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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Prostate Hyperplasia

Intervention / Treatment
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* Drug: cyproterone acetate
* Drug: finasteride
* Drug: no treatment received


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cyproterone acetate<br>20 patients received cyproterone acetate 50 mg twice per day for two weeks before TURP | Drug: cyproterone acetate<br>* two weeks Cyproterone acetate administration before TURP<br>|
| Active Comparator: finasteride group<br>20 patients received finasteride 5 mg once per day for two weeks before TURP | Drug: finasteride<br>* two weeks finasteride administration before TURP<br>|
| Placebo Comparator: control group<br>20 patients received no treatment before TURP | Drug: no treatment received<br>* no treatment received before TURP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |