Efficacy and safety of combination of Silodosin and Tadalafil vs. Silodosin or Tadalafil alone in patients with Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH): An open label randomized control trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- To estimate improvement in IPSS score for lower urinary tract symptoms due to Benign Prostatic Hyperplasia.
研究概览
简要总结
Benign prostatic hyperplasia (BPH) is a common cause of lower urinary tract symptoms (LUTS) in middle-aged and elderly men. LUTS due to Prostatic enlargement leads to voiding symptoms and storage symptoms. LUTS is known to interfere with the activities of daily living and decrease the quality of life (QoL). The objective of medical therapy is to improve LUTS due to BPH and hence quality of life. For LUTS due to BPH, medical management with both α1-adrenoceptor blockers and phosphodiesterase type 5 inhibitors are recommended. There is limited scientific literature comparing the efficacy and safety of selective alpha blocker Silodosin and Tadalafil either as monotherapy or combination. Therefore, we will conduct an open label randomized control trial in patients with LUTS due to BPH and compare the efficacy and safety of Silodosin and Tadalafil
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- Male
入选标准
- •An International Prostatic Symptom Score (IPSS) of more than 7, Maximum Urinary Flow Rate (Qmax) less than 15 ml/second with minimum voided volume of more than 150 ml at screening, Willing and able to give written informed consent and comply with study procedures, Patients agreed not to use BPH medications during the research other than the study medications.
排除标准
- •Known allergy or contraindications to Silodosin and Tadalafil and use of finasteride or dutasteride, History of syncope, and orthostatic hypotension, Bladder outlet obstruction due to cancer, calculi or stricture, Previous Transurethral Resection of the Prostate (TURP), Any neurological disorders affecting storage and voiding functions, Prostatitis, PSA greater than 4 ng/ml, An episode of acute urinary retention within 4 weeks of study initiation, Documented urinary tract infection, Poorly controlled diabetes mellitus, Poorly controlled hypertension.
结局指标
主要结局
To estimate improvement in IPSS score for lower urinary tract symptoms due to Benign Prostatic Hyperplasia.
时间窗: 4 weeks, 8 weeks, 12 weeks
次要结局
- To estimate improvement in IPSS QoL INDEX, improvement in Qmax, improvement in PVR, improvement in erectile function [EF] domain scores from IIEF 5 efficacy end points, and to determine safety assessment of Silodosin and Tadalafil including patient’s reporting of adverse event.(4 weeks, 8 weeks, 12 weeks)