Shaeer's Vein Ligation - I: Internal Pudendal Vein Sub-Gluteal Ligation For The Management of Veno Occlusive Erectile Dysfunction. The Surgical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Treatment Satisfaction Scale
研究概览
简要总结
The goal of this interventional study is to evaluate a new surgical technique (Shaeer's Sub-Gluteal Internal Pudendal Vein Ligation (SHAEER-I)) in patients with deep system veno-occlusive erectile dysfunction (VOD)
. The main question[s] it aims to answer are:
- [Will the patients have satisfactory rigidity after surgery]
- [What will the Satisfaction rates be]
- [Will there be complications]
Participants will
- Undergo SHAEER-I or PPI surgery
- Report the results of surgery for at least 6 months
详细描述
Title Shaeer's Vein Ligation - I: Internal Pudendal Vein Sub-Gluteal Ligation For The Management of Veno Occlusive Erectile Dysfunction. The Surgical Study
Objectives Vein ligation surgery for veno-occlusive erectile dysfunction (VOD) has largely been unsuccessful, possibly due to the extensive collateral circulation, but also due to confinement to intermediate vein system ligation. The deep system of veins has been surgically inaccessible.
This is study evaluates Shaeer's Vein Ligation - I (Shaeer-I): the first surgical technique for ligation of the deep system of veins; the internal pudendal vein.
Methods Surgery shall be performed for patients with VOD who are not responding to medical treatment and are candidate for penile prosthesis implantation. VOD will be documented by cavernosography to affect the deep system of veins; the internal pudendal vein, unilaterally.
Patients will be randomized into two groups: one to proceed to Penile Prosthesis Implantation (PPI Group), and another to be offered a choice between PPI or SHAEER-I. Patients opting for PPI will be assigned to the PPI group. Patients opting to SHAEER-I will be assigned to (SHAEER-I group).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients with deep system veno-occlusive erectile dysfunction
- •Lack of response to medical treatment for erectile dysfunction including PDEi (Phosphodiesterase Inhibitors), aphrodisiacs, hormonal therapy (if there is a hormonal disturbance), and intracavernous injections, despite control of risk factors such as diabetes mellitus.
排除标准
- •Patients with uncontrolled diabetes, smokers and patients with anesthesia risk
- •Patients with arteriogenic erectile dysfunction, penile fibrosis, Peyronie's disease or psychiatric disorders.
- •Patients with bilateral deep system VOD
- •Patients who refuse to participate in the study
结局指标
主要结局
Treatment Satisfaction Scale
时间窗: 6 months
A questionnaire to assess satisfaction with the results of surgery
International Index of Erectile Function
时间窗: 6 months
A questionnaire to assess erectile function
次要结局
- Complications(6 months)
研究者
Osama Shaeer
Prof.Dr.
Kasr El Aini Hospital