Comparative Study Between Intracavernosal Injection of Botulinum Toxin Type A (50 and 100 Unit) Efficacy and Durability in the Treatment of Vascular Erectile Dysfunction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF)
研究概览
简要总结
purpose: The aim of this study is to compare the safety, efficacy and durability of different doses of BTX-A (50 and 100 unit) in the treatment of Vasculogenic Erectile Dysfunction after failure of other ICI therapy.
Patients and Methods: This study will be conducted on 200 patients diagnosed as vascular erectile dysfunction by penile color Doppler not responding to medical and injection therapy presenting to Urology department and outpatient clinic at Benha University Hospital, Andrology, Sexology & STD's outpatient clinic, Kasr El Aini Hospitals, Cairo University.(multicentric study).
A- Inclusion criteria:
- Age between 40 to 70 years.
- Vascular ED proved by penile duplex.
- Unable to develop erections sufficient for intercourse.
- A "No" response on Sexual encounter profile questions (SEP 2 & 3)
- Failing to respond to first line and second line treatments for Erectile Dysfunction with surgery as the only remaining treatment option.
B-Exclusion criteria:
- Significant cardiovascular disease interfering with sexual activity
- Any history of an unstable medical or psychiatric condition
- Any presence of penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function.
patients will be simply randomized into 3 equal groups, one control group and two treatment groups. Ethics committee approval and informed consent were obtained.
详细描述
introduction: Evidence has been arising suggesting that Botulinum toxin type A (BTX-A) injections can relax smooth muscles fibers in the treatment of obesity and Detrusor muscle over-activity, similar effect on cavernosal smooth muscles would help in the treatment of erectile dysfunction (ED) resistant to oral and intracavernous (IC) therapy, thus avoiding surgical treatment options.
patient and methods: All patients will perform penile color Doppler evaluation to confirm a vascular etiology, a trimix solution (PGE1 10 ug + Phentolamine 1 mg + Papaverine 30 mg) was injected IC during the penile Doppler study.
The control group: received an IC 1 ml saline injection one day after the penile Doppler/trimix test.
The treatment group B: received a single IC injection of BTX-A 50 units one day after the penile Doppler/trimix test.
The treatment group C: received a single IC injection of BTX-A 100 units one day after the penile Doppler/trimix test.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age between 40 to 70 years. Vascular ED proved by penile duplex. Unable to develop erections sufficient for intercourse. A "No" response on Sexual encounter profile questions (SEP 2 & 3) Failing to respond to first line and second line treatments for Erectile Dysfunction with surgery as the only remaining treatment option.
排除标准
- •Significant cardiovascular disease interfering with sexual activity Any history of an unstable medical or psychiatric condition Any presence of penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function.
结局指标
主要结局
Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF)
时间窗: pre-treatment and 2 weeks after treatment also, 3 and 6 months after treatment
Changes in the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) between treatment periods and baseline in different study arms. the score as follow: \> 7 severe dysfunction 7-12 Moderate dysfunction 13-18 Mild to moderate dysfunction 19-24 Mild dysfunction 25-30 No dysfunction
the Sexual Event Profile (SEP) scores
时间窗: baseline, 2 weeks post treatment , 3, and 6 months post treatment
Changes in the Sexual Event Profile (SEP) scores between treatment periods and baseline in different study arms by a \<yes or no\> response .
Global Assessment Questionnaire (GAQ) scores
时间窗: baseline, 2 weeks post treatment , 3, and 6 months post treatment
Changes in the Global Assessment Questionnaire (GAQ) scores between treatment periods in different study arms by a \<yes or no\> response
Cavernosal artery peak systolic and end diastolic velocities
时间窗: baseline, 2 weeks post treatment , 3, and 6 months post treatment
Change in Peak systolic velocity in the Cavernosal arteries, on color Doppler examination, in the patient and control groups.
次要结局
未报告次要终点
研究者
Waleed El-Shaer, MD
Principal Investigator
Benha University