Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-01-29 @ 5:28 PM
Study NCT ID:
NCT00939120
Status:
COMPLETED
Last Update Posted:
2015-05-01
First Post:
2009-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dutasteride With Tolterodine ER or Placebo to Treat Lower Urinary Tract Symptoms (LUTS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, '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': 'paul.siami@deaconess.com', 'phone': '812-426-9548', 'title': 'Dr. Paul Siami', 'organization': 'Research institute at Deaconess Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '19 months.', 'description': 'Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.', 'eventGroups': [{'id': 'EG000', 'title': 'Tolterodine ER 4mg + Dutasteride 0.5mg', 'description': 'Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.', 'otherNumAtRisk': 23, 'otherNumAffected': 21, 'seriousNumAtRisk': 23, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Placebo + Dutasteride 0.5mg', 'description': 'Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.', 'otherNumAtRisk': 23, 'otherNumAffected': 22, 'seriousNumAtRisk': 23, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Difficulty urinating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary urgency / incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'URI / sinusitis / rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis / pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Plantar fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Actinic keratosis, basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increase in prostate specific antigen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostate nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cataracts', 'notes': 'Incidence and surgery of cataracts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperlipidemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney stones', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gynecomastia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Transient ischemic attacks', 'notes': 'Moderate, intermittent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal airway obstruction', 'notes': 'Bilateral, moderate intensity.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'notes': 'Mild intensity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney stone', 'notes': 'Severe', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gallstones', 'notes': 'Severe, requiring cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mass on kidney', 'notes': 'Severe, continuous.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cervical stenosis', 'notes': 'Severe', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral thrush', 'notes': 'Mild', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Schatzki ring', 'notes': 'Mild, continuous, shallow', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Presbyesophagus, dysphagia', 'notes': 'Moderate to severe', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'notes': 'Severe, continuous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hiatal hernia', 'notes': 'Mild, continuous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal self-inflicted gunshot wound, lethal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastropathy', 'notes': 'Mild', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteoarthritis', 'notes': 'Moderate intermittent exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Post-void Residual (PVR) Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tolterodine ER 4mg + Dutasteride 0.5mg', 'description': 'Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.'}, {'id': 'OG001', 'title': 'Placebo + Dutasteride 0.5mg', 'description': 'Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '101.7', 'spread': '22.4', 'groupId': 'OG000'}, {'value': '75.8', 'spread': '9.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: post-voiding residual volume measured via ultrasound.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Last data point carried forward for participants who were randomized and dropped prior to study end.'}, {'type': 'SECONDARY', 'title': 'Overactive Bladder Questionnaire (OABq)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tolterodine ER 4mg + Dutasteride 0.5mg', 'description': 'Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.'}, {'id': 'OG001', 'title': 'Placebo + Dutasteride 0.5mg', 'description': 'Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.2', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '67.7', 'spread': '5.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: overactive bladder questionnaire (OABq) - 33 questions scored via 1-6 (higher scores indicate more severe symptoms), thus values ranged from 33-198.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Last data point carried forward for participants who were randomized and dropped prior to study end.'}, {'type': 'PRIMARY', 'title': 'Maximum Urine Flow Rate (Qmax).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tolterodine ER 4mg + Dutasteride 0.5mg', 'description': 'Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.'}, {'id': 'OG001', 'title': 'Placebo + Dutasteride 0.5mg', 'description': 'Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: maximum urine flow rate (Qmax) measured via uroflowmetry.', 'unitOfMeasure': 'mL/sec', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Last data point carried forward for participants who were randomized and dropped prior to study end.'}, {'type': 'PRIMARY', 'title': 'Urine Voided Volume (Voiding)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tolterodine ER 4mg + Dutasteride 0.5mg', 'description': 'Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.'}, {'id': 'OG001', 'title': 'Placebo + Dutasteride 0.5mg', 'description': 'Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '219.9', 'spread': '20.6', 'groupId': 'OG000'}, {'value': '232.9', 'spread': '32.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: urine voided volume (voiding) measured by uroflowmetry.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Last data point carried forward for participants who were randomized and dropped prior to study end.'}, {'type': 'PRIMARY', 'title': 'Acute Urinary Retention (AUR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tolterodine ER 4mg + Dutasteride 0.5mg', 'description': 'Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.'}, {'id': 'OG001', 'title': 'Placebo + Dutasteride 0.5mg', 'description': 'Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: acute urinary attention (AUR) - inability to urinate requiring catheterization.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Last data point carried forward for participants who were randomized and dropped prior to study end.'}, {'type': 'SECONDARY', 'title': 'Patient Perception of Bladder Condition (PPBC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tolterodine ER 4mg + Dutasteride 0.5mg', 'description': 'Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.'}, {'id': 'OG001', 'title': 'Placebo + Dutasteride 0.5mg', 'description': 'Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: participant reported patient perception of bladder condition (PPBC), one question scored from 1-6, higher scores indicating more severe symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Last data point carried forward for participants who were randomized and dropped prior to study end.'}, {'type': 'SECONDARY', 'title': 'International Prostate Symptoms Score (IPSS), Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tolterodine ER 4mg + Dutasteride 0.5mg', 'description': 'Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.'}, {'id': 'OG001', 'title': 'Placebo + Dutasteride 0.5mg', 'description': 'Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.4', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: total international prostate symptoms score (IPSS) - 7 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-35.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Last data point carried forward for participants who were randomized and dropped prior to study end.'}, {'type': 'SECONDARY', 'title': 'International Prostate Symptoms Score, Voiding Subscore', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tolterodine ER 4mg + Dutasteride 0.5mg', 'description': 'Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.'}, {'id': 'OG001', 'title': 'Placebo + Dutasteride 0.5mg', 'description': 'Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: voiding subscore of international prostate symptoms score (IPSS) - 4 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-20.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Last data point carried forward for participants who were randomized and dropped prior to study end.'}, {'type': 'SECONDARY', 'title': 'International Prostate Symptoms Score (IPSS), Storage Subscore', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tolterodine ER 4mg + Dutasteride 0.5mg', 'description': 'Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.'}, {'id': 'OG001', 'title': 'Placebo + Dutasteride 0.5mg', 'description': 'Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: storage subscore international prostate symptoms score (IPSS) - 3 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-15.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Last data point carried forward for participants who were randomized and dropped prior to study end.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tolterodine ER 4mg + Dutasteride 0.5mg', 'description': 'Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.'}, {'id': 'FG001', 'title': 'Placebo + Dutasteride 0.5mg', 'description': 'Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tolterodine ER 4mg + Dutasteride 0.5mg', 'description': 'Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.'}, {'id': 'BG001', 'title': 'Placebo + Dutasteride 0.5mg', 'description': 'Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.6', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '67.7', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '68.2', 'spread': '8.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Age of patient at enrollment', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Gender of participant.', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race of the participant.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Region in which participant was enrolled.', 'unitOfMeasure': 'participants'}, {'title': 'Prostate volume', 'classes': [{'categories': [{'measurements': [{'value': '43.9', 'spread': '15.8', 'groupId': 'BG000'}, {'value': '43.1', 'spread': '16.0', 'groupId': 'BG001'}, {'value': '43.5', 'spread': '15.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Prostate volume measured by transrectal ultrasound, age-adjusted for this study.', 'unitOfMeasure': 'mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Prostate specific antigen', 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '2.1', 'groupId': 'BG000'}, {'value': '5.3', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '4.6', 'spread': '6.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Prostate specific antigen measured via blood test.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Voided volume', 'classes': [{'categories': [{'measurements': [{'value': '202.5', 'spread': '96.5', 'groupId': 'BG000'}, {'value': '273.7', 'spread': '189.9', 'groupId': 'BG001'}, {'value': '238.1', 'spread': '153.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Voided urinary volume via uroflowmetry.', 'unitOfMeasure': 'mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Maximum flow rate', 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'spread': '3.5', 'groupId': 'BG000'}, {'value': '12.4', 'spread': '4.8', 'groupId': 'BG001'}, {'value': '11.7', 'spread': '4.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Maximum urine flow rate (Qmax) measured via uroflowmetry.', 'unitOfMeasure': 'mL/sec', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Post-void residual volume', 'classes': [{'categories': [{'measurements': [{'value': '93.0', 'spread': '69.2', 'groupId': 'BG000'}, {'value': '81.6', 'spread': '60.7', 'groupId': 'BG001'}, {'value': '87.3', 'spread': '64.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Post-voiding residual volume (PVR) measured in each participant via ultrasound.', 'unitOfMeasure': 'mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Overactive bladder questionnaire', 'classes': [{'categories': [{'measurements': [{'value': '86.4', 'spread': '22.3', 'groupId': 'BG000'}, {'value': '86.1', 'spread': '29.9', 'groupId': 'BG001'}, {'value': '86.3', 'spread': '26.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Overactive Bladder Questionnaire score is based on the answers to 33 questions concerning bladder symptoms. Each question is assigned points from 1 to 6 indicating increasing severity of the particular symptom. The total score can therefore range from 33 to 198 (asymptomatic to very symptomatic).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Patient's perception of bladder condition", 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '3.7', 'spread': '1.0', 'groupId': 'BG001'}, {'value': '3.7', 'spread': '0.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Patient-reported scores on a scale of 1-6 indicating how their bladder condition affects them. Scores are as follows: 1 = Does not cause me any problems at all; 2 = Causes me some very minor problems; 3 = Causes me some minor problems; 4 = Causes me (some) moderate problems; 5 = Causes me severe problems; 6 = Causes me many severe problems.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'International prostate symptoms score, total', 'classes': [{'categories': [{'measurements': [{'value': '18.0', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '17.7', 'spread': '4.5', 'groupId': 'BG001'}, {'value': '17.9', 'spread': '5.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The IPSS is based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'International prostate symptoms score, voiding subscore', 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'spread': '4.3', 'groupId': 'BG000'}, {'value': '9.0', 'spread': '3.8', 'groupId': 'BG001'}, {'value': '9.1', 'spread': '4.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The IPSS is based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).\n\nVoiding sub-component is 4/7 questions, thus ranging from 0-20.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'International prostate symptoms score, storage subscore', 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '8.7', 'spread': '2.2', 'groupId': 'BG001'}, {'value': '8.8', 'spread': '2.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The IPSS is based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).\n\nStorage sub-component is 3/7 questions, thus ranging from 0-15.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Urinary urgency', 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '3.5', 'groupId': 'BG000'}, {'value': '8.6', 'spread': '3.5', 'groupId': 'BG001'}, {'value': '7.7', 'spread': '3.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Patient reported number of urgency episodes during a 24-hour period.', 'unitOfMeasure': 'urgency episodes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Urinary frequency', 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'spread': '2.2', 'groupId': 'BG000'}, {'value': '11.4', 'spread': '2.2', 'groupId': 'BG001'}, {'value': '11.3', 'spread': '2.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Participant reported urinary frequency episodes during a 24-hour period.', 'unitOfMeasure': 'frequency episodes', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Number of patients randomized into control or experimental groups.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-15', 'studyFirstSubmitDate': '2009-06-12', 'resultsFirstSubmitDate': '2015-03-16', 'studyFirstSubmitQcDate': '2009-07-13', 'lastUpdatePostDateStruct': {'date': '2015-05-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-15', 'studyFirstPostDateStruct': {'date': '2009-07-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-void Residual (PVR) Volume', 'timeFrame': '12 months', 'description': 'To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: post-voiding residual volume measured via ultrasound.'}, {'measure': 'Maximum Urine Flow Rate (Qmax).', 'timeFrame': '12 months', 'description': 'To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: maximum urine flow rate (Qmax) measured via uroflowmetry.'}, {'measure': 'Urine Voided Volume (Voiding)', 'timeFrame': '12 months', 'description': 'To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: urine voided volume (voiding) measured by uroflowmetry.'}, {'measure': 'Acute Urinary Retention (AUR)', 'timeFrame': '12 months', 'description': 'To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: acute urinary attention (AUR) - inability to urinate requiring catheterization.'}], 'secondaryOutcomes': [{'measure': 'Overactive Bladder Questionnaire (OABq)', 'timeFrame': '12 months', 'description': 'To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: overactive bladder questionnaire (OABq) - 33 questions scored via 1-6 (higher scores indicate more severe symptoms), thus values ranged from 33-198.'}, {'measure': 'Patient Perception of Bladder Condition (PPBC)', 'timeFrame': '12 months', 'description': 'To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: participant reported patient perception of bladder condition (PPBC), one question scored from 1-6, higher scores indicating more severe symptoms.'}, {'measure': 'International Prostate Symptoms Score (IPSS), Total', 'timeFrame': '12 months', 'description': 'To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: total international prostate symptoms score (IPSS) - 7 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-35.'}, {'measure': 'International Prostate Symptoms Score, Voiding Subscore', 'timeFrame': '12 months', 'description': 'To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: voiding subscore of international prostate symptoms score (IPSS) - 4 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-20.'}, {'measure': 'International Prostate Symptoms Score (IPSS), Storage Subscore', 'timeFrame': '12 months', 'description': 'To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: storage subscore international prostate symptoms score (IPSS) - 3 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-15.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Benign prostatic hyperplasia (BPH)', 'dutasteride', 'tolterodine ER'], 'conditions': ['Benign Prostatic Hyperplasia (BPH)']}, 'descriptionModule': {'briefSummary': 'This is an investigator-initiated study of safety, efficacy and tolerability of dutasteride given for 18 months, including a 1-year double-blind randomized co-administration with either tolterodine ER or placebo in men suffering from lower urinary tract symptoms (LUTS) including urgency and frequency, with or without urgency urinary incontinence (i.e., overactive bladder (OAB) symptoms).', 'detailedDescription': 'Men who are treated with an alpha blocker (AB) or 5-alpha reductase inhibitor (5-ARI) for benign prostatic enlargement (BPE) and lower urinary tract symptoms (LUTS) often have symptoms including urinary frequency and urgency. ABs and 5-ARIs may improve the obstructive voiding symptoms but not necessarily the storage symptoms.\n\nThis study will evaluate the safety and efficacy of dutasteride 0.5 mg once daily for 6 months in an open label fashion. Those patients who continue to report storage urinary symptoms, will be randomized to receive dutasteride 0.5 mg once daily for an additional one year together with double-blind tolterodine ER 4 mg or matched tolterodine ER placebo once daily.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThis subject population will consist of males ≥ 50 years of age who have lower urinary tract symptoms (LUTS) due to benign prostatic enlargement (BPE) for a minimum of 3 months\n\nInclusion criteria at screening:\n\n1. Subjects who understand and speak English and are able to comply with the protocol, complete the diaries, and other study tools\n2. Subject has provided written informed consent and HIPAA authorization\n3. Ambulatory male subjects ≥ 50 years of age\n4. Able to use the toilet without difficulty\n5. History of LUTS due to BPE, as diagnosed by history as well as digital rectal exam (DRE), for ≥ 3 months suitable for medical therapy with 5-ARI in combination with antimuscarinic drugs\n6. Prostate volume (PV) ≥ 30 cc as measured by transrectal ultrasound (TRUS)\n7. International prostate symptoms score (IPSS) ≥12\n8. Post Void Residual Volume \\< 150 mL at baseline\n9. Uroflowmetry-Qmax \\> 5 mL/sec and ≤ 15 mL/sec\n10. Prostate specific antigen (PSA) ≥ 1.5 ng/ml and in normal age-adjusted range. For those subjects with an elevated age-adjusted PSA, it is the responsibility of the investigator to take standard of care measures to assure reasonable absence of prostate cancer\n11. Have an average of ≥ 8 micturitions per 24 hrs\n12. Have an average of 2 episodes of urgency per 24 hrs (defined as those with the Urinary Sensation Scale rating of 3 or more)\n\nExclusion Criteria:\n\n1. Concurrent use of 5-ARI therapy within the past 3 months\n2. Concurrent use of alpha blockers within the past 2 weeks\n3. Concurrent use of antimuscarinics within the past 4 weeks\n4. Concurrent use of Phosphodiesterase type 5 (PDE-5) inhibitors on a daily basis\n5. Evidence of chronic inflammation such as interstitial cystitis and bladder stones.\n6. Evidence of untreated urethral stricture disease\n7. Uncontrolled narrow angle glaucoma\n8. Increased post-void residual volume (PVR) defined as PVR \\> 150 mL\n9. Uroflowmetry-Qmax ≤ 5 mL/sec\n10. Acute urinary tract infection (UTI). These subjects may be treated and re-screened\n11. Acute urinary retention (AUR) requiring catheter within the last 3 months\n12. Previous or planned transurethral resection of the prostate (TURP)\n13. Minimally invasive surgery (MIS) such as transurethral microwave treatment (TUMT), transurethral needle ablation (TUNA), laser, or other minimally invasive procedures within 12 months. Those patients who in the opinion of the investigator did not respond adequately to MIS and fulfill the inclusion criteria are eligible to participate\n14. A known diagnosis of prostate cancer.\n15. A known diagnosis of bladder cancer within 5 years of screening. Those patients with history of non-muscle invasive bladder cancer who have not had a recurrence in the past 5 years are eligible to screen for this study and must maintain continued adequate bladder cancer screening at the discretion of the Investigator\n16. Renal or hepatic impairment defined as 2.5 x upper limit of normal. Some isolated abnormalities would be left at the discretion of the investigator with always keeping in mind to not pose a hazard to the patient.\n17. PSA \\> 10 ng/mL (if the PSA is greater than 4 ng/mL and less than or equal to 10 ng/mL, subjects may be included at the discretion of the Investigator if the PSA has been stable and the patient has had a prostate biopsy showing no evidence of prostate cancer)\n18. Known or suspected hypersensitivity to dutasteride or tolterodine ER .\n19. Participation in a clinical trial involving an investigational drug, within 30 days prior to enrollment.\n20. History of diagnosed gastrointestinal obstruction disease.\n21. Myocardial infarction within the past 8 weeks.\n22. Known or suspected drug and/or alcohol abuse.\n23. Any clinical condition, which, in the opinion of the Investigator, would not allow safe completion of the study.'}, 'identificationModule': {'nctId': 'NCT00939120', 'acronym': 'LUTS', 'briefTitle': 'Dutasteride With Tolterodine ER or Placebo to Treat Lower Urinary Tract Symptoms (LUTS)', 'organization': {'class': 'OTHER', 'fullName': 'Siami, Paul F., M.D.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Study of Safety and Efficacy of Dutasteride in Combination With Tolterodine ER or Placebo in Men With Lower Urinary Tract Symptoms (LUTS) Including Urgency and Frequency', 'orgStudyIdInfo': {'id': '110983'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tolterodine ER 4mg', 'description': '1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily', 'interventionNames': ['Drug: Tolterodine ER 4mg', 'Drug: Pre-randomization Dutasteride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': '1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily', 'interventionNames': ['Drug: Placebo', 'Drug: Pre-randomization Dutasteride']}], 'interventions': [{'name': 'Tolterodine ER 4mg', 'type': 'DRUG', 'otherNames': ['Detrol LA'], 'description': '1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4 mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily', 'armGroupLabels': ['Tolterodine ER 4mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily', 'armGroupLabels': ['placebo']}, {'name': 'Pre-randomization Dutasteride', 'type': 'DRUG', 'description': 'All participants were on Dutasteride 0.5mg orally once daily prior to randomization.', 'armGroupLabels': ['Tolterodine ER 4mg', 'placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47630', 'city': 'Newburgh', 'state': 'Indiana', 'country': 'United States', 'facility': 'Deaconess Clinic Gateway Health Center', 'geoPoint': {'lat': 37.94449, 'lon': -87.40529}}], 'overallOfficials': [{'name': 'Paul F Siami, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Deaconess Clinic Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Siami, Paul F., M.D.', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director, Deaconess Clinic Research Institute', 'investigatorFullName': 'Paul F. Siami, MD', 'investigatorAffiliation': 'Siami, Paul F., M.D.'}}}}