Safety and Efficacy of Low Intensity Shockwaves for the Treatment of Erectile Dysfunction - Comparison of Two Treatment Schedules
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- International Index of Erectile Function (IIEF-EF) Questionnaire
研究概览
简要总结
MoreNovaED is a Linear Shockwaves (LISW) device in which shockwaves are focused onto line segments for improved organ coverage. Shockwaves produced by MoreNovaED are aimed at the left and right corpora cavernosa and the crura. The study is aimed at determining the safety and effectiveness of this new type LISW in the relief of ED.
详细描述
Morenova-Erectile dysfunction (ED) is a Linear Shockwaves (LISW) device which incorporates a unique shockwave transducer operable to deliver shockwaves to a treated region confined to a narrow rectangle. Shockwaves generation follows the electromagnetic principle. Low intensity shockwaves do not inflict pain and anesthesia or sedation is not required.
This current study is a prospective, pilot, randomized, uncontrolled clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on symptomatic ED patients. The patients are randomized in a 1:1 ratio into active treatment groups.
Rationale:Linear Shockwaves has been known to bolster angiogenesis by increasing the levels of vascular endothelial growth factor.
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
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The patient has been correctly informed about the study
- •The patient must have given his informed and signed consent
- •The patient is a man between 40 and 80 years of age
- •The patient has ED of Vasculogenic origin
- •The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
- •The patient has been in a stable heterosexual relationship for over 3 months prior to enrollment
- •A minimum of 2 sexual attempts per month for at least one month prior to enrollment
- •The patient is suffering from erectile dysfunction lasting for over 6 months and not more than 5 years
- •IIEF-EF score between 17 and 25
- •Testosterone level 300-1000 ng/dL within 1 month prior to enrollment
- •A1C level ≤ 7% within 1 month prior to enrollment
- •Patients have at least a natural tumescence during sexual stimulation (EHS score ≥ 1).
排除标准
- •The patient is participating in another study that may interfere with the results or conclusions of this study
- •Within the past three months, the patient has participated in another study that may interfere with the results or conclusions of this study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection
- •The patient is an adult under guardianship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •History of radical prostatectomy or extensive pelvic surgery
- •Venous leak
- •Past radiation therapy of the pelvic region within 12 months prior to enrollment
- •Recovering from cancer within 12 months prior to enrollment
- •Neurological disease which effects erectile function
- •Psychiatric disease which effects erectile function
- •Anatomical malformation of the penis, including Peyronie's disease
- •Testosterone level <300 or >1000 ng/dL within 1 month prior to enrollment
- •A1C level > 7% within 1 month prior to enrollment
- •The patient is taking blood thinners and has an international normalized ratio >3.
研究组 & 干预措施
720 Low Intensity shockwave therapy
Five daily sessions within a week, Monday thru Friday, in which 720 shocks of treatment energy applied every session to each treated region (left and right corpora cavernosa and crura)
干预措施: Low Intensity Linear Shockwave Device for the treatment of Erectile Dysfunction (Device)
600 Low Intensity shockwaves therapy
Three weekly sessions for 2 consecutive weeks, Monday-Wednesday-Friday, in which 600 shocks of treatment energy applied every session to each treated region (left and right corpora cavernosa and crura)
Following the last treatment session, each patient will resume his baseline consumption of phosphodiesterase 5 inhibitor in terms of type and dose of drug, for the remainder of study duration.
干预措施: Low Intensity Linear Shockwave Device for the treatment of Erectile Dysfunction (Device)
结局指标
主要结局
International Index of Erectile Function (IIEF-EF) Questionnaire
时间窗: 7 months
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials
次要结局
- EHS (Erection Hardness Score) at follow-ups(7 months)
- SEP (Sexual Encounter Profile) 2 & 3 at follow-ups(7 months)
- GAQ (Global Assessment Questions) at follow-ups(7 months)
研究者
Ryan Smith, MD
Assistant Professor of Urology
University of Virginia