Efficacy Study of Tamsulosin and Tolterodine Treatment of Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome and Lower Urinary Tract Symptoms
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- National Institutes of Health Chronic Prostatitis Symptom Index
研究概览
简要总结
The purpose of this study is to determine whether tamsulosin and tolterodine are effective in the treatment of men with lower urinary tract symptoms and chronic prostatitis/chronic pelvic pain syndrome.
详细描述
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common disorder in urological clinics. Most of the clinically CP/CPPS are to some extent associated with storage (irritative) symptoms, such as increased frequency, urgency, and nocturia, namely many patients with CP/CPPS have overactive bladder symptoms. Alpha-blocker therapy has been advocated as a treatment modality for CP/CPPS. Some trials showed a statistically and likely clinically significant treatment effect, while other trials showed no benefit. Therefore, tamsulosin combination with tolterodine treatment for CP/CPPS may be more effective than tamsulosin single.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •diagnosis of CP/CPPS based on the classification of US National Institutes of Health, aged 18-45 years
- •total score of at least 12 on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI)
- •urinary score of at least 4 on the CPSI
- •subjects who anticipate improving symptoms
排除标准
- •previous treatment with any other alpha-adrenergic receptor blocker and antimuscarinic agents for symptoms of CP/CPPS or for any other reason
- •those who had had previous urinary tract infection with the last year
- •those who had been treat or were taking medication that could affect lower urinary tract function
- •those who met the criteria for chronic bacterial prostatitis after lower urinary tract localization studies
- •those who had other significant medical problems
研究组 & 干预措施
tolterodine + tamsulosin
干预措施: tolterodine (Drug)
tolterodine + tamsulosin
干预措施: tamsulosin (Drug)
tamsulosin + placebo
干预措施: tamsulosin (Drug)
tamsulosin + placebo
干预措施: placebo (Drug)
结局指标
主要结局
National Institutes of Health Chronic Prostatitis Symptom Index
时间窗: 4 months
次要结局
- International Index of Erectile Function(4 months)
- Peak urinary flow rate(4 months)