Extracorporeal Shockwave Therapy in the Treatment for Erectile Dysfunction in Male Renal Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changing in International Index of Erectile Function (IIEF-5) from baseline
研究概览
简要总结
The primary objective of this study is to determine the impact of the shock wave application in renal transplant patients with diagnosis of erectile dysfunction. Secondary objectives are to assess the effects of therapy on quality of life and depression.
It is expected that with the study is defined the usefulness of the therapy and the dissemination of knowledge generated for change in clinical management in renal transplant patients with erectile dysfunction.
详细描述
The Renal Transplant Unit, performs about 230 kidney transplants per year and has a screening service for registration of candidates for renal transplantation, interviewing about 70 patients a month. Since the potential and likely benefits of extracorporeal shock wave therapy in these patients as well as the anticipation of mild side effects, there is no reason for refusal to participate in the study.
Patients who meet the inclusion criteria will be divided into 2 groups using a randomization table created by computer. Patients will be followed for 2 years.
The study procedure and monitoring will be performed on an outpatient basis.
Patients are divided into a group of extracorporeal shockwave (ESWT) treatment and placebo in a ratio of 1: 1 using a table of random numbers generated by computer.
The ESWT protocol is protocol-based suggested by Vardi et al. 6. Patients will undergo a 2 treatment sessions per week for 3 weeks.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients between 40 and 70 years
- •Kidney transplant for at least 6 months
- •Erectile dysfunction (ED) for at least 6 months.
- •Patients with IIEF score <21
- •Functioning kidney graft.
排除标准
- •ED because of known endocrine disease (e.g., hypogonadism, hypothyroidism)
- •ED due to drug treatment (androgen deprivation therapy, for example)
- •ED due to neurological disease (spinal cord injury, for example)
- •ED due to structural abnormality of the penis
- •History of radical prostatectomy or other pelvic surgery
- •History of pelvic irradiation
- •penile implant
- •coagulopathies or on anticoagulants
结局指标
主要结局
Changing in International Index of Erectile Function (IIEF-5) from baseline
时间窗: 1 month, 3 months, 6 months, 1 year, 2 years
Changing in Erection Hardness score from baseline
时间窗: 1 month, 3 months, 6 months, 1 year, 2 years
Changing in The World Health Organization Quality of Life (WHOQOL) from baseline
时间窗: 1 month, 3 months, 6 months, 1 year, 2 years
Changing in Peak systolic velocity by Penile doppler ultrasonography
时间窗: baseline ( previous to treatment) and 3 months after treatment
次要结局
未报告次要终点
研究者
Kleiton Gabriel Ribeiro Yamaçake
MD
University of Sao Paulo