The Effect of Pre-operative Use of Finasteride Versus Cyproterone Acetate on Blood Loss With Transurethral Resection of Prostate
NCT ID: NCT04848181
Last Updated: 2021-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
60 participants
INTERVENTIONAL
2019-07-01
2020-07-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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cyproterone acetate
20 patients received cyproterone acetate 50 mg twice per day for two weeks before TURP
cyproterone acetate
two weeks Cyproterone acetate administration before TURP
finasteride group
20 patients received finasteride 5 mg once per day for two weeks before TURP
finasteride
two weeks finasteride administration before TURP
control group
20 patients received no treatment before TURP
no treatment received
no treatment received before TURP
Interventions
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cyproterone acetate
two weeks Cyproterone acetate administration before TURP
finasteride
two weeks finasteride administration before TURP
no treatment received
no treatment received before TURP
Eligibility Criteria
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Inclusion Criteria
* Lower urinary tract symptoms (LUTS) not responding to medical treatment
* Recurrent prostatic bleeding
* Recurrent acute urinary retention
* Chronic urinary retention
Exclusion Criteria
* Previous prostatic surgery
* Previous finasteride administration
* Bladder pathology (urinary bladder stones - bladder mass)
* Suspected or proved cancer prostate
* Hepatic or renal impairment
* Patients unfit for operation eg. Decompensated heart failure, poor chest condition
MALE
Yes
Sponsors
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Benha University
OTHER
Responsible Party
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Shabieb Ahmed
shabieb ahmed ( assistant professor - urology department - Benha University)
Principal Investigators
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shabieb ahmed, Ph.D
Role: STUDY_DIRECTOR
faculty of medicine, Benha university
abdallah fathy, Ph.D
Role: STUDY_DIRECTOR
faculty of medicine, Benha university
mohamed hefnawy, Ph.D
Role: STUDY_CHAIR
faculty of medicine, Benha university
adel al falah, Ph.D
Role: PRINCIPAL_INVESTIGATOR
faculty of medicine, Benha university
Locations
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Benha University
Banhā, Qalyubia Governorate, Egypt
Countries
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References
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Treharne C, Crowe L, Booth D, Ihara Z. Economic Value of the Transurethral Resection in Saline System for Treatment of Benign Prostatic Hyperplasia in England and Wales: Systematic Review, Meta-analysis, and Cost-Consequence Model. Eur Urol Focus. 2018 Mar;4(2):270-279. doi: 10.1016/j.euf.2016.03.002. Epub 2016 Mar 23.
Yang TY, Chen M, Lin WR, Li CY, Tsai WK, Chiu AW, Ko MC. Preoperative treatment with 5alpha-reductase inhibitors and the risk of hemorrhagic events in patients undergoing transurethral resection of the prostate - A population-based cohort study. Clinics (Sao Paulo). 2018 Mar 12;73:e264. doi: 10.6061/clinics/2018/e264.
Khwaja MA, Nawaz G, Muhammad S, Jamil MI, Faisal M, Akhter S. The Effect of Two Weeks Preoperative Finasteride Therapy in Reducing Prostate Vascularity. J Coll Physicians Surg Pak. 2016 Mar;26(3):213-5.
Tian HL, Zhao CX, Wu HY, Xu ZX, Wei LS, Zhao RT, Jin DL. Finasteride reduces microvessel density and expression of vascular endothelial growth factor in renal tissue of diabetic rats. Am J Med Sci. 2015 Jun;349(6):516-20. doi: 10.1097/MAJ.0000000000000451.
Related Links
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Transurethral Resection of Prostate is Still the Gold Standard for Small to Moderate Sized Prostates
Other Identifiers
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benign prostatic hyperplasia
Identifier Type: -
Identifier Source: org_study_id
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