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

NCT04848181 | Completed Early Phase 1

• 1 other identifier: benign prostatic hyperplasia
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Hyperplasia

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

cyproterone acetate

ACTIVE COMPARATOR

20 patients received cyproterone acetate 50 mg twice per day for two weeks before TURP

Drug: cyproterone acetate

finasteride group

ACTIVE COMPARATOR

20 patients received finasteride 5 mg once per day for two weeks before TURP

Drug: finasteride

control group

PLACEBO COMPARATOR

20 patients received no treatment before TURP

Drug: no treatment received

Interventions

cyproterone acetate DRUG

two weeks Cyproterone acetate administration before TURP

cyproterone acetate

finasteride DRUG

two weeks finasteride administration before TURP

finasteride group

no treatment received DRUG

no treatment received before TURP

control group

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, Qalyubia Governorate, 15311, Egypt

Location

Related Publications (4)

• 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.

  PMID: 28753756 BACKGROUND

• 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.

  PMID: 29538495 BACKGROUND

• 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.

  PMID: 26975954 BACKGROUND

• 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.

  PMID: 25789687 BACKGROUND

Related Links

• Transurethral Resection of Prostate is Still the Gold Standard for Small to Moderate Sized Prostates

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Cyproterone Acetate; Finasteride

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cyproterone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Androstenes; Androstanes; Azasteroids; Steroids, Heterocyclic

Study Officials

• shabieb ahmed, Ph.D

  faculty of medicine, Benha university

  STUDY DIRECTOR

• abdallah fathy, Ph.D

  faculty of medicine, Benha university

  STUDY DIRECTOR

• mohamed hefnawy, Ph.D

  faculty of medicine, Benha university

  STUDY CHAIR

• adel al falah, Ph.D

  faculty of medicine, Benha university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: shabieb ahmed ( assistant professor - urology department - Benha University)

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 19, 2021
• Study Start: July 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 9, 2020
• Last Updated: July 21, 2021

Record last verified: 2021-07

Locations

EG (1)