NCT07010900招募中不适用
Platelet-Rich Plasma Injections From Cord Blood + Penile Traction vs. Penile Traction Alone in Patients With Peyronie's Disease.
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年5月28日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- patient satisfaction
研究概览
简要总结
The goal of this clinical trial is to learn if Platelet-Rich Plasma Injections from Cord Blood (CB-PRP) is useful in Peyronie disease.
The primary goal is evaluation of patient satisfaction at 1 and 3 months after treatment completion using the PDQ Questionnaire
Secondary Objectives are:
- Measurement of penile curvature measured with a goniometer with spontaneous erection before and after treatment (1 and 3 months)
- Measurement of penile length in stretching before and after treatment (1 and 3 months)
- Evaluation of the improvement in quality of life, through the Short-Form Health Survey 12 (SF-12) health status questionnaire and through the Hospital Anxiety and Depression Scale (HADS)
Participants will be randomized in two groups:
- penile extender alone
- penile extender + CB PRP injection (1 injection every 15 days - 3 in totalinjections)
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with Peyronie's Disease (IPP) Penile curvature greater than 30 degrees (autophotography in erection with goniometer measurement) Patients candidates for penile traction Age: 18-75 years Good health conditions Preserved erection (IIEF >20) Complete blood count with differential and coagulation within the normal range (platelets between 150,000 and 450,000 μL) HIV, HCV, and HbsAg negative The fertile partner of the patient randomized to the experimental group must use an acceptable highly effective contraceptive method (oral contraceptives, intrauterine device, abstinence, vasectomized partner) for the entire duration of the study Informed consent to the study
排除标准
- •Coagulopathies, platelet disorders Major active infections Previous penile surgery (excluding circumcision and condyloma removal) Previous infiltrative therapy or penile traction treatment
研究组 & 干预措施
Penile extender
No Intervention
routine treatment with medical device
CB-PRP Injection
Experimental
experimental arm
干预措施: Injection (Procedure)
结局指标
主要结局
patient satisfaction
时间窗: From enrollment to the end of follow-up at 6 months
using PDQ questionnaire
次要结局
未报告次要终点
研究者
研究点 (1)
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