Intraprostatic Injection of Botulinum Toxin A Versus Ethanol for Treatment of Patients With Benign Prostatic Hyperplasia Refractory to Medical Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- International prostate symptom score (IPSS)
研究概览
简要总结
To compare safely and efficacy of intraprostatic injection of botulinum toxin A versus ethanol for treatment of benign prostatic hyperplasia (BPH).
详细描述
To compare safely and efficacy of transrectal intraprostatic injection of botulinum toxin A versus ethanol for treatment of symptomatic benign prostatic hyperplasia (BPH) refractory to medical treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Only the surgeon during injection knows the active material
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •international prostate symptoms score (IPSS) > 7
- •Qmax < 15
- •Patients with refractory symptomatic BPH to medications
- •patients high risk for surgery or unwilling to do surgery
排除标准
- •bladder stones
- •acute or chronic urinary retention
- •urethral stricture
- •bladder or prostatic carcinoma.
- •Neurogenic bladder dysfunctions
研究组 & 干预措施
Ethanol
Intraprostatic injection of dehydrated ethanol through transrectal ultrasonography.
An amount equal to 25% of prostate volume was injected distributed over 6-8 sites among both prostatic lobes with an average of 2 ml per site.
one gm intramuscular ceftriaxone started and continued 3 days. A rectal enema performed the night before the procedure. The anal area sterilized A 21 gauge needle introduced to the prostate.
干预措施: Ethanol (Procedure)
botulinum toxin A
Intraprostatic injection of botulinum toxin A (onabotulinumtoxinA; 100 IU) through transrectal ultrasonography.
One vial (100 IU) is dissolved in 10 ml saline and injected in the transition zone of each lobe of the prostate in 3 sites; basal, middle and apical.
one gm intramuscular ceftriaxone started and continued 3 days. A rectal enema performed the night before the procedure. The anal area sterilized A 21 gauge needle was introduced to the prostate.
干预措施: Botulinum toxin A (Procedure)
结局指标
主要结局
International prostate symptom score (IPSS)
时间窗: 1, 3, 6 months and one year
7 items Questionnaire with a score range from 0 - 35 (5 points for each item) A score of 35 is considered the worst The score is calculated during each period of follow-up The difference in the score in each group will be compared versus each other to detect any significant difference between both groups
次要结局
- Maximum flow rate (Qmax)(1, 3, 6 months and one year)
- Prostate volume(1, 3, 6 months and one year)
- quality of life (QoL)(1, 3, 6 months and one year)
研究者
Mohammed Said ElSheemy
Associate Professor of Urology
Cairo University