Effect of Extracorporeal Shock Wave Therapy (ESWT) on Erectile Dysfunction in Type 2 Diabetes Mellitus Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- the Five-Version of International Index of Erectile function
研究概览
简要总结
Diabetes mellitus (DM) is known not only for its widespread prevalence, but also for its significant complications including cerebrovascular disease, coronary artery disease, renal failure, vision loss, and neuropathy. Of particular importance to sexual medicine, diabetes has also been strongly associated with erectile dysfunction (ED).ED is defined as the inability to obtain and/or maintain the erection firm enough to achieve a successful sexual intercourse on a regular basis. It is a more common condition in males with type 2 DM. In the field of sexual medicine numerous studies have shown that extracorporal shock wave therapy (ESWT) is safe, noninvasive, and, most importantly, an effective method for treating vascular ED
详细描述
ED in DM is often complex and caused by several mechanisms including vascular disease, autonomic neuropathy, hormonal imbalance, and psychogenic factors. However, as the endothelial dysfunction is an important factor contributing to the development of ED in diabetic patients, such patients can be resistant to phosphodiesterase 5 inhibitors (PDE5I) like sildenafil therapy. There are reports of lower efficacy of sildenafil in DM patients compared to general population.In the field of sexual medicine numerous studies have shown that ESWT is safe, noninvasive, and, most importantly, an effective method for treating vascular ED
Before starting the study, clearance will be obtained from the institutional ethical committee and prior informed consent of all the participants will be obtained before conducting the study. Patients will be recruited from outpatient clinic of andrology (Cairo University Hospitals). The patients were randomly divided into two equal groups:
Group (1): (Study group): Men in this group (n= 20) men receive extracorporeal shock wave (ESWT) twice weekly for 3 consecutive weeks and repeated after a 3-week rest period, for a total of 12 treatment sessions+sildenafil 5mg) Group (2): (Control group):) will receive sham treatment underwent identical therapy with ESWT application with a similar appearance and sound as the active low intensity ESWT+sildenafil 5mg
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Forty married diabetic type 2 men with mild and moderate ED score (21-8) on Five-Item Version of the International Index of Erectile Function.
- •Patients who will have erectile dysfunction ( ED) from 6 months.
- •Patients with diabetes mellitus ( DM )duration ≥ 5 years with fasting blood glucose level of ≥ 126 mg/dl and glycosalyated haemoglobin (HbA1c ) ≥ 6.5% mg dl.
- •Body mass index ( BMI) will be < 30 kg/m²
- •The age of patients will be between 40- 60 years.
排除标准
- •History of pelvic trauma, pelvic surgery, psychiatric disease.
- •Patients with neuromuscular disorders, cardiovascular or pulmonary problems and spinal cord injuries.
- •Vascular surgical intervention that recommended for the patients.
- •Other renal conditions, respiratory disease, liver failure.
- •Prostatectomy and patients with prostatic disease.
- •Patients lacking complete follow-up data.
- •hypogonadism.
结局指标
主要结局
the Five-Version of International Index of Erectile function
时间窗: 6 months after last treatment session
Each patient will self- administrated the Arabic translated five- Item Version of International Index of Erectile Function (IIEF-5) (in which every patient in both groups will be asked about erectile dysfunction (ED) over their last four weeks). The procedure of IIEF-5 conducted in the following steps: 1. The patient will be asked to answer each item by choosing an answer from the five answers of each five items 2. The number opposite to each answer from the five answers will be determined 3. The final number obtained by the sum of the ordinal responses to the five items. 4. The improvement of erectile dysfunction will be detected according ED severity classification: no ED (score 25-22) mild ED (score 21-17), mild to moderate ED (score 16-12), moderate ED (score 11-8) and severe ED (score 7-1). 5. Measurements will be done before initial session in both groups. Follow up will be after the sixth treatment and at 1, 3, 6 months in both groups.
次要结局
未报告次要终点
研究者
Al Shaymaa Shaaban Abd El Azeim
Principal Investigator
Cairo University