Efficacy and Safety of Focused Shockwave Therapy Plus Tadalafil vs Tadalafil Alone in Patient With Erectile Dysfunction: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- IIEF-5
研究概览
简要总结
The goal of this trial is that using tadalafil plus low-intensity extracorporeal shockwave therapy (li-ESWT) is more effective than using tadalafil alone in improving erection rigidity and sexual function. The efficacy of the combination of li-ESWT and tadalafil has been confirmed by a number of studies, including in patients after radical prostatectomy. However, this method is still not a "first-line" method in young primary patients and its benefits in combination with drugs for these patients are not obvious.
The investigators assume that the combination of tadalafil plus low-intensity extracorporeal shockwave therapy (li-ESWT) will improve the subjective state of patients assessed by points of validated questionnaires and Number of successful intercourse per week.
详细描述
The aim of the study is to test the hypothesis that using tadalafil plus shockwave in primary patient with ED treatment in more effective in improving erection rigidity and sexual function, then using tadalafil alone.
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
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 20 to 45;
- •Married or have had a permanent sex partner for at least 3 months;
- •IIEF-5 questionnaire scores below 20
排除标准
- •History of previous use of PDE-5 inhibitors or fSWT;
- •Patients with diabetes mellitus;
- •Patients after the radical prostatectomy or major pelvic surgery;
- •Patients with a confirmed neurological disease that may have caused the ED (Multiple Sclerosis, Parkinson's Disease, spinal cord injury);
- •Patients with contraindications to the use of PDE-5 inhibitors and/or fSWT;
研究组 & 干预措施
Combination group
PDE5 inhibitor tadalafil in dosage 5 mg daily by 1 month plus Device BTL-6000 fSWT: 6 sessions with EFD 0,09 mJ/mm2 by 5000 impulses per session in 5 points in corpora cavernosa penis
干预措施: PDE5 inhibitor (tadalafil) (Drug)
Medication group
PDE5 inhibitor tadalafil in dosage 5 mg daily by 1 month
干预措施: PDE5 inhibitor (tadalafil) (Drug)
Combination group
PDE5 inhibitor tadalafil in dosage 5 mg daily by 1 month plus Device BTL-6000 fSWT: 6 sessions with EFD 0,09 mJ/mm2 by 5000 impulses per session in 5 points in corpora cavernosa penis
干预措施: PDE5 inhibitor (tadalafil) and BTL-6000 fSWT (Combination Product)
结局指标
主要结局
IIEF-5
时间窗: 60 days
IIEF-5 (International Index of Erectile Function-5) is validated erectile function assessment questionnaire. The possible scores for the IIEF-5 range from 5 to 25, with lower values representing poorer sexual function.
次要结局
- PGI-I(14 days,30 days, 60days.)
- Likert scale (7-point preferably) satisfaction questionnaire(14 days,30 days, 60days.)
- Therapy comfort survey(14 days,30 days, 60days.)
- Number of successful intercourse per week(14 days,30 days, 60days.)
研究者
Gleb Kovalev
The head of outpatient urology department, phD
Saint Petersburg State University, Russia