Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 315
- 主要终点
- Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12
研究概览
简要总结
This study will evaluate the safety and efficacy of intraprostatic administration of botulinum toxin Type A (BOTOX®) compared with placebo to treat urinary tract symptoms due to 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
- Double (Participant, Investigator)
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
- •Clinical enlargement of the prostate gland
- •Body weight ≥ 50 kg or 110 lbs
排除标准
- •History of chronic prostatitis
- •History of two or more urinary tract infections in the past year or one in the last 6 months
- •History of bladder stones
- •History of previous prostate surgery
- •History of bladder cancer or prostate cancer
- •Any previous or current usage of botulinum toxin therapy of any serotype for any urological condition
- •Botulinum toxin therapy of any serotype for any non-urological condition or usage (e.g., cosmetic) during the previous 12 weeks prior to study entry
研究组 & 干预措施
botulinum toxin Type A
botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
干预措施: botulinum toxin Type A (Drug)
Placebo (Normal saline)
Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
干预措施: Normal saline (Drug)
结局指标
主要结局
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12
时间窗: Baseline, Week 12
IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement.
次要结局
- Duration of Effect(24 Weeks)
- Change From Baseline in Peak Urine Flow Rate(Baseline, Weeks 6, 12 and 24)
- Change From Baseline in the Total International Prostate Symptom Score (IPSS)(Baseline, Week 6, Week 24)