Interest of a Systematic Assessment of the Treatment of LUTS in the Management of BPH (UROEVAL)
Interest of a Systematic Assessment of the Treatment of Lower Urinary Tract Symptoms (LUTS) in the Management of Benign Prostatic Hyperplasia (BPH) in Urology
研究概览
地位
条件
研究类型
注册 (实际的)
联系人和位置
学习地点
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-
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Puteaux、法国
- LBR
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
The frequency of patients with IPSS score <8 after three months of treatment with alpha-blockers is about 40%. The sample size required to detect a proportion of 40% with a precision of 0.04 is 550 patients. Based on a literature review of Lacoin et al, the frequency of treated patients with LUTS associated with BPH with an IPSS ≥ 8 is approximately 60%. Thus, 917 patients will be needed to obtain a sample of 550 patients with treatment of alpha-blockers (550/0.6 = 917).
Considering 10% of patients lost for follow-up or refusing treatment change, the total number required is estimated at about 1,000 patients.
描述
Inclusion Criteria:
Patients aged 60 years or more suffering from LUTS/BPH AND medically treated for at least 6 months.
Exclusion Criteria:
- Patients with prostate cancer
- Patients requiring surgical treatment
- The absence of Lower Urinary Tract Symptoms
- Treatment initiation for less than 6 months
- Cognitive disorders or other pathologies leading to the inability to give its consent to the collection of data.
- Refusal to participate.
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Percentage of patients treated for LUTS associated with BPH displaying unsatisfactory outcome after at least 6 months of treatment and not requiring surgical treatment.
大体时间：6 months
|
6 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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