Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2026-01-28 @ 11:41 PM
Study NCT ID:
NCT03385161
Status:
COMPLETED
Last Update Posted:
2017-12-28
First Post:
2017-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraprostatic Injection of Botulinum Toxin A Versus Ethanol for Treatment of Patients With Benign Prostatic Hyperplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D011470', 'term': 'Prostatic Hyperplasia'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'C000629279', 'term': 'onabotulinum toxin A'}, {'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Only the surgeon during injection knows the active material'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-27', 'studyFirstSubmitDate': '2017-12-20', 'studyFirstSubmitQcDate': '2017-12-27', 'lastUpdatePostDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'retention of urine', 'timeFrame': '1, 3, 6 months and one year', 'description': 'Significant difference between the rate (%) of development of retention of urine in both groups during follow-up'}, {'measure': 'Other lines of treatment including TURP', 'timeFrame': '1, 3, 6 months and one year', 'description': 'Significant difference between the rate (%) of required TURP and other lines of treatment in both groups (due to failure of studied intervention to improve symptoms of the patient )'}], 'primaryOutcomes': [{'measure': 'International prostate symptom score (IPSS)', 'timeFrame': '1, 3, 6 months and one year', 'description': '7 items Questionnaire with a score range from 0 - 35 (5 points for each item) A score of 35 is considered the worst The score is calculated during each period of follow-up The difference in the score in each group will be compared versus each other to detect any significant difference between both groups'}], 'secondaryOutcomes': [{'measure': 'Maximum flow rate (Qmax)', 'timeFrame': '1, 3, 6 months and one year', 'description': 'The peak flow rate measured during flowmetry (mL/Sec) Increase in the flow rate is considered improvement The Qmax is calculated during each period of follow-up by flowmetry The difference in the Qmax in each group will be compared versus each other to detect any significant difference between both groups'}, {'measure': 'Prostate volume', 'timeFrame': '1, 3, 6 months and one year', 'description': 'Prostate volume (PV) will be measured by transrectal US (Cubic cm) Decrease in size is considered improvement The PV is calculated during each period of follow-up The difference in the PV in each group will be compared versus each other to detect any significant difference between both groups'}, {'measure': 'quality of life (QoL)', 'timeFrame': '1, 3, 6 months and one year', 'description': 'one items Questionnaire It is the QoL portion of the International prostate symptom score (IPSS) The score range from 0 - 6 A score of 6 is considered the worst The score is calculated during each period of follow-up The difference in the score in each group will be compared versus each other to detect any significant difference between both groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ethanol ablation of the prostate', 'Benign prostatic hyperplasia (BPH)', 'Prostate', 'Ethanol', 'Transrectal', 'BPH', 'onaBoNT-A', 'Botox', 'Lower urinary tract symptoms', 'Botulinum toxin', 'OnabotulinumtoxinA', 'Quality of life', 'IPSS', 'Randomised controlled study'], 'conditions': ['Male', 'Ultrasonography', 'Botulinum Toxins, Type A', 'Injection; Complications, Infection', 'Prostatic Hyperplasia']}, 'referencesModule': {'references': [{'pmid': '28840969', 'type': 'RESULT', 'citation': 'Totaro A, Pinto F, Pugliese D, Vittori M, Racioppi M, Foschi N, Bassi PF, Sacco E. Intraprostatic botulinum toxin type "A" injection in patients with benign prostatic hyperplasia and unsatisfactory response to medical therapy: A randomized, double-blind, controlled trial using urodynamic evaluation. Neurourol Urodyn. 2018 Mar;37(3):1031-1038. doi: 10.1002/nau.23390. Epub 2017 Aug 25.'}, {'pmid': '23098762', 'type': 'RESULT', 'citation': 'Marberger M, Chartier-Kastler E, Egerdie B, Lee KS, Grosse J, Bugarin D, Zhou J, Patel A, Haag-Molkenteller C. A randomized double-blind placebo-controlled phase 2 dose-ranging study of onabotulinumtoxinA in men with benign prostatic hyperplasia. Eur Urol. 2013 Mar;63(3):496-503. doi: 10.1016/j.eururo.2012.10.005. Epub 2012 Oct 12.'}, {'pmid': '18478352', 'type': 'RESULT', 'citation': 'Magno C, Mucciardi G, Gali A, Anastasi G, Inferrera A, Morgia G. Transurethral ethanol ablation of the prostate (TEAP): an effective minimally invasive treatment alternative to traditional surgery for symptomatic benign prostatic hyperplasia (BPH) in high-risk comorbidity patients. Int Urol Nephrol. 2008;40(4):941-6. doi: 10.1007/s11255-008-9394-z. Epub 2008 May 14.'}, {'pmid': '19054163', 'type': 'RESULT', 'citation': 'Sakr M, Eid A, Shoukry M, Fayed A. Transurethral ethanol injection therapy of benign prostatic hyperplasia: four-year follow-up. Int J Urol. 2009 Feb;16(2):196-201. doi: 10.1111/j.1442-2042.2008.02205.x. Epub 2008 Nov 27.'}]}, 'descriptionModule': {'briefSummary': 'To compare safely and efficacy of intraprostatic injection of botulinum toxin A versus ethanol for treatment of benign prostatic hyperplasia (BPH).', 'detailedDescription': 'To compare safely and efficacy of transrectal intraprostatic injection of botulinum toxin A versus ethanol for treatment of symptomatic benign prostatic hyperplasia (BPH) refractory to medical treatment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'genderBased': True, 'genderDescription': 'Prostate is only in males', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* international prostate symptoms score (IPSS) \\> 7\n* Qmax \\< 15\n* Patients with refractory symptomatic BPH to medications\n* patients high risk for surgery or unwilling to do surgery\n\nExclusion Criteria:\n\n* bladder stones\n* acute or chronic urinary retention\n* urethral stricture\n* bladder or prostatic carcinoma.\n* Neurogenic bladder dysfunctions'}, 'identificationModule': {'nctId': 'NCT03385161', 'briefTitle': 'Intraprostatic Injection of Botulinum Toxin A Versus Ethanol for Treatment of Patients With Benign Prostatic Hyperplasia', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Intraprostatic Injection of Botulinum Toxin A Versus Ethanol for Treatment of Patients With Benign Prostatic Hyperplasia Refractory to Medical Treatment', 'orgStudyIdInfo': {'id': '61352'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'botulinum toxin A', 'description': 'Intraprostatic injection of botulinum toxin A (onabotulinumtoxinA; 100 IU) through transrectal ultrasonography.\n\nOne vial (100 IU) is dissolved in 10 ml saline and injected in the transition zone of each lobe of the prostate in 3 sites; basal, middle and apical.\n\none gm intramuscular ceftriaxone started and continued 3 days. A rectal enema performed the night before the procedure. The anal area sterilized A 21 gauge needle was introduced to the prostate.', 'interventionNames': ['Procedure: Botulinum toxin A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ethanol', 'description': 'Intraprostatic injection of dehydrated ethanol through transrectal ultrasonography.\n\nAn amount equal to 25% of prostate volume was injected distributed over 6-8 sites among both prostatic lobes with an average of 2 ml per site.\n\none gm intramuscular ceftriaxone started and continued 3 days. A rectal enema performed the night before the procedure. The anal area sterilized A 21 gauge needle introduced to the prostate.', 'interventionNames': ['Procedure: Ethanol']}], 'interventions': [{'name': 'Botulinum toxin A', 'type': 'PROCEDURE', 'otherNames': ['onaBONT/A', 'botox', 'onabotulinumtoxinA'], 'armGroupLabels': ['botulinum toxin A']}, {'name': 'Ethanol', 'type': 'PROCEDURE', 'otherNames': ['dehydrated ethanol'], 'armGroupLabels': ['Ethanol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12222', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mohammed S ElSheemy, Ass. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Urology', 'investigatorFullName': 'Mohammed Said ElSheemy', 'investigatorAffiliation': 'Cairo University'}}}}