The Effect of Low Intensity Shock Wave Therapy on Erectile Dysfunction in Patients Responding to PDE5i's
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- International Index of Erectile function- Erectile Function Domain
研究概览
简要总结
This study aims to evaluate the effect of shockwave therapy on erectile dysfunction on patients responding to PDE5i therapy in a sham controlled randomized double blind manner.
详细描述
This study aims to evaluate the effect of a 12-session low intensity shockwave therapy protocol for patients with erectile dysfunction.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 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 ≥ 3 under PDE5i therapy
- •SHIM ≤21 under PDE5i therapy
- •Non- hormonal, neurological or psychological pathology
- •Stable heterosexual relationship for more than 3 months
排除标准
- •Prior prostatectomy surgery
- •Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
- •Clinically significant chronic hematological disease
- •Anti-androgens, oral or injectable androgens
- •Radiotherapy in pelvic region
研究组 & 干预措施
shock wave treatment
干预措施: "MEDISPEC" treatment probe (Device)
shock wave treatment
干预措施: "MEDISPEC" Low intensity shock waves (Device)
"MEDISPEC" Sham
"MEDISPEC" Probe does not deliver energy but creates same noise and sensation of active probe
干预措施: "MEDISPEC" Sham Probe (Device)
"MEDISPEC" Sham
"MEDISPEC" Probe does not deliver energy but creates same noise and sensation of active probe
干预措施: Sham (Device)
结局指标
主要结局
International Index of Erectile function- Erectile Function Domain
时间窗: At screening and 17 weeks later at last visit
An increase in score of 5points and above will be considered success.
次要结局
- Rigidity scale(At screening and 17 weeks later at last visit)
- Flow Mediated Dilatation Technique(At screening and 17 weeks later at last visit)