Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-30 @ 6:24 PM
Study NCT ID:
NCT00943735
Status:
COMPLETED
Last Update Posted:
2018-12-04
First Post:
2009-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
This Is An Open-Label Study To Evaluate Fesoterodine Plus "Your Way" Patient Support Plan In Patients With Symptoms Of Overactive Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C526675', 'term': 'fesoterodine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Enrollment (Day 0) up to 28 days after last dose of study treatment', 'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD', 'otherNumAtRisk': 774, 'otherNumAffected': 100, 'seriousNumAtRisk': 774, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oesophageal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Mood swings', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nightmare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bladder obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cystitis interstitial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Micturition urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urge incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dry throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Respiratory disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypertensive heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Asphyxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Activities of daily living impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Colporrhaphy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Transurethral bladder resection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 774, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Filled at Least 90 Days Supply of Fesoterodine (4mg QD or 8mg QD) Within 90 Days of Study Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '13.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Enrollment (Day 0) up to 90 days', 'description': 'Prototypical pattern for meeting primary endpoint was to fill 3 separate prescriptions (Rx), each for a 30-day supply between enrollment and Day 90. Rx fills could happen as early as Day 0, 30, and 60 of the study period. Participants could also have chosen to wait until their 14-day medication sample was exhausted before receiving their first fill. Investigators received no prescribing restrictions, but were advised not to write Rx for a 90-day supply of fesoterodine at enrollment visit. Participants whose first observed Rx was for a ≥90-day supply were non-evaluable for the primary endpoint.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol (PP) population: all participants who returned a signed informed consent form (Intent to Treat) and enrollment questionnaire, had evidence of ≥1 prescription in LRx database for any medication class, and did not receive an initial fesoterodine prescription for ≥ a 90-day supply.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Filled at Least One Fesoterodine Prescription During the Study Period (Primary Adherence)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000', 'lowerLimit': '22.5', 'upperLimit': '29.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Enrollment (Day 0) up to 90 days', 'description': 'The prototypical pattern was to fill 3 separate prescriptions, each for a 30-day supply, between the enrollment date and Day 90 of the study period; these prescription fills could happen as early as Day 0, 30, and 60 of the study period. Primary adherence was met if the participant filled at least 1 fesoterodine prescription during the study period.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Filled at Least Two Fesoterodine Prescriptions (First Refill) During the Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '16.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Enrollment (Day 0) up to 90 days', 'description': 'The prototypical pattern was to fill 3 separate prescriptions, each for a 30-day supply, between the enrollment date and Day 90 of the study period; these prescription fills could happen as early as Day 0, 30, and 60 of the study period. At enrollment, the Investigator provided participants with a prescription for fesoterodine 4mg or 8mg to be filled at a pharmacy of their choice. The first refill indicated that 2 fesoterodine prescriptions had been filled.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Visited the YourWay Website', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000', 'lowerLimit': '24.0', 'upperLimit': '33.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'description': "YourWay plan was available and accessible to all participants prescribed fesoterodine, but was not defined as an explicit or required component. Plan included motivational support for taking fesoterodine and behavioral interventions shown in clinical studies to improve participants' Overactive Bladder (OAB) outcomes. Objectives included intervening quickly after treatment initiation, before participants had an opportunity to discontinue medication, reinforcing the treatable nature of OAB, and setting appropriate expectations for onset of action with therapy and degree of symptom improvement.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Among Participants Who Used the YourWay Website, the Percentage of Participants Who Agreed That the Website Was Useful', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '5.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Reported Having Read the YourWay Plan Materials Received From Their Physician or From the Resource Kit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '97.3', 'groupId': 'OG000', 'lowerLimit': '95.0', 'upperLimit': '98.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'description': 'YourWay plan included a starter pack with a 14-day supply of 4 mg or 8 mg fesoterodine; guidebook for YourWay plan components and lifestyle modification tips; plan progress tracker with additional lifestyle tips; plan enrollment form. About 1 week after plan enrollment, participants received a resource kit by mail which included: a cover letter; brochures for "Core 4" elements (food and drink, teach your bladder, daily fesoterodine, and track your progress); bladder diary and "track your progress" brochure; and recipes using bladder-friendly foods.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Reported Having Adopted Lifestyle Changes to Help Improve Their Overactive Bladder (OAB) Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '85.3', 'groupId': 'OG000', 'lowerLimit': '81.0', 'upperLimit': '88.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'description': 'The use of the YourWay plan was optional but was available to all participants and included guidance for food and drink choices, bladder training, treatment compliance, and use of a daily tracker.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Reported That They Made Bladder-friendly Food and Drink Choices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '82.4', 'groupId': 'OG000', 'lowerLimit': '77.9', 'upperLimit': '86.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'description': 'The use of the YourWay plan was optional but was available to all participants and included bladder-friendly food and drink choices and recipes as well as information for maintaining hydration and avoidance of potential bladder irritants (such as caffeine, citrus fruits and juices, artificial sweeteners, tomato-based foods, soda, alcohol, and spicy foods).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Reported That They Trained Their Bladder to "Wait"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '86.6', 'groupId': 'OG000', 'lowerLimit': '82.4', 'upperLimit': '90.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'description': 'The use of the YourWay plan was optional but was available to all participants and included bladder training techniques such as to urinate each day when getting up and before going to bed, gradually increasing the amount of time between urinating, staying with timing goals whether there was a need to urinate or not, and bladder control tips (such as pelvic floor muscle squeeze, sit down and take 5 deep breaths, or stating "I\'m the boss - not my bladder").', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Reported That They Took Toviaz® (Fesoterodine) as Directed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '93.9', 'groupId': 'OG000', 'lowerLimit': '90.7', 'upperLimit': '96.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Reported That They Recorded Their Treatment Goals in the Daily Core 4 Tracker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '56.8', 'groupId': 'OG000', 'lowerLimit': '51.7', 'upperLimit': '61.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'description': 'YourWay Daily Core 4 Tracker to track daily progress in the 4 core areas of food and drink (make more informed choices), teach your bladder (train your bladder to "wait"), daily Toviaz® (always take as directed), and keep track (share with your doctor).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Reported That They Kept Track of Symptoms in the 12 Week Tracker Bladder Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'groupId': 'OG000', 'lowerLimit': '52.4', 'upperLimit': '62.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'description': 'For each week, the 12 Week Tracker included a participant determined weekly goal, a reminder to fill the prescription (if appropriate interval), participant reported progress in response to "this week I did well at", and a 7-day Daily Core 4 Tracker checklist (food and drink, teach your bladder, daily fesoterodine, and track your progress).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Reported That They Let Their Doctor Know How They Were Doing With the YourWay Plan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '56.6', 'groupId': 'OG000', 'lowerLimit': '51.4', 'upperLimit': '61.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'description': 'Participants were recruited for study participation when they presented with OAB symptoms during regularly-scheduled physician visits; screening and enrollment occurred during the same visit. Follow-up visits could be scheduled per standard clinical practice.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Agreed That They Found the YourWay Program Materials Easy to Understand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '91.9', 'groupId': 'OG000', 'lowerLimit': '88.5', 'upperLimit': '94.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Agreed That the YourWay Program Provided a Good Amount of Information', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000', 'lowerLimit': '92.7', 'upperLimit': '97.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Agreed That the YourWay Plan Provided a Strong Support System That Participants Could Count on for Information and Advice', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '81.7', 'groupId': 'OG000', 'lowerLimit': '77.1', 'upperLimit': '85.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'description': 'YourWay participants received 6 telephone calls from an automated speech-recognition system over a period of approximately 11 weeks. The calls included reinforcement of treatment participation, treatment expectations, compliance, general health messages regarding OAB, review of training materials, optional weekly email communication, and a wrap-up call which included a summary of lessons learned from each of the Core 4 lessons calls and guidance to find additional information about medication and lifestyle tips to support management of OAB symptoms.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Agreed That They Were Able to Incorporate the YourWay Plan Into Their Lives', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '81.6', 'groupId': 'OG000', 'lowerLimit': '77.0', 'upperLimit': '85.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Agreed That the YourWay Plan Helped Them Play a More Active Role in Managing Their Condition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '79.9', 'groupId': 'OG000', 'lowerLimit': '75.8', 'upperLimit': '84.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Agreed That They Understood What to Expect From Their OAB Medication, Toviaz® (Fesoterodine)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '88.2', 'groupId': 'OG000', 'lowerLimit': '84.2', 'upperLimit': '91.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'description': 'Product indication and safety information was provided to all participants by the investigator and / or within the YourWay plan program information.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Agreed That They Learned Something About Their Condition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '87.0', 'groupId': 'OG000', 'lowerLimit': '82.9', 'upperLimit': '90.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Agreed That They Increased Their Knowledge of Healthy Bladder Behaviors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '85.3', 'groupId': 'OG000', 'lowerLimit': '81.0', 'upperLimit': '88.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'description': 'The use of the YourWay plan was optional but was available to all participants and included healthy bladder behaviors such as setting and maintaining personal goals and choice of bladder-friendly food and drinks.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Agreed That They Understand OAB is a Chronic Condition That Can be Successfully Managed, But Generally Not Cured', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '93.8', 'groupId': 'OG000', 'lowerLimit': '90.6', 'upperLimit': '96.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Reported They Felt Confident That They Could Manage Their OAB as a Result of the YourWay Plan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '72.4', 'groupId': 'OG000', 'lowerLimit': '67.3', 'upperLimit': '77.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Reported They Were Satisfied With the Overall Content of the YourWay Plan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '86.9', 'groupId': 'OG000', 'lowerLimit': '83.3', 'upperLimit': '90.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Reported They Were Satisfied With the Participant Support Telephone Calls', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '78.5', 'groupId': 'OG000', 'lowerLimit': '73.6', 'upperLimit': '82.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'description': 'YourWay participants received 6 telephone calls from an automated speech-recognition system over a period of approximately 11 weeks. The calls included reinforcement of treatment participation, treatment expectations, compliance, general health messages regarding OAB, review of training materials, optional weekly email communication, and a wrap-up call which included a summary of lessons learned from each of the Core 4 lessons calls and guidance to find additional information about medication and lifestyle tips to support management of OAB symptoms.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Reported They Were Satisfied With the Treatment Goals and Bladder Symptoms Progress Trackers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '74.1', 'groupId': 'OG000', 'lowerLimit': '69.0', 'upperLimit': '78.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'description': 'Treatment goals and bladder symptoms progress trackers were incorporated in the 12 Week Tracker which included a participant determined weekly goal, a reminder to fill the prescription (if appropriate interval), participant reported progress in response to "this week I did well at", and a 7-day Daily Core 4 Tracker checklist (food and drink, teach your bladder, daily fesoterodine, and track your progress).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Reported They Were Satisfied With Their Physician', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '93.4', 'groupId': 'OG000', 'lowerLimit': '90.2', 'upperLimit': '95.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Reported the YourWay Plan Encouraged Their Use of Toviaz® (Fesoterodine)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000', 'lowerLimit': '63.9', 'upperLimit': '74.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'categories': [{'measurements': [{'value': '89.6', 'groupId': 'OG000', 'lowerLimit': '85.8', 'upperLimit': '92.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response."}, {'type': 'SECONDARY', 'title': 'Comparison of Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it, Between Enrollment Date and End of Study CATI Interview', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'classes': [{'title': 'Good understanding at enrollment (n=500)', 'categories': [{'measurements': [{'value': '78.4', 'groupId': 'OG000', 'lowerLimit': '75.5', 'upperLimit': '81.3'}]}]}, {'title': 'Good understanding at end of study (n=335)', 'categories': [{'measurements': [{'value': '89.6', 'groupId': 'OG000', 'lowerLimit': '85.8', 'upperLimit': '92.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Enrollment (Day 0) up to 90 days', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PP population; (n)=CATI response valid n at observation. Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid n, therefore, may have varied from response to response."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '774'}]}, {'type': 'Per Protocol Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '500'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '742'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'This was a non-interventional, observational study. Study investigators contacted through prescription records in the IMS Longitudinal prescription (LRx) Database recruited symptomatic, fesoterodine-naive subjects (N=788 recruited; 774 entered) when they presented with overactive bladder (OAB) symptoms during regularly-scheduled physician visits.', 'preAssignmentDetails': 'The use and dosage recommendations for fesoterodine 4 milligram (mg) or 8 mg tablet taken by mouth (PO) once daily (QD) adhered completely to the approved product label and was adjusted solely according to medical and therapeutic necessity.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '774', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'Fesoterodine 4 mg or 8 mg tablet PO, QD'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18 to 24 years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': '25 to 44 years', 'categories': [{'measurements': [{'value': '119', 'groupId': 'BG000'}]}]}, {'title': '45 to 64 years', 'categories': [{'measurements': [{'value': '325', 'groupId': 'BG000'}]}]}, {'title': '≥ 65 years', 'categories': [{'measurements': [{'value': '325', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '593', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '181', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 774}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-07', 'studyFirstSubmitDate': '2009-07-20', 'resultsFirstSubmitDate': '2011-11-16', 'studyFirstSubmitQcDate': '2009-07-21', 'lastUpdatePostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-02-10', 'studyFirstPostDateStruct': {'date': '2009-07-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Filled at Least 90 Days Supply of Fesoterodine (4mg QD or 8mg QD) Within 90 Days of Study Enrollment', 'timeFrame': 'Enrollment (Day 0) up to 90 days', 'description': 'Prototypical pattern for meeting primary endpoint was to fill 3 separate prescriptions (Rx), each for a 30-day supply between enrollment and Day 90. Rx fills could happen as early as Day 0, 30, and 60 of the study period. Participants could also have chosen to wait until their 14-day medication sample was exhausted before receiving their first fill. Investigators received no prescribing restrictions, but were advised not to write Rx for a 90-day supply of fesoterodine at enrollment visit. Participants whose first observed Rx was for a ≥90-day supply were non-evaluable for the primary endpoint.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Filled at Least One Fesoterodine Prescription During the Study Period (Primary Adherence)', 'timeFrame': 'Enrollment (Day 0) up to 90 days', 'description': 'The prototypical pattern was to fill 3 separate prescriptions, each for a 30-day supply, between the enrollment date and Day 90 of the study period; these prescription fills could happen as early as Day 0, 30, and 60 of the study period. Primary adherence was met if the participant filled at least 1 fesoterodine prescription during the study period.'}, {'measure': 'Percentage of Participants Who Filled at Least Two Fesoterodine Prescriptions (First Refill) During the Study Period', 'timeFrame': 'Enrollment (Day 0) up to 90 days', 'description': 'The prototypical pattern was to fill 3 separate prescriptions, each for a 30-day supply, between the enrollment date and Day 90 of the study period; these prescription fills could happen as early as Day 0, 30, and 60 of the study period. At enrollment, the Investigator provided participants with a prescription for fesoterodine 4mg or 8mg to be filled at a pharmacy of their choice. The first refill indicated that 2 fesoterodine prescriptions had been filled.'}, {'measure': 'Percentage of Participants Who Visited the YourWay Website', 'timeFrame': 'Baseline up to 90 days', 'description': "YourWay plan was available and accessible to all participants prescribed fesoterodine, but was not defined as an explicit or required component. Plan included motivational support for taking fesoterodine and behavioral interventions shown in clinical studies to improve participants' Overactive Bladder (OAB) outcomes. Objectives included intervening quickly after treatment initiation, before participants had an opportunity to discontinue medication, reinforcing the treatable nature of OAB, and setting appropriate expectations for onset of action with therapy and degree of symptom improvement."}, {'measure': 'Among Participants Who Used the YourWay Website, the Percentage of Participants Who Agreed That the Website Was Useful', 'timeFrame': 'Baseline up to 90 days'}, {'measure': 'Percentage of Participants Who Reported Having Read the YourWay Plan Materials Received From Their Physician or From the Resource Kit', 'timeFrame': 'Baseline up to 90 days', 'description': 'YourWay plan included a starter pack with a 14-day supply of 4 mg or 8 mg fesoterodine; guidebook for YourWay plan components and lifestyle modification tips; plan progress tracker with additional lifestyle tips; plan enrollment form. About 1 week after plan enrollment, participants received a resource kit by mail which included: a cover letter; brochures for "Core 4" elements (food and drink, teach your bladder, daily fesoterodine, and track your progress); bladder diary and "track your progress" brochure; and recipes using bladder-friendly foods.'}, {'measure': 'Percentage of Participants Who Reported Having Adopted Lifestyle Changes to Help Improve Their Overactive Bladder (OAB) Symptoms', 'timeFrame': 'Baseline up to 90 days', 'description': 'The use of the YourWay plan was optional but was available to all participants and included guidance for food and drink choices, bladder training, treatment compliance, and use of a daily tracker.'}, {'measure': 'Percentage of Participants Who Reported That They Made Bladder-friendly Food and Drink Choices', 'timeFrame': 'Baseline up to 90 days', 'description': 'The use of the YourWay plan was optional but was available to all participants and included bladder-friendly food and drink choices and recipes as well as information for maintaining hydration and avoidance of potential bladder irritants (such as caffeine, citrus fruits and juices, artificial sweeteners, tomato-based foods, soda, alcohol, and spicy foods).'}, {'measure': 'Percentage of Participants Who Reported That They Trained Their Bladder to "Wait"', 'timeFrame': 'Baseline up to 90 days', 'description': 'The use of the YourWay plan was optional but was available to all participants and included bladder training techniques such as to urinate each day when getting up and before going to bed, gradually increasing the amount of time between urinating, staying with timing goals whether there was a need to urinate or not, and bladder control tips (such as pelvic floor muscle squeeze, sit down and take 5 deep breaths, or stating "I\'m the boss - not my bladder").'}, {'measure': 'Percentage of Participants Who Reported That They Took Toviaz® (Fesoterodine) as Directed', 'timeFrame': 'Baseline up to 90 days'}, {'measure': 'Percentage of Participants Who Reported That They Recorded Their Treatment Goals in the Daily Core 4 Tracker', 'timeFrame': 'Baseline up to 90 days', 'description': 'YourWay Daily Core 4 Tracker to track daily progress in the 4 core areas of food and drink (make more informed choices), teach your bladder (train your bladder to "wait"), daily Toviaz® (always take as directed), and keep track (share with your doctor).'}, {'measure': 'Percentage of Participants Who Reported That They Kept Track of Symptoms in the 12 Week Tracker Bladder Diary', 'timeFrame': 'Baseline up to 90 days', 'description': 'For each week, the 12 Week Tracker included a participant determined weekly goal, a reminder to fill the prescription (if appropriate interval), participant reported progress in response to "this week I did well at", and a 7-day Daily Core 4 Tracker checklist (food and drink, teach your bladder, daily fesoterodine, and track your progress).'}, {'measure': 'Percentage of Participants Who Reported That They Let Their Doctor Know How They Were Doing With the YourWay Plan', 'timeFrame': 'Baseline up to 90 days', 'description': 'Participants were recruited for study participation when they presented with OAB symptoms during regularly-scheduled physician visits; screening and enrollment occurred during the same visit. Follow-up visits could be scheduled per standard clinical practice.'}, {'measure': 'Percentage of Participants Who Agreed That They Found the YourWay Program Materials Easy to Understand', 'timeFrame': 'Baseline up to 90 days'}, {'measure': 'Percentage of Participants Who Agreed That the YourWay Program Provided a Good Amount of Information', 'timeFrame': 'Baseline up to 90 days'}, {'measure': 'Percentage of Participants Who Agreed That the YourWay Plan Provided a Strong Support System That Participants Could Count on for Information and Advice', 'timeFrame': 'Baseline up to 90 days', 'description': 'YourWay participants received 6 telephone calls from an automated speech-recognition system over a period of approximately 11 weeks. The calls included reinforcement of treatment participation, treatment expectations, compliance, general health messages regarding OAB, review of training materials, optional weekly email communication, and a wrap-up call which included a summary of lessons learned from each of the Core 4 lessons calls and guidance to find additional information about medication and lifestyle tips to support management of OAB symptoms.'}, {'measure': 'Percentage of Participants Who Agreed That They Were Able to Incorporate the YourWay Plan Into Their Lives', 'timeFrame': 'Baseline up to 90 days'}, {'measure': 'Percentage of Participants Who Agreed That the YourWay Plan Helped Them Play a More Active Role in Managing Their Condition', 'timeFrame': 'Baseline up to 90 days'}, {'measure': 'Percentage of Participants Who Agreed That They Understood What to Expect From Their OAB Medication, Toviaz® (Fesoterodine)', 'timeFrame': 'Baseline up to 90 days', 'description': 'Product indication and safety information was provided to all participants by the investigator and / or within the YourWay plan program information.'}, {'measure': 'Percentage of Participants Who Agreed That They Learned Something About Their Condition', 'timeFrame': 'Baseline up to 90 days'}, {'measure': 'Percentage of Participants Who Agreed That They Increased Their Knowledge of Healthy Bladder Behaviors', 'timeFrame': 'Baseline up to 90 days', 'description': 'The use of the YourWay plan was optional but was available to all participants and included healthy bladder behaviors such as setting and maintaining personal goals and choice of bladder-friendly food and drinks.'}, {'measure': 'Percentage of Participants Who Agreed That They Understand OAB is a Chronic Condition That Can be Successfully Managed, But Generally Not Cured', 'timeFrame': 'Baseline up to 90 days'}, {'measure': 'Percentage of Participants Who Reported They Felt Confident That They Could Manage Their OAB as a Result of the YourWay Plan', 'timeFrame': 'Baseline up to 90 days'}, {'measure': 'Percentage of Participants Who Reported They Were Satisfied With the Overall Content of the YourWay Plan', 'timeFrame': 'Baseline up to 90 days'}, {'measure': 'Percentage of Participants Who Reported They Were Satisfied With the Participant Support Telephone Calls', 'timeFrame': 'Baseline up to 90 days', 'description': 'YourWay participants received 6 telephone calls from an automated speech-recognition system over a period of approximately 11 weeks. The calls included reinforcement of treatment participation, treatment expectations, compliance, general health messages regarding OAB, review of training materials, optional weekly email communication, and a wrap-up call which included a summary of lessons learned from each of the Core 4 lessons calls and guidance to find additional information about medication and lifestyle tips to support management of OAB symptoms.'}, {'measure': 'Percentage of Participants Who Reported They Were Satisfied With the Treatment Goals and Bladder Symptoms Progress Trackers', 'timeFrame': 'Baseline up to 90 days', 'description': 'Treatment goals and bladder symptoms progress trackers were incorporated in the 12 Week Tracker which included a participant determined weekly goal, a reminder to fill the prescription (if appropriate interval), participant reported progress in response to "this week I did well at", and a 7-day Daily Core 4 Tracker checklist (food and drink, teach your bladder, daily fesoterodine, and track your progress).'}, {'measure': 'Percentage of Participants Who Reported They Were Satisfied With Their Physician', 'timeFrame': 'Baseline up to 90 days'}, {'measure': 'Percentage of Participants Who Reported the YourWay Plan Encouraged Their Use of Toviaz® (Fesoterodine)', 'timeFrame': 'Baseline up to 90 days'}, {'measure': 'Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it', 'timeFrame': 'Baseline up to 90 days'}, {'measure': 'Comparison of Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it, Between Enrollment Date and End of Study CATI Interview', 'timeFrame': 'Enrollment (Day 0) up to 90 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Overactive Bladder Incontinence Adherence Behavioral interventions'], 'conditions': ['Overactive Bladder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221078', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to assess the level of medication adherence observed among subjects receiving a specific combination of education and support materials (YourWay plan) along with a prescription for fesoterodine.', 'detailedDescription': 'This is a non-interventional, observational study. Study investigators will recruit symptomatic, fesoterodine-naïve subjects when they present with OAB symptoms during regularly-scheduled physician visits fesoterodine-naïve subjects with OAB symptoms present during regularly-scheduled physician visits'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'fesoterodine-naïve subjects with OAB symptoms present during regularly-scheduled physician visits', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female outpatients \\>=18 years old\n* Eligible for receiving Toviaz 4mg or 8mg QD treatment based on the approved US label.\n\nExclusion Criteria:\n\n* Female subjects who are pregnant, lactating, or who are intending to become pregnant within 28 days after the completion of the study (use of contraceptives is not required to participate in the study)\n* Have participated in any other studies involving study drugs within 30 days prior to entry in the study\n* Subjects who have previously taken fesoterodine.'}, 'identificationModule': {'nctId': 'NCT00943735', 'briefTitle': 'This Is An Open-Label Study To Evaluate Fesoterodine Plus "Your Way" Patient Support Plan In Patients With Symptoms Of Overactive Bladder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A 13-Week, Single-Arm, Open-Label, Multicenter Study To Evaluate Refill Adherence And Satisfaction With Fesoterodine Plus "Your Way" Patient Support Plan In Patients With Symptoms Of Overactive Bladder.', 'orgStudyIdInfo': {'id': 'A0221078'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fesoterodine arm', 'description': 'subjects who present with OAB symptoms during medical office visits and who appear to be candidates for fesoterodine therapy', 'interventionNames': ['Drug: Fesoterodine', 'Behavioral: Your Way']}], 'interventions': [{'name': 'Fesoterodine', 'type': 'DRUG', 'description': 'Fesoterodine 4 mg and 8 mg QD', 'armGroupLabels': ['Fesoterodine arm']}, {'name': 'Your Way', 'type': 'BEHAVIORAL', 'description': 'early intervention after treatment initiation and before patients have an opportunity to discontinue medication; reinforcing the treatable nature of OAB', 'armGroupLabels': ['Fesoterodine arm']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}