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
- 入组人数
- 20
- 试验地点
- 2
- 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. On screening patients will undergo evaluation by thorough medical history and by questionnaires for evaluation of sexual function. A one-month active treatment with PDE5i will be provided followed by re-evaluation using the same questionnaires. Then another one-month period without PDE5i medication (washout period ) will be done and finally on the following visit evaluation will include the same questionnaires and if fit for inclusion- additional objective evaluation of endothelial function using the Flow mediated dilatation technique and penile blood flow measurement by doppler ultrasound of the Penis will be performed. At the end of this screening pahse the first shock wave session will be performed. Altogether 12 treatment sessions will be performed - 6 treatments twice a week followed by a 3 week no-treatment interval and again 6 treatments twice a week. Follow-up which will include the same evaluation as in the first treatment visit will be performed one month after end of treatment
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
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)