[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bladder-exstrophy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bladder-exstrophy":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,54,81,105],{"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":35,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100410565","early-phase-1-concomitant-renal-and-urinary-bladder-allograft-transplantation-100410565",false,"NCT04626167","Concomitant Renal and Urinary Bladder Allograft Transplantation","Inclusion Criteria:\n\n* Male or female patients between 1 yr. and 60 years of age.\n* Subject is willing and able to give signed informed consent, or have a legally authorized representative who is willing and able to give consent. Informed assent will be required for children 6-17 years of age as appropriate or warranted.\n* Patients with CKD secondary to neurogenic bladder, lower urinary tract obstruction or other disorders of the urinary bladder.\n* Medical need for a bladder transplant, as defined by the presence of exhibiting \"hostile bladders\" defined as end filling pressure or detrusor leak point pressure (DLPP) of or greater than 40 cm H20 or at below estimated bladder capacity for age, or detrusor overactivity with detrusor sphincter dyssynergia, or new onset of upper urinary tract changes (hydronephrosis, vesicoureteral reflux) in the last 12 months\n* If a concomitant kidney transplant is being considered, additionally, estimated GFR less than or equal to 20 mL\u002Fmin or dialysis. If GFR 20-25 mL\u002Fmin would also qualify if expected progression is rapid (\\>10 mL\u002Fmin\u002Fyear)\n* Vetting and approval by the Mayo Clinic multidisciplinary transplant team (MDC) for renal transplantation.\n* Ability of subject and\u002For care provider to be successfully trained in clean intermittent catheterization and bladder cycling. Or current use of CIC.\n* Utilization of maximally-tolerated dose and regimen of medical therapy (e.g. anticholinergics) or failure to tolerate\u002Fcontraindications to such agents.\n* Psychosocial clearance: Demonstrated commitment to psychological evaluation perioperatively, in which the psychologist must confirm that the subject has the maturity and stable psychosocial environment necessary for this research study.\n* Agree to avoid pregnancy for 1 year after surgery through abstinence or approved contraception as noted in Appendix A (female subjects only)\n* If patient has a history of malignancy (with the exception of localized non-melanoma skin cancer) the patient must be at least 5 years from termination of treatment without evidence of recurrent disease.\n\nExclusion Criteria:\n\n* They are pregnant or breastfeeding, or planning a pregnancy during the course of the study, or who are of child bearing potential and not willing to continue using an effective method of birth control (i.e. with a low failure rate of less than 1 percent per year including injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence, or a vasectomized partner), or\n* Any contraindication to general anesthesia or evaluation reveals that the subject cannot safely undergo general anesthesia and post-operative recovery due to severe cardiovascular, pulmonary, neurological, metabolic, or rheumatologic disease (requires special consultation)\n* Any contraindication or known anaphylactic or severe systemic reaction to either human blood products or materials of bovine origin\n* Subjects with a current positive (\\>=5 mm induration for high-risk subjects; otherwise \\>=10 mm of induration) purified protein derivative (PPD) test are excluded unless they have completed a full course of treatment for latent TB and have a negative chest x-ray film at enrollment.\n* Known history of hypersensitivity to aminoglycosides or fluoroquinolones\n* Use of any investigational product within 3 months\n* Prior participation in the study\n* Currently smoking\n* Current incarceration for any reason\n* Unwillingness, inability, or unlikely compliance of individual and\u002For primary caregiver with study related schedules procedures, management, or follow -up in the opinion of the PI and\u002For co-investigators\n* Any circumstance in which the investigator deems participation in the study is not in the subject's best interest\n* Subjects with an ALT or AST value \\>3 times the upper limit of normal\n* Subjects with acute or chronic abdominal skin infections and\u002For acute or chronic abdominal inflammatory conditions such as inflammatory bowel disease\n* Subjects with uncontrolled diabetes defined as HgA1c\\>10, unstable cardiac and\u002For pulmonary disorders, or bleeding disorders\n* Active malignant neoplasm (with the exception of localized non-melanoma skin cancer) that is untreated, unresponsive to available treatment, or too recently treated to determine relapse risk.\n* Surgical procedure for transplantation cannot be successfully performed for anatomical reasons\n* Life expectancy with successful transplantation is estimated to be \\\u003C5 years for any reason.\n* There is any other disease, physical examination finding, or clinical laboratory result that provides a reasonable suspicion of a disease or condition that contraindicates the procedure or the interpretation of results or render the subject at high risk for treatment complications, or\n* Serious or uncontrolled psychiatric illness or disorder that could compromise their understanding of, or compliance with, follow-up visits\u002Fcare after transplant, or\n* Taking medications on specified hourly intervals that may be affected by changes to renal clearance, or\n* Hypertension stage II \\> 99th percentile, unless they had a complete workup to exclude secondary etiologies other than being overweight, or\n* Presence of severe coagulopathy, (hyper or hypo)\n* Patient is not up to date on current CDC recommended vaccines","ALL","1 Year","60 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","The purpose of this study is to establish if concomitant renal and vascularized urinary bladder allograft transplantation is feasible.",[26,27,28,29,30,31,32,33,34],"Chronic Kidney Diseases","Bladder Dysfunction","Bladder Absence","Posterior Urethral Valve","Neurogenic Bladder","Bladder Exstrophy","Bladder Outlet Obstruction","Failure, Kidney","Transplant",[36,37,38,39,40],"Urinary Bladder Transplant","Bladder Transplant","Bladder Augment","Neobladder","Ileocystoplasty","RECRUITING","2026-04-20",{"date":44,"type":45},"2026-04-23","ACTUAL",{"date":47,"type":45},"2021-06-01",{"date":49,"type":20},"2026-08",{"name":51,"class":52},"Mayo Clinic","OTHER",2,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":15,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":21,"phases":66,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100571218","pelvic-osteotomy-in-bladder-exstrophy-100571218","NCT06717386","Pelvic Osteotomy in Bladder Exstrophy","Modified Diagonal Pelvic Osteotomy and External Fixator in the Surgical Treatment of Bladder Exstrophy","Inclusion Criteria:\n\n1. age: all cases of delayed exstrophy repaior\n2. sex : both gender\n3. children who received no operative treatment befor\n\nExclusion Criteria:\n\n1. previous pelvic surgery\n2. sever comorbidities",true,"6 Months","6 Years",{"count":65,"type":20},10,[67],"NA","The study focuses on the surgical treatment of bladder exstrophy, a congenital condition where the bladder is located outside the body. It examines the use of modified diagonal pelvic osteotomy combined with an external fixator as a treatment approach. This method aims to improve pelvic support and facilitate proper bladder reconstruction. The study likely evaluates the outcomes, complications, and overall effectiveness of this surgical technique in enhancing patient quality of life and functional results. Key findings may include insights into recovery times, rates of successful bladder closure, and potential long-term benefits for patients.",[31],"NOT_YET_RECRUITING","2024-12-03",{"date":73,"type":45},"2024-12-05",{"date":75,"type":20},"2024-12-02",{"date":77,"type":20},"2026-02-02",{"name":79,"class":52},"Sohag University",1,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":15,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":80},"100434345","evaluation-of-the-safety-and-efficacy-of-adjustable-continence-therapy-balloons-in-bladder-exstrophy-and-incontinent-epispadias-patients-100434345","NCT04935918","EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENCE THERAPY BALLOONS IN BLADDER EXSTROPHY AND INCONTINENT EPISPADIAS PATIENTS","PROSPECTIVE STUDY EVALUATING THE SAFETY AND EFFECTIVENESS OF ADJUSTABLE CONTINENCE THERAPY (ACT) BALLOONS FOR THE MANAGEMENT OF URINARY INCONTINENCE IN CHILDREN WITH BLADDER EXSTROPHY OR INCONTINENT EPISPADIAS","ACT","Inclusion Criteria:\n\n* Boys and girls \\> 5 years with bladder exstrophy or isolated epispadias;\n* sphincteric incontinence (leak point pressure \\\u003C 45 cm d'H20, open bladder neck during filling, stress urinary incontinence);\n* normal renal function (eGFR \\> 90ml\u002Fmin);\n* no (or stable) upper urinary tract dilatation in ultrasound.\n\nExclusion Criteria:\n\n* under 5 years or more than 18 years old;\n* renal insufficiency (acute or chronic);\n* evolutive deterioration of the upper urinary tract (hydronephrosis);\n* unmanageable detrusor instability;\n* residual volume greater than 100 ml after voiding;\n* bleeding disorders.","5 Years","18 Years",{"count":92,"type":20},7,[67],"The purpose of this study is to evaluate the effectiveness and safety of a minimally invasive surgical procedure with ACT (Adjustable Continence Therapy) balloons implantation for the treatment of urinary incontinence in children with bladder exstrophy or isolated epispadias.\n\nThe ACT therapy consists of two small adjustable silicone balloons connected with a tubing to a port, surgically placed around the bladder neck, one on each side of the urethra.",[31],"2021-06-15",{"date":98,"type":45},"2021-06-23",{"date":100,"type":45},"2021-04-16",{"date":102,"type":20},"2028-04",{"name":104,"class":52},"Assistance Publique Hopitaux De Marseille",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":113,"minAge":90,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":116,"phases":4,"briefSummary":117,"conditions":118,"keywords":123,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"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":115,"type":20},365,"OBSERVATIONAL","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.",[119,120,121,31,122],"Spina Bifida","Urothelial Neoplasm","Bladder, Neurogenic","Hypospadias",[124,125,126,127],"Tissue engineering","Collagen scaffold","Alginate scaffold","Urothelial cells","2018-10-04",{"date":130,"type":45},"2018-10-09",{"date":132,"type":20},"2018-10",{"date":134,"type":20},"2026-10",{"name":136,"class":52},"Central Hospital, Nancy, France"]