Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT00323635
Status:
TERMINATED
Last Update Posted:
2018-03-29
First Post:
2006-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Comparison of Tolterodine and Placebo Treatments on Nocturnal Frequency and Sleep Quality in Women After Menopause.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D053158', 'term': 'Nocturia'}, {'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'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'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068737', 'term': 'Tolterodine Tartrate'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'qregestein@partners.org', 'phone': '617-732-4497', 'title': 'Quentin Regestein', 'organization': "Brigham and Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '9 weeks', 'description': 'Only serious adverse effects were collected', 'eventGroups': [{'id': 'EG000', 'title': 'Tolterodine', 'description': 'Tolterodine 4 mg q.d. X 8 weeks', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Pneumonia', 'notes': 'Dropout patient explained she had to go to hospital because of pneumonia. However, tt remained unclear whether she in fact had pneumonia.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Nocturnal Urinary Frequency, Recorded on an Event/Symptom Chart;', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tolterodine', 'description': 'Tolterodine 4 mg q.d. X 8 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine'}], 'timeFrame': '2 months', 'description': 'Subjects note: 1. Number of nocturnal and diurnal voids; 2) level of urgency for 7 days, graded 1 to 4, beginning after the first void on the Friday morning of week 7 and week 13 of their participation; 3) Number of incontinence episodes; 4) Relationship of incontinence to urge or stress (4 grade scale); 4) Whether she used any pads.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected or analyzed for the outcome measures.'}, {'type': 'PRIMARY', 'title': 'Urgency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tolterodine', 'description': 'Tolterodine 4 mg q.d. X 8 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine'}], 'timeFrame': 'Beginning after the first void on the Friday morning of week 7 and week 13 of their participation;', 'description': 'Level of urgency for 7 days, graded 1 to 4,', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected or analyzed for the outcome measures.'}, {'type': 'PRIMARY', 'title': 'Number of Incontinence Episodes;', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tolterodine', 'description': 'Tolterodine 4 mg q.d. X 8 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine'}], 'timeFrame': 'Duration of Study', 'description': 'Number', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected or analyzed for the outcome measures.'}, {'type': 'PRIMARY', 'title': 'Relationship of Incontinence to Urge or Stress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tolterodine', 'description': 'Tolterodine 4 mg q.d. X 8 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine'}], 'timeFrame': 'Duration of study', 'description': '4-grade scale', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected or analyzed for the outcome measures.'}, {'type': 'SECONDARY', 'title': 'Psychological Self-reports, Scores on Anxiety and Depression Rating Scales;', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tolterodine', 'description': 'Tolterodine 4 mg q.d. X 8 weeks\n\ntolterodine: tablet, 4 mg, daily, 1 month'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine\n\ntolterodine: tablet, 4 mg, daily, 1 month'}], 'timeFrame': '2 weeks', 'description': 'State and Trait scores on Spielberger State-Trait Anxiety Inventory; The score measured by the Zung Self-Rating Depression Inventory.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected or analyzed for the outcome measures.'}, {'type': 'SECONDARY', 'title': "Quality of Life, Scores on the Women's Health Questionnaire.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tolterodine', 'description': 'Tolterodine 4 mg q.d. X 8 weeks\n\ntolterodine: tablet, 4 mg, daily, 1 month'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine\n\ntolterodine: tablet, 4 mg, daily, 1 month'}], 'timeFrame': '2 weeks', 'description': 'Self-reported vasomotor symptoms, other somatic symptoms, anxiety, depression, sleep and cognitive symptoms (memory, concentration and clumsiness problems), measured as category scores. Subjective sleep onset and total sleep times measured as 7-day averaged minutes.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected or analyzed for the outcome measures.'}, {'type': 'SECONDARY', 'title': 'Sleep Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tolterodine', 'description': 'Tolterodine 4 mg q.d. X 8 weeks\n\ntolterodine: tablet, 4 mg, daily, 1 month'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine\n\ntolterodine: tablet, 4 mg, daily, 1 month'}], 'timeFrame': '2 months', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected or analyzed for the outcome measures.'}, {'type': 'SECONDARY', 'title': 'Cognitive Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tolterodine', 'description': 'Tolterodine 4 mg q.d. X 8 weeks\n\ntolterodine: tablet, 4 mg, daily, 1 month'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine\n\ntolterodine: tablet, 4 mg, daily, 1 month'}], 'timeFrame': 'Two 20-minute sessions during 2 months', 'description': 'Motor speed (number of finger taps in 30 seconds); Continuous Performance (mean response time elicited by appearance of target alphabet letter presented in a series of letters on a monitor screen for 1 minute); Color-Word Stroop Test (response times to stimuli with congruent word and color)', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected or analyzed for the outcome measures.'}, {'type': 'SECONDARY', 'title': 'Hyperarousal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tolterodine', 'description': 'Tolterodine 4 mg q.d. X 8 weeks\n\ntolterodine: tablet, 4 mg, daily, 1 month'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine\n\ntolterodine: tablet, 4 mg, daily, 1 month'}], 'timeFrame': 'At baseline and 8 weeks later', 'description': 'Score on 26-item self-report Hyperarousal Scale that indicates proportion of attention allocated to visceral-somatic information vs. external sensory data.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected or analyzed for the outcome measures.'}, {'type': 'SECONDARY', 'title': 'Whether She Used Any Pads.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tolterodine', 'description': 'Tolterodine 4 mg q.d. X 8 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine'}], 'timeFrame': 'Duration of Study', 'description': 'Yes/No', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected or analyzed for the outcome measures.'}, {'type': 'SECONDARY', 'title': 'Pads Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tolterodine', 'description': 'Tolterodine 4 mg q.d. X 8 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine'}], 'timeFrame': 'Duration of Study', 'description': 'Pads used', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected or analyzed for the outcome measures.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Sleep / Wake Pattern', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tolterodine', 'description': 'Tolterodine 4 mg q.d. X 8 weeks\n\ntolterodine: tablet, 4 mg, daily, 1 month'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine\n\ntolterodine: tablet, 4 mg, daily, 1 month'}], 'timeFrame': 'Two weeks', 'description': 'Wrist actigraphy measures of total daytime and nighttime activity scored by standardized Actiwatch measures of sleep and sake.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected or analyzed for the outcome measures.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tolterodine', 'description': 'Tolterodine 4 mg q.d. X 8 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Women 45 to 65 years old were mailed post-cards with the study telephone number and e-mail address. Subjects were assessed for eligibility. The PI determined eligibility based on the study criteria. Eligible subjects were informed about the study requirements, risks and benefits, and then required to read and sign a consent form.', 'preAssignmentDetails': 'Placebo responders were excluded after one week.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tolterodine', 'description': 'Tolterodine 4 mg q.d. X 8 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '5.2', 'groupId': 'BG000'}, {'value': '53', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '52', 'spread': '5.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'New department chairman instructed PI to discontinue study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-01', 'studyFirstSubmitDate': '2006-05-05', 'resultsFirstSubmitDate': '2013-08-09', 'studyFirstSubmitQcDate': '2006-05-05', 'lastUpdatePostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-12-02', 'studyFirstPostDateStruct': {'date': '2006-05-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sleep / Wake Pattern', 'timeFrame': 'Two weeks', 'description': 'Wrist actigraphy measures of total daytime and nighttime activity scored by standardized Actiwatch measures of sleep and sake.'}], 'primaryOutcomes': [{'measure': 'Nocturnal Urinary Frequency, Recorded on an Event/Symptom Chart;', 'timeFrame': '2 months', 'description': 'Subjects note: 1. Number of nocturnal and diurnal voids; 2) level of urgency for 7 days, graded 1 to 4, beginning after the first void on the Friday morning of week 7 and week 13 of their participation; 3) Number of incontinence episodes; 4) Relationship of incontinence to urge or stress (4 grade scale); 4) Whether she used any pads.'}, {'measure': 'Urgency', 'timeFrame': 'Beginning after the first void on the Friday morning of week 7 and week 13 of their participation;', 'description': 'Level of urgency for 7 days, graded 1 to 4,'}, {'measure': 'Number of Incontinence Episodes;', 'timeFrame': 'Duration of Study', 'description': 'Number'}, {'measure': 'Relationship of Incontinence to Urge or Stress', 'timeFrame': 'Duration of study', 'description': '4-grade scale'}], 'secondaryOutcomes': [{'measure': 'Psychological Self-reports, Scores on Anxiety and Depression Rating Scales;', 'timeFrame': '2 weeks', 'description': 'State and Trait scores on Spielberger State-Trait Anxiety Inventory; The score measured by the Zung Self-Rating Depression Inventory.'}, {'measure': "Quality of Life, Scores on the Women's Health Questionnaire.", 'timeFrame': '2 weeks', 'description': 'Self-reported vasomotor symptoms, other somatic symptoms, anxiety, depression, sleep and cognitive symptoms (memory, concentration and clumsiness problems), measured as category scores. Subjective sleep onset and total sleep times measured as 7-day averaged minutes.'}, {'measure': 'Sleep Quality', 'timeFrame': '2 months'}, {'measure': 'Cognitive Function', 'timeFrame': 'Two 20-minute sessions during 2 months', 'description': 'Motor speed (number of finger taps in 30 seconds); Continuous Performance (mean response time elicited by appearance of target alphabet letter presented in a series of letters on a monitor screen for 1 minute); Color-Word Stroop Test (response times to stimuli with congruent word and color)'}, {'measure': 'Hyperarousal', 'timeFrame': 'At baseline and 8 weeks later', 'description': 'Score on 26-item self-report Hyperarousal Scale that indicates proportion of attention allocated to visceral-somatic information vs. external sensory data.'}, {'measure': 'Whether She Used Any Pads.', 'timeFrame': 'Duration of Study', 'description': 'Yes/No'}, {'measure': 'Pads Used', 'timeFrame': 'Duration of Study', 'description': 'Pads used'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['nocturia', 'urinary incontinence', 'overactive bladder', 'tolterodine', 'sleep', 'sleep disorder', 'menopause', 'midlife women', 'psychological tests'], 'conditions': ['Urinary Incontinence']}, 'referencesModule': {'references': [{'pmid': '7991955', 'type': 'BACKGROUND', 'citation': 'Roehrs T, Merlotti L, Petrucelli N, Stepanski E, Roth T. Experimental sleep fragmentation. Sleep. 1994 Aug;17(5):438-43. doi: 10.1093/sleep/17.5.438.'}, {'pmid': '8285088', 'type': 'BACKGROUND', 'citation': 'Shaver JL, Paulsen VM. Sleep, psychological distress, and somatic symptoms in perimenopausal women. Fam Pract Res J. 1993 Dec;13(4):373-84.'}, {'pmid': '12749557', 'type': 'BACKGROUND', 'citation': 'Ancoli-Israel S, Cole R, Alessi C, Chambers M, Moorcroft W, Pollak CP. The role of actigraphy in the study of sleep and circadian rhythms. Sleep. 2003 May 1;26(3):342-92. doi: 10.1093/sleep/26.3.342.'}, {'pmid': '8446835', 'type': 'BACKGROUND', 'citation': 'Brooks JO 3rd, Friedman L, Bliwise DL, Yesavage JA. Use of the wrist actigraph to study insomnia in older adults. Sleep. 1993 Feb;16(2):151-5. doi: 10.1093/sleep/16.2.151.'}]}, 'descriptionModule': {'briefSummary': "This study is being done to compare frequency of urination during the night when women take tolterodine tablets vs. when they take placebo tablets.\n\nWe will also measure whether between these two treatment conditions there are any differences in women's sleep, mood and performance on cognitive tests.", 'detailedDescription': "From midlife onwards, about half of women complain of poor sleep quality. One possible reason might be an increased frequency of need to urinate during the night. Women feel more frequent urges to urinate when structures that support the bladder become more lax. Tolterodine is a drug that can raise the threshold for volume of urine that accumulates in the bladder before the urge to urinate arises.\n\nMany factors determine how people say they sleep, such as their sleep as recorded by sleep-measuring instruments, how closely they notice their night's sleep, whether they are generally prone to make positive or negative judgments or to have a lot or a few body symptoms.\n\nIn this study, women between ages 45 to 65 who are past the menopause and who are frequently bothered by the need to urinate during the night will take either tolterodine or placebo tablets for 8 weeks. During the last week they will record the hours they slept and the quality of their sleep each morning. They will wear a device on their wrist through the week that continuously records whether they are asleep or awake. During three nights of the week they will record the volume of urine whenever they urinate. At the end of the week they will complete questionnaires about their mood and take some computerized tests that measure their alertness. Thereafter they will repeat these procedures, taking the kind of tablets they did not take during the first 8-week treatment period.\n\nWe will compare the frequency of urination, sleep, mood as adjusted for the tendency to make positive or negative judgments and daytime attention level to find if any of these differ between the two treatment periods, and to explain differences between any differences that may be found."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Post-menopausal women, age 45 to 65 years old.\n2. No menses for at least 6 months before the study start.\n3. Have at least 14 episodes of nocturia per week.\n4. Have at least 4 hot flashes daily.\n5. Overall good health, as evidenced by a letter from the primary care provider.\n6. Agree not to use exogenous hormones including soy isoflavones or soybean-based shakes, or nutritional supplements that potentially reduce hot flashes.\n7. Have discontinued all hormone treatments, systemic, topical, or vaginal, at least 60 days before admission and throughout participation in the study.\n\nExclusion Criteria:\n\n1. Use of anti-cholinergic, hypnotic or sedating drugs\n2. Presence of urinary retention, gastric retention, chronic severe constipation,or narrow-angled glaucoma.\n3. A urinary tract infection within a month of study start.\n4. Undiagnosed abnormal vaginal bleeding.\n5. Benign or malignant liver disease.\n6. History or presence of chronic alcoholism or medication addiction within the past 5 yrs.\n7. An acute systemic infection within seven days before the study start.\n8. Concurrent participation in another clinical trial and/or receiving an experimental medication/device in the last 30 days before admission to the study.\n9. History of shift work within the past 6 months.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT00323635', 'briefTitle': 'A Comparison of Tolterodine and Placebo Treatments on Nocturnal Frequency and Sleep Quality in Women After Menopause.', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'A Parallel, Double-blind Comparison of Tolterodine vs. Placebo Treatments for Nocturia in Postmenopausal Women.', 'orgStudyIdInfo': {'id': '2005-P-000960'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tolterodine', 'description': 'Tolterodine 4 mg q.d. X 8 weeks', 'interventionNames': ['Drug: tolterodine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine', 'interventionNames': ['Drug: tolterodine']}], 'interventions': [{'name': 'tolterodine', 'type': 'DRUG', 'otherNames': ['Detrol'], 'description': 'tablet, 4 mg, daily, 1 month', 'armGroupLabels': ['Placebo', 'Tolterodine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02120', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham & Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Quentin R Regestein, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Quentin Rodney Regestein, MD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}