Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-28 @ 1:52 AM
Study NCT ID:
NCT00815334
Status:
COMPLETED
Last Update Posted:
2009-06-17
First Post:
2008-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Endoscopic Subureteral Injection for Vesicoureteral Reflux in Adults With Decreased Bladder Compliance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014718', 'term': 'Vesico-Ureteral Reflux'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-16', 'studyFirstSubmitDate': '2008-12-28', 'studyFirstSubmitQcDate': '2008-12-28', 'lastUpdatePostDateStruct': {'date': '2009-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cure rate', 'timeFrame': '3, 12 months'}], 'secondaryOutcomes': [{'measure': 'adverse events', 'timeFrame': '3, 12 months'}, {'measure': 'predictive factor for cure', 'timeFrame': '3, 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vesicoureteral reflux', 'low compliant bladder'], 'conditions': ['Vesicoureteral Reflux']}, 'referencesModule': {'references': [{'pmid': '15149753', 'type': 'BACKGROUND', 'citation': 'Choo MS, Hong B, Ji YH, Chung H, Choe JH, Park WH, Park T, Lee KS. Endoscopic treatment of vesicoureteral reflux with polydimethylsiloxane in adult women. Eur Urol. 2004 Jun;45(6):787-9. doi: 10.1016/j.eururo.2003.11.025.'}, {'pmid': '17070296', 'type': 'BACKGROUND', 'citation': 'Okeke Z, Fromer D, Katz MH, Reiley EA, Hensle TW. Endoscopic management of vesicoureteral reflux in women presenting with pyelonephritis. J Urol. 2006 Nov;176(5):2219-21. doi: 10.1016/j.juro.2006.07.076.'}, {'pmid': '11148731', 'type': 'BACKGROUND', 'citation': 'Puri P. Endoscopic correction of vesicoureteral reflux. Curr Opin Urol. 2000 Nov;10(6):593-7. doi: 10.1097/00042307-200011000-00010.'}]}, 'descriptionModule': {'briefSummary': 'Endoscopic subureteral injection for vesicoureteral reflux has become an established alternative to ureter reimplantation in children. Some recent studies suggest that ESI can be also a primary treatment option for VUR in adults. However, the experience with ESI in adults who have VUR associated with decreased bladder compliance is limited. We evaluated the efficacy of endoscopic subureteral injection treatment for vesicoureteral reflux in adults with decreased bladder compliance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Who is aged 18 and greater\n* Who underwent endoscopic subureteral injection for vesicoureteral reflux\n\nExclusion Criteria:\n\n* Medical records of whom is not evaluabe'}, 'identificationModule': {'nctId': 'NCT00815334', 'briefTitle': 'Efficacy of Endoscopic Subureteral Injection for Vesicoureteral Reflux in Adults With Decreased Bladder Compliance', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Efficacy of Endoscopic Subureteral Injection for Vesicoureteral Reflux in Adults With Decreased Bladder Compliance', 'orgStudyIdInfo': {'id': '2008-10-094'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with decreased bladder compliance', 'description': 'Patients who have decreased bladder compliance', 'interventionNames': ['Procedure: Endoscopic subureteric injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patients with normal bladder compliance', 'description': 'Patients who have normal bladder compliance', 'interventionNames': ['Procedure: Endoscopic subureteric injection']}], 'interventions': [{'name': 'Endoscopic subureteric injection', 'type': 'PROCEDURE', 'description': 'Endoscopic subureteric injection for the treatment of vesicoureteral reflux using variable materials (polydimethylsiloxane, collagen, and dextranomer/hyaluronic acid copolymer)', 'armGroupLabels': ['Patients with decreased bladder compliance', 'Patients with normal bladder compliance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kyu-Sung Lee, Ph.D., M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kyu-Sung Lee/Professor', 'oldOrganization': 'Samsung Medical Center'}}}}