Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-28 @ 1:56 PM
Study NCT ID:
NCT00892450
Status:
COMPLETED
Last Update Posted:
2014-10-03
First Post:
2009-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'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'}, {'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': 'C005419', 'term': 'oxybutynin'}, {'id': 'C101207', 'term': 'darifenacin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-02', 'studyFirstSubmitDate': '2009-04-28', 'studyFirstSubmitQcDate': '2009-04-30', 'lastUpdatePostDateStruct': {'date': '2014-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'compare cognitive side effects', 'timeFrame': '10 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Overactive bladder symptoms', "Parkinson's disease", 'darifenacin', 'oxybutynin', 'cognition'], 'conditions': ["Parkinson's Disease", 'Overactive Bladder']}, 'descriptionModule': {'briefSummary': "The purpose of this research study is to investigate the cognitive (thinking, memory, knowledge, intelligence) side effects of two medications commonly used to treat overactive bladder (OAB) symptoms in veteran patients with Parkinson's disease (PD) seen at the Philadelphia PADRECC.", 'detailedDescription': 'This study will be a double-blinded cross-over clinical trial design to assess the prevalence of cognitive effects, the efficacy, and the effect on quality of life (QOL) of two anticholinergic medications commonly used in the treatment of overactive bladder (OAB): oxybutynin and darifenacin. This will be done by use of a well-established and validated computer-based cognitive battery. Secondary endpoints will assess efficacy of anticholinergic therapy on symptoms of OAB via QOL questionnaire and participant urinary diaries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of idiopathic PD (ICD9=332.0)\n* MMSE 24, able to give informed consent and complete questionnaires and voiding diaries.\n* Urological work-up within 3 months of enrollment to:\n\n * Rule out treatable causes of urinary symptoms\n\n * Urinalysis (UA)\n * Post-void residual ultrasound (PVR)\n * Urinary cytology\n * Documented symptoms OAB on screening 3-day voiding diary:\n\n * Average of 1 urgency episode / 24 hours, and\n * Average of 8 micturitions / 24 hours\n * Subjective complaints of symptoms for 3 months\n\nExclusion Criteria:\n\n* Exposure to anticholinergics or antispasmodics within the last 4 weeks (among them: atropine, tolterodine, benztropine, trihexyphenidyl, dicyclomine, hyoscyamine, and scopolamine)\n* Exposure to drugs with known effects on cognition (i.e. opioids, benzodiazepines or sedating antihistamines) within the last week\n* Exposure to drugs contraindicated or cautioned in use with the 2 study medications (drugs that also use the cytochrome P450 enzyme, primarily CYP3A4). These include: ketoconazole, itraconazole, miconazole, erythromycin, clarithromycin, ritonavir, nelfinavir, nefazodone, flecainide, thioridazine and tricyclic antidepressants.\n* Nonpharmacological treatment of OAB within the last 4 weeks (for example: biofeedback, physical therapy, acupuncture)\n* Uncontrolled narrow angle glaucoma\n* History of gastric or urinary retention / dysmotility (ulcerative colitis, myasthenia gravis and severe constipation)\n* History of hepatic or renal impairment\n* History of severe gastro-esophageal reflux disease and/or use of bisphosphonates, patients at risk for esophagitis\n* Previous exposure to anticholinergic for OAB symptoms that resulted in side effects that caused cessation of the medication'}, 'identificationModule': {'nctId': 'NCT00892450', 'briefTitle': "Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease", 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': "Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease: A Randomized, Double-blind, Crossover Pilot Study", 'orgStudyIdInfo': {'id': '01143'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'crossover design', 'interventionNames': ['Drug: Oxybutynin and darifenacin']}], 'interventions': [{'name': 'Oxybutynin and darifenacin', 'type': 'DRUG', 'description': 'Participants with overactive bladder will take each medication for 4 weeks.', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'VA Medical Center, Philadelphia', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Jayne R Wilkinson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Medical Center, Philadelphia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}