NCT01566292已完成2 期
Intraprostatic Botulinum Toxin Type "A" Injection in Patients With Benign Prostatic Hyperplasia and Unsatisfactory Response to Medical Therapy: a Randomised, Double-blind, Controlled Trial Using Subjective and Objective Outcomes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- evaluation of symptomatic improvement after treatment as measured by the IPSS score. A successful outcome was defined as a reduction of IPSS score of > 50% from baseline.
研究概览
简要总结
The injection of botulinum neurotoxin A into the prostate represents an alternative, minimal invasive treatment in patient with lower urinary tract symptoms (LUTS) associated to benign prostatic hyperplasia (BPH).
Objective: To evaluate the effectiveness of BTA in treating patients with symptomatic BPH and unsatisfactory response to combined medical therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Moderate-to-severe LUTS as determined by the International Prostate Symptom Score
- •Mean peak urinary flow rate of no more than 15 mL/s with a voided volume of at least 150 mL, or postvoid residual urine volume (PVR) of more than 100 ml and urodynamic parameters indicative of bladder outlet obstruction (BOO) according to International Continence Society
排除标准
- •Patients with neurogenic voiding disorders, prostate or bladder cancer, bladder stones, urethral stricture, chronic bladder catheterization were excluded from the study.
研究组 & 干预措施
BOTOX
Experimental
干预措施: BOTOX (Drug)
结局指标
主要结局
evaluation of symptomatic improvement after treatment as measured by the IPSS score. A successful outcome was defined as a reduction of IPSS score of > 50% from baseline.
时间窗: 3 month
次要结局
- safety and tolerability of treatment(3 month)
研究者
PROFESSOR PIER FRANCESCO BASSI
Prof
Catholic University of the Sacred Heart
研究点 (1)
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