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NCT04848181 Clinical Trial

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

Prostate Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04848181
Other study ID # benign prostatic hyperplasia
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date July 1, 2019
Est. completion date July 9, 2020

Study information
Verified date July 2021
Source Benha University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date July 9, 2020
Est. primary completion date July 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Egypt Benha University Banha Qalyubia

Sponsors (1)
Lead Sponsor Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Yang TY, Chen M, Lin WR, Li CY, Tsai WK, Chiu AW, Ko MC. Preoperative treatment with 5a-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. — View Citation

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