Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2025-12-31 @ 12:03 PM
Study NCT ID:
NCT00253006
Status:
TERMINATED
Last Update Posted:
2006-10-09
First Post:
2005-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Expression of Nitric Oxide Syntheses and Their Functional Role in Human Urothelium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018856', 'term': 'Cystitis, Interstitial'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D003556', 'term': 'Cystitis'}, {'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'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011506', 'term': 'Proteins'}], 'ancestors': [{'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'DEFINED_POPULATION'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-10', 'completionDateStruct': {'date': '2008-01'}, 'lastUpdateSubmitDate': '2006-10-06', 'studyFirstSubmitDate': '2005-11-11', 'studyFirstSubmitQcDate': '2005-11-11', 'lastUpdatePostDateStruct': {'date': '2006-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-15', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['NO', 'mRNA-expression', 'pathophysiology', 'painful bladder syndrome'], 'conditions': ['Interstitial Cystitis', 'Bladder Diseases', 'Urinary Incontinence']}, 'referencesModule': {'references': [{'pmid': '15643277', 'type': 'BACKGROUND', 'citation': 'Birder LA, Wolf-Johnston A, Buffington CA, Roppolo JR, de Groat WC, Kanai AJ. Altered inducible nitric oxide synthase expression and nitric oxide production in the bladder of cats with feline interstitial cystitis. J Urol. 2005 Feb;173(2):625-9. doi: 10.1097/01.ju.0000145900.22849.1d.'}, {'pmid': '12811295', 'type': 'BACKGROUND', 'citation': 'Bouchelouche K, Nordling J. Recent developments in the management of interstitial cystitis. Curr Opin Urol. 2003 Jul;13(4):309-13. doi: 10.1097/00042307-200307000-00007.'}, {'pmid': '14767289', 'type': 'BACKGROUND', 'citation': 'Logadottir YR, Ehren I, Fall M, Wiklund NP, Peeker R, Hanno PM. Intravesical nitric oxide production discriminates between classic and nonulcer interstitial cystitis. J Urol. 2004 Mar;171(3):1148-50; discussion 50-1. doi: 10.1097/01.ju.0000110501.96416.40.'}]}, 'descriptionModule': {'briefSummary': 'Painful bladder syndrome (PBS)/interstitial cystitis (IC) may be due to the actions of nitric oxide (NO) in the bladder tissue. NO is a gaseous substance with a very short half-life, synthesized by a group of NO-synthase-enzymes in many tissues.\n\nThe goal of this study is to illuminate bladder tissue production of NO in individuals with PBS and healthy individuals, by quantification of NO and NO-enzyme expression by different molecular biological methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PBS/IC according to International Continence Society (ICS)\n* Cystoscopy with bladder distension and deep biopsies within last 5 years\n* Cystometry within last 5 years\n* Normal urine culture within last month\n\nInclusion Criteria (for control group):\n\n* Benign non-invasive bladder disease\n* No PBS/IC\n* Normal urine culture\n* No functional bladder disease of known nature (ex. infravesical obstruction)\n\nExclusion Criteria:\n\n* Age under 18 years\n* Inability to understand instructions\n* Pregnancy and lactation'}, 'identificationModule': {'nctId': 'NCT00253006', 'briefTitle': 'Analysis of Expression of Nitric Oxide Syntheses and Their Functional Role in Human Urothelium', 'organization': {'class': 'OTHER', 'fullName': 'Copenhagen University Hospital at Herlev'}, 'officialTitle': 'A Quantitative Analysis of Protein- and mRNA-Expression of Nitric Oxide Syntheses and Their Functional Role in Human Urothelium', 'orgStudyIdInfo': {'id': 'UA_H_Ka-05104-m'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tissue examination for protein- and mRNA-expression of NO', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK- 2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital at Herlev', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Pierre Bouchelouche, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Roskilde County University Hospital at Koege, Dept. of Clinical Biochemistry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Copenhagen University Hospital at Herlev', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zealand University Hospital', 'class': 'OTHER'}]}}}