Treatment of Peyronie's Disease With Platelet-Rich Plasma: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Platelet Concentration in the PRP
研究概览
简要总结
The purpose of this pilot study is to optimize a planned randomized, double-blind, placebo-controlled clinical trial evaluating the effects of Platelet-Rich Plasma (PRP) intralesional injections in men affected by Peyronie's disease (PD) in the fibrotic phase. The pilot study aims to identify potential challenges in the practical execution of the clinical trial, particularly regarding PRP preparation and the blinding process. Furthermore, it seeks to evaluate the effects of PRP injections.
详细描述
The study protocol is structured such that participants, after being informed about the project and providing consent, will attend a baseline visit where relevant data will be collected from the participant, questionnaires, the patient's medical record, and through an objective examination. Subsequently, participants will attend weekly injection sessions for 6 weeks, during which they will receive 3 PRP injections and 3 saline injections (placebo) in a randomized order. Three months after the final injection, participants will attend a follow-up visit, where the final data will be collected. Analysis will then be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The participant and the investigator/treating doctor will be masked. The syringes will be covered. Only the care provider who prepare the PRP will not be masked.
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
- •18 years or older
- •Be able to provide written informed consent
- •Diagnosis of PD without active pain and without progressive curvature over the past 3 months (fibrotic phase).
- •Penile curvature of 30-95 degrees
排除标准
- •Erectile Dysfunction unresponsive to on-demand PDE5 inhibitors
- •Hourglass malformation
- •Severely calcified plaques where injection is considered unfeasible
- •History of priapism.
- •History of penile fracture.
- •Previous treatment for PD with injections and/or surgery.
结局指标
主要结局
Platelet Concentration in the PRP
时间窗: The 6 week intervention period.
In the placebo sessions, the Platelet-Rich Plasma (PRP) sample (prepared using the Magellan Autologous Platelet Separator) will be sent for analysis of platelet concentration levels to ensure the quality of the PRP.
Evaluation of the Blinding Process
时间窗: The 6 week intervention period.
After each injection, both the administering physician and the participant will be asked to state whether they believe the injection contained PRP or saline. They will also be asked to justify their response, which will allow for adjustments to the practical implementation of the blinding process in the Randomized Controlled Trial (RCT), if necessary.
次要结局
- Adverse Events(From the first injection to the 3 months post intervention follow-up.)
- Degree Changes in Penile Curvature.(From enrollment to 3 months post intervention.)
- Changes in Plaque Size(From enrollment to 3 months post intervention.)
- Changes in the Peyronie's Disease Questionnaire (PDQ)(From enrollment to 3 months post intervention.)
- Changes in the Erection Hardness Score (EHS)(From enrollment to 3 months post intervention.)
- Changes in the Major Depression Inventory (MDI)(From enrollment to 3 months post intervention.)
- The Ability to Engage in Sexual Intercourse (question)(From enrollment to 3 months post intervention.)
- Preference for Surgical Intervention (question)(From enrollment to 3 months post intervention.)
- Satisfaction(From enrollment to 3 months post intervention.)
研究者
Mikael Heering
Medical Doctor, Clinical Assistant
Herlev Hospital