Intracavernosal Injection of Botulinum Toxin Type A in the Treatment of Erectile Dysfunction (Phase 2 Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Right (PSV R) and Left (PSV L) Cavernosal Artery Mean PSV After Treatment
研究概览
简要总结
To evaluate the safety and efficacy of intra-cavernosal Botulinum toxin injection as an alternative line of treatment in patients with erectile dysfunction - not responding to oral PDE5i - through cavernosal smooth muscle relaxation.
详细描述
The initial Phase 1 study demonstrated safety and efficacy of Botulinum toxin type A in the treatment of Erectile dysfunction in a small randomized controlled trial of 24 men.
The investigators conduct a phase 2 trial to confirm the initial results in a larger group of men.70 males will be included in the study. The participants will be subjected for full history taking, general and genital examination. Penile duplex will be performed to assess a vascular etiology before the treatment and 2 weeks later. The patients will be randomized into a treatment group (35 patients) and a control group (35 patients).
All patients will sign an informed consent. The treatment group will be injected IC with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for color Doppler assessment, followed, next day by 50 units of BTX-A. The control group will be injected with the trimix solution during penile color Doppler assessment followed next day with a normal saline injection. The erection hardness score (EHS) will be assessed during the Doppler exam.
Procedure: At least 1 day after the penile color Doppler test, the patient is placed in the supine position flaccid and stretched penile length and girth would be measured from tip of the penis to the pubic bone will be done. A rubber band will be applied to the base of the penis. The skin will be prepped with alcohol swabs followed by the IC injection of 100 units of BTX-A. Direct pressure will be applied for 2 minutes. The rubber band will be removed after 15 minutes.
Patients and controls will fill the Sexual Health Inventory for men (SHIM) questionnaire and answer the the Sexual Encounter Profile questions 1 and 2 (SEP 2 & SEP 3), and the global assessment question (GAQ) before and 4 weeks after 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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •70 males will be included in the study recruited from Andrology, Sexology & STD's outpatient clinic, Kasr El Aini Hospitals, Cairo University, complaining of ED.
- •Unable to develop erections sufficient for intercourse.
- •Failing to respond to first line and second line treatments for Erectile Dysfunction with surgery as the only remaining treatment option.
- •Age between 18 to 80 years.
排除标准
- •Significant cardiovascular disease interfering with sexual activity
研究组 & 干预措施
Botulinum Toxin Type A (BTX-A) Group
Experimental: BTX-A Group The treatment group, 35 patients, will be injected with 100 units BTX-A one day following penile colour Doppler assessment.
干预措施: Botulinum Toxin Type A (Drug)
Placebo Group
Saline Group:
The control group, 35 patients, will be injected with 1 ml normal saline one day following penile colour Doppler assessment.
干预措施: Normal saline (Drug)
结局指标
主要结局
Right (PSV R) and Left (PSV L) Cavernosal Artery Mean PSV After Treatment
时间窗: 2 weeks
Cavernosal artery mean peak systolic velocity (PSV) after treatment, on color Doppler examination, in the patient and control groups.
Right (PSV R) and Left (PSV L) Cavernosal Artery Mean PSV Before Treatment
时间窗: Baseline
Baseline mean Peak systolic velocity (PSV) in the Cavernosal arteries, on color Doppler examination, in the patient and control groups.
次要结局
- SHIM Score Before Treatment(Baseline)
- SHIM Score After Treatment(6 and 12 weeks after injection.)
- Penile Size Before Treatment(Baseline)
- Penile Size After Treatment(6 and 12 weeks after injection.)
- Intra-vaginal Latency Time Before Treatment(Baseline)
- Intra-vaginal Latency Time After Treatment(6 and 12 weeks after injection.)