Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-27 @ 11:53 PM
Study NCT ID:
NCT00465894
Status:
COMPLETED
Last Update Posted:
2018-11-01
First Post:
2007-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Detrol Long Acting (LA) vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 'D000068737', 'term': 'Tolterodine Tartrate'}, {'id': 'D004958', 'term': 'Estradiol'}], 'ancestors': [{'id': 'D010665', 'term': 'Phenylpropanolamine'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D003408', 'term': 'Cresols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hrichter@uabmc.edu', 'phone': '205-934-1704', 'title': 'Dr. Holly E. Richter', 'organization': 'University of Alabama at Birmingham'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From Baseline through 52 weeks of Intervention', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: Extended Release Tolterodine', 'description': '4 mg Tolterodine po daily for 12-weeks\n\nAt 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 17, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2: Intra Vaginal Estradiol Cream', 'description': '0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks\n\nAt 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 6, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'xerostomia', 'notes': 'Xerostomia (also termed dry mouth as a symptom or dry mouth syndrome) is dryness in the mouth (xero- + stom- + -ia), which may be associated with a change in the composition of saliva, or reduced salivary flow, or have no identifiable cause.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Extended Release Tolterodine', 'description': '4 mg Tolterodine po daily for 12 weeks'}, {'id': 'OG001', 'title': 'Group 2: Intravaginal Estradiol Cream', 'description': '0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.4', 'spread': '15.3', 'groupId': 'OG000'}, {'value': '61.6', 'spread': '20.0', 'groupId': 'OG001'}]}]}, {'title': '12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.7', 'spread': '23.4', 'groupId': 'OG000'}, {'value': '45.4', 'spread': '21.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.45', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline through 12 Weeks of Intervention', 'description': 'The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A baseline measure was achieved for Group 1 with 30 patients and Group 2 with 28 patients. At the 12 week measurement period, we were unable to analyze 5 patients in Group 1 (leaving 25 patients) and unable to analyze 3 patients in Group 2 (leaving 25 patients). These participants left for reasons identified in the Participant Flow.'}, {'type': 'SECONDARY', 'title': 'Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Health Related Quality of Life (HRQL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended Release Tolterodine', 'description': 'Tolterodine LA: Tolterodine LA 4 mg once daily for 52 weeks'}, {'id': 'OG001', 'title': 'Intravaginal Estradiol Cream', 'description': 'Estrace Intravaginal Cream: 17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.1', 'spread': '22.2', 'groupId': 'OG000'}, {'value': '60.9', 'spread': '22.5', 'groupId': 'OG001'}]}]}, {'title': '12 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.0', 'spread': '26.6', 'groupId': 'OG000'}, {'value': '69.8', 'spread': '18.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline through 12 Weeks of Intervention', 'description': 'Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In Group 1, we were unable to analyze 5 patients and in Group 2 we were unable to analyze 3 patients. These participants left for reasons identified in the Participant Flow.'}, {'type': 'SECONDARY', 'title': 'Evaluate Subjective Patient Change in Irritative Urinary Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Extended Release Tolterodine', 'description': '4 mg Tolterodine po daily for 12 weeks'}, {'id': 'OG001', 'title': 'Group 2: Intravaginal Estradiol Cream', 'description': '0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks'}], 'classes': [{'title': 'Very Much Better', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Much Better', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'A Little Better', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'A Litlle Worse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline through 12 Weeks of Intervention', 'description': 'Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse.\n\nFrequencies of each response was reported. Each level achieved (movement towards 1), is considered an improvement.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'In Group 1, we were unable to analyze 5 patients and in Group 2 we were unable to analyze 3 patients. These participants left for reasons identified in the Participant Flow.'}, {'type': 'SECONDARY', 'title': 'Subjective Patient Change in Irritative Urinary Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended Release Tolterodine LA', 'description': 'An anti-muscarinic drug that is used for symptomatic treatment of urinary incontinence.\n\nExtended Release Tolterodine LA: Tolterodine LA 4 mg once daily for 52 weeks'}, {'id': 'OG001', 'title': 'Intravaginal Estradiol Cream', 'description': 'For topical application to the vaginal area to treat symptoms of urgency or irritation with urination.\n\nIntravaginal Estradiol Cream: 17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks'}], 'classes': [{'title': 'Completely Satisfied', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat Satisfied', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Not Satisfied', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline through 12 Weeks of Intervention', 'description': 'This was measured using the Patient Satisfaction Questionnaire (PSQ). The PSQ consists of a single question, "How satisfied are you with your progress since your treatment" in which the 3 possible responses are "completely satisfied," "somewhat satisfied," and "not satisfied." The goal of treatment was to move all participants to "completely satisfied.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'In Group 1, we were unable to analyze 5 patients and in Group 2 we were unable to analyze 3 patients. For this outcome ONLY, 1 patient from each Group were not available to obtain the measurements from this questionnaire. Therefore the overall number of participants analyzed for this outcome is less than other outcomes. Please see Participant Flow.'}, {'type': 'SECONDARY', 'title': 'Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Extended Release Tolterodine', 'description': '4 mg Tolterodine po daily for 12 weeks\n\nAt 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks.'}, {'id': 'OG001', 'title': 'Group 2: Intravaginal Estradiol Cream', 'description': '0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks.\n\nAt 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks'}], 'classes': [{'title': 'Number of voids', 'categories': [{'measurements': [{'value': '30.4', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '26.4', 'spread': '10.5', 'groupId': 'OG001'}]}]}, {'title': 'Number of voids 12 week follow-up', 'categories': [{'measurements': [{'value': '26.3', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '24.6', 'spread': '10.2', 'groupId': 'OG001'}]}]}, {'title': 'Number of accidents/leakage', 'categories': [{'measurements': [{'value': '10.8', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '10.5', 'groupId': 'OG001'}]}]}, {'title': 'Number of accidents/leakage at 12 weeks', 'categories': [{'measurements': [{'value': '7.2', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '8.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline through 12 weeks of Intervention', 'description': 'Number of voids and accidents/leakage per 3 day diary. A void is a voluntary and intentional event. An accident is involuntary and unintentional.', 'unitOfMeasure': 'events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '25 patients in each group completed voiding diary at baseline. 21 patients completed the voiding diary at 12 weeks in the Tolterodine group (complete diary). 25 patients in the estradiol group completed diary at 12 weeks. Incomplete diaries were not included in our analysis.'}, {'type': 'SECONDARY', 'title': 'Subjective Patient Change in Irritative Urinary Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Extended Release Tolterodine + Intravaginal Estradiol', 'description': 'After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy. They continued with the 4 mg Tolterodine po daily for 12 weeks and added the 0.5 grams intravaginal estradiol twice per week for 24 weeks.'}, {'id': 'OG001', 'title': 'Group 2: Intravaginal Estradiol Cream + Tolterodine', 'description': '0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks + 4 mg Tolterodine daily\n\n(At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks.)'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.4', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '-28.7', 'spread': '20.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 weeks', 'description': 'The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'At 24 weeks, only 14 patients from Group 1 \\& 2 had complete data sets. Those without complete data sets were not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Subjective Patient Change in Irritative Urinary Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Extended Release Tolterodine + Intravaginal Estradiol', 'description': 'After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy . They continued with the 4 mg Tolterodine po daily for 12 weeks and added the 0.5 grams intravaginal estradiol twice per week for 24 weeks.'}, {'id': 'OG001', 'title': 'Group 2: Intravaginal Estradiol Cream + Tolterodine', 'description': '0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks + 4 mg Tolterodine daily\n\n(At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks.)'}], 'classes': [{'categories': [{'measurements': [{'value': '19.3', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '20.9', 'spread': '15.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 weeks', 'description': 'Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'At 24 weeks, only 14 patients from Group 1 \\& 2 had complete data sets. Those without complete data sets were not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Extended Release Tolterodine + Intravaginal Estradiol', 'description': 'After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy. They continued with the 4 mg Tolterodine po daily for 12 weeks and added the 0.5 grams intravaginal estradiol twice per week for 24 weeks.'}, {'id': 'OG001', 'title': 'Group 2: Intravaginal Estradiol Cream + Tolterodine', 'description': '0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks + 4 mg Tolterodine daily\n\n(After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy.)'}], 'classes': [{'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 24 weeks', 'description': 'Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse. Each level achieved(movement towards 1), is considered an improvement.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'At 24 weeks, only 14 patients from Group 1 \\& 2 had complete data sets. Those without complete data sets were not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Extended Release Tolterodine + Intravaginal Estradiol', 'description': 'After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy. They continued with the 4 mg Tolterodine po daily for 12 weeks and added the 0.5 grams intravaginal estradiol twice per week for 24 weeks'}, {'id': 'OG001', 'title': 'Group 2: Intravaginal Estradiol Cream + Tolterodine', 'description': '0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks+ 4 mg Tolterodine daily\n\n(After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy.)'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 24 weeks', 'description': 'As measured by the Patient Satisfaction Questionnaire (PSQ). The PSQ consists of a single question, "How satisfied are you with your progress since your treatment" in which the 3 possible responses are "completely satisfied," "somewhat satisfied," and "not satisfied." The goal of treatment was to move all participants to "completely satisfied.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'At 24 weeks, only 14 patients from Group 1 \\& 2 had complete data sets. Those without complete data sets were not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Subjective Patient Change in Irritative Urinary Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Extended Release Tolterodine + Intravaginal Estradiol', 'description': 'After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy. They continued with the 4 mg Tolterodine po daily for 12 weeks and added the 0.5 grams intravaginal estradiol twice per week for 52 weeks'}, {'id': 'OG001', 'title': 'Intravaginal Estradiol Cream + Tolterodine', 'description': 'Intravaginal estradiol Cream: 17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks+ 4 mg Tolterodine daily\n\nAt 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-23.4', 'spread': '15.6', 'groupId': 'OG000'}, {'value': '-31.3', 'spread': '24.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through 52 weeks', 'description': 'The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'At 52 weeks, only 11 patients in Group 1 and 14 patients from Group 2 had complete data sets. Those without complete data sets were not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Subjective Patient Change in Irritative Urinary Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Extended Release Tolterodine + Intravaginal Estradiol', 'description': 'After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy. They continued with the 4 mg Tolterodine po daily for 12 weeks and added the 0.5 grams intravaginal estradiol twice per week for 52 weeks.'}, {'id': 'OG001', 'title': 'Group 2: Intravaginal Estradiol Cream', 'description': '0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks.\n\nAt 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '26.8', 'spread': '20.5', 'groupId': 'OG000'}, {'value': '19.7', 'spread': '25.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through 52 weeks', 'description': 'Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'At 52 weeks, only 11 patients in Group 1 and 14 patients from Group 2 had complete data sets. Those without complete data sets were not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Subjective Patient Change in Irritative Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Extended Release Tolterodine + Intravaginal Estradiol', 'description': 'After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy. They continued with the 4 mg Tolterodine po daily for 12 weeks and added the 0.5 grams intravaginal estradiol twice per week for 52 weeks'}, {'id': 'OG001', 'title': 'Group 2: Intravaginal Estradiol Cream', 'description': '0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks.\n\nAt 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 52 weeks', 'description': 'Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse. Each level achieved(movement towards 1), is considered an improvement.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'At 52 weeks, only 11 patients in Group 1 and 14 patients from Group 2 had complete data sets. Those without complete data sets were not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Extended Release Tolterodine + Intravaginal Estradiol', 'description': 'After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy. They continued with the 4 mg Tolterodine po daily for 12 weeks and added the 0.5 grams intravaginal estradiol twice per week for 52 weeks.'}, {'id': 'OG001', 'title': 'Group 2: Intravaginal Estradiol Cream', 'description': '0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks.\n\nAt 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 52 Weeks', 'description': 'As measured by the Patient Satisfaction Questionnaire (PSQ).The PSQ consists of a single question, "How satisfied are you with your progress since your treatment" in which the 3 possible responses are "completely satisfied," "somewhat satisfied," and "not satisfied." The goal of treatment was to move all participants to "completely satisfied.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'At 52 weeks, only 11 patients in Group 1 and 14 patients from Group 2 had complete data sets. Those without complete data sets were not included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: Extended Release Tolterodine', 'description': '4 mg Tolterodine po daily for 12 weeks\n\nAt 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks.'}, {'id': 'FG001', 'title': 'Group 2: Intra Vaginal Estradiol Cream', 'description': '0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks.\n\nAt 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks'}], 'periods': [{'title': 'Treatment For 12 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Family Issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Treatment From 12 Weeks To 24 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'We included data only from participants that had complete data sets.', 'groupId': 'FG000', 'numSubjects': '14'}, {'comment': 'We included data only from participants that had complete data sets.', 'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Treatment From 24 Weeks to 52 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'We included data only from participants that had complete data sets.', 'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: Extended Release Tolterodine', 'description': '4 mg Tolterodine po daily for 12 weeks'}, {'id': 'BG001', 'title': 'Group 2: Intra Vaginal Estradiol Cream', 'description': '0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'spread': '6', 'groupId': 'BG000'}, {'value': '60', 'spread': '2', 'groupId': 'BG001'}, {'value': '61.5', 'spread': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-30', 'size': 1962917, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-08-01T13:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-01', 'studyFirstSubmitDate': '2007-04-23', 'resultsFirstSubmitDate': '2012-06-01', 'studyFirstSubmitQcDate': '2007-04-24', 'lastUpdatePostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-09-21', 'studyFirstPostDateStruct': {'date': '2007-04-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score', 'timeFrame': 'From baseline through 12 Weeks of Intervention', 'description': 'The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.'}], 'secondaryOutcomes': [{'measure': 'Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Health Related Quality of Life (HRQL)', 'timeFrame': 'From baseline through 12 Weeks of Intervention', 'description': 'Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.'}, {'measure': 'Evaluate Subjective Patient Change in Irritative Urinary Symptoms', 'timeFrame': 'From baseline through 12 Weeks of Intervention', 'description': 'Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse.\n\nFrequencies of each response was reported. Each level achieved (movement towards 1), is considered an improvement.'}, {'measure': 'Subjective Patient Change in Irritative Urinary Symptoms', 'timeFrame': 'From baseline through 12 Weeks of Intervention', 'description': 'This was measured using the Patient Satisfaction Questionnaire (PSQ). The PSQ consists of a single question, "How satisfied are you with your progress since your treatment" in which the 3 possible responses are "completely satisfied," "somewhat satisfied," and "not satisfied." The goal of treatment was to move all participants to "completely satisfied.'}, {'measure': 'Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary', 'timeFrame': 'From baseline through 12 weeks of Intervention', 'description': 'Number of voids and accidents/leakage per 3 day diary. A void is a voluntary and intentional event. An accident is involuntary and unintentional.'}, {'measure': 'Subjective Patient Change in Irritative Urinary Symptoms', 'timeFrame': 'Baseline to 24 weeks', 'description': 'The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.'}, {'measure': 'Subjective Patient Change in Irritative Urinary Symptoms', 'timeFrame': 'Baseline to 24 weeks', 'description': 'Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.'}, {'measure': 'Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)', 'timeFrame': 'Baseline through 24 weeks', 'description': 'Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse. Each level achieved(movement towards 1), is considered an improvement.'}, {'measure': 'Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)', 'timeFrame': 'Baseline through 24 weeks', 'description': 'As measured by the Patient Satisfaction Questionnaire (PSQ). The PSQ consists of a single question, "How satisfied are you with your progress since your treatment" in which the 3 possible responses are "completely satisfied," "somewhat satisfied," and "not satisfied." The goal of treatment was to move all participants to "completely satisfied.'}, {'measure': 'Subjective Patient Change in Irritative Urinary Symptoms', 'timeFrame': 'Baseline through 52 weeks', 'description': 'The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.'}, {'measure': 'Subjective Patient Change in Irritative Urinary Symptoms', 'timeFrame': 'Baseline through 52 weeks', 'description': 'Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.'}, {'measure': 'Subjective Patient Change in Irritative Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)', 'timeFrame': 'Baseline through 52 weeks', 'description': 'Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse. Each level achieved(movement towards 1), is considered an improvement.'}, {'measure': 'Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)', 'timeFrame': 'Baseline through 52 Weeks', 'description': 'As measured by the Patient Satisfaction Questionnaire (PSQ).The PSQ consists of a single question, "How satisfied are you with your progress since your treatment" in which the 3 possible responses are "completely satisfied," "somewhat satisfied," and "not satisfied." The goal of treatment was to move all participants to "completely satisfied.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['overactive bladder', 'urge leakage', 'nightime urination', 'incontinence', 'urinary frequency'], 'conditions': ['Overactive Bladder']}, 'referencesModule': {'references': [{'pmid': '26945271', 'type': 'DERIVED', 'citation': 'Ellington DR, Szychowski JM, Malek JM, Gerten KA, Burgio KL, Richter HE. Combined Tolterodine and Vaginal Estradiol Cream for Overactive Bladder Symptoms After Randomized Single-Therapy Treatment. Female Pelvic Med Reconstr Surg. 2016 Jul-Aug;22(4):254-60. doi: 10.1097/SPV.0000000000000256.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if long acting tolterodine confers more benefit than intravaginal low dose estrogen in the treatment of Overactive Bladder Syndrome at 12 weeks post-treatment initiation. The hypothesis is that low dose intra-vaginal estrogen confers greater benefit than tolterodine in the treatment of Overactive Bladder symptoms. Secondary outcomes were to assess if the addition of the other therapy to the treatment regimen conferred benefit at 24 weeks and 52 weeks.', 'detailedDescription': 'Lower urinary tract bladder storage symptoms include urinary frequency, urinary urgency, nocturia and urge incontinence. Overactive Bladder (OAB)Syndrome is a condition in which urgency is the predominant symptom with or without urge incontinence and is usually accompanied by frequency and nocturia. The mainstay of treatment of women with OAB syndrome is treatment with anticholinergic medication as well as behavioral therapy. This method of treatment has demonstrated a 60% response rate as reported in the Cochrane Database of Systemic Reviews.\n\nIn addition to anticholinergic therapy, vaginal atrophy is often corrected as part of a pharmacologic treatment plan. Vaginal atrophy is a condition this is vastly prevalent in post-menopausal women. It is thought to affect up to 48% of post-menopausal women. Many women with this condition experience vaginal dryness, irritation, painful intercourse, as well as urinary symptoms including dysuria, urgency, frequency, nocturia, incontinence and recurrent urinary tract infections.\n\nComparison: Tolterodine LA compared to low dose intra-vaginal estrogen cream for the treatment of OAB symptoms'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Irritative voiding symptoms to include sensory urgency, frequency, urge incontinence, nocturia\n* Postmenopausal women with a prior oophorectomy or 1 year from last menstrual period\n* Women age 40-90\n* Women with hysterectomy with preserved ovaries must be age 55 or greater or have a documented follicle-stimulating hormone (FSH)\\>40 to ensure post-menopausal status\n* Community dwelling\n* Ambulatory\n* Ability to participate in a 12 month study\n\nExclusion Criteria:\n\n* Post-void residual volume\\>150ml\n* Glaucoma without ophthalmologist clearance\n* Hormone replacement therapy in the past 6 months\n* Current anticholinergic treatment\n* Breast cancer\n* Impaired mental status\n* Undiagnosed vaginal bleeding in the past 12 months\n* Endometrial thickness on pelvic ultrasound \\>5mm\n* History of thromboembolic event\n* Gynecologic cancer\n* Untreated urinary tract infection (would be eligible after treatment)\n* Stage III pelvic organ prolapse or greater\n* Recent diuretic medication changes (one month from change)\n* Neurologic condition affecting bladder function (Multiple Sclerosis, Parkinsons, spinal cord injury, spina bifida)\n* Congestive heart failure\n* Prior pelvic irradiation\n* Interstitial cystitis'}, 'identificationModule': {'nctId': 'NCT00465894', 'acronym': 'DRIVE', 'briefTitle': 'Detrol Long Acting (LA) vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Randomized Controlled Trial of Tolterodine in Combination With or Without Low-Dose Intravaginal Estradiol Cream for the Treatment of Overactive Bladder in Post-Menopausal Women', 'orgStudyIdInfo': {'id': 'F061208008'}, 'secondaryIdInfos': [{'id': 'IIR - DRIVE'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Extended Release Tolterodine LA', 'description': 'An anti-muscarinic drug that is used for symptomatic treatment of urinary incontinence.', 'interventionNames': ['Drug: Extended Release Tolterodine LA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intra Vaginal Estradiol Cream', 'description': 'For topical application to the vaginal area to treat symptoms of urgency or irritation with urination.', 'interventionNames': ['Drug: Intra Vaginal Estradiol Cream']}], 'interventions': [{'name': 'Extended Release Tolterodine LA', 'type': 'DRUG', 'otherNames': ['Detrol'], 'description': 'Tolterodine LA 4 mg once daily for 52 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks', 'armGroupLabels': ['Extended Release Tolterodine LA']}, {'name': 'Intra Vaginal Estradiol Cream', 'type': 'DRUG', 'otherNames': ['Estrace', 'Premarin vaginal cream'], 'description': '17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks.', 'armGroupLabels': ['Intra Vaginal Estradiol Cream']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kimberly Gerten, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Park Nicollette, St. Louis, Minnesota'}, {'name': 'Holly E. Richter, Ph.D., M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'David Rich Ellington', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}