NCT02068417终止3 期
A Prospective, Randomised, Blinded, Placebo-controlled Pilot Study of the Treatment of Erectile Dysfunction With Extracorporeal Shockwave Therapy (ESWT)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Effects of erection problems on the sex life (International Index of Erectile Function (IIEF) Questionnaire)
研究概览
简要总结
The objective of the pilot study is to assess the feasibility of a full randomised, placebo-controlled clinical trial.The aim is to demonstrate that penile shockwave application in patients with erectile dysfunction of vascular origin leads to a greater increase in potency than in the control group.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Erectile dysfunction for more than 6 months
- •Informed consent
- •Positive effect of phosphodiesterase type 5 inhibitor (PDE5i)
- •IIEF-15 score less than 20
- •No neurological disease
- •Stable partnership for more than 3 months
- •Age 18-75
排除标准
- •Total prostatectomy
- •Another reason for ED except for vascular disorder
- •Clinically significant hematological disease
- •Heart stroke, Arrythmia during the last 6 months
- •Cancer during the last 5 years
- •Intake of antiandrogen
- •ED treatment with the last 7 days
- •IIEF score higher than, equal to 20
- •Previous shockwave treatment
结局指标
主要结局
Effects of erection problems on the sex life (International Index of Erectile Function (IIEF) Questionnaire)
时间窗: up to 6 months post treatment
次要结局
- Quality of erection (Quality of Erection Questionnaire)(At screening, 1, 3 and 6 months post treatment)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
4 期
A Pilot Trial Evaluating the Effect of Tropisetron on Postoperative Cognitive Dysfunction After Cardiac SurgeryPostoperative Cognitive DysfunctionPostoperative DeliriumNCT04195204Beijing Chao Yang Hospital72
已完成
2 期
Pilot Study of Rituximab for the Treatment of Acute Immune Thrombocytopenic Purpura (ITP)Purpura, Thrombocytopenic, IdiopathicNCT00372892Hamilton Health Sciences Corporation60
已完成
1 期
Trial of Early Noninvasive Ventilation for Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisNCT00580593University of Michigan60
撤回
1 期
Nitric Oxide During CPB to Reduce AKI in NeonatesCongenital Heart DiseaseAcute Kidney InjuryNCT03946462Fabio Savorgnan
已完成
1 期
Study Using Xolair in Rush Multi Oral Immunotherapy in Multi Food Allergic PatientsFood AllergyNCT02643862Stanford University48