The Effect of Combination Therapy Using Li-ESWT (Low Intensity Extracorporeal Shockwave Therapy) and PDE-5 Inhibitor in Patients With Erectile Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Erectile Hardness Score (EHS)
研究概览
简要总结
to compare the effect of combination of li-eswt and pde-5 inhibitor to pde-5 alone in erectile dysfunction patients
详细描述
Comparing the effect of Combination therapy (Li-ESWT combined with PDE5-inhibitor) vs SIngle therapy (PDE5-inhibitor) in mild to moderate Erectile Dysfunction patients.
Parameters used for comparation are EHS score, IIEF-5 score, VEGF level and PSV
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
- 40 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Mild to Moderate Erectile dysfunction
- •Sexually active
- •Consenting to participate in the trial
排除标准
- •Psychological problems
- •Spinal injury
- •History of malignancy
- •Penile anatomy abnormalities
- •Allergic and Contraindications to tadalafil
- •On anti-mitotic drugs
研究组 & 干预措施
Combination therapy
Li-ESWT + tadalafil
干预措施: Li-ESWT (Procedure)
Combination therapy
Li-ESWT + tadalafil
干预措施: Tadalafil 2.5Mg Tab (Drug)
Single Therapy
tadalafil only
干预措施: Tadalafil 2.5Mg Tab (Drug)
结局指标
主要结局
Erectile Hardness Score (EHS)
时间窗: 4 weeks
Developed in 1998, the EHS is a single-item Likert scale that men can use on their own. The tool asks them to consider the question "How would you rate the hardness of your erection?" and select one of the following options: 0 Penis does not enlarge 1. Penis is larger, but not hard 2. Penis is hard, but not hard enough for penetration 3. Penis is hard enough for penetration, but not completely hard 4. Penis is completely hard and fully rigid The EHS score was taken pre and post intervention
International Index of Erectile Function (IIEF-5) score
时间窗: 4 weeks
IIEF-5 is a tool for ED (Erectile Dysfunction)diagnosis. The possible scores for the IIEF-5 range from 5 to 25, and ED was classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25) IIEF-5 score was taken pre and post intervention
Peak Systolic Velocity (PSV)
时间窗: 4 weeks
PSV was measured in cm/s, by using Doppler Ultrasonography. The probe is located at the penis, to be precise in the penoscrotal junction, to measure the velocity of the blood flow in the cavernous arteries. The test was done in flaccid state of the penis Measurement was taken by an experienced ultrasonographer in the radiology unit. Measurement was taken pre and post intervention
Vascular Endothelial Growth Factor (VEGF) level in plasma
时间窗: 4 weeks
VEGF was measured in pg/ml. VEGF test were done by blood test in the laboratory using the VEGF-A ELISA Kit. Blood for tests were drawn pre and post test
次要结局
未报告次要终点
研究者
Andrian, dr., Sp.And
Resident of Andrology Department, Principal Investigator, Medical Doctor
Dr. Soetomo General Hospital