Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-27 @ 11:33 PM
Study NCT ID:
NCT05236634
Status:
UNKNOWN
Last Update Posted:
2022-02-11
First Post:
2022-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
(Phosphodiesterase 5 Inhibitors & α-blockers): Single Versus Combined Therapy in Benign Prostatic Hyperplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D058986', 'term': 'Phosphodiesterase 5 Inhibitors'}, {'id': 'D000068581', 'term': 'Tadalafil'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D000317', 'term': 'Adrenergic alpha-Antagonists'}], 'ancestors': [{'id': 'D010726', 'term': 'Phosphodiesterase Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'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': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D018674', 'term': 'Adrenergic Antagonists'}, {'id': 'D018663', 'term': 'Adrenergic Agents'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A total of (120) patients with LUTS due to BPH fulfilling the inclusion criteria will be included in this study. Patients will be randomly divided into 3 groups: Group A: Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks. Group B: Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks. Group C: Forty patients with LUTS due to BPH will be given combined therapy for 12 weeks.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-10', 'studyFirstSubmitDate': '2022-01-14', 'studyFirstSubmitQcDate': '2022-02-10', 'lastUpdatePostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in International prostate symptom score (IPSS) after 12 weeks', 'timeFrame': 'At start of study and after 12 weeks from drug intake', 'description': 'The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.'}, {'measure': 'Change in International index of erectile function (IIEF) after 12 weeks', 'timeFrame': 'At start of study and after 12 weeks from drug intake', 'description': 'The International Index of Erectile Function (IIEF) is a widely used, multi-dimensional self-report instrument for the evaluation of male sexual function. It is has been recommended as a primary endpoint for clinical trials of erectile dysfunction (ED) and for diagnostic evaluation of ED severity.'}, {'measure': 'Change in Maximal urinary flow rate (Qmax) after 12 weeks', 'timeFrame': 'At start of study and after 12 weeks from drug intake', 'description': 'The flow rate is calculated as milliliters (ml) of urine passed per second. Both average and top flow rates are measured. The fastest flow rate, also known as Qmax, is used to understand if a block or obstruction is severe.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Phosphodiesterase5 inhibitors and Alpha Blockers'], 'conditions': ['Benign Prostatic Hyperplasia']}, 'referencesModule': {'references': [{'pmid': '24165272', 'type': 'BACKGROUND', 'citation': 'Singh DV, Mete UK, Mandal AK, Singh SK. A comparative randomized prospective study to evaluate efficacy and safety of combination of tamsulosin and tadalafil vs. tamsulosin or tadalafil alone in patients with lower urinary tract symptoms due to benign prostatic hyperplasia. J Sex Med. 2014 Jan;11(1):187-96. doi: 10.1111/jsm.12357. Epub 2013 Oct 25.'}, {'pmid': '25994648', 'type': 'BACKGROUND', 'citation': 'Wang XH, Wang X, Shi MJ, Li S, Liu T, Zhang XH. Systematic review and meta-analysis on phosphodiesterase 5 inhibitors and alpha-adrenoceptor antagonists used alone or combined for treatment of LUTS due to BPH. Asian J Androl. 2015 Nov-Dec;17(6):1022-32. doi: 10.4103/1008-682X.154990.'}, {'pmid': '21718399', 'type': 'BACKGROUND', 'citation': 'Mirone V, Sessa A, Giuliano F, Berges R, Kirby M, Moncada I. Current benign prostatic hyperplasia treatment: impact on sexual function and management of related sexual adverse events. Int J Clin Pract. 2011 Sep;65(9):1005-13. doi: 10.1111/j.1742-1241.2011.02731.x. Epub 2011 Jul 1.'}], 'seeAlsoLinks': [{'url': 'https://uroweb.org/guideline/treatment-of-non-neurogenic-male-luts/#1', 'label': 'Gravas S, Cornu JN, Gacci M, Gratzke C, Herrmann TR, Mamoulakis C, Rieken M, Speakman MJ and Tikkinen KA. (2015): Guidelines on the management of non neurogenic male (LUTS), incl. (BPO). EAU Guidelines'}, {'url': 'https://uroweb.org/guideline/treatment-of-non-neurogenic-male-luts/.', 'label': 'Gravas S, Cornu JN, Gacci M, Gratzke C, Herrmann TRW, Mamoulakis C, et al. Management of nonneurogenic male LUTS. In: EAU Guidelines 2020. Arnhem,The Netherlands: EAU Guidelines Office; 2020. Available from:https://uroweb.org/guideline/treatment-of-non'}]}, 'descriptionModule': {'briefSummary': 'To compare between efficacy of phosphodiesterase5 inhibitors (tadalafil 5 mg) and Alpha Blockers (tamsulosin 0.4 mg) monotherapy vs combined therapy in treatment of lower urinary tract symptoms of benign prostatic hyperplasia.', 'detailedDescription': 'The proposed research aims to answer the question about efficacy and safety of phosphodiesterase 5 inhibitors (tadalafil 5 mg) and Alpha Blockers (tamsulosin 0.4 mg) monotherapy vs combined therapy in treatment of lower urinary tract symptoms of benign prostatic hyperplasia .\n\nBenign prostatic hyperplasia (BPH) is a disorder histologically characterized as the non-malignant hyperplasia of prostatic cells. Most of patients with BPH present with lower urinary tract symptoms (LUTS). About half of men develop BPH, among those; about half develop some degree of bladder outlet obstruction (BOO). BOO and/or changes in smooth muscle tone and resistance that can accompany BPH may result in (LUTS).\n\nAlpha-blockers have been widely used for the treatment of LUTS/BPH for a long time. Some alpha-blockers may cause ejaculatory dysfunction in some individuals. Tadalafil, a (PDE-5), was approved by the Food and Drug Administration (FDA) for the treatment of (ED) in 2003 and for the treatment of BPH in 2011.\n\nThe PDE5 inhibitors are used in the treatment of ED and there are increasing data of effects of these drugs on bladder and urethral relaxation as well as of prostatic smooth muscles that may relief the symptoms of BPH.\n\nMedical treatments for LUTS/BPH are able to significantly impact on sexual function. Sexual side effects like ejaculatory dysfunction, reduced or lost libido, and ED have been widely reported in patients treated with alpha blockers (ABs) and 5-alpha reductase inhibitors, the most utilized drugs for the treatment of LUTS/BPH.\n\nThe inclusion of Tadalafil in complex of combined conservative therapy of patients with BPH not only improves sexual function but has a positive effect on symptoms of the disease and the psychological state of the patient.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'genderBased': True, 'genderDescription': 'Men \\> 45 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1 - Men \\> 45 years with LUTS/BPH for \\> 6 months 2- IPSS of ≥ 8 and Qmax of ≥ 4 to≤ 15 mL/s\n\nExclusion Criteria:\n\n1. PSA level of \\> 10.0 ng/mL (if ≥ 4.0 to≤ 10.0 ng/mL prostate cancer will be excluded).\n2. Post-voidresidual urine volume of ≥ 150 mL.\n3. Previous Urine Retention or Urethral Catheterization .\n4. other pathology such as urinary bladder stone , bladder mass or neurogenic bladder .\n5. Any case of LUTS other than BPH (urinary bladder stone, neurogenic bladder, bladder neck contracture,rethral stricture, bladder cancer, acute or chronic prostatitis, acute or chronic urinary tract infection).\n6. patients supposed to undergo intraocular operation (as cataract operation) .\n7. History of head injury or cerebrovascular stroke or spinal injury.\n8. pelvic fracture.\n9. Uncontrolled diabetic patient.\n10. Patients with chronic obstructive lung disease on medical treatment.\n11. Parasympatholytic drugs are contraindicated during the study. 12. Patients refusing to share in the study.'}, 'identificationModule': {'nctId': 'NCT05236634', 'briefTitle': '(Phosphodiesterase 5 Inhibitors & α-blockers): Single Versus Combined Therapy in Benign Prostatic Hyperplasia', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparative Study Between Fixed Dose Monotherapy (Phosphodiesterase 5 Inhibitors or Alpha Blockers) Versus Combined Therapy in Benign Prostatic Hyperplasia Patients With Lower Urinary Tract Symptoms', 'orgStudyIdInfo': {'id': 'Drug therapies in BPH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks.', 'interventionNames': ['Drug: Alpha Blockers']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks.', 'interventionNames': ['Drug: Phosphodiesterase 5 Inhibitors']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', 'description': 'Forty patients with LUTS due to BPH will be given combined therapy(tamsulosin 0.4 mg and tadalafil 5 mg) for 12 weeks.', 'interventionNames': ['Drug: Combined Alpha Blockers and Phosphodiesterase 5 Inhibitors']}], 'interventions': [{'name': 'Phosphodiesterase 5 Inhibitors', 'type': 'DRUG', 'otherNames': ['tadalafil 5 mg oral Tablet'], 'description': 'A total of (120) patients with LUTS due to BPH fulfilling the inclusion criteria will be included in this study. Patients will be randomly divided into three groups: Group A: Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks. Group B: Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks. Group C: Forty patients with LUTS due to BPH will be given combined therapy for 12 weeks.', 'armGroupLabels': ['Group B']}, {'name': 'Alpha Blockers', 'type': 'DRUG', 'otherNames': ['Tamsulin 0.4 mg oral tablet'], 'description': 'A total of (120) patients with LUTS due to BPH fulfilling the inclusion criteria will be included in this study. Patients will be randomly divided into three groups: Group A: Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks. Group B: Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks. Group C: Forty patients with LUTS due to BPH will be given combined therapy for 12 weeks.', 'armGroupLabels': ['Group A']}, {'name': 'Combined Alpha Blockers and Phosphodiesterase 5 Inhibitors', 'type': 'DRUG', 'otherNames': ['Tadalafil 5 mg oral Tablet and Tamsulin 0.4 mg oral tablet'], 'description': 'A total of (120) patients with LUTS due to BPH fulfilling the inclusion criteria will be included in this study. Patients will be randomly divided into three groups: Group A: Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks. Group B: Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks. Group C: Forty patients with LUTS due to BPH will be given combined therapy for 12 weeks.', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed M Hussein, Master', 'role': 'CONTACT', 'email': 'ahmedawd99991@gmail.com', 'phone': '01004744048', 'phoneExt': '002'}, {'name': 'Nasreldin A Mohamed, MD', 'role': 'CONTACT', 'email': 'nasreldin@aun.edu.eg', 'phone': '01061635080', 'phoneExt': '002'}], 'overallOfficials': [{'name': 'Mohamed E Osman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University, Urology department, Faculty of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Ahmed Mostafa Hussein Mostafa', 'investigatorAffiliation': 'Assiut University'}}}}