The Effect of Low Intensity Shock Wave Therapy in Severe ED Patients Not Responding to Oral Medication
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 29
- 主要终点
- IIEF-ED Domain score
研究概览
简要总结
Low Intensity Shock Wave Therapy (LI-ESWT) was shown to have a beneficial effect on ED patients responding to PDE5i's. This study aimed to determine the capability of swt to convert PDE5 inhibitor non responders to sexually functioning males under PDE5i therapy.
详细描述
We included severe ED patients (60% diabetic, 85% with cardiovascular disease) that failed to respond to PDE5i therapy, who scored 0-2 on the rigidity scale (RS) during PDE5i therapy.Treatment included 2 sessions/week for 3 weeks, repeated after a 3-week no-treatment interval. At each session LI-ESWT was applied on the penile shaft and crus for 3 minutes in 5 different penile anatomical sites (intensity of 0.09 mj/mm2, 300 shocks/site). One-month after end of treatment the same baseline assessment was repeated. An active PDE5i medication regime was then provided and final erectile function was reassessed. Main endpoints for success were changes in RS and in the International Index of Erectile Function (IIEF-ED) Domain score. We found that LI-ESWT can effectively treat severe ED patients who failed PDE5i therapy. This study further emphasises the physiological effect that LI-ESWT can have on the erectile mechanism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •ED of more than 6 months
- •Rigidity score ≤ 2 during PDE5i therapy
- •Stable heterosexual relationship for more than 3 months
- •Patients need to know and to agree that the study protocol does not allow any PDE5I therapy till week 13 .
排除标准
- •Prior surgery or radiotherapy in pelvic region
- •Any unstable, psychiatric, spinal cord injury and penile anatomical abnormalities
- •Clinically significant chronic hematological disease
- •Anti-androgens, oral or injectable androgens
- •Cardiovascular conditions that prevent sexual activity
结局指标
主要结局
IIEF-ED Domain score
时间窗: 17 weeks after first visit
Change of 5 points and above in IIEF-ED Domain score
次要结局
- rigidity scale(17 weeks from visit 1)
研究者
i_gruenwald
MD
Rambam Health Care Campus
