Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- IPSS change
研究概览
简要总结
Failed medical treatment to alleviate LUTS and AUR is an indication for intervention, some trials were published elucidating the possible use of standard dose tamsulosin and silodosin and double dose tamsulosin but to the best of our knowledge, no studies with head-to-head comparison between Tamsulosin and Combination of Tamsulosin and Silodosin for Management of Lower Urinary Tract Symptoms and Acute Urine Retention in Patients with Benign Prostatic Hyperplasia.
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 (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥40 years. Catheterized patients due to acute urine retention secondary to BPO. Patients with moderate and severe LUTS secondary to BPH as proven by IPSS (International Prostate Symptoms score) ≥8 and Qmax <15 ml/sec with total void urine volume >125 cc.
排除标准
- •Patients with neurological problems as: uncontrolled DM, parkinsonism and cerebral stroke.
- •Patients with history of previous prostate surgery. Patients with complicated BPH necessitating intervention as: recurrent/persistent UTI, recurrent hematuria, bladder stones and indwelling urethral catheter due to chromic urine retention (CUR).
- •Patients with suspected malignancy by abnormal Digital Rectal Examination (DRE) and or high PSA.
研究组 & 干预措施
Single alpha blocker for BPH treatment
BPH patients in this arm are given single alpha blocker drug with placebo
干预措施: alpha blocker monotherapy Tamsulosin (Drug)
Double alpha blockers for BPH management
BPH patients in this arm are given double alpha blocker drugs
干预措施: alpha blockers Tamsulosin and Silodosin (Drug)
结局指标
主要结局
IPSS change
时间窗: 3 months
IPSS score change at 1 and 3 months following drug adminstration
次要结局
未报告次要终点
研究者
Ahmed Abolazm
Consultant
Mansoura University