NCT02244320已完成不适用
Observational Study in Patients With Functional BPH (Benign Prostatic Hyperplasia) Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)
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
- 4,150
- 主要终点
- Change in IPSS sum score
研究概览
简要总结
The objective of the observational study were to investigate the switch from phytotherapy to ALNA® after at least 4 weeks of phytotherapy and still presented with a symptom sum score of ≥ 8 points (International Prostate Symptom Score (IPSS))
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 BPH symptoms
- •Preceding treatment with a phytotherapeutic for at least 4 weeks
- •IPSS sum score ≥ 8 points prior to treatment start with ALNA®
- •Indication for a switch to treatment with ALNA® for a minimum period of 2 months
排除标准
- •Patients fulfilling one of the general or specific contraindications listed in the ALNA® Summary of Product Characteristic, particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredient of the product, orthostatic dysregulation or severe liver insufficiency
- •Patients receiving ALNA® within the 4 weeks prior to the start of the present observational study
研究组 & 干预措施
functional BPH
patients with functional BPH who switched from phytotherapy to ALNA®
干预措施: Tamsulosin (Drug)
结局指标
主要结局
Change in IPSS sum score
时间窗: Day 1, 2 months
Change in Quality-of-Life Index (QoL) rated on a 7-point scale
时间窗: Day 1, 2 months
次要结局
- Change in sexual satisfaction rated on a 4-point scale(Day 1, 2 months)
- Change in maximum urinary flow rate (ml/sec)(Day 1, 2 months)
- Change in residual urine volume (ml)(Day 1, 2 months)
- Patient's global assessment of the preceding phytotherapy on a 3-point scale(Day 1)
- Patient's global assessment of the therapy with ALNA® on a 3-point scale(after 2 months)
- Efficacy assessment of the preceding phytotherapy by physician rated on 4-point scale(Day 1)
- Efficacy assessment of the therapy with ALNA® by physician rated on 4-point scale(after 2 months)
- Tolerability assessment of the preceding phytotherapy by physician rated on 4-point scale(Day 1)
- Tolerability assessment of the therapy with ALNA® by physician rated on 4-point scale(after 2 months)
- Number of patients with adverse drug reactions (ADR)(up to 2 months)
研究者
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