NCT02244268已完成不适用
Effect of ALNA® (Tamsulosin) on the Primary Symptoms of BPH (Benign Prostatic Hyperplasia) Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,629
- 主要终点
- Change in obstructive BPH symptoms
研究概览
简要总结
The aims of this observational study are to identify the primary BPH symptoms responsible for the patients to consult a urologic practice, resulting in the prescription of ALNA®, to assess the clincial efficacy on an improved occupational performance of the patients being still employed. Additionally to obtain relevant information for the 5-year report of experience with this product according to the requirements in § 49, para 6 of the German Medicines Act.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from symptomatic benign prostatic hyperplasia (BPH) symptoms and receiving ALNA® treatment are to be included in the observation according to the prescribing information
排除标准
- •No exclusion criteria is defined, prescribing information is to be considered
研究组 & 干预措施
Patient with symptomatic of benign prostatic hyperplasia
干预措施: ALNA® (Drug)
结局指标
主要结局
Change in obstructive BPH symptoms
时间窗: up to 12 weeks
Change in irritative BPH symptoms
时间窗: up to 12 weeks
次要结局
- Change in Residual Urine volume(up to 12 weeks)
- Number of patients with adverse events(up to 12 weeks)
- Assessment of the number of days on sick leave(up to 12 weeks)
- Global assessment of efficacy by investigator on a 4-point scale(after 12 weeks)
- Change in Quality-of-Life Index(up to 12 weeks)
- Global assessment of tolerability by investigator on a 4-point scale(after 12 weeks)
- Changes in urinary flow rate(up to 12 weeks)
研究者
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