The Effect of Short Term Use of Finasteride Versus Cyproterone Acetate on Perioperative Blood Loss With Mono Polar Transurethral Resection of Prostate
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- microvascular density(MVD)
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
cyproterone acetate
20 patients received cyproterone acetate 50 mg twice per day for two weeks before TURP
干预措施: cyproterone acetate (Drug)
finasteride group
20 patients received finasteride 5 mg once per day for two weeks before TURP
干预措施: finasteride (Drug)
control group
20 patients received no treatment before TURP
干预措施: no treatment received (Drug)
结局指标
主要结局
microvascular density(MVD)
时间窗: 2 weeks after drug intake
assesment of MVD of the prostate by histological examination using high power field microscope
post operative Hb
时间窗: 24 hour post operative
measuring serum haemoglobin level at first post operative
post operative Hcv
时间窗: 24 hour post operative
measuring serum haematocrit value at first post operative
operative duration
时间窗: immediately after surgery
assessment of the duration of the operation
intraoperative blood loss
时间窗: immediately after surgery
assessment of intraoperative blood loss during TURP
次要结局
未报告次要终点
研究者
Shabieb Ahmed
shabieb ahmed ( assistant professor - urology department - Benha University)
Benha University