NCT01301599已完成4 期
Comparison Between Alpha Blocker Monotherapy and 5-alpha-reductase Inhibitor Monotherapy Following Combination Therapy in Benign Prostatic Hyperplasia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- Numeric change of IPS and Numeric change of IPSS total score
研究概览
简要总结
This study is designed to investigate the comparison between alpha blocker monotherapy and 5-alpha-reductase inhibitor monotherapy following combination therapy in benign prostatic hyperplasia.
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
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male aged 45 years old and above (with no upper limit of age)
- •patients who underwent combination therapy of alpha blocker and 5 ARI for more than 9 months
- •Ability and willingness to correctly complete the micturition diary and questionnaire
- •Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits
排除标准
- •An anticholinergic or antidiuretic if started less than 3 months prior to screening
- •Patients who had surgical treatment due to LUTS
- •Patients with suspected neurogenic bladder disorder
- •Patients with cancer of any type including cancer of the prostate or bladder
- •Patients with urethral stricture or bladder neck contracture
- •Patients with suspicious chronic prostatitis/chronic pelvic pain syndrome
- •Acute bacterial prostatitis less than 6 months prior to screening
- •Symptomatic acute urinary tract infection (UTI) less than 1 months prior to screening
- •Patients who had underwent prostatic biopsy less than one month prior to screening
- •Patients who had unstable angina or cerebral vascular disease less than 6 months prior to screening
研究组 & 干预措施
alpha blocker group
Active Comparator
alpha blocker monotherapy
干预措施: alpha blocker monotherapy (Drug)
5 ARI group
Active Comparator
5 alpha-reductase inhibitor group
干预措施: 5 alpha reductase inhibitor monotherapy (Drug)
combination group
Experimental
combination therapy of alpha blocker and 5-alpha-reductase inhibitor medication
干预措施: combination therapy (Drug)
结局指标
主要结局
Numeric change of IPS and Numeric change of IPSS total score
时间窗: from baseline to 12 months of treatment
次要结局
- Changes in patients' symptom questionnaires : IPSS, ICIQ male LUTS(from baseline to 12 months of treatment)
- Changes in urodynamic parameters : maximal flow rate and PVR(from baseline to 12 months of treatment)
- change in finding of TRUS(from baseline to 12 months of treatment)
- safety evaluation : incidence and severity of adverse events(12 months of treatment)
- Numeric Change and percent change in PSA(from baseline to 12 months of treatment)
研究者
KYU-SUNG LEE
Professor
Samsung Medical Center
研究点 (1)
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