Early Extracorporeal Shockwave Therapy for Erectile Dysfunction in Radically Prostatectomised Men.
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- IIEF-5 Score 3
研究概览
简要总结
The purpose of this project is to assess the relationship between low intensity shock wave treatment (LI-SWT) and erectile function (ED) in patients who have undergone radical prostatectomy (RP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Sham LI-ESWT treatment.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Radically prostatectomised men
- •Non nerve-sparing or nerve-sparing RP.
- •Age 20-80 years
- •Have been in a relationship for more than 3 months.
- •Sexually active
- •Patient can give informed consent.
排除标准
- •Men with ED of neuropathological or psychogenic origin
- •Rectal extirpation, radiation therapy to the pelvic area and recovery from any other cancer within the past 5 years are excluded.
- •Patients with heart disease prohibiting sexual activity or taking medication with antiandrogens, anticoagulant (apart from aspirin) or systemic use of glucocorticoids within 5 weeks.
研究组 & 干预措施
Active LI-ESWT
Active group receives five sessions of low intensity extracorporeal shockwave treatment, once per week for five consecutive weeks. Treatment is initiated three weeks after radical prostatectomy and is given using DUOLITH® SD1 manufactured by STORZ MEDICAL AG.
干预措施: Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) (Device)
Sham
Sham group receives five sessions of sham low intensity extracorporeal shockwave treatment, once per week for five consecutive weeks. Treatment is initiated three weeks after radical prostatectomy and is given using DUOLITH® SD1 manufactured by STORZ MEDICAL AG with a shockwave absorbing adapter.
干预措施: Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) (Device)
结局指标
主要结局
IIEF-5 Score 3
时间窗: Three months after final treatment session
Change in International Index of Erectile Function (IIEF-5) score compared to baseline
IIEF-5 Score 6
时间窗: Six months after final treatment session
Change in International Index of Erectile Function (IIEF-5) score compared to baseline
IIEF-5 Score 1
时间窗: One month after final treatment session
Change in International Index of Erectile Function (IIEF-5) score compared to baseline
次要结局
- RigiScan(One month after final treatment session)
- EDITS(One month after final treatment session)
- EHS 6(Six months after final treatment session)
- EHS 1(One month after final treatment session)
- EHS 3(Three months after final treatment session)
研究者
Lars Lund,MD
Professor
Odense University Hospital