Effects of Low-intensity Shockwave Therapy Versus Kegel Exercises on Arteriogenic Erectile Dysfunction in Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Penile color-coded Duplex scanning
研究概览
简要总结
- To assess the effectiveness of low-intensity shockwave therapy (Li-ESWT) in the management of Arteriogenic erectile dysfunction in diabetic patients.
- To assess the effectiveness of Kegel Exercises in the management of Arteriogenic erectile dysfunction in diabetic patients.
- To compare the effectiveness of Li-ESWT and Kegel Exercises in the management of Arteriogenic erectile dysfunction in diabetic patients.
详细描述
Erectile dysfunction is defined as the persistent inability to attain and maintain an erection enough to permit satisfactory sexual performance. Although ED is a benign disorder, it may affect physical and psychosocial health and may have a significant impact on the quality of life of sufferers and their partners.
According to the underlying causes, ED can be classified as psychogenic, endocrinologic, neurogenic, and vasculogenic. Vasculogenic erectile dysfunction is defined as an inability to get or keep an erection firm enough for sexual intercourse due to diseases such as diabetes mellitus and atherosclerotic vascular occlusive disease .
ED has been reported to occur in ≥50% of men with DM worldwide. It is usually present within 10 years of diagnosis of DM. The incidence of ED was reported to be higher in men with DM than for men without DM and up to 12% of men who present with ED were found to have previously undiagnosed DM.
Low-intensity extracorporeal shock wave therapy (Li-ESWT) was used in both in vitro and in vivo studies and the results showed that this energy can stimulate angiogenesis. The idea of applying Li-ESWT to the penis came from animal studies in which Li-ESWT was applied to the myocardium of pigs, where it has been reported that there was an improvement in ischemia-induced myocardial dysfunction.
Low-intensity extracorporeal SW therapy (Li-ESWT) of the penis would improve penile blood flow and endothelial function by stimulating angiogenesis in the corpora.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Ninety married men were diagnosed with T2DM participated in this study.
- •The patients complained from arteriogenic ED > 6 months (Reisman et al., 2015) before the participation in this study
- •All patients aged between 35-55 years old.
- •Glycated hemoglobin (HbA1c) less than 9%.
- •Body mass index of the patients was < 30 Kg/m2.
排除标准
- •Alcohol-abuse, illegal drug consumer patients.
- •Patients with cardiac diseases that prevent or affect sexual activity (heart attack, stroke, heart failure, myocardial infarction life-threatening, arrhythmia, etc within the previous 6 months).
- •Patients with any pulmonary, liver, or kidney diseases.
- •Patients with neurological insults, spinal cord injuries, stroke, polyneuropathy, etc.
- •Patients with diagnosed psychiatric/mental complaints.
- •Patients with blood pressure of more than 140/90 mmHg.
- •Patients with peripheral vascular disease.
- •Patients with venogenic ED.
- •Patients with past radical prostatectomy, extensive pelvic surgery, or previous pelvic trauma.
- •Patients recovering from cancer in the past 5 years
- •Penile anatomical abnormalities.
- •Patients with clinically significant chronic hematological disease.
- •Patients who received Anti-androgens or radiotherapy treatment of pelvic region.
- •Patients with untreated hypogonadism.
- •Patients with psychogenic ED (normal nocturnal penile tumescence parameters)
- •Patient with penile prosthesis
研究组 & 干预措施
Low-intensity Shockwave Therapy
patients will receive 6 sessions, once per week of low-intensity extracorporeal shock wave with the following parameters: - 3000 SWs (energy intensity of 0.09 mJ/mm2) to each of five different sites: three along the penile shaft and two at the crural level plus Sildenafil 25mg of daily dose and 50mg on-demand dose one hour before intercourse for 6 weeks.
干预措施: Low-intensity Shockwave Therapy (Device)
Kegel Exercises
kegel exercises plus sildenafil 25mg of daily dose and 50mg on-demand dose one hour before intercourse for 6 weeks.
干预措施: Kegel Exercises (Other)
control group
结局指标
主要结局
Penile color-coded Duplex scanning
时间窗: baseline
for exclusion of psychogenic and venogenic erectile dysfunction (ED) and confirm arteriogenic ED. It will be used at baseline and post-intervention.
International Index of Erectile Function (IIEF-EF) questionnaire
时间窗: baseline
At baseline and post-intervention, patients will be assessed and scored according to the five-item version of the International Index of Erectile Function (IIEF-5), which consists of five questions. Its score ranges from 1 to 25 and classifies ED severity with the following breakpoints: severe (1-7/25), moderate (8-11/25), mild to moderate (12-16/25), mild (17-21/25), and no ED (22-25/25)
次要结局
未报告次要终点
研究者
Elsayed Hassan Elsayed Abosteit
Principal Investigator
Cairo University