A Prospective Randomized Double Blinded Placebo Controlled Clinical Trial Evaluating the Combined Effect of Low-Intensity Extracorporeal Shockwave Therapy (LI-ESWT) and Vacuum Erectile Device Combined With Manipulation Exercises on Peyronies Disease.
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in penile curvature
研究概览
简要总结
Aim The primary aim is to examine whether LI-ESWT and vacuum erectile device (VED) followed by manipulation exercises has beneficial effect on PD patients compared to a placebo group.
Primary Outcome
- Peyronie's Disease Questionnaire (PDQ)
- Visual Analogue Scale score (VAS)
- International Index of Erectile Function 5 (IEFF-5)
- Penile curve measurements (gold standard) on pictures before and after treatment
- Plaque size
Method This study is designed as a prospective, randomized, double-blinded, placebo-controlled with follow-up after 1, 3 and 6 months.
A total of 50 participants who meets the inclusion criteria's will randomly be assigned to I(intervention) or C(control) group based on a randomization list which is retained in a sealed envelope. The content of the envelope is only familiar to the Head of the Department of Urology to ensure valid randomization.
All treatment sessions are executed at the outpatient clinic of the department of urology department L at Odense University Hospital(OUH). All patients receive treatment with the same device a Duolith® SD1 T-Top from Storz Medical. However, when treating patients in the control group the handpiece will be covered by a shockwave absorbent material. Settings and setup are identical in both groups to make sure that patients are unable to acknowledge which treatment is being performed.
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
- Double (Participant, Investigator)
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
- •PD for more than 6 months
- •Penile curve greater than 30 degrees and less than 90 degrees
- •Age 18-80
- •No previous penile surgery
- •Informed consent
- •Able to speak and understand Danish
排除标准
- •Penile curve greater than 90 degrees
- •Previous surgery for PD
- •Patients undergoing other interventions for PD
研究组 & 干预措施
Intervention
Active shockwaves
干预措施: low-intensity extracorporeal shockwave therapy (Device)
Intervention
Active shockwaves
干预措施: Penile pump (Device)
Placebo
Placebo shockwaves
干预措施: Placebo LI-ESWT (Device)
Placebo
Placebo shockwaves
干预措施: Penile pump (Device)
结局指标
主要结局
Change in penile curvature
时间窗: penile curve will be assessed at baseline, and 1,3 and 6 months.
Change in penile curvature from baseline to follow-up at 1,3 and 6 months. Penile curvature is measured on pictures submitted by the patient.
次要结局
- Change in pain score using the Visual Analogue Scale (VAS)(VAS will be assessed at baseline, and 1,3 and 6 months.)
- Change in Erectile function using the International Index of Erectile Function 5 (IIEF-5).(IIEF-5 will be assessed at baseline, and 1,3 and 6 months.)
- Change in Peyronies disease questionnaire score(Peyronies disease questionnaire will be assessed at baseline, and 1,3 and 6 months.)
研究者
Lars Lund,MD
Professor
Odense University Hospital