weeks of optimal dose treatment, unable to take oral oxybutynin or intolerable adverse events\n* Having performed renal ultrasonography less than 2 months ago\n* Having performed cystomanometry less than 6 months ago including maximal bladder capacity and maximal bladder pressure (preferably not under oral oxybutynin treatment)\n* Age between 6 and 17 years old\n* Informed about study organization, having given consent to participate and each legal representative have signed the informed consent\n* Having undergone the medical examination adapted to research\n* Presenting overactive bladder due to spina bifida confirmed by urodynamic check-up of less than 6 months. Overactive bladder is defined according to International Children's Continence Society, (ICCS): \"a urodynamic observation characterized by involuntary detrusor contractions during the filling phase which may be spontaneous or provoked\"\n* Carrying out intermittent catheterization for at least 6 weeks and at least three times a day\n* Able and volunteer to perform intravesical catheterization and instillation (patient or parents).\n\nExclusion Criteria:\n\n* Person displaying known allergy to one of the components of evaluated product (notably oxybutynin).\n* Person with congestive cardiac failure\n* Person with cardiac arrhythmia\n* Person with tachycardia\n* Person with uncontrolled hypertension\n* Person under one of the following treatments : Bisphosphonates; Cytochrome P450 Inhibitors (such as ketoconazole and Erythromycin); Cholinesterase inhibitors.\n* Person displaying a contraindication to evaluated product, in particular: Hypersensitivity to oxybutynin; Myasthenia; Angle-closure glaucoma; Functional or organic gastrointestinal obstruction including pyloric stenosis, paralytic ileus and intestinal atony; Serious gastro-intestinal disorders (e.g., severe ulcerative colitis and toxic megacolon); Patients who have undergone ileostomy, colostomy, severe hemorrhagic colectasis or rectocolitis; Subvesical obstruction (urethral stenosis, posterior urethra valve); Ongoing treatment with anticholinergic drugs for another indication that could not be stopped; Patient with polyuria of other origin (renal, heart, potomania); Concomitant oxygenotherapy.\n* Woman of childbearing age without highly effective contraception (Sexual abstinence OR combined contraception by oral, intravaginal or transdermal ovulation inhibition OR progestin-only contraception by oral, injectable or implantable ovulation inhibition OR Intrauterine device or hormonal IUD).\n* Pregnant, parturient or breastfeeding woman.\n* Person deprived of liberty for judicial or administrative decision.\n* Person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1.\n* Intradetrusor injection of botulinum toxin less than 6 months before.\n* Person with hyperthyroidism\n* Person with coronary cardiac disease.","6 Years",{"count":153,"type":20},60,[155],"PHASE3","Malformation of the lumbosacral region (spina bifida) affects the innervation of the bladder in children. The usual evolution leads to a neurological bladder with small capacity, poor compliancy and overactivity, exposing to incontinence and obstruction to the evacuation of urine. It is responsible for renal failure requiring dialysis and transplantation. Current therapeutics aim to evacuate urine and reduce intravesical pressure. It gradually combines 1) intermittent catheterization, 2) anticholinergics, 3) botulinum toxin (Botox®) injection into the detrusor (bladder muscle) by cystoscopy and 4) surgery (vesicostomy, Bricker, enterocystoplasty). Oxybutynin relaxes the detrusor, improves continence and reduces intravesical pressure. It is usually administered per os, but there are contraindications (glaucoma, myasthenia), side effects (constipation, dry mouth). It can be difficult to swallow for children, and drug resistance may develop. It can lead to ineffective treatment requiring therapeutic escalation. The next step, intradetrusor Botox® injection, is invasive (cystoscopy), has a limited duration of action (6 months) and must be performed under general anesthesia in children.\n\nSurgical treatments are effective but irreversible and responsible for morbidity and mortality. A randomized study was performed demonstrating the efficacy of intravesical oxybutynin compared to oral administration in adult patients. This study found a significant increase in bladder capacity and a significant decrease in side effects in the intravesical oxybutynin group. Due to the relative difficulties of intravesical oxybutynin delivery (preparation, cost) and the more invasive nature, it is not used as an alternative to oral oxybutynin.\n\nThe hypothesis of this study is that this treatment may have a legitimate place in the treatment of neurogenic bladder in patients with failure of anticholinergic treatment before a therapeutic escalation requiring an invasive procedure (Botox®, enterocystoplasty) especially in children for whom repeated general anesthesia for Botox® injection may interfere with brain development. In this way, the investigators aim to extend the time to therapeutic escalation in the pediatric population.\n\nThe main objective of the trial is to compare the efficacy on maximal bladder capacity of intravesical oxybutynin instillation versus placebo in the treatment of children with overactive neurogenic bladder (spina bifida), performing intermittent catheterization, for whom oral anticholinergic treatment is ineffective or poorly tolerated.",[26],[159,160,161,162,163,164],"Intravesical Oxybutynin","overactive neurogenic bladder","intermittent catheterization","Oxybutynin","anticholinergic","Pediatric patients","2026-04-09",{"date":167,"type":36},"2026-04-14",{"date":169,"type":36},"2026-01-15",{"date":171,"type":20},"2028-06",{"name":173,"class":82},"Central Hospital, Nancy, France",19,{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":15,"minAge":182,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":44},"100504511","evaluation-of-the-transitional-and-lifelong-care-program-100504511","NCT05849285","Evaluation of the Transitional and Lifelong Care Program","Evaluating a Model of Transitional and Lifelong Care for Adults With Childhood-Onset Disabilities","Inclusion Criteria:\n\nEach participant dyad will consist of one person, of either sex and gender, who is over the age of 21 years with a childhood-onset disability, and the primary caregiver (based on contact hours) or support person, of either sex and gender, involved in their care. In cases where the patient participant is independent with care, a spouse or family member may still participate in the caregiver portion of the study.\n\n2\\. Patient participants will have continuously resided in Ontario during the years of 2015 to 2020 to facilitate full data retrieval from the administrative dataset.\n\n3\\. Healthcare providers, of any discipline, who provide care to adults with childhood-onset conditions in the TLC program.\n\nExclusion Criteria:\n\nPatient participants will be ineligible if they are in a phase of deterioration associated with a progressive health condition identified either personally or by the caregiver participant.","21 Years",{"count":184,"type":20},410,"The population cared for in the Transitional and Lifelong Care (TLC) clinic is youth and adults with childhood-onset disability, of which the large majority are adults with brain-based, neurodevelopmental conditions such as cerebral palsy, spina bifida and developmental disability. The TLC program was created to address the health inequities that have long existed for this population because of the gaps in care they experience once they transition from pediatric healthcare services to the adult healthcare sector. The TLC program offers coordinated and comprehensive management of co-occurring mental, social and physical health conditions for this group of adults with neurodiverse conditions. The proposed study will provide much needed evaluation of the TLC model as an intervention to provide transitional and lifelong care that reduces the barriers experienced because of the undefined clinic path - potentially more appropriately referred to as a \"cliff\" by a Freeman et al., (2015) - for these individuals. With appropriate evidence of effectiveness, scaling of the TLC program to other Ontario Health regions and more widely across Canada would improve access healthcare providers who are knowledgeable and competent in the management of physical and mental health conditions for adults with neurodiverse conditions as well as service integration and coordination between social and health sectors. The TLC clinic was co-designed with adults with neurodiverse conditions and health care providers in 2014 and represents a significant and sustainable change in the way healthcare has been delivered for this population in the Ontario Health West region over the last 7 years. More than 750 people have accessed coordinated and comprehensive care from Physiatrists, a Nurse Practitioner, Social Worker, Physiotherapist, Occupational Therapist, Speech Language Pathologist, Registered Dietitian and Rehabilitation Therapist in the TLC program since it began, documenting the effectiveness of this care has the power to re-shape care received for adults with neurodiverse conditions that onset in childhood in Canada.",[187,26,188],"Cerebral Palsy","Developmental Disability","2026-02-25",{"date":191,"type":36},"2026-02-27",{"date":193,"type":36},"2024-01-03",{"date":195,"type":20},"2027-12",{"name":197,"class":82},"Western University, Canada",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":52,"enrollmentInfo":205,"targetDuration":4,"studyType":21,"phases":207,"briefSummary":208,"conditions":209,"keywords":210,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":44},"100518068","transcutaneous-tibial-nerve-stimulation-ttns-treatment-in-spina-bifida-pediatric-patients-with-neurogenic-bladder-100518068","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",{"count":206,"type":20},12,[23],"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.",[26],[211,212,213],"Pediatrics","Neurogenic bladder","TTNS","2026-02-09",{"date":216,"type":36},"2026-02-12",{"date":218,"type":36},"2025-11-18",{"date":220,"type":20},"2028-12",{"name":222,"class":82},"University of Texas Southwestern Medical Center",{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":15,"minAge":151,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":21,"phases":232,"briefSummary":233,"conditions":234,"keywords":235,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":44},"100519268","evaluation-of-multimodal-and-non-invasive-spina-bifida-neurovessels-during-prospective-follow-up-100519268","NCT06041334","Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up","SPINLESS","Inclusion Criteria:\n\n* Spina patients consulted as part of the multidisciplinary consultation of the spina bifida rare disease reference centre;\n* Written consent to participate in the research.\n* Compulsory membership of a social security scheme\n\nExclusion Criteria:\n\n* Patients with a non-continuous trans ileal urinary diversion ;\n* Patients with enterocystoplasty;\n* Untreated bacteriuria at the time of urodynamic assessment and urine sample collection;\n* History of urinary tract tumour;\n* History of histologically proven interstitial cystitis;\n* Persons under legal protection (safeguard of justice, curatorship, guardianship);\n* Persons deprived of their liberty.\n* Women claiming to be pregnant",{"count":231,"type":20},50,[23],"The aim of the study is to investigate known urinary biomarkers in order to determine whether they can be predictive of a risk of damage to the upper urinary tract and therefore the kidneys in patients with spina bifida. The risk of damage to the upper urinary tract can be calculated using the Galloway score, based on the results of the urodynamic study and retrograde urethrocystography, which all patients with spina bifida have regularly.\n\nThe urinary biomarkers studied TIMP-2 (Tissue inhibitor of metalloproteinases 2) and MMP-2 (matrix metalloproteinase-2) are potentially associated with renal degradation, but this has not yet been demonstrated.\n\nVolunteers to take part in the study will have their biomarkers measured at the time of their urodynamic assessment.",[26],[26,236,237,238,239,240],"urinary biomarker","upper urinary tract","Galloway score","urodynamic work-up","urethrocystography","2025-12-15",{"date":243,"type":36},"2025-12-22",{"date":245,"type":36},"2024-01-18",{"date":247,"type":20},"2028-07-18",{"name":249,"class":82},"Rennes University Hospital",{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":15,"minAge":52,"maxAge":257,"enrollmentInfo":258,"targetDuration":4,"studyType":21,"phases":260,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":44},"100606693","psychosocial-teleassistance-programme-for-adults-with-spina-bifida-100606693","NCT07178873","Psychosocial Teleassistance Programme for Adults With Spina Bifida","Effects of a Psychosocial Teleassistance Programme for Adults With Spina Bifida","Inclusion Criteria:\n\n* To be diagnosed with spina bifida by a specialist.\n* Being between 18 and 75 years old.\n* Having their informed consent or the informed consent of their legal guardians.\n* Having Spanish as one of their main languages.\n* Having access to a computer (with a camera, microphone and speakers integrated) and Internet connection to take part in the videoconferences.\n\nExclusion Criteria:\n\n* Age that is inconsistent with the established range.\n* The presence of any comorbid diagnosis or sensory deficit that would impede the effective execution of the intervention's activities.","75 Years",{"count":259,"type":20},35,[23],"This clinical trial assesses the effect of a telecare psychosocial intervention designed for adults with spina bifida. The intervention consists of 10 weekly 1.5-hour group sessions, followed by two 3-month follow-up sessions. Each group will consist of 6 to 7 individuals. The intervention is aimed at strengthening aspects of self-concept, self-esteem, social skills and aims at a reduction of symptomatology and a general improvement of psychological well-being.",[26,263,264,265,266,267,268],"Self Esteem","Quality of Life (QOL)","Self Concept","Anxiety","Depression","Interpersonal Needs","2025-12-02",{"date":271,"type":36},"2025-12-10",{"date":273,"type":36},"2024-06-25",{"date":275,"type":20},"2027-01",{"name":277,"class":82},"University of Deusto",{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":21,"phases":286,"briefSummary":287,"conditions":288,"keywords":293,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":83},"100579773","comparing-digitally-and-traditionally-made-ankle-foot-orthoses-100579773","NCT06828653","Comparing Digitally and Traditionally Made Ankle Foot Orthoses","Feasibility RCT Evaluating Digitally and Traditionally Produced Ankle Foot Orthoses for Individuals With Impaired Lower Limb Function","Inclusion Criteria:\n\n* Participants must be aged 8 years or older.\n* Participants should have either flaccid or spastic paresis resulting from conditions such as cerebral palsy, stroke, spinal cord injury, spina bifida, or traumatic peripheral nerve injury, leading to lower limb mobility impairments.\n* Participants must require a custom articulating, rigid, or energy storage and return (ESR) AFO to improve physical function for one or both sides (unilateral or bilateral).\n* Participants must be able to ambulate independently, though the use of gait aids is permitted.\n* Participants must be capable of completing questionnaires with no more than orienting guidance.\n* Participants must meet the requirements to have their AFO funded by the Assistive Devices Program (ADP).\n\nExclusion Criteria:\n\n* Clients for whom the primary goal of the AFO includes wound management.\n* Those whose AFO is not worn for ambulation.\n* Clients with insensate feet or a history of ulcerations.\n* First-time AFO users.",{"count":231,"type":20},[23],"The research is being done to compare two methods of creating AFOs: 1. The traditional method, which involves manually creating a mold from a plaster cast of the client's limb. This is time-consuming and labor-intensive; and 2. The newer method uses digital technology, such as 3D scanning and printing, to design and produce the AFOs, potentially making the process faster and less costly. We want to know whether AFOs made using digital technology can provide the same clinical benefits as those made traditionally.",[289,290,187,291,59,26,292],"Flaccid Paresis","Spastic Paresis","Stroke","Traumatic Peripheral Nerve Injury",[294,295,296,297,298,299,300],"Ankle foot orthosis","ankle foot orthoses","digital ankle foot orthoses","digital technology","3D scanning","3D printing","randomized control trial",{"date":302,"type":36},"2025-11-20",{"date":304,"type":36},"2025-09-05",{"date":306,"type":20},"2027-03-31",{"name":308,"class":82},"Holland Bloorview Kids Rehabilitation Hospital",{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":15,"minAge":316,"maxAge":17,"enrollmentInfo":317,"targetDuration":4,"studyType":21,"phases":319,"briefSummary":320,"conditions":321,"keywords":324,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":44},"100495085","evaluating-long-term-use-of-a-pediatric-robotic-exoskeleton-prexagilik-to-improve-gait-in-children-with-movement-disorders-100495085","NCT05726591","Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX\u002FAgilik) to Improve Gait in Children With Movement Disorders","A Phase I\u002FII Trial Evaluating Long-Term Use of a Pediatric Robotic Exoskeleton (P.REX\u002FAgilik) to Improve Gait in Children With Movement Disorders","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Provision of signed and dated separate informed consent and assent forms for screening purposes. Upon inclusion in the protocol, provision of signed and dated informed consent and assent forms to begin participation in the study will be necessary.\n* Stated willingness to comply with all study procedures and availability for the duration of the study, or alternatively, ability to do so based on parent report and physician observation during history and physical examination.\n* Age 3 to 17 years old.\n* Have a gait pathology involving the knee joint, from a diagnosis of cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury.\n* Knee joint range of motion of at least 25 degrees in the sagittal plane (knee extension\u002Fflexion) assessed with hip extended in supine position. Hamstring contracture as assessed by straight leg raising test does not limit ability to participate in the study.\n* Ankle joint range of motion of at least 15 degrees in the sagittal plane (dorsi-plantar flexion) with the foot in neutral alignment.\n* A measured foot-thigh angle of -15 to 30 degrees in prone position.\n* Able to walk at least 10 feet without stopping with or without a walking aid.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury that would affect the ability to walk as directed with the robotic exoskeleton.\n* A history of uncontrolled seizure in the past year.\n* Pregnancy. A urine test will be performed for all participants who are able to become pregnant at the initial screening visit and in the case of a positive test, the participant will be excluded from participation. Further monitoring will rely on self-reporting of interruption in menstruation that would require re-testing for pregnancy at the next visit.\n* Any acute cardiopulmonary condition which limits exercise to less than 60 minutes per session or less than 5 days per week.","3 Years",{"count":318,"type":20},44,[23],"Background:\n\nPeople with cerebral palsy, spina bifida, muscular dystrophy, or spinal cord injury often have muscle weakness and problems controlling how their legs move. This can affect how they walk. The NIH has designed a robotic device (exoskeleton) that can be worn on the legs while walking. The wearable robot offers a new form of gait training.\n\nObjective:\n\nTo learn whether a robotic device worn on the legs can improve walking ability in those with a gait disorder.\n\nEligibility:\n\nPeople aged 3 to 17 years with a gait disorder involving the knee joint.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam. Their walking ability will be tested.\n\nParticipants will have markers taped on their body; they will walk while cameras record their movements. They will undergo other tests of their motor function and muscle strength.\n\nThe study will be split into three 12-week phases. During 1 phase, participants will continue with their standard therapy.\n\nDuring another phase, participants will work with the exoskeleton in a lab setting. Their legs will be scanned to create an exoskeleton with a customized fit. The exoskeleton operates in different modes: in exercise mode, it applies force that makes it difficult to take steps; in assistance mode, it applies force meant to aid walking; in combination mode, it alternates between these two approaches.\n\nDuring the third phase, participants may take the exoskeleton home. They will walk in the device at least 1 hour per day, 5 days per week, for 12 weeks.\n\nParticipants walking ability will be retested after each phase....",[187,322,26,323],"Muscular Dystrophy","Incomplete Spinal Cord Injury",[325,326,187,327,328],"EEG","Muscular Dystophies","Knee","incomplete spinal cord injury","2025-10-24",{"date":331,"type":36},"2025-10-27",{"date":333,"type":36},"2023-05-02",{"date":335,"type":20},"2027-10-31",{"name":337,"class":338},"National Institutes of Health Clinical Center (CC)","NIH",{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":11,"sex":15,"minAge":118,"maxAge":52,"enrollmentInfo":346,"targetDuration":4,"studyType":21,"phases":347,"briefSummary":348,"conditions":349,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":44},"100586649","transcutaneous-spinal-stimulation-for-children-and-youth-with-spina-bifida-100586649","NCT06918119","Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida","Characterization of Transcutaneous Spinal Cord Stimulation for Enabling Reflex Motor Evoked Responses in Children and Youth With Spina Bifida","Inclusion Criteria\n\n* Congenital diagnosis of myelomeningocele (MMC)\n* Able to follow verbal commands or instructions.\n* If female and able to become pregnant, must be willing to use medically-acceptable method of contraception during study participation.\n\nExclusion Criteria\n\n* Severe cognitive deficits demonstrating inability to communicate needs\n* Gaping, weeping, or unhealed open wounds at the site of electrode placement\n* Unhealed fractures on load bearing bones\n* History of osteoporosis\n* History of implanted electronic devices at the stimulation location(e.g. deep brain stimulator, cardiac pacemaker, diaphragmatic pacer, baclofen pumps, insulin pumps, etc.)\n* Pregnancy\n* Epilepsy\n* History of seizure\n* Ongoing infections (currently being treated or are symptomatic)\n* Any illness or condition which, based on the research team's assessment, will compromise the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study.",{"count":19,"type":20},[23],"A study to use transcutaneous spinal cord stimulation to characterize sensorimotor deficits in a pediatric population of individuals with spina bifida.",[97,26],"2025-10-09",{"date":352,"type":36},"2025-10-14",{"date":354,"type":36},"2025-08-07",{"date":356,"type":20},"2030-07",{"name":358,"class":82},"Mayo Clinic",{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":366,"sex":15,"minAge":367,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":21,"phases":370,"briefSummary":371,"conditions":372,"keywords":377,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":44},"100254540","mobile-health-self-management-and-support-system-for-chronic-and-complex-health-conditions-100254540","NCT02592291","Mobile Health Self-Management and Support System for Chronic and Complex Health Conditions","Mobile Health Self-Management and Support System for Chronic and Complex Health Conditions (Component 3)","Inclusion Criteria:\n\n1. 12 years or older.\n2. have a diagnosis of a chronic and complex condition such as Spina Bifida, Spinal Cord Injury, Cerebral Palsy and Traumatic Brain Injury, etc.\n3. live in a community setting (not within a residential facility that provides care to them).\n4. pass all the functional screening tests which include basic usage of a smart phone, and impairment severity assessments\n\nExclusion Criteria:\n\n1. Diagnosis of severe intellectual disability or severe and persistent psychiatric illness.\n2. Failing all the screening tests due to severe impairments that cannot be accommodated by the mHealth system (for patient participants)",true,"12 Years",{"count":369,"type":20},160,[23],"This study will assess the benefits of using mobile health system designed for individuals with chronic and complex health conditions (such as those with Spinal Cord Injury,Cerebral Palsy, Spina Bifida, and Traumatic Brain Injury) to improve their wellness and self-management skills compared to those who receive standard of care only.",[373,187,374,375,26,376],"Spinal Cord Injuries","Spinal Dysraphism","Brain Injuries","Traumatic Brain Injury",[378,379,380,381,382,383,384,385],"Mobile health","Apps","Applications","Smart phone","mHealth","Chronic and Complex Conditions","Self-Management","Self-Care","2025-10-01",{"date":388,"type":36},"2025-10-03",{"date":390,"type":36},"2019-10-01",{"date":392,"type":20},"2026-09",{"name":394,"class":82},"University of Pittsburgh",{"id":396,"slug":397,"hasResults":11,"nctId":398,"briefTitle":399,"officialTitle":399,"acronym":4,"eligibilityCriteria":400,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":401,"enrollmentInfo":402,"targetDuration":4,"studyType":21,"phases":404,"briefSummary":405,"conditions":406,"keywords":407,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":44},"100587529","autologous-human-umbilical-cord-tissue-patch-for-postnatal-closure-of-open-neural-tube-defects-100587529","NCT06929572","Autologous Human Umbilical Cord Tissue Patch for Postnatal Closure of Open Neural Tube Defects","Inclusion Criteria:\n\n* Neonates born with prenatal diagnosis of open neural tube defect (myelomeningocele or myeloschisis)\n* Resident of the United States\n* Provision of signed and dated informed consent form\n* Stated willingness by legally authorized representative (LAR) to comply with all study procedures and availability for the duration of the study\n* Maternal age 18 years and older\n* Mother is English or Spanish Speaking\n\nExclusion Criteria:\n\n* Sepsis or signs of infection of the neonate\n* Febrile or other acute illness of the neonate at time of delivery\n* Major congenital anomaly unrelated to spina bifida that may impact safety of neonate for surgery\n* Evidence of intra-amniotic or maternal infection related to pregnancy at time of delivery\n* Maternal use of steroid therapy during pregnancy or neonate use of steroid therapy,except for lung maturity indications\n* Vaginal delivery\n* Patch closure of dura is deemed unnecessary\n* Umbilical cord abnormality\n* Insufficient autologous cord tissue or patch\n* Autologous umbilical cord patch that does not meet laboratory safety standards per standard operating procedure (SOP)\n* Treatment with an investigational drug or other intervention that would influence morbidity or mortality","24 Hours",{"count":403,"type":20},15,[23],"The purpose of this study is to determine the impact of an autologous umbilical cord patch for dural closure on the repair of open neural tube defect. The outcomes will evaluate successful defect closure, creation of a more capacious spinal canal, and reduction in inflammatory tissue response versus historical controls.",[26],[408,409,100,410],"open neural tube defects","autologous umbilical cord patch","myeloschisis",{"date":412,"type":36},"2025-09-12",{"date":414,"type":36},"2025-08-05",{"date":416,"type":20},"2033-01",{"name":418,"class":82},"The University of Texas Health Science Center, Houston",{"id":420,"slug":421,"hasResults":11,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":425,"eligibilityCriteria":426,"healthyVolunteers":11,"sex":427,"minAge":52,"maxAge":4,"enrollmentInfo":428,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":430,"conditions":431,"keywords":433,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":44},"100588834","fetoscopic-neural-tube-defect-repair-100588834","NCT06946563","Fetoscopic Neural Tube Defect Repair","Fetoscopic Neural Tube Defect Repair: Observational Pilot Study","NTD","Inclusion Criteria:\n\n* Maternal age 18 years or older\n* Capable of consenting for their own participation in the study\n* Decision to have fetoscopic repair following counseling of all options\n* Open spina bifida with the upper boundary between T1 and S1\n* Gestational age between 24 0\u002F7 to 26 6\u002F7 weeks' gestation at the time of surgery\n* Normal karyotype and\u002For normal chromosomal microarray by invasive testing. In the case of a microdeletion, microduplication, or variant of uncertain significant, the decision to include or exclude will be at the discretion of the Principal Investigators.\n* Absence of major cardiac anomalies confirmed by fetal echocardiogram\n* Adequate social support throughout pregnancy\n* Parental or guardian willingness to undergo follow-up evaluations of the child after birth\n\nExclusion Criteria:\n\n* Multiple gestation\n* Major fetal anomalies unrelated to the neural tube defect\n* Kyphosis in fetus of 30 degrees or more as assessed by ultrasound or MRI\n* Previous spontaneous singleton preterm birth prior to 37 weeks\n* Presence of cervical cerclage at the time of surgery or history of cervical insufficiency\n* Cervical length less than 20 mm by endovaginal ultrasound\n* Placenta previa or evidence of placental abruption\n* Technical factors such as large uterine fibroids, uterine anomalies, or fetal membrane separation for which the risks of surgery are deemed to outweigh the benefits\n* Maternal obesity precluding surgical access with a BMI \\> 45 or if the Principal Investigator determines the body habitus to be technically challenging\n* Alloimmunization in pregnancy including Kell sensitization or a history of neonatal alloimmune thrombocytopenia\n* Maternal HIV or Hepatitis B positive status. If the patient's HIV or Hepatitis B status is unknown, the patient must be tested and found to be negative prior to surgery\n* Known Hepatitis C positivity. If the patient's Hepatitis C status is known, they do not need to be screened\n* Maternal medical condition which is a contraindication to surgery or general anesthesia. This includes previous hysterotomy in the active segment of the uterus\n* Maternal medical co-morbidities which would significantly increase the risk of spontaneous or iatrogenic preterm delivery\n* Inability of the patient to comply with travel and follow-up requirements of the study\n* Patient not meeting psychosocial criteria determined by fetal care social worked to comply with the medical care and plan for follow ups\n* Participation in another interventional study that influences maternal and fetal morbidity and mortality\n* Known history of hypersensitivity to collagen products or chondroitin materials","FEMALE",{"count":429,"type":20},25,"This is a single-arm prospective study to record maternal and neonatal outcomes on subjects who undergo fetoscopic repair of Neural Tube Defects (NTD) at Oregon Health \\& Science University (OHSU). Fetoscopic repair will take place between 24 weeks 0 days and 27 weeks 6 days gestation. Surgical, post-operative, delivery, and neonatal outcomes will be collected.",[432,26],"Neural Tube Defects",[434,435],"Fetal Surgery","Fetoscopy","2025-04-20",{"date":438,"type":36},"2025-04-27",{"date":440,"type":36},"2023-04-01",{"date":442,"type":20},"2033-04",{"name":444,"class":82},"Oregon Health and Science University",{"id":446,"slug":447,"hasResults":11,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":366,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":454,"conditions":455,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":460,"leadSponsor":462,"locationsCount":83},"100571722","qualas-validation-in-dutch-100571722","NCT06723951","QUALAS Validation in Dutch","Validation of the Quality of Life Assessment in Spina Bifida for Children and Adolescents in Dutch","Inclusion Criteria:\n\nPatient group:\n\n* Male or female patients aged 8 -12 years (QUALAS-C)\n* Male or female patients aged 13 - 17 years (QUALAS-T)\n* Adult patients (QUALAS-A)\n* Has spina bifida\n* Adult or child and at least one parent fluent in the Dutch language\n* Signed informed consent\n\nControl group:\n\n* Male or female children aged 8 -12 years (QUALAS-C)\n* Male or female adolescents aged 13 - 17 years (QUALAS-T)\n* Adults (QUALAS-A)\n* Has no spina bifida\n* Adult or child and at least one parent fluent in the Dutch language\n* Signed informed consent\n\nExclusion Criteria:\n\n* Has a neurogenic disease other than spina bifida\n* Has had surgery in the last month",{"count":453,"type":20},300,"Rationale Patients with spina bifida often experience a decreased quality of life compared to patients without spina bifida. The Quality of Life Assessment for Spina Bifida (QUALAS) is a validated questionnaire to assess the quality of life in children, teenagers and adults with spina bifida, accounting for specific factors, such as bladder and bowel dysfunction. This questionnaire enables us to assess the current spina bifida related quality of life and identify if bladder and bowel dysfunction is of influence.\n\nObjective(s) To validate the Quality of Life Assessment for Spina Bifida in Children, Teenagers and Adults in Dutch.\n\nStudy type A multicenter prospective validation cohort study.\n\nStudy population Children aged 8 - 17 years and adults who are diagnosed with spina bifida. As a control group children aged 8 - 17 years and adults without spina bifida will be approached at the Ear-Nose-Throat (ENT) and paediatric clinics.\n\nMethods The main study parameter is the validation of the Dutch version of the questionnaire. Patients with spina bifida are asked to fill out the QUALAS at two time-points. They are also asked to fill out an extra questionnaire at two time-points, in order to validate the QUALAS. Children and adults in the control groups are asked to fill out the two questionnaires only once.\n\nBurden and risks No (extra) outpatient visit is required. The questions in the questionnaires are similar to the medical history during an outpatient visit. The burden is therefore minimal for these patients. Participation in this study will not influence patient treatment.\n\nRecruitment and consent Parents of children and children and adults who meet the inclusion criteria and none of the exclusion criteria will be informed orally about this study by their treating urologist during a regular visit. A patient information and consent form will be handed over to the parents and children over eight years of age and adults. Parents of children and children and adults at the ENT clinic will be approached by the local urologist for participation for this study. If they are willing to participate they will be asked to sign informed consent and fill out the questionnaire.",[26],"2024-12-09",{"date":458,"type":36},"2024-12-12",{"date":456,"type":20},{"date":461,"type":20},"2025-03-31",{"name":463,"class":82},"Erasmus Medical Center",{"id":465,"slug":466,"hasResults":11,"nctId":467,"briefTitle":468,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":11,"sex":15,"minAge":470,"maxAge":471,"enrollmentInfo":472,"targetDuration":4,"studyType":21,"phases":473,"briefSummary":474,"conditions":475,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":4},"100458713","enema-device-for-children-with-spina-bifida-100458713","NCT05253196","Enema Device for Children With Spina Bifida","Inclusion Criteria:\n\n* Poor sphincter tone\n* Perform regular enemas for bowel management (due to fecal incontinence)\n* 2 - 30 years old\n\nExclusion Criteria:\n\n* Non English speakers\n* Prisoners\n* Pregnant women\n* Wards of state\n* Decisionally challenged adults","2 Years","30 Years",{"count":93,"type":20},[23],"The International Center for Colorectal and Urogenital Care at Children's Hospital Colorado treats patients who suffer from many different colorectal issues such as anorectal malformation, Hirschsprung disease, and severe constipation. Many of these patients suffer from fecal incontinence. The investigators have developed a week long bowel management program (BMP) that is offered every month to help these kids stay clean of stool in the underwear, by finding the perfect enema recipe to clean the colon for 24 hours. This allows one to perform an enema once every day, clean their colon, and remain free of 'accidents'. Many spina bifida patients also suffer from fecal incontinence and are referred to this BMP. The overall success rate for all patients who suffer from fecal incontinence is 95%, however the success rate for spina bifida patients is only 77%. The reason for this decrease in success is due to the lack of anal sphincter tone in spina bifida patients, which leads to inadvertent leakage and spillage of enema fluid and bowel content during enema administration. The purpose of this study is to create and test an enema administration device that improves upon current methods.",[26,476],"Fecal Incontinence","2024-10-10",{"date":479,"type":36},"2024-10-15",{"date":481,"type":20},"2025-06",{"date":483,"type":20},"2027-06",{"name":485,"class":82},"University of Colorado, Denver",{"id":487,"slug":488,"hasResults":11,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":11,"sex":15,"minAge":118,"maxAge":52,"enrollmentInfo":493,"targetDuration":4,"studyType":21,"phases":494,"briefSummary":495,"conditions":496,"keywords":497,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":4},"100563608","effectiveness-of-biofeedback-training-in-children-with-neurogenic-bladder-and-bowel-disorder-wth-spina-bifida-100563608","NCT06618378","Effectiveness of Biofeedback Training in Children with Neurogenic Bladder and Bowel Disorder Wıth Spina Bifida","Effectiveness of Biofeedback Training in Children with Neurogenic Bladder and Bowel Disorder with Spina Bifida","Inclusion Criteria:\n\n* Diagnosed with meningomyelocele type spina bifida\n* Individuals between the ages of 5-18.\n\nExclusion Criteria:\n\n* Presence of lower urinary tract infection\n* Presence of abdominal surgery in the last 3 months.",{"count":142,"type":20},[23],"The aim of this study is to examine and compare the bladder and bowel functions, activation of pelvic floor and abdominal muscle groups and quality of life of children diagnosed with spina bifida who did not receive any treatment due to bladder-intestinal dysfunction, received only urotherapy training and received biofeedback training combined with breathing.\n\nThe type of study is clinical trial. Question 1: Does biofeedback training combined with breathing have an effect on bladder and bowel functions, activation of pelvic floor and abdominal muscle groups and quality of life in spina bifida patients with neurogenic bladder and bowel disorders? Question 2: Does urotherapy training have an effect on bladder and bowel functions, activation of pelvic floor and abdominal muscle groups and quality of life in spina bifida patients with neurogenic bladder and bowel disorders? Group 1: control group Group 2: urotherapy training group Group 3: Biofeedback exercise training group combined with breathing There will be no extra treatment to group 1. Urotherapy Training: Standard urotherapy is a combined method that includes clinical assessment (recording voiding frequencies, voiding volumes and incontinence episodes in a bladder diary), voiding habit training, behavior modification instructions, lifestyle recommendations regarding fluid intake and supporting children and their parents through the process.\n\nExercise Training: Urotherapy training will be given at the beginning of the treatment process. Contraction and relaxation will be applied around the external sphincter in combination with diaphragmatic breathing by visual imagery with EMG biofeedback application.\n\nGroup 1, group 2 and group 3 will be compared.",[26],[99,498,499,500],"biofeedback","urotherapy","neurogenicbladder","2024-09-26",{"date":503,"type":36},"2024-10-01",{"date":505,"type":20},"2024-10-21",{"date":507,"type":20},"2026-07-21",{"name":509,"class":82},"Hasan Kalyoncu University",{"id":511,"slug":512,"hasResults":11,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":4,"eligibilityCriteria":516,"healthyVolunteers":11,"sex":15,"minAge":367,"maxAge":52,"enrollmentInfo":517,"targetDuration":4,"studyType":21,"phases":519,"briefSummary":520,"conditions":521,"keywords":525,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":44},"100499517","downstream-effects-of-personalized-top-down-participation-based-interventions-among-youth-with-physical-disabilities-100499517","NCT05784285","Downstream Effects of Personalized 'Top-down' Participation-based Interventions Among Youth With Physical Disabilities","BEYOND: Body-function Enhancement for YOuth Through participatioN in Real-worlD Contexts. The Downstream Effects of Personalized 'Top-down' Participation-based Interventions Among Youth With Physical Disabilities","Inclusion Criteria:\n\n* a physical disability (e.g., due to cerebral palsy, spina bifida, spinal cord injury, non progressive musculoskeletal disorders, juvenile arthritis);\n* restricted mobility, such as an inability to navigate all surfaces and stairs independently and safely without the use of aids, physical assistance, or external support;\n* youth with various diagnoses will be eligible;\n* youth with cognitive and communication issues and\u002For intellectual delay will be included and a proxy version of self-reported assessments will be used.\n* living in the province of Quebec or Ontario\n\nExclusion Criteria:\n\n* youth who are recovering within the first year following a severe brain injury or an orthopedic surgery or botulinum toxin treatment 6 months prior or anticipated during the study period\n* youth with degenerative disorders\n* youth with a severe untreated mental health condition will also be excluded based on the Kessler Psychological Distress Scale (K6)",{"count":518,"type":20},150,[23],"Participation in community-based activities is essential to the health and well-being of youth with physical disabilities; yet, it is extremely restricted. Emerging treatment approaches aimed at improving participation have shifted from focusing only on impaired body functions towards the performance of functional meaningful activities within the youth's natural environment. Investigators' initial results from studies in Quebec show that targeting intervention at the activity\u002Fparticipation level can result in improvement of impaired body functions (e.g., balance, attention, anxiety) - important components to address in rehabilitation. Investigators' team aims to continue studying the impact of participation by launching a larger more rigorous study. Investigators have partnered with major organizations providing rehabilitation services for youth as well as key community-based stakeholders including youth, clinicians, and managers, and together investigators plan to further examine whether engaging in an 8-week community-based activity individually chosen by the youth (e.g., sledge hockey, drawing, playing a musical instrument) can lead to a significant improvement in three key body functions: motor, behavioral and emotional. One hundred and fifty youth with physical disabilities living in Quebec and Ontario will participate and engage in an activity of choice. Changes in their body functions (e.g., movement, attention, mood) will be measured multiple times before, during and after engagement in the chosen activity. Findings of this study can guide clinicians, families and policy-makers to select effective approaches that not only promote participation but also facilitate additional motor and mental benefits from a single intervention. Such 'real-world' treatment approaches involving activities of choice can also increase motivation, compliance and reduce burden on the healthcare system and on the youth and families.",[373,26,522,523,524,187],"Musculoskeletal Disorder","Juvenile Arthritis","Amputation",[526,527,528,529,530],"participation","environmental barriers","youth","disabilities","body functions","2023-10-13",{"date":533,"type":36},"2023-10-16",{"date":535,"type":20},"2023-11",{"date":537,"type":20},"2027-04",{"name":539,"class":82},"McGill University",{"id":541,"slug":542,"hasResults":11,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":11,"sex":427,"minAge":52,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":21,"phases":548,"briefSummary":549,"conditions":550,"keywords":552,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":83},"100351453","laparotomy-versus-percutaneous-endoscopic-correction-of-myelomeningocele-100351453","NCT03856034","Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele","In Utero Endoscopic Correction of Myelomeningocele: Laparotomy Versus Percutaneous - A Pilot Study","Inclusion Criteria:\n\n1. Myelomeningocele (including myeloschisis) at level T1 through S1 with hindbrain herniation. Lesion level and hindbrain herniation will be confirmed by MRI and ultrasonography.\n2. Maternal age ≥18 years.\n3. Gestational age of 19 to 27 6\u002F7 weeks' gestation as determined by clinical information and evaluation of first ultrasound.\n4. Balanced karyotype with written confirmation of culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is at 24 weeks or more.\n5. Positive evaluation of social work consult indicating the patient is capable of consenting to the procedure and has the appropriate social support system to participate in the study.\n6. Positive evaluation from pediatric neurology consult.\n7. Willing to remain in the greater Wellington or Pasadena area (within a 30-minute car ride) for remainder of the pregnancy and deliver at Wellington Regional Medical Center or Huntington Memorial Hospital for postnatal management. The participants must be willing to return to our center for the 12, 24, 30, 48, and 60 months for follow-up evaluation.\n\nExclusion Criteria:\n\n1. Multiple gestation\n2. Insulin-dependent pregestational diabetes\n3. Presence of a fetal anomaly not related to myelomeningocele. A fetal echocardiogram will be conducted before surgery and if the finding is abnormal, the patient will be excluded.\n4. Fetal kyphosis of 30 degrees or more, assessed by ultrasound or MRI.\n5. Presence of uterine cervical cerclage or history of incompetent cervix.\n6. Placenta previa or placental abruption.\n7. Short cervix \\\u003C 25 mm measured by cervical ultrasound.\n8. Obesity as defined by body mass index (BMI) of 35 or greater.\n9. History of previous spontaneous singleton delivery prior to 37 weeks.\n10. Maternal-fetal Rh isoimmunization, Kell sensitization or a history of neonatal alloimmune thrombocytopenia.\n11. Maternal HIV or Hepatitis-B status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis B status is unknown, the patient must be tested and found to have negative results before she can be enrolled.\n12. Known Hepatitis-C positivity. If the patient's Hepatitis C status is unknown, she does not need to be screened.\n13. Uterine anomaly such as large (greater than 6 cm) fibroids, cervical fibroids or multiple fibroids or Mullerian duct abnormality.\n14. Other maternal medical condition which is a contraindication to surgery or anesthesia.\n15. Patient does not have a support person (e.g., husband, partner, parents).\n16. Inability to comply with the travel and follow-up requirements of the study.\n17. Patient does not meet psychosocial criteria as determined by the social worker evaluation.\n18. Participation in another intervention study that influences maternal and fetal morbidity and mortality.\n19. Maternal hypertension as determined by the investigator, which would increase the risk of preeclampsia or preterm delivery (including, but not limited to: uncontrolled hypertension, chronic hypertension with end organ damage and new onset hypertension in current pregnancy).\n20. Bicornuate uterus or any other uterine malformation the PI decides is not safe for surgery.\n21. Nickel allergy.\n22. Maternal request to undergo open fetal surgery for the antenatal correction of open spina bifida at our institution primarily or after failed fetoscopic approach.\n23. Known maternal hypersensitivity to bovine collagen or chondroitin materials.",{"count":206,"type":20},[23],"The purpose of this study is to evaluate the feasibility of a fetoscopic surgical technique for antenatal correction of fetal myelomeningocele. Two surgical approaches will be utilized. The percutaneous approach will be offered to participants with a posterior placenta. The laparotomy\u002Futerine exteriorization approach will be offered to participants regardless of placental location.",[432,26,97,551],"Chiari Malformation",[99,100,553,554,555,556,557],"neural tube defect","chiari malformation","fetoscopy","percutaneous","fetus","2019-11-11",{"date":560,"type":36},"2019-11-13",{"date":562,"type":36},"2018-11-02",{"date":564,"type":20},"2027-12-31",{"name":566,"class":82},"USFetus",{"id":568,"slug":569,"hasResults":11,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":573,"eligibilityCriteria":574,"healthyVolunteers":11,"sex":575,"minAge":52,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":578,"conditions":579,"keywords":584,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":4},"100339378","urothelium-tissue-engineering-using-biopsies-from-transurethral-resection-of-prostate-100339378","NCT03698721","Urothelium Tissue Engineering Using Biopsies From Transurethral Resection of Prostate","Urothelium Tissue Engineering Using Bladder Mucosa From Transurethral Resection of Prostate","IMOPU","Inclusion Criteria:\n\n* Patient needing a Transurethral Resection of Prostate (TURP)\n* Weight of prostate (evaluated by ultrasonography)greater than or equal to 30 grams\n* Affiliation to a social security system\n* Patient over the age of majority\n* Patient receiving complete information on research organization without opposition to the use of biological specimen\n\nExclusion Criteria:\n\n* Patient for whom no TURP is realized during endoscopic procedure\n* Patient for whom no resection is realized on the bladder neck\n* Patient with prostate weight estimated under 30 grams\n* Patient who opposed to the realization of the study","MALE",{"count":577,"type":20},365,"Different clinical conditions can require urinary bladder augmentation or replacement. Tissue engineered bladder has been clinically evaluated but is not recommended due to diverse side effects. Thus, there is a real interest for the development of regenerative approach with innovative scaffolds and cell transplantation.\n\nThe investigators propose the use of urothelial cells obtained by Trans-Urethral Resection of Prostate or bladder (TURP) to obtain a tissue engineered urothelium in association with different scaffolds.",[26,580,581,582,583],"Urothelial Neoplasm","Bladder, Neurogenic","Bladder Exstrophy","Hypospadias",[585,586,587,588],"Tissue engineering","Collagen scaffold","Alginate scaffold","Urothelial cells","2018-10-04",{"date":591,"type":36},"2018-10-09",{"date":593,"type":20},"2018-10",{"date":595,"type":20},"2026-10",{"name":173,"class":82}]