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

Early Phase 1CompletedNCT04848181

Benha University60 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Prostate Hyperplasia

Interventions

cyproterone acetateDRUG

two weeks Cyproterone acetate administration before TURP

finasterideDRUG

two weeks finasteride administration before TURP

no treatment receivedDRUG

no treatment received before TURP

Eligibility

Sex: MALEHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Benha University

Banhā, Qalyubia Governorate, Egypt

Outcomes

Primary Outcomes

post operative Hb

measuring serum haemoglobin level at first post operative

Time frame: 24 hour post operative

post operative Hcv

measuring serum haematocrit value at first post operative

Time frame: 24 hour post operative

operative duration

assessment of the duration of the operation

Time frame: immediately after surgery

microvascular density(MVD)

assesment of MVD of the prostate by histological examination using high power field microscope

Time frame: 2 weeks after drug intake

intraoperative blood loss

assessment of intraoperative blood loss during TURP

Time frame: immediately after surgery

Data from ClinicalTrials.gov

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