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
• Status: Completed
• Phase: Early Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Hyperplasia
• Prostate Hyperplasia
• Prostatic Hyperplasia

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