Low-Intensity Extracorporeal Shock Wave Therapy for the Treatment of Vasculogenic Erectile Dysfunction
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Changes in the mean of the International Index of Erectile Function ED Domain ("IIEF-ED") scores, in the absence of severe adverse events.
研究概览
简要总结
This study aims to evaluate the safety and efficacy of low-intensity extracorporeal shock wave therapy utilizing the Dornier Aries in the treatment of erectile dysfunction of vasculogenic origin.
详细描述
An increasing number of men are suffering from the effects of Erectile Dysfunction (ED) each year. The development of oral therapies (phosphodiesterase 5 inhibitors) has been successful for many with the disease. However, these drugs may be contraindicated in patients with cardiovascular risk factors (which are often predecessors to developing ED) and are often ineffective in patients with other comorbid conditions, such as diabetes mellitus. The main objective of this study is to determine the safety and efficacy of low-intensity extracorporeal shock wave therapy using the Dornier Aries in the treatment of erectile dysfunction of vasculogenic origin.
This protocol allows for treatment of 23 men with 21-75 years of age with vasculogenic erectile dysfunction of at least 6 months' duration with low intensity extracorporeal shock wave therapy utilizing the Dornier Aries device.
This protocol includes the application of 5000 shockwaves per session in 5 treatment areas with 1000 SW each at energy level 4-5 (energy flux density (0.051-0.062 mJ/mm²), while moving the applicator along the penile shaft within the treatment areas. The maximum energy applied during this treatment would be 23.35J.
Conversely, the treatment protocol described within is designed to actually restore penile function as a disease-modifying therapy, and is not expected to require a maintenance regimen or continued treatments, as previous studies have demonstrated retained benefits at six months after the end of treatments.
Dornier MedTech hired an independent party to monitor data and perform internal audits to ensure the precision, quality, and integrity of the data collected. The investigator(s) agrees to permit access to study records, source data, and source documents for this purpose.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 21 - 75 years
- •Presence of Erectile Dysfunction for at least 6 months
- •Having some response to a PDE5i or injection therapy (ICI) without penile scarring
- •Vasculogenic ED
- •IIEF-ED score ≥11 up to ≤25 while taking PDE5i or on ICI
- •In a stable heterosexual relationship of more than three months' duration
- •Agree to suspend all ED therapy for duration of study
- •Agree to maintain their normal sexual habits
- •Consent to participate
排除标准
- •Radical prostatectomy
- •Previous radiation therapy to pelvis
- •Previous stem cell or platelet rich plasma therapy
- •Previous pelvic surgeries
- •Untreated Hypogonadism or thyroid disease
- •Hormone usage, other than testosterone, clomiphene or thyroid medication
- •Illicit drug usage as demonstrated in the drug screen
- •Psychogenic ED
- •Peyronie's Disease or penile curvature that negatively influences sexual activity
- •Current anticoagulation therapy or significant hematological conditions
结局指标
主要结局
Changes in the mean of the International Index of Erectile Function ED Domain ("IIEF-ED") scores, in the absence of severe adverse events.
时间窗: 1 month and 3 months
Changes in the mean of the International Index of Erectile Function ED Domain ("IIEF-ED") scores, in the absence of severe adverse events. Higher scores indicate improved functionality according to the minimal clinically important difference (MCID) in erectile function from Rosen et al. 2011.
次要结局
- Changes in penile corporal fibrosis(1 month, 3 months)
- Changing in Erection Hardness score (EHS)(1 month, 3 months)
- Changes in mean scores of the entire IIEF(1 month, 3 months)
- Changes in penile base and tip rigidity(3 months)
- Changes in penile cavernosal artery peak systolic velocity (PSV) in [cm/s] by Penile doppler ultrasonography(3 months)
- Changes in mean scores of the SEP(1 month, 3 months)
- Changes in mean scores of the GAQ(1 month, 3 months)