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

Benha University

Status and phase: Completed; Early Phase 1

Conditions: Prostate Hyperplasia

Treatments: Drug: cyproterone acetate; Drug: no treatment received; Drug: finasteride

Study type: Interventional

Funder types: Other

Identifiers

NCT04848181

benign prostatic hyperplasia

Details and patient eligibility

About

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

Full 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

Enrollment: 60 patients

Sex: Male

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups, including a placebo group

cyproterone acetate

Active Comparator group

Description:

20 patients received cyproterone acetate 50 mg twice per day for two weeks before TURP

Treatment:

Drug: cyproterone acetate

finasteride group

Active Comparator group

Description:

20 patients received finasteride 5 mg once per day for two weeks before TURP

Treatment:

Drug: finasteride

control group

Placebo Comparator group

Description:

20 patients received no treatment before TURP

Treatment:

Drug: no treatment received