Safety and Efficacy of Tadalafil vs. Tadalafil With Sildosin in the Management of Moderately and Severely Symptomatic Patients of Prostatic Hyperplasia
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 主要终点
- Symptom relief
研究概览
简要总结
To study Safety and efficacy of Tadalafil vs. Tadalafil with Sildosin in the management of moderately and severely symptomatic patients of prostatic hyperplasia
详细描述
Introduction Benign prostatic hyperplasia (BPH) is a common cause of lower urinary tract symptoms (LUTS) in middle-aged and elderly men, and the incidence rate of LUTS associated with BPH (LUTS/BPH) increases with age.
LUTS can be broadly grouped into: (i) storage symptoms, such as frequency, urgency, and nocturia (ii) voiding symptoms, such as intermittency, weak stream and straining, and (iii) post-micturition symptoms, such as a feeling of incomplete emptying and post micturition dribble.
For optimal management of LUTS/BPH, medications should be chosen based on age, disease progression, need for long-term management, and other clinical parameters.
Alpha 1 adreno-receptors antagonists (alpha 1 blockers) are proposed as first-line drug therapy for LUTS/BPH as these agents reduce the adrenergic tone of the smooth muscle within the prostate and bladder neck, thereby relieving the bladder outlet obstruction.
Tadalafil (phosphodiesterase type 5 [PDE-5] inhibitor) was approved for treating LUTS/BPH. The inhibition of PDE-5leads to accumulation of cyclic guanosine monophosphate in the smooth muscles of the prostate and urethra which causes their relaxation resulting in alleviation of the symptoms of LUTS/BPH.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients to be included in the study will be either:
- •diagnosis of BPH based on abdominal ultrasound or digital rectal examination.
- •Moderate IPSS Score between 8 :
- •severe IPSS Score between 20 :
- •post void volume > 100 c.
- •prostate size 50 to 80 gm.
- •2 or more weeks of freedom or washout from any medications known to influence LUTS before enrollment.
- •mental and physical capacity to understand and fill out the study questionnaires.
排除标准
- •contraindications to Sildosin or Tadalafil.
- •diagnosis of prostate cancer.
- •possible presence of urinary infection, neurogenic bladder, stone bladder, refractory retention, hematuria of prostate origin or any cause for surgical intervention.
- •clinically significant cardiovascular, hepatic, or renal disorders.
- •cataract surgery planned during the study period.
研究组 & 干预措施
1
Tadalafil in moderate puts
干预措施: Tadalafil 5mg (Drug)
2
Tadalafil in severe puts
干预措施: Tadalafil 5mg (Drug)
3
Tadalafil with sildosin in moderate luts
干预措施: Tadalafil 5mg (Drug)
4
Tadalafil with sildosin in severe luts
干预措施: Tadalafil 5mg (Drug)
结局指标
主要结局
Symptom relief
时间窗: 2 weeks
Decreased AUA score
次要结局
未报告次要终点
研究者
Mohamed Yaseen
Menoufia governorate
Menoufia University