Impact of Focused Low-intensity Shockwave Therapy (LiSWT) in Penile Disorders (Peyronie's Disease, Erectile Dysfunction, or Both), With or Without Intralesional Clostridial Collagenase (Xiaflex) Injection, Compared With Radial Shock Wave Therapy or Xiaflex Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 试验地点
- 1
- 主要终点
- Change in penile curvature
研究概览
简要总结
The purpose of this research is to determine the pure or additional effects of penile shockwave therapy with low intensity linear shock wave machine for penile curvature (and/or erectile dysfunction) vs patients' undergoing other treatments (including Xiaflex therapy, patients that have undergone older generations of SWT, or medical treatment).
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Peyronie's Disease (PD) at any stage
- •The presence of penile plaque or pain at erection or curvature
- •PD therapy with or without simultaneous intralesional Xiaflex injection.
排除标准
- •Prior penile surgery or LiSWT.
- •Erective Dysfunction (ED) not responding to phosphodiesterase-type five inhibitors or intracavernosal injections.
- •Unwillingness or inability to provide informed consent.
- •Having active or life-threatening coagulopathies ore using anti-coagulation /anti-platelet medications
研究组 & 干预措施
Collagenase Clostridium Histolyticum with LiSWT for PD Group
Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection with focused low-intensity shockwave therapy (LiSWT).
干预措施: Collagenase Clostridium Histolyticum (Drug)
Collagenase Clostridium Histolyticum with LiSWT for PD Group
Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection with focused low-intensity shockwave therapy (LiSWT).
干预措施: Duolith SD1 T-TOP (Device)
Collagenase Clostridium Histolyticum for PD Group
Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection
干预措施: Collagenase Clostridium Histolyticum (Drug)
Radial Shockwave Therapy for ED Group
Subjects being treated for erectile dysfunction (ED) will have radial shockwave therapy.
干预措施: Duolith SD1 T-TOP (Device)
Linear Shockwave Therapy for ED Group
Subjects being treated for erectile dysfunction (ED) will have linear shockwave therapy
干预措施: Duolith SD1 T-TOP (Device)
结局指标
主要结局
Change in penile curvature
时间窗: Baseline, 10 weeks
Measured with a goniometer after artificial erection reported in degree unit of measurements
次要结局
- Change in penile length(Baseline, 10 weeks)
- Change in Sexual function(Baseline, 10 weeks)
- Li-SWL related pain at therapy sessions(6 weeks)
研究者
Tobias S. Kohler, MD, MPH
Principal Investigator
Mayo Clinic