Safety And Efficacy of Tamsulosin and Silodosin in Patients of Benign Prostatic Hyperplasia: A Randomized Controlled Trial
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 1
研究概览
简要总结
This study is a prospective, randomized, open-label, parallel-group study that will be conducted at Geetanjali Medical College and Hospital, Udaipur. It aims to compare the safety and efficacy of tamsulosin (0.4 mg) and silodosin (8 mg) in patients with benign prostatic hyperplasia (BPH). Eligible patients aged above 40 years with an International Prostate Symptom Score (IPSS) 8 or more than 8 and maximum urinary flow rate less than 10 ml/s will be randomly allocated into two groups to receive either tamsulosin or silodosin once daily. Treatment outcomes will be evaluated at baseline and 8 weeks using changes in IPSS, maximum urinary flow rate (Qmax), and post-void residual urine volume (PVR). Safety will be assessed by monitoring adverse effects such as dizziness, postural hypotension, and retrograde ejaculation. The study will aim to determine the comparative effectiveness and safety profile of these two drugs in patients with BPH.
Hypothesis - There is no significant difference in the efficacy and safety between tamsulosin and silodosin in patients with benign prostatic hyperplasia.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Male
入选标准
- •Patients diagnosed with BPH with an age of more than 40 years old come to the outpatient department (OPD),
- •International Prostate Symptom Score (IPSS) score of 8 and above,
- •Maximum flow rate of less than 10 ml/s.
排除标准
- •Patients with Neurogenic bladder, Bladder neck contracture, Stricture urethra, Bladder calculi, Active urinary tract infection, Prostate cancer,
- •Hemodynamically unstable patients,
- •Patients having an absolute indication for surgery,
- •Allergic to test drugs,
- •Not willing to participate in the study.
研究者
Dr Pritkumar Hirani
Department of Pharmacology