A Prospective, Randomized, Open Label, Parallel Trial Comparing the Efficacy of α-blocker or 5-ARI Withdrawal to Continued Combination Therapy on the Maintenance of LUTS in Men With Benign Prostatic Hyperplasia
试验速览
- 阶段
- 3 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in International Prostate Symptom Score (IPSS) score from baseline
研究概览
简要总结
The investigators compare the efficacy of alpha-blocker and 5-ARI withdrawal to continued combination therapy on the maintenance of LUTS and improvement of quality of life outcomes in men with benign prostatic hyperplasia.
详细描述
Benign Prostatic Hyperplasia (BPH) is the primary cause of lower urinary tract symptoms (LUTS). Combination therapy with an alpha-blocker and 5α reductase inhibitors (5-ARI) is the first-line treatment of BPH-related LUTS for the reduction of the size of the prostate and LUTS improvement. Combination therapy is tolerated well by most men; however, the incidence of adverse events is higher than with either therapy alone. In patients with improved LUTS following combination therapy, the aim of this study is based on the hypothesis that the withdrawal of either therapy will not increase the risk of LUTS aggravation while improving the quality of life.
The investigators plan a prospective, randomized, open-label, parallel trial, comparing alpha-blocker withdrawal and 5-ARI withdrawal to continued combination therapy. Treatments will be allocated in a 1:1:1 ratio, based on IPSS score (≤30% decrease from baseline) and prostate volume (≤35% decrease from baseline).
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged ≥50 or <80 years AND
- •On combination therapy (alpha-blocker and 5-ARI) ≥12 months AND
- •IPSS score (≤30% decrease from baseline) AND
- •Prostate volume (≤35% decrease from baseline)
排除标准
- •Suspected prostate cancer (PSA density >0.15 ng/ml/cc) requiring specific management
- •On-going prostatitis or urinary retention
- •Acontractile detrusor
- •Neurogenic lower urinary tract dysfunction
- •Urethral stenosis
- •Patient unable or unwilling to provide written informed consent
研究组 & 干预措施
combination therapy
receives alpha-blocker and 5-ARI
干预措施: Maintenance of alpha-blocker and 5-ARI (Drug)
alpha-blocker withdrawal
receives 5-ARI monotherapy
干预措施: alpha-blocker or 5-ARI withdrawal (Drug)
5-ARI withdrawal
receives alpha-blocker monotherapy
干预措施: alpha-blocker or 5-ARI withdrawal (Drug)
结局指标
主要结局
Change in International Prostate Symptom Score (IPSS) score from baseline
时间窗: 18 months
IPSS is the sum of the seven questions with each score ranging from 0 (best) to 5 (worst). IPSS is self-administered at screening and each time-point of month 3, 6, 12, and 18. Seven questions included are incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. The total IPSS score can range from 0-35 with severity catagories of mild (0 to 7), moderate (8 to 19) or severe (20 to 35). Month 18 is the primary timepoint and earlier timepoints are considered secondary. Change from baseline defined as difference between post-baseline value and baseline value.
次要结局
- Change in prostate-specific antigen (PSA) level from baseline(18 months)
- Change in EuroQol five dimension scale (EQ-5D) score from baseline(3, 6, 12, 18 months)
- Change in prostate volume from baseline(18 months)
- Number of adverse events(3, 6, 12, 18 months)
- Change in International Prostate Symptom Score (IPSS) from baseline(3, 6, 12 months)
- Change in Overactive bladder symptom score (OABSS) from baseline(3, 6, 12, 18 months)
- Change in Qmax from baseline(3, 12, 18 months)
研究者
Kyo Chul Koo
Associate Professor
Gangnam Severance Hospital