Randomized Control Trial of Low Intensity Shockwaves for the Treatment of Erectile Dysfunction. 12- Month Follow-Up of a Double-Blinded, Sham-Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- International Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores.
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the shockwave therapy to treat Erectile Dysfunction.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The patient must be able willing and able to provide informed consent.
- •The patient is a male between 30 and 70 years of age (inclusive).
- •The patient has erectile dysfunction (ED) based of IIEF scores.
- •The patient has been in a stable relationship for over 3 months prior to enrollment.
- •A minimum of 2 sexual attempts per month for at least one month prior to enrollment - as documented by International Index of Erectile Dysfunction (IIEF)
- •The patient is suffering from erectile dysfunction lasting for over 6 months and not more than 5 years as per history provided by patient.
- •IIEF-EF score between 16 and
- •Testosterone level 300-1000 ng/dL within 1 month prior to enrollment. A1C level ≤ 7% 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.
- •Evidence of venous leak.
- •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 Parkinson's disease which affects erectile function at the discretion of the investigator.
- •Psychiatric diagnosis or medications such as antidepressants, anxiolytic, antipsychotic that 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.
- •A1C level > 7% within 1 month prior to enrollment or history of Insulin dependent diabetes.
- •The patient is taking blood thinners and has an international normalized ratio >
- •Received shockwave treatment at least 6 months before enrollment.
研究组 & 干预措施
720 shockwave therapy Group
Participants in this group will receive a total of 5 daily sessions of shockwave therapy within a week. Each therapy session will consist of 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
干预措施: Shockwave therapy (Device)
Sham shockwave therapy
Participants in this group will receive a total of 5 daily sessions of sham shockwave therapy within a week. Sham therapy will be applied to the penis and to the left and right crus (shaft near the base).
干预措施: Sham shockwave therapy (Other)
结局指标
主要结局
International Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores.
时间窗: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
The IIEF-EF questionnaire has a total score ranging from 0 - 30 with the higher score indicating better erectile function.
次要结局
- Number of Participants Responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire(Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12)
- Erection Hardness Score (EHS)(Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12)
研究者
Ranjith Ramasamy, MD
Director of Male Fertility/ Andrology department
University of Miami