Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-26 @ 3:59 AM
Study NCT ID:
NCT06787092
Status:
COMPLETED
Last Update Posted:
2025-01-22
First Post:
2025-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Outcome of Pre-transplant Bladder Cycling in Patients With Defunctionalized Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-05', 'size': 718540, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-01-16T19:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'the study main objective is to describe various parameters related to bladder functionality in renal transplanted cases with defunctionalized bladder when treated with pre-transplant bladder cycling and due to limited data available, estimation of sample size will be based on effect size. A sample size of at least 20 cases achieves a power of 80% to detect a large effect size of 0.7 comparing pre- and post- cystometric capacity using paired t-test with level of significance of 0.05.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-16', 'studyFirstSubmitDate': '2025-01-16', 'studyFirstSubmitQcDate': '2025-01-16', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measuring bladder size', 'timeFrame': '3 months', 'description': 'measuring bladder size by ACUG'}], 'secondaryOutcomes': [{'measure': 'increasing bladder size to facilitate uretrovesical reimplantation during renal transplantationn', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bladder cycling, defunctionalized bladder'], 'conditions': ['Bladder Cycling, Defunctionalized Bladder']}, 'referencesModule': {'references': [{'pmid': '38570243', 'type': 'RESULT', 'citation': 'Silverii H, Cain MP. A novel approach to bladder cycling for defunctionalized bladders prior to pediatric kidney transplantation: A case series. J Pediatr Urol. 2024 Aug;20(4):762-764. doi: 10.1016/j.jpurol.2024.03.022. Epub 2024 Mar 24.'}, {'pmid': '36682701', 'type': 'RESULT', 'citation': 'Osman Y, Zahran MH, Harraz AM, Mashaly M, Kamal AI, Ali-El-Dein B. Utility of Pre-Transplant Bladder Cycling for Patients With a Defunctionalized Bladder. A Randomized Controlled Trial. Urology. 2023 Apr;174:172-178. doi: 10.1016/j.urology.2023.01.008. Epub 2023 Jan 19.'}], 'seeAlsoLinks': [{'url': 'https://www.mims.com/hongkong/news-updates/topic/bladder-cycling-pretransplant-offers-no-clinical-advantage-in-patients-with-defunctionalized-bladder', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the efficacy of pre-transplant programmed bladder cycling for patient with defunctionalized urinary bladder', 'detailedDescription': 'Kidney transplantation still remains the best treatment for end-stage renal disease (ESRD). Indeed, increasing numbers of patients are referred for transplantation, but there has been no concomitant increase in the supply of kidneys from the traditional donor pool. Many potential recipients awaiting transplantation, therefore must undergo dialysis for a long time. Regarding the detrimental effect of long-term dialysis associated with oliguria or anuria on the lower urinary tract, and especially in bladder, the interruption of physiological cycle of storage and voiding brings to a situation called Defunctionalized Bladder (DB) in which the bladder capacity became smaller in size. (Errando et al 2018).\n\nIn this study we will evaluate the outcome of renal transplantation into a defunctionalized bladder by comparing direct transplantation into this defunctionalized bladder and pre-transplant programmed bladder cycling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 16 years and older.\n2. ESRD patients maintained on hemodialysis for more than 12 months.\n3. Have oliguria or anuria\n4. reduced bladder capacity (less than 100 ml) assessed by cystogram.\n\nExclusion Criteria:\n\n* 1- Previous bladder or pelvic surgery or procedure having affected the bladder function.\n\n 2- Neurogenic bladder dysfunction. 3-Patients with history of lower urinary tract symptoms before developing renal failure.\n\n 4-Those with lower urinary tract disease resulting in renal failure.'}, 'identificationModule': {'nctId': 'NCT06787092', 'acronym': 'PBC and DF', 'briefTitle': 'The Outcome of Pre-transplant Bladder Cycling in Patients With Defunctionalized Bladder', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Outcome of Pre-transplant Bladder Cycling in Patients With Defunctionalized Bladder', 'orgStudyIdInfo': {'id': 'bladder cycling'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Egyptian patients attending Ain Shams University hospitals', 'description': 'ESRD patients maintained on hemodialysis for more than 12 months having oliguria or anuria with reduced bladder capacity (less than 100 ml) assessed by cystogram.', 'interventionNames': ['Procedure: bladder cycling']}], 'interventions': [{'name': 'bladder cycling', 'type': 'PROCEDURE', 'description': 'started by the instillation of the sterile water in the bladder in amount equal to the estimated bladder capacity. Then the amount will be gradually increased till the patient can withstand filling the bladder with 250 cc of sterile saline for 2 hours.', 'armGroupLabels': ['Egyptian patients attending Ain Shams University hospitals']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'will be available at any time forever', 'ipdSharing': 'YES', 'description': 'all my IPD can be shared', 'accessCriteria': 'medical student only'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Mohamed Shaker', 'investigatorAffiliation': 'Ain Shams University'}}}}