The Effect of Low Intensity Shock Wave Therapy in Post Radical Prostatectomy 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
- 20
- 试验地点
- 1
- 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 LI-ESWT to affect patients who underwent radical prostatectomy who did not respond to PDE5 inhibitor therapy.
详细描述
We included severe ED patients that underwent radical prostatectomy at least one year previously and 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. This study further emphasises the need to study specific populations with unique etiologies causing ED.
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
- •Post Radical prostatectomy
- •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
研究组 & 干预措施
LI-ESWT
Low intensity shock wave treatment- 12 sessions
干预措施: LI-ESWT (Device)
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 after first visit)