Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary 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
- 380
- 主要终点
- Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12
研究概览
简要总结
The purpose of this study was to determine the safety and effectiveness of different doses of botulinum toxin Type A in treating lower 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Lower urinary tract symptoms due to benign prostatic hyperplasia
- •Enlarged prostate volume by rectal ultrasound
排除标准
- •Previous prostate surgery
- •Previous or current diagnosis of prostate cancer
- •Use of other medications for the treatment of prostatic hyperplasia
- •Urinary tract infection
研究组 & 干预措施
botulinum toxin Type A 100 U
Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
干预措施: botulinum toxin Type A (Biological)
botulinum toxin Type A 300 U
Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
干预措施: botulinum toxin Type A (Biological)
botulinum toxin Type A 200 U
Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
干预措施: botulinum toxin Type A (Biological)
Placebo (Normal Saline)
Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
干预措施: normal saline (Drug)
结局指标
主要结局
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12
时间窗: Baseline, Week 12
The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.
次要结局
- Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72(Baseline, Week 72)
- Change From Baseline in Peak Urine Flow Rate(Baseline, Week 12, Week 72)
- Change From Baseline in Total Prostate Volume(Baseline, Week 12, Week 72)
- Change From Baseline in Transitional Zone Prostate Volume(Baseline, Week 12, Week 72)
- Change From Baseline in Post-Void Residual(Baseline, Week 2, Week 12, Week 72)