Intracavernous Injection of Onabotulinumtoxin-A 100 U For Treatment of Phosphodiesterase Type 5 Inhibitors-Inconvenient Patients With Erectile Dysfunction: A Randamized Controlled Trial.
试验速览
- 阶段
- 2 期
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- International Index of Erectile Function (IIEF)
研究概览
简要总结
There is a new emerging concept that Botulinum Toxin Type A may have a potential role in treatment of erectile dysfunction with a longer duration of action. So, the investigators opted to perform this study to compare ICI of Botulinum Toxin Type A versus Trimix for treatment of ED.
详细描述
Background: Direct Intracavernosal injections of vasoactive agents to treat erectile dysfunction were first described in 1982 using papaverine. Later on many agents have been introduced for ICI. one of most newly introduced ICI agents for treatment of ED is Botulinum Toxin Type A.
Purpose: The aim of this study will to compare the safety, efficacy, tolerability and adverse events s of ICI of BTX-A 100 unit in comparison with ICI Trimix in the treatment of Erectile Dysfunction for PDE5Is non-responders.
Design, Settings, and Participants: This study will be conducted on 124 patients at minimum, complain of erectile dysfunction not responding to different PDE5Is therapy presenting to Urology department and outpatient clinic at Banha University Hospital.
patients will be randomized into 2 equal groups: The treatment group A: will receive a single ICI of BTX-A 100 units . The treatment group B: will receive on-demand ICI of Trimix .
Assessment for all groups will be done by Sexual Health Inventory for men (SHIM), Sexual Encounter Profile questions 2 and 3 (SEP 2 & SEP 3), and the global assessment question (GAQ) based on pre-treatment, 2 weeks, 3 months and every 3 months 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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age more than 40 years with ED not responding to PDE5Is, non compliant or contraindicated to PDE5Is. A "No" response on Sexual encounter profile questions (SEP 2 & 3)
排除标准
- •psychiatric condition Any presence of penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function.
研究组 & 干预措施
Trimix group
ICI of Trimix
干预措施: Trimix (Drug)
BTX100 group
ICI of Botox 100 U
干预措施: OnabotulinumtoxinA (Biological)
结局指标
主要结局
International Index of Erectile Function (IIEF)
时间窗: baseline, 2 weeks post treatment then every 3 months post treatment
Changes in the Erectile Function (EF) domain score of the International Index of change of Erectile Function measured by (IIEF) between treatment periods and baseline in the 2 study arms. It ranges between 0 to 25
Dopller study
时间窗: baseline, 2 weeks post treatment then every 3 months post treatment
measurement of Cavernosal artery peak systolic and end diastolic velocities before and after ICI
Erection hardness score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] Clinical assessment of the Erection hardness score by the investigators in both Erection hardness score
时间窗: baseline, 2 weeks post treatment then every 3 months post treatment
Erection hardness score which is ranged 0 to 4
次要结局
- Sexual Encounter Profile 2&3(baseline, 2 weeks post treatment then every 3 months post treatment)
- Global Assessment Questionnaire(baseline, 2 weeks post treatment then every 3 months post treatment)
研究者
Waleed El-Shaer, MD
Principal Investigator
Benha University