Ekstracorporal Shock Wave Therapy as a Treatment for Erectile Dysfunction in Men After Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- IIEF-5 point
研究概览
简要总结
Extra Corporal Shock wave Therapy Has proven effective as treatment with mild to moderate erectile dysfunction in men with erectile dysfunction. Investigator will examine whether the treatment also applies to men with moderate to severe erectile dysfunction after nerve injury associated with prostatectomy.
详细描述
All patients have undergone prostatectomy and are without recurrence. None of the men have sufficient effect of medical treatment for erectile dysfunction (tablets or injection therapy).
Each participant will fill out two validated sexual function questionnaires: IIEF-5 (International Index of Erectile Function), and EHS (Erection Hardness Score).
Our treatment protocol consists of one treatment sessions per week for 5 wk. The shockwaves are delivered to the distal, mid, and proximal penile shaft, and the left and right crura. The duration of each LI-ESWT session was about 20min, and each session comprised 500 shocks per treatment point (3000 per session) at an energy density of 0.15 mJ/mm2.
Patients are randomized to active treatment or placebo.By placebo added a blocking membrane in the machine, handling is carried out exactly the same way as the active treatment. None of the attending staff members will be familiar with who receive active and who receive placebo treatment.
For evaluation, the International index of erectile function (IIEF-5) will be used after 1, 3- and 6-mo follow-up.
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, Care Provider, Outcomes Assessor)
盲法说明
Patient and therapist are blind. Primary investigator is not blind. Unblinding occurs 3 months after the end of treatment
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Erectil dysfunction after radical prostatectomy less than two years ago
- •IIEF - less than 20
- •EHS - less than 4
排除标准
- •not sexual active
- •penile prostesis
结局指标
主要结局
IIEF-5 point
时间窗: 1, 3 and 6 months
Change in IIEF-5 point
次要结局
未报告次要终点
研究者
Martha Haahr M.D
M.D
Odense University Hospital