Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-02-07 @ 2:56 PM
Study NCT ID:
NCT02197533
Status:
COMPLETED
Last Update Posted:
2019-12-04
First Post:
2014-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Educating Patients on Management of Overactive Bladder: Written Versus Verbal Instructions
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-03', 'studyFirstSubmitDate': '2014-07-21', 'studyFirstSubmitQcDate': '2014-07-21', 'lastUpdatePostDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recall', 'timeFrame': '0 and 2 weeks', 'description': 'Mean number of treatment strategies recalled (scored out of seven) immediately and two weeks after the clinic appointment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Overactive Bladder']}, 'descriptionModule': {'briefSummary': "Background: Overactive bladder (OAB) is a common condition among postmenopausal women, requiring a multifaceted treatment approach that requires patient retention of information given to them in clinic. Recall of recommendations is a key component of compliance. Supplemental educational tools such as handouts and audiovisual information have been investigated for their ability to improve patients' recall of information and increase satisfaction with the clinical encounter.\n\nObjective: To determine if a written list of seven management strategies for overactive bladder leads to improved immediate and delayed recall of these recommendations in postmenopausal women presenting with OAB compared to a traditional verbal discussion.\n\nMethods: In this single-blind, randomized controlled trial, patients' immediate and delayed (2-week) recall of seven OAB management strategies will be compared between two groups. The intervention group will receive a handwritten list during their verbal discussion of OAB treatment while the control group will receive standard care (verbal discussion only). Immediate and delayed recall will be assessed by a member of the study team who has been blinded to participants' group assignments.\n\nResults: The results of this study may guide clinicians in the most effective mode of providing treatment recommendations to post-menopausal patients with OAB."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New diagnosis of overactive bladder\n* post-menopausal\n\nExclusion Criteria:\n\n* Pre-existing diagnosis of dementia or other cognitive disorders\n* Patients with mixed incontinence\n* Non-English speaking\n* Patients with contraindications to taking vaginal estrogen or anticholinergic medications'}, 'identificationModule': {'nctId': 'NCT02197533', 'briefTitle': 'Educating Patients on Management of Overactive Bladder: Written Versus Verbal Instructions', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'Educating Patients on Management of Overactive Bladder: Written Versus Verbal Instructions', 'orgStudyIdInfo': {'id': '14-213'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Written list', 'description': 'Patients in the intervention group will receive both verbal information and a written supplement (Appendix 1), produced during the discussion by CM or a fellow (not the individual who obtained consent), on treatment recommendations for OAB. They will leave clinic with this written list of recommendations and will be able to take it home with them.', 'interventionNames': ['Other: Written List']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients in the control group will receive the same verbal information on the treatment recommendations for OAB, however, these patients will not receive the written list of management strategies for their condition.'}], 'interventions': [{'name': 'Written List', 'type': 'OTHER', 'description': 'Written list of seven management strategies for OAB to be produced during verbal discussion about management.', 'armGroupLabels': ['Written list']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5B1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Colleen McDermott, MD, MSc, FRSCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unity Health Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}