Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-30 @ 6:29 AM
Study NCT ID:
NCT00780832
Status:
TERMINATED
Last Update Posted:
2016-02-24
First Post:
2008-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], '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'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Insufficient elligible patients available in a reasonable time frame.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-23', 'studyFirstSubmitDate': '2008-10-27', 'studyFirstSubmitQcDate': '2008-10-27', 'lastUpdatePostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Bladder Function Questionnaire score', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Does the amount of caffeine consumed relate to symptom severity?', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['overactive bladder', 'dietary caffeine', 'anticholinergic medication', 'lifestyle modification', 'incontinence', 'urinary frequency'], 'conditions': ['Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effects of caffeine reduction/elimination on urinary symptoms in women with overactive bladders and compare this therapeutic approach to anticholinergic therapy. We hope to show a reduction in symptoms with caffeine reduction and determine how effective caffeine reduction is compared to medication. If caffeine reduction is shown to be beneficial, women may be encouraged to use this strategy before resorting to medications.', 'detailedDescription': 'Urinary symptoms such as frequency, urgency, nocturia, and incontinence occur in many women. Overactive bladder (OAB) accounts for forty to seventy percent of urinary incontinence. These symptoms can be mildly annoying to life altering. Many women wear pads or adult diapers daily and avoid social situations for fear of embarrassment. It is felt that up to sixteen percent of the adult population may suffer from these symptoms and many of these women seek medical help.\n\nCurrently, the standard of care for OAB includes some combination of lifestyle modification counseling, bladder retraining, or anticholinergic medications. It is anticipated that stimulants such as caffeine irritate the bladder and exacerbate OAB symptoms. There have been a few studies looking at the effect of caffeine but interventions have varied, and the results have been mixed.\n\nPerhaps the most common treatment for significant OAB symptoms is the prescription of anticholinergic medications. We know that these are efficacious in many women but they can be expensive and have significant side effects4. In fact, many women discontinue their anticholinergics due to dry mouth, dry eyes, gastrointestinal, and genitourinary effects.\n\nTo date there have been no studies comparing caffeine reduction to anticholinergic medications.\n\nResearch Questions\n\n1. Does caffeine reduction decrease OAB symptoms?\n2. Does the amount of caffeine consumed relate to symptom severity?\n3. If symptoms do improve with caffeine reduction, are women compliant with this treatment?\n4. How does caffeine reduction compare to anticholinergic medication in treating OAB?\n\nStudy Goal:Compare caffeine reduction to anticholinergic medication as a treatment for overactive bladder.\n\nStudy Design:Randomized prospective study. Eligible participants will be randomized to either the anticholinergic arm or the caffeine reduction arm.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women with OAB symptoms including urgency, frequency (voids ≥8/day), and urge incontinence\n2. Women who consume \\> one cup (250ml) caffeinated beverage per day\n3. Women who score $ 6 on the QUID Questionnaire for urgency symptoms\n\nExclusion Criteria:\n\n1. Women currently receiving treatment for OAB symptoms\n2. Women with narrow angle Glaucoma\n3. Women taking anticholinergics or loop diuretics\n4. Women with an untreated urinary tract infection. After resolution of the UTI, and if all other eligibility criteria are met, the woman can be a candidate for inclusion in the study.\n5. Women with a diagnosis of painful bladder syndrome or other abnormal urinary tract lesions\n6. Women scoring \\>4 on the QUID Questionnaire for stress symptoms\n7. Women with de novo symptoms following surgery\n8. Women with major pelvic prolapse'}, 'identificationModule': {'nctId': 'NCT00780832', 'briefTitle': 'Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder', 'organization': {'class': 'OTHER', 'fullName': 'IWK Health Centre'}, 'officialTitle': 'Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder', 'orgStudyIdInfo': {'id': 'REB #4121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Caffeine reduction through diet and beverage counselling', 'interventionNames': ['Behavioral: Dietary Caffeine reduction']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Anticholinergic medication', 'interventionNames': ['Drug: Anticholinergic medication']}], 'interventions': [{'name': 'Dietary Caffeine reduction', 'type': 'BEHAVIORAL', 'otherNames': ['Lifestyle modification'], 'description': 'Participants are counseled about reduction of dietary caffeine, given written information and a bladder control log.', 'armGroupLabels': ['1']}, {'name': 'Anticholinergic medication', 'type': 'DRUG', 'description': 'Detrol LA 4mg. orally, once daily for 30 days', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3K 6R8', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'IWK Health Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'overallOfficials': [{'name': 'Scott A Farrell, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IWK Health Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IWK Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}