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

Early Phase 1

Completed

• Conditions: Prostate Hyperplasia
• Interventions: Drug: no treatment received; Drug: cyproterone acetate; Drug: finasteride

• Registration Number: NCT04848181
• Lead Sponsor: Benha University

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

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 Timeline

• Study Start: 2019-07-01
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-09
• Study First Submitted: 2021-04-09
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-19
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	no treatment received	20 patients received no treatment before TURP
cyproterone acetate	cyproterone acetate	20 patients received cyproterone acetate 50 mg twice per day for two weeks before TURP
finasteride group	finasteride	20 patients received finasteride 5 mg once per day for two weeks before TURP

Primary Outcome Measures

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

Trial Locations

Locations (1)

Benha University; 🇪🇬 Banhā, Qalyubia, Egypt