Comparison Between Tamsulosin and Tadalafil in Management of Benign Prostatic Hyperplasia A Randomised Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- drug discontinuation rate
研究概览
简要总结
Comparison between tamsulosin and Tadalafil in management of benign prostatic hyperplasia A Randomised Trial
详细描述
Assessment of the discontinuation rate of tamsulosin and tadalafil after 12 months follow up either and evaluate the changes in urinary parameters and sexual parameters in patients with lower urinary tract symptoms due to BPH concomitant with erectile dysfunction. We tried to overcome the limitations of the previous studies by designing a prospective randomized controlled trial as the present study is the first randomized controlled trial that evaluate the safety, discontinuation rate and efficacy of tadalafil compared with tamsulosin for long term follow up (12 months).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •patients with Lower Urinary Tract Symptoms
- •married and sexually active
- •age more than 50 years
- •IPSS more than 12
- •Q max less than 15 ml/s
- •Post voiding residual less than 150 ml
排除标准
- •prostatic adenocarcinoma
- •cardiac patients on nitrates, patient with unstable angina or recent history of myocardial infarction
- •vesical stones
- •active Urinary Tract Infection
- •patient refused participation in the study
研究组 & 干预措施
tamsulosin
patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) treated by tamsulosin with 12 months follow up
干预措施: Tamsulosin (Drug)
tadalafil
patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) treated by tadalafil 5 mg with 12 months follow up
干预措施: Tadalafil (Drug)
结局指标
主要结局
drug discontinuation rate
时间窗: 12 months
drug discontinuation rate either : lack of response, adverse events or poor compliance
次要结局
- changes in post voiding residual urine(12 months)
- changes in uroflowmetry(12 months)
- changes in sexual parameters(12 months)
- changes in urinary parameters(12 months)