: Efficacy of Silodosin Versus Tamsulosin in Patients With Moderate to Severe Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: A Randomized Crossover Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change in International Prostate Symptom Score
研究概览
简要总结
The goal of this randomized crossover clinical trial is to compare the efficacy and safety of Silodosin versus Tamsulosin in patients with moderate to severe lower urinary tract symptoms due to Benign Prostatic Hyperplasia. The main questions it aims to answer are:
Does Silodosin provide superior improvement in symptom scores (IPSS) compared to Tamsulosin?
Is there a difference in safety profile and adverse events between the two treatments?
Researchers will compare both treatments in a crossover design, where each participant receives both medications in different periods without a washout phase, to evaluate individual response differences.
Participants will:
Receive both study medications in different periods according to random allocation.
Undergo periodic assessment of urinary symptoms and quality of life.
Perform routine follow-up evaluations including symptom scoring and urine flow measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male participants aged 50 years or older
- •Diagnosis of benign prostatic hyperplasia with moderate to severe lower urinary tract symptoms
- •International Prostate Symptom Score of 8 or greater
- •Prostate volume of 30 mL or greater
- •Able and willing to provide informed consent
- •No active treatment for benign prostatic hyperplasia during the month before enrollment
排除标准
- •Suspected neurogenic bladder
- •Bladder neck contracture
- •Urethral stricture
- •Chronic urinary retention
- •Prostate cancer
- •Urinary bladder stones
- •Urinary bladder tumors
- •History of prostate surgery
- •Known allergy, hypersensitivity, or contraindication to silodosin or tamsulosin
- •Current use of alpha-adrenergic blocker therapy
- •Severe renal impairment with creatinine clearance less than 30 mL/min
- •Severe hepatic impairment
- •Concomitant use of strong cytochrome P450 3A4 inhibitors, including ketoconazole, clarithromycin, itraconazole, or ritonavir
研究组 & 干预措施
Silodosin followed by Tamsulosin
Participants assigned to this sequence will receive silodosin 8 mg oral capsules once daily for 4 weeks, followed by tamsulosin 0.4 mg oral capsules once daily for 4 weeks. Outcomes will be assessed at baseline, week 4, and week 8, including International Prostate Symptom Score, post-void residual urine volume, uroflowmetry parameters, quality of life, sexual function, and adverse events.
干预措施: Silodosin (Drug)
Silodosin followed by Tamsulosin
Participants assigned to this sequence will receive silodosin 8 mg oral capsules once daily for 4 weeks, followed by tamsulosin 0.4 mg oral capsules once daily for 4 weeks. Outcomes will be assessed at baseline, week 4, and week 8, including International Prostate Symptom Score, post-void residual urine volume, uroflowmetry parameters, quality of life, sexual function, and adverse events.
干预措施: Tamsulosin (Drug)
Tamsulosin followed by Silodosin
Participants assigned to this sequence will receive tamsulosin 0.4 mg oral capsules once daily for 4 weeks, followed by silodosin 8 mg oral capsules once daily for 4 weeks. Outcomes will be assessed at baseline, week 4, and week 8, including International Prostate Symptom Score, post-void residual urine volume, uroflowmetry parameters, quality of life, sexual function, and adverse events.
干预措施: Silodosin (Drug)
Tamsulosin followed by Silodosin
Participants assigned to this sequence will receive tamsulosin 0.4 mg oral capsules once daily for 4 weeks, followed by silodosin 8 mg oral capsules once daily for 4 weeks. Outcomes will be assessed at baseline, week 4, and week 8, including International Prostate Symptom Score, post-void residual urine volume, uroflowmetry parameters, quality of life, sexual function, and adverse events.
干预措施: Tamsulosin (Drug)
结局指标
主要结局
Change in International Prostate Symptom Score
时间窗: Baseline, Week 4, and Week 8
Change in total International Prostate Symptom Score from baseline to the end of each 4-week treatment period to compare symptom improvement with silodosin and tamsulosin in patients with benign prostatic hyperplasia-associated lower urinary tract symptoms. The International Prostate Symptom Score ranges from 0 to 35, with higher scores indicating more severe symptoms.
次要结局
- Change in Quality of Life Score(Baseline, Week 4, and Week 8)
- Change in International Index of Erectile Function-5 Score(Baseline, Week 4, and Week 8)
- Change in Postvoid Residual Urine Volume(Baseline, Week 4, and Week 8)
- Change in Peak Urinary Flow Rate(Baseline, Week 4, and Week 8)
- Incidence of Ejaculatory Dysfunction(Throughout Week 1 to Week 8)
- Incidence of Dizziness(Baseline to Week 4 and Week 4 to Week 8)
- Incidence of Hypotension(Baseline to Week 4 and Week 4 to Week 8)
- Incidence of Ejaculatory Dysfunction(Baseline to Week 4 and Week 4 to Week 8)
- Incidence of Gastrointestinal Adverse Events(Baseline to Week 4 and Week 4 to Week 8)
研究者
Ahmed Mokhtar kamal mustafa
Resident of Urology
Ain Shams University