Vardenafil Versus Tadalafil Versus Tamsulosin in Patients With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Prospective Randomized Study.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- International prostate symptom score (IPSS total score)
研究概览
简要总结
The main objective of this prospective randomized controlled study is to compare safety and efficacy of Vardenafil versus Tadalafil versus Tamsulosin in terms of (voiding function, sexual function and quality of life) in the management of moderate BPH related LUTS.
详细描述
This is prospective randomized controlled study that will be conducted on men with BPH related LUTS amenable to medical treatment at Urology Department, Faculty of Medicine, Tanta University - Egypt after having their written informed consent.
The study is planned to include 150 patients in the study period from April 2024 to April 2025. Each enrolled patient must complete 12 weeks on medication with strict scheduled follow up.
Inclusion criteria:
Sexually active patients with moderate BPH related LUTS amenable to medical treatment and completed 12 weeks follow up period.
Exclusion criteria:
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 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Sexually active patients .
- •ModerateBPH related LUTS ( bengin prostatic hyperplasia related lower urinary tract symtoms ) i.e: (international prostatic symptom score 8 to 19 : the higher score is the worse symptoms ).
- •Patients accepted medical treatment and completed 12 weeks on medical treatment and strict follow up .
排除标准
- •Indication for combined therapy as prostate size over 40 gm .
- •Gross hematuria.
- •Refractory urine retention .
- •Bilateral hydro-ureteronephrosis or renal insufficiency secondary to bengin prostatic hyperplasia.
- •Bladder diverticula or calculi .
- •History of bladder or prostate cancer.
- •Unwilling patients to medical therapy.
- •History of pelvic surgery or urethral stricture.
研究组 & 干预措施
Vardenafil in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia
50 patients will take Vardenafil 5 mg tabs twice daily and will be assessed at 4th week and 12th week. Treatment efficacy will be assessed by a change in pre and post treatment Q-max, PVR (post void residual urine), IPSS, (International Prostate Symptom Score) and Sexual Health Inventory for Men (SHIM) with monitoring any side effects
干预措施: Vardenafil 5 Mg Oral Tablet (Drug)
Tadalafil in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia
50 patients will take Tadalafil 5 mg tabs once daily and will be assessed at 4th week and 12th week. Treatment efficacy will be assessed by a change in pre and post treatment Q-max, PVR (post void residual urine), IPSS, (International Prostate Symptom Score) and Sexual Health Inventory for Men (SHIM) with monitoring any side effects
干预措施: Vardenafil 5 Mg Oral Tablet (Drug)
Tamsulosin in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia
50 patients will take Tamsulosin 0.4 mg tabs once daily and will be assessed at 4th week and 12th week. Treatment efficacy will be assessed by a change in pre and post treatment Q-max, PVR (post void residual urine), IPSS, (International Prostate Symptom Score) and Sexual Health Inventory for Men (SHIM) with monitoring any side effects
干预措施: Vardenafil 5 Mg Oral Tablet (Drug)
结局指标
主要结局
International prostate symptom score (IPSS total score)
时间窗: 3 months
Change in pre and post treatment condition (IPSS : international prostate symptom score - decresing in the score equals improving the symptoms )
The maximum urinary flow rate (Q-max)
时间窗: 3 months
Change in pre and post treatment condition (increasing at Q-max equals improving the symptoms )
次要结局
- Sexual Health Inventory for Men (SHIM)(3 months)
研究者
Hazem Bashir Ali Mohamed Baz
Urology resident at Tanta university hospitals
Tanta University