Changes in Penile Firmness With Low-Intensity Shockwave Therapy (LiST)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Evaluate changes in corporal cavernosal firmness with Low-Intensity Acoustic Shockwave Therapy (LiST)
研究概览
简要总结
Patients presenting with erectile dysfunction are often found to have increased corporal firmness on elastography. We hypothesize that this corporal firmness reflects reversable changes that can be altered by Low-Intensity Shockwave Therapy (LiST). In this pilot study patients found to have increased corporal firmness will be treated with LiST.
详细描述
This study will enroll men between the ages of 18 and 65 with corporal cavernosal firmness on elastography. The participants study duration is 3 months long and includes eight visits at the study center. Study visits consist of physical exam, vital signs, questionnaires, blood draws, and administration of low-intensity shockware therapy (LiST).
Low intensity extracorporeal (i.e., outside the body) shockwave therapy (LiST) is a treatment that has been in use since 2010 and has become commonly used Internationally and in the United States since 2015. The device applies a low-intensity shockwave to the surface of the penis using an ultrasound gel as the coupling agent.
The study will evaluate changes in corporal cavernosal firmness and changes in penile vascular blood flow.
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 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Men aged 18-64
- •Sexually active men and evidence of increased firmness on elastography during their standard evaluation for erectile dysfunction.
排除标准
- •Within two weeks of Visit 1 using erectogenic medications including PDE5 inhibitors and/or penile injection therapy
- •Presence of a penile implant.
- •Presence of cardiac pacemaker or defibrillator
- •Patients who are using devices which are sensitive to electromagnetic radiation.
- •Screening ultrasound positive for testicular cancer
- •Presence of untreated prostate cancer
- •Patients with severe coagulation disorders
- •Patient that in the opinion of the Principal Investigator would be non-compliant with the study
结局指标
主要结局
Evaluate changes in corporal cavernosal firmness with Low-Intensity Acoustic Shockwave Therapy (LiST)
时间窗: 12 Weeks
Change in corporal firmness (KPa) with Low-Intensity Acoustic Shockwave Therapy (LiST)
次要结局
未报告次要终点