The Effect of Pre-operative Use of Finasteride Versus Cyproterone Acetate on Blood Loss With Transurethral Resection of Prostate

Overview

Perioperative bleeding is the most common complication related to transurethral resection of prostate, the aim of the study is to compare the effect of pre-operative use of finasteride versus Cyproterone acetate on blood loss with mono polar TURP

Full Title of Study: “The Effect of Short Term Use of Finasteride Versus Cyproterone Acetate on Perioperative Blood Loss With Mono Polar Transurethral Resection of Prostate”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: June 1, 2022

Detailed Description

This prospective randomized controlled study to compare the effect of pre-operative use of finasteride versus Cyproterone acetate on blood loss with mono polar TURP

Interventions

  • Drug: cyproterone acetate
    • two weeks Cyproterone acetate administration before TURP
  • Drug: finasteride
    • two weeks finasteride administration before TURP
  • Drug: no treatment received
    • no treatment received before TURP

Arms, Groups and Cohorts

  • Active Comparator: cyproterone acetate
    • 20 patients received cyproterone acetate 50 mg twice per day for two weeks before TURP
  • Active Comparator: finasteride group
    • 20 patients received finasteride 5 mg once per day for two weeks before TURP
  • Placebo Comparator: control group
    • 20 patients received no treatment before TURP

Clinical Trial Outcome Measures

Primary Measures

  • post operative Hb
    • Time Frame: 24 hour post operative
    • measuring serum haemoglobin level at first post operative
  • post operative Hcv
    • Time Frame: 24 hour post operative
    • measuring serum haematocrit value at first post operative
  • operative duration
    • Time Frame: immediately after surgery
    • assessment of the duration of the operation
  • microvascular density(MVD)
    • Time Frame: 2 weeks after drug intake
    • assesment of MVD of the prostate by histological examination using high power field microscope
  • intraoperative blood loss
    • Time Frame: immediately after surgery
    • assessment of intraoperative blood loss during TURP

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with benign prostatic hyperplasia with prostate size (60-100) grams – Lower urinary tract symptoms (LUTS) not responding to medical treatment – Recurrent prostatic bleeding – Recurrent acute urinary retention – Chronic urinary retention Exclusion Criteria:

  • Patients with coagulation disorders – 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

Gender Eligibility: Male

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Benha University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shabieb Ahmed, shabieb ahmed ( assistant professor – urology department – Benha University) – Benha University
  • Overall Official(s)
    • shabieb ahmed, Ph.D, Study Director, faculty of medicine benha university
    • abdallah fathy, Ph.D, Study Director, faculty of medicine benha university
    • mohamed hefnawy, Ph.D, Study Chair, faculty of medicine benha university
    • adel al falah, Ph.D, Principal Investigator, faculty of medicine benha university
  • Overall Contact(s)
    • shabieb ahmed, Ph.D, 01001606356, drshabeb2021@gmail.com

References

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 5α-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. doi: 03.2016/JCPSP.213215.

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.

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