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

The Effect of Short Term Use of Finasteride Versus Cyproterone Acetate on Perioperative Blood Loss With Mono Polar Transurethral Resection of Prostate

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

Study Overview

• Status: Completed
• Conditions: Prostate Hyperplasia
• Intervention / Treatment: Drug: cyproterone acetate; Drug: finasteride; Drug: no treatment received

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Qalyubia
    • Banhā, Qalyubia, Egypt, 15311
      • Benha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: cyproterone acetate; 20 patients received cyproterone acetate 50 mg twice per day for two weeks before TURP	Drug: cyproterone acetate; two weeks Cyproterone acetate administration before TURP
Active Comparator: finasteride group; 20 patients received finasteride 5 mg once per day for two weeks before TURP	Drug: finasteride; two weeks finasteride administration before TURP
Placebo Comparator: control group; 20 patients received no treatment before TURP	Drug: no treatment received; no treatment received before TURP

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Study Director: shabieb ahmed, Ph.D, faculty of medicine benha university; Study Director: abdallah fathy, Ph.D, faculty of medicine benha university; Study Chair: mohamed hefnawy, Ph.D, faculty of medicine benha university; Principal Investigator: adel al falah, Ph.D, faculty of medicine benha university

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 9, 2020

Study Registration Dates

• First Submitted: April 9, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Urological Agents; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; Contraceptive Agents; Reproductive Control Agents; Androgen Antagonists; 5-alpha Reductase Inhibitors; Contraceptive Agents, Male; Cyproterone Acetate; Cyproterone; Finasteride
• Other Study ID Numbers: benign prostatic hyperplasia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes