Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 3:47 AM
Study NCT ID:
NCT04383093
Status:
COMPLETED
Last Update Posted:
2020-05-11
First Post:
2020-05-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tadalafil Plus Tamsulosin for Male LUTS and ED
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D007172', 'term': 'Erectile Dysfunction'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], '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'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068581', 'term': 'Tadalafil'}, {'id': 'D000077409', 'term': 'Tamsulosin'}], 'ancestors': [{'id': 'D002243', 'term': 'Carbolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-07', 'studyFirstSubmitDate': '2020-05-05', 'studyFirstSubmitQcDate': '2020-05-07', 'lastUpdatePostDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lower Urinary Tract Symptoms', 'timeFrame': 'Changes from Baseline IPSS at 3 months', 'description': 'Through IPSS'}, {'measure': 'Lower Urinary Tract Symptoms - Storage', 'timeFrame': 'Changes from Baseline OAB-q at 3 months', 'description': 'Through OAB-q'}, {'measure': 'Erectile Dysfunction', 'timeFrame': 'Changes from Baseline IIEF-5 at 3 months', 'description': 'Through IIEF-5'}, {'measure': 'Flowmetry Maximum Flow', 'timeFrame': 'Changes from Baseline Maximum Flow at 3 months', 'description': 'Through Maximum Flow (ml/s)'}, {'measure': 'Flowmetry Post Void Residual', 'timeFrame': 'Changes from Baseline Post Void Residual at 3 months', 'description': 'Through Post Void Residual (ml)'}], 'secondaryOutcomes': [{'measure': 'Combination Therapy Adverse Events', 'timeFrame': '3 months', 'description': 'Drug related adverse events were collected'}, {'measure': 'Combination Therapy Compliance', 'timeFrame': '3 months', 'description': 'Adherence to therapy - did all the patients took the combination therapy daily'}, {'measure': 'Combination Therapy Tolerability', 'timeFrame': '3 months', 'description': 'Measured by the study completion rate by the participants'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tadalafil', 'Tamsulosin', 'BPH', 'LUTS', 'ED', 'PDE5-I', 'Alpha-Blockers', 'METS'], 'conditions': ['Prostatic Hyperplasia, Benign', 'Lower Urinary Tract Symptoms', 'Erectile Dysfunction', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'Metabolic Syndrome (MetS) is a complex epidemic disorder with an impact on both lower urinary tract symptoms (LUTS) and erectile dysfunction (ED). Combination therapy of daily tadalafil and tamsulosin may provide relief to both diseases.\n\nAim of the present study is to assess the impact of combination therapy of Tadalafil 5mg plus Tamsulosin 0.4mg on LUTS and ED, according to presence vs. absence of Mets.', 'detailedDescription': '75 Consecutive men presenting with ED and LUTS suggestive of bladder prostatic obstruction were enrolled. Patients were divided into two groups according to MetS presence or absence. All subjects were then treated with tadalafil 5 mg/die plus tamsulosin 0.4 mg/die for 12 weeks. Patients were re-evaluated after 12 weeks of treatment with Uroflowmetry and PVR, IPSS, IPSS QoL, OAB-q and IIEF-5 and comparison were made in and between groups.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '75 Consecutive men presenting with ED and LUTS suggestive of bladder prostatic obstruction (BPO) were screened for the trial. Inclusion criteria were age \\>40 to 80 years, mild to severe ED (International Index of Erectile Function-Erectile Function-5 \\<22), moderate to severe LUTS (International Prostate Symptom Score \\>7), while exclusion criteria were hypersensitivity to tadalafil or tamsulosin, prostatic cancer or suspected with prostate-specific antigen (PSA) \\>4 ng/mL, bladder lithiasis, previous prostatic surgery, urinary tract infection, neurogenic bladder, finasteride or dutasteride use within 3 or 6 months, respectively, clinical history of urethral and/or proven bladder neck obstruction.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mild to severe ED (International Index of Erectile Function-Erectile Function-5 \\<22)\n* moderate to severe LUTS (International Prostate Symptom Score \\>7)\n\nExclusion Criteria:\n\n* hypersensitivity to tadalafil or tamsulosin\n* prostatic cancer or suspected with prostate-specific antigen (PSA) \\>4 ng/mL\n* bladder lithiasis\n* previous prostatic surgery\n* urinary tract infection\n* neurogenic bladder\n* finasteride or dutasteride use within 3 or 6 months respectively\n* clinical history of urethral and/or proven bladder neck obstruction'}, 'identificationModule': {'nctId': 'NCT04383093', 'briefTitle': 'Tadalafil Plus Tamsulosin for Male LUTS and ED', 'organization': {'class': 'OTHER', 'fullName': 'University of Florence'}, 'officialTitle': 'Prospective Observational Trial of Combination Therapy of Tadalafil 5mg Plus Tamsulosinmg for Men With Lower Urinary Tract Symptoms and Erectile Dysfunction', 'orgStudyIdInfo': {'id': 'OSS.15.031/2015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Combination Therapy', 'description': 'Patients initial assessment included age, waist circumference, blood pressure, clinical laboratory parameters, digital rectal examination. LUTS were evaluated with total IPSS, focusing also on storage, voiding IPSS sub-scores, and IPSS QoL, and Overactive Bladder questionnaire (OAB-q), while ED with IIEF-515. Each patient underwent uroflowmetry and postvoid residual volume (PVR) was measured with abdominal ultrasound immediately after voiding. All patients reporting any intake of therapies for LUTS or ED underwent a 4 weeks treatment-free washout period.\n\nAll subjects were treated with tadalafil 5 mg/die plus tamsulosin 0.4 mg/die for 12 weeks. The medications were self-administered every day at the same time, before the night rest, without any limitations or variations of sexual activity timing or food intake. Patients were re-evaluated after 12 weeks of treatment with Uroflowmetry and PVR, IPSS, IPSS QoL, OAB-q and IIEF-5', 'interventionNames': ['Drug: Tadalafil 5mg']}], 'interventions': [{'name': 'Tadalafil 5mg', 'type': 'DRUG', 'otherNames': ['Tamsulosin 0.4mg'], 'description': 'Combination therapy of daily tadalafil plus tamsulosin', 'armGroupLabels': ['Combination Therapy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mauro Gacci, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florence'}, {'name': 'Arcangelo Sebastianelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florence'}, {'name': 'Sergio Serni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florence'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florence', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Simone Morselli', 'investigatorAffiliation': 'University of Florence'}}}}