Clinical Randomized Multicentric Trial to Evaluate the Comparative Effectiveness and Safety of Three Protocols Using Low-intensity Shock Waves for the Treatment of Erectile Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 277
- 试验地点
- 2
- 主要终点
- IIEF-EF score 6 months after completing the treatment
研究概览
简要总结
The patients with primary erectile dysfunction (IIEF-EF <26 points), will be randomly assigned to three shockwave treatment protocols: Protocol 1 six sessions, one per week; Protocol 2, six initial sessions, one per week, followed by monthly maintenance sessions (every 4 weeks) for five months; Protocol 3, six monthly sessions. The EHS and IIEF-EF scores will be compared as well as the possible adverse events from the therapy upon beginning and completing the treatment and at the 3-month and 6-month follow-ups. Self-esteem and quality of life will also be evaluated using the SEAR scale.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men over 18 years of age
- •Presence of ED for more than 3 months in over 50% of sexual intercourses.
- •Baseline ED domain score under 26 on the IIEF-15 EF domain.
- •Patient agrees to participate in the trial by providing signed informed consent.
排除标准
- •EHS score of
- •Patients with an INR over
- •Patients with sickle-cell anemia.
- •Patients with clinical suspicion of hypogonadism (AMS over 36).
- •Endocrine diseases that present with ED, such as acromegaly, gigantism, Addison's disease, hyperprolactinemia, androgen deficiency.
- •Active vesicular, prostrate or colon cancer.
- •Radical prostatectomy or other radical pelvic surgery.
- •History of pelvic radiation therapy.
- •Patients with ED of psychological origin.
- •Spinal cord injury or other neurological diseases associated with ED.
- •Anatomical penile dysfunction, penile implant.
- •Patients with active infections or lesions on the penis or pubic area.
- •Patients with ED secondary to drug therapy (antiandrogen therapy, alpha blockers for BPH, use of corticosteroids, medication for Parkinson's disease, antipsychotics).
- •Abuse of psychoactive substances.
研究组 & 干预措施
Protocol 1
Low-intensity extracorporeal shock wave therapy (Li-ESWT): Six sessions, one per week, with 3000 pulses at 0.20 mj/mm2, at a frequency of 4Hz. At all of the shockwave sessions, 2000 pulses will be distributed to the body of the penis and 1000 pulses will be applied to the base.
干预措施: Low-intensity extracorporeal shock wave therapy (Li-ESWT) (Other)
Protocol 2
Low-intensity extracorporeal shock wave therapy (Li-ESWT): Six initial sessions, one per week, with 3000 pulses at 0.20 mj/mm2, at a frequency of 4Hz for six weeks, followed by monthly maintenance sessions (every 4 weeks) for five months. At all of the shockwave sessions, 2000 pulses will be distributed to the body of the penis and 1000 pulses will be applied to the base.
干预措施: Low-intensity extracorporeal shock wave therapy (Li-ESWT) (Other)
Protocol 3
Low-intensity extracorporeal shock wave therapy (Li-ESWT): Six monthly sessions in which 3000 pulses will be applied at 0.20 mj/mm2, at a frequency of 4Hz, with 2000 pulses distributed to the body of the penis and 1000 pulses applied to the base
干预措施: Low-intensity extracorporeal shock wave therapy (Li-ESWT) (Other)
结局指标
主要结局
IIEF-EF score 6 months after completing the treatment
时间窗: 6 month follow-ups
This is a highly sensitive and specific scale for detecting changes in erectile function in response to treatment. The degree of dysfunction is scored on a range of 0 to 30 points on the Erectile Functioning domain (questions 1, 2, 3, 4, 5, 15). The categories are: severe between 0 and 10, moderate between 11 and 16, mild-to-moderate between 17 and 21, mild between 22 and 25, and no ED between 26 and 30.
次要结局
- Number of satisfactory relations(3-month and 6-month follow-ups)
- Erection Hardness Score(3-month and 6-month follow-ups)
- Clinical improvement(6-month follow-ups)