Safety and Efficacy of Low Intensity Shockwave for the Treatment of Erectile Dysfunction- Comparison of Two Treatment Schedule
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- International Index of Erectile Function (IIEF-EF) Questionnaire
研究概览
简要总结
Renova- Erectile Dysfunction (ED) is a Linear Shockwaves (LISW) device which incorporates a unique shockwave transducer operable to deliver shockwaves to a treated region. Shockwaves 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 erectile dysfunction.
HYPOTHESIS Alternate Hypothesis (HA): Active Treatment groups will show a >2-point increase in the IIEF-EF score from baseline for mild erectile dysfunction, and >5 points for moderate erectile dysfunction and will show significant change.
Null Hypothesis (HO): There is no difference from baseline and after-treatment in Treatment groups for alleviating erectile dysfunction measured using International Index of Erectile Function score (IIEF-EF).
Primary Efficacy Objective: To evaluate change of International Index of Erectile Function score Questionnaire score from baseline to follow-ups 1, 3 and 6 months' post treatment.
Secondary Objectives:To study sexual activity improvement leading to optimal penetration at follow-ups according to:
- SEP- Sexual Encounter Profile Questionnaire.
- GAQ- Global Assessment Questionnaire.
- EHS- Erection Hardness Score.
详细描述
Renova-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.
Linear Shockwaves (LISW), as a treatment for erectile dysfunction has been in evaluation in contemporary medicine, It has been in use for the last three years.
The present study is about a device called "Renova-erectile dysfunction", in which shockwaves are focused onto line segments for improved organ coverage. Shockwaves produced by "Renova-erectile dysfunction" 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 erectile dysfunction.
Rationale:Linear Shockwaves has been known to bolster angiogenesis by increasing the levels of vascular endothelial growth factor.
Principal mode of action used in other disease:
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The patient must be willing and able to provide informed consent.
- •The patient is a male between >30 and <80 years of age.
- •PDE5i responsive or non-responsive. If on PDE5i patient will discontinue medication for 4 weeks before IIEF.
- •Stable sexual relationship for over 3 months prior to enrollment.
- •A minimum of 2 sexual attempts per month for at least one month prior to enrollment.
- •Erectile dysfunction lasting for over 6 months and not more than 5 years.
- •Baseline IIEF-EF score between 11 and
- •If taking PDE5i, stop medication for at least 4 weeks before baseline IIEF-EF.
- •Testosterone level 300-1000 ng/dL.
- •If diabetic, HgbA1C level ≤ 7.5% within 1 month prior to enrollment.
排除标准
- •The patient is currently or has participated in another study within the past three months, that may interfere with the results or conclusions of this study.
- •The patient is under judicial protection (prison or custody).
- •The patient is an adult under guardianship.
- •The patient refuses to sign the consent.
- •History of radical prostatectomy or extensive pelvic surgery ever.
- •Past radiation therapy of the pelvic region within 12 months prior to enrollment.
- •Recovering from any cancer within 12 months prior to enrollment.
- •Neurological disease such as Alzheimers or Parkinsons disease which affects erectile function at the discretion of the investigator.
- •Psychiatric diagnosis or medications such as antidepressants which affects erectile function or any other medications at the discretion of the investigator.
- •Anatomical malformation of the penis, including Peyronie's disease.
- •Testosterone level <300 or >1000 ng/dL within 1 month prior to enrollment.
- •HgbA1C level > 7.5% within 1 month prior to enrollment.
- •Androgen deprivation treatment in the last year.
- •History of spinal cord injury.
- •The patient is taking blood thinners (eg Coumadin, Plavix)
研究组 & 干预措施
720 shockwave therapy
5 daily sessions of shockwave therapy within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in 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 shockwave therapy
Three sessions of shockwave therapy per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in 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
IIEF is a 15 item self-administered questionnaire assessing erectile dysfunction and treatment outcomes. Total IIEF score range from 5-25 with scores classifying erectile dysfunction (ED) as: severe (5-7); moderate (8-11); mild to moderate (12-16); mild (17-21) and no ED (22-25). The questionnaire will be assessed at baseline (before 1 month washout prior to treatment initiation), 1 month follow up (at 2 months), 3 month follow up (at 4 months) and 6 months follow up (at 7 months). Time Frame: 7 months
次要结局
- Erection Hardness Score (EHS)(7 months)
- Global Assessment Question (GAQ)(7 months)
- Sexual Encounter Profile (SEP)(7 months)
研究者
Ranjith Ramasamy, MD
Urologist/ Director of Male Reproductive Medicine/ Assistant professor Urology Department University of Miami
University of Miami