Treatment of Peyronie's Disease With Platelet-Rich Plasma: A Randomized, Double-blind, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Degree Changes in Penile Curvature.
研究概览
简要总结
The purpose of this clinical trial is to evaluate the effects of Platelet-Rich Plasma (PRP) intralesional injections in men affected by Peyronie's disease (PD) in the fibrotic phase.
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. A total of 84 patients with Peyronie's disease will be included. Participants will be stratified based on the degree of penile curvature at baseline (30-60 degrees or >60 degrees) and randomized in a 1:1 ratio to receive either active treatment with Platelet-Rich Plasma (PRP) or placebo (saline). Subsequently, participants will attend weekly injection sessions for 3 weeks consisting of either PRP or saline in a randomized, double-blind manner. A follow-up visit will take place three months after the final injection for outcome assessment. Two additional long-term follow-up visits will be conducted at 6 and 12 months post-treatment. Analysis will then be conducted.
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)
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
- •Clearly palpable penile plaque
排除标准
- •Erectile Dysfunction unresponsive to on-demand PDE5 inhibitors
- •Hourglass malformation
- •Severely calcified plaques where injection is considered unfeasible
- •Intrapenile plaque
- •History of priapism.
- •History of penile fracture.
- •Previous treatment for PD with injections and/or surgery.
- •Antithrombotic therapy associated with a high risk of bleeding
研究组 & 干预措施
Platelet Rich Plasma (PRP)
干预措施: Autologous Platelet Rich Plasma (Other)
Saline Solution (Placebo)
干预措施: Saline solution (Other)
结局指标
主要结局
Degree Changes in Penile Curvature.
时间窗: From enrollment to 12 months post intervention.
Dominant curvature angles will be measured bedside in the outpatient clinic using a goniometer following intracavernosal administration of Alprostadil to ensure high quality and consistency. At the same visit, standardized photographs of the erect penis will be captured (in two plans) to support objective assessment. These procedures will be performed at baseline and at follow-up three months after the final injection. At the 6- and 12-months long-term follow-up visits, no pharmacological erection induction will be performed. Instead, penile curvature will be assessed based on standardized photographs of the participant's erection taken at home following detailed instructions, allowing evaluation of the durability of any treatment effect.
次要结局
- Changes in the Major Depression Inventory (MDI)(From enrollment to 12 months post intervention.)
- Changes in Plaque Size(From enrollment to 12 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 12 months post intervention.)
- The Ability to Engage in Sexual Intercourse (question)(From enrollment to 12 months post intervention.)
- Changes in Global Assessment Scale Questionnaire(From 3 to 12 months post intervention.)
- Preference for Surgical Intervention (question)(From enrollment to 12 months post intervention.)
研究者
Mikael Heering
Medical Doctor, PhD-student
Herlev and Gentofte Hospital