Platelet-Rich Plasma Alone Versus PRP Plus Low-Intensity Shock Wave Therapy for Erectile Dysfunction
2026年8月20日 更新者：Tamer Abd El-Wahab Diab、Benha University
Effect of Platelet-Rich Plasma Injection Alone Versus Combined Platelet-Rich Plasma and Low-Intensity Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction
Erectile dysfunction is a common condition that may result from vascular, neurological, hormonal, psychological, or medication-related factors. Platelet-rich plasma (PRP) and low-intensity extracorporeal shock wave therapy (Li-ESWT) are regenerative treatment approaches that may improve erectile function through mechanisms involving angiogenesis, tissue repair, and improvement of penile vascular function.
This randomized prospective study will compare the efficacy and safety of PRP injection alone with combined PRP injection and Li-ESWT in men with erectile dysfunction. A total of 80 participants will be randomly assigned to two groups. One group will receive PRP injections alone, while the other group will receive PRP injections combined with Li-ESWT. Participants will be followed after treatment to assess changes in erectile function, erection hardness, penile blood flow, patient satisfaction, and treatment-related adverse events.
The study hypothesis is that adding Li-ESWT to PRP therapy will result in greater improvement in erectile function than PRP therapy alone.
研究概览
研究类型
介入性
注册 (估计的)
80
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Tamer A Diab, MD
- 电话号码：+2 01003583264
- 邮箱：Tamer.diab@fmed.bu.edu.com
学习地点
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Qalyubia Governorate
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Banhā、Qalyubia Governorate、埃及、13511
- Benha University Hospital
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接触：
- Tamer A Diab, MD
- 电话号码：+2 01003583264
- 邮箱：Tamer.diab@fmed.bu.edu.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Male participants aged 30-65 years.
- Diagnosis of erectile dysfunction for at least 3 months.
- Mild to moderate erectile dysfunction, defined by an International Index of Erectile Function-5 (IIEF-5) score of 8-21.
- In a stable heterosexual relationship for at least 6 months.
- Sexually active, with at least one sexual attempt per week.
Exclusion Criteria:
- Severe erectile dysfunction, defined as IIEF-5 score <8.
- Primary psychogenic erectile dysfunction based on clinical history with or without psychosexual assessment.
- Anatomical penile abnormalities, including Peyronie's disease.
- History of radical pelvic surgery or pelvic radiotherapy.
- Uncontrolled diabetes mellitus, defined as HbA1c >9%.
- Uncontrolled hypertension, defined as blood pressure >160/100 mmHg.
- Recent myocardial infarction or stroke within the previous 6 months.
- Unstable angina.
- New York Heart Association class III-IV heart failure.
- Severe hepatic impairment.
- Severe renal impairment.
- Hypogonadism, defined as total testosterone <300 ng/dL.
- Hyperprolactinemia.
- Untreated thyroid disease.
- Current use of nitrates or nitric oxide donors.
- Current use of alpha-blockers, unless the participant is on a stable low dose.
- Current use of other phosphodiesterase type 5 inhibitors.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Platelet-Rich Plasma Alone
Participants will receive platelet-rich plasma (PRP) injections alone.
PRP will be prepared from approximately 20 mL of autologous blood using a double-spin method, targeting a platelet concentration of 3-5 times baseline.
PRP will be administered by intracavernosal injection at two sites.
Participants will receive three PRP injections over 6 weeks, with one injection every 2 weeks.
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Autologous platelet-rich plasma will be prepared from approximately 20 mL of the participant's blood using a double-spin centrifugation method, targeting a platelet concentration of 3-5 times baseline.
PRP will be administered by intracavernosal injection at two sites, with three injections given over 6 weeks at 2-week intervals.
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实验性的：Platelet-Rich Plasma Plus Li-ESWT
Participants will receive the same PRP injection regimen as the PRP-alone group combined with low-intensity extracorporeal shock wave therapy (Li-ESWT).
Li-ESWT will be administered at an energy density of 0.15 mJ/mm² with 2,000 shocks per session to the penile shaft with or without the crura.
Participants will receive six Li-ESWT sessions over 6 weeks, with one session per week.
PRP injections will be administered before Li-ESWT sessions according to the study protocol.
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Low-intensity extracorporeal shock wave therapy will be delivered to the penile shaft with or without treatment of the crura using an energy density of 0.15 mJ/mm² and 2,000 shocks per session.
Participants will receive six sessions over 6 weeks, at a frequency of one session per week.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Baseline in International Index of Erectile Function-5 (IIEF-5) Score
大体时间：Baseline and 4, 12, and 24 weeks after intervention
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Erectile function will be assessed using the International Index of Erectile Function-5 (IIEF-5), a 5-item self-administered questionnaire assessing erectile function and intercourse-related sexual performance.
Each item is scored from 1 to 5, giving a total score ranging from 5 to 25, with higher scores indicating better erectile function.
Scores are interpreted as: 22-25, no erectile dysfunction; 17-21, mild erectile dysfunction; 12-16, mild-to-moderate erectile dysfunction; 8-11, moderate erectile dysfunction; and 5-7, severe erectile dysfunction.
Change from baseline in the total IIEF-5 score will be compared between the treatment groups.
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Baseline and 4, 12, and 24 weeks after intervention
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Change From Baseline in Erection Hardness Score (EHS)
大体时间：Baseline and 4, 12, and 24 weeks after intervention
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Erection hardness will be assessed using the Erection Hardness Score (EHS), a single-item scale ranging from 0 to 4, with higher scores indicating greater erection rigidity.
Scores are defined as follows: 0, penis does not enlarge; 1, penis is larger but not hard; 2, penis is hard but not hard enough for penetration; 3, penis is hard enough for penetration but not completely rigid; and 4, penis is completely hard and fully rigid.
Change from baseline in the EHS will be compared between the treatment groups.
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Baseline and 4, 12, and 24 weeks after intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Baseline in Penile Peak Systolic Velocity
大体时间：Baseline and 4, 12, and 24 weeks after intervention
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Peak systolic velocity (PSV) will be measured using penile duplex Doppler ultrasonography to assess changes in penile arterial blood flow following treatment.
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Baseline and 4, 12, and 24 weeks after intervention
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Change From Baseline in Penile End-Diastolic Velocity
大体时间：Baseline and 4, 12, and 24 weeks after intervention
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End-diastolic velocity (EDV) will be measured using penile duplex Doppler ultrasonography to assess changes in penile hemodynamics following treatment.
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Baseline and 4, 12, and 24 weeks after intervention
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Patient Satisfaction With Treatment
大体时间：4, 12, and 24 weeks after intervention
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Patient satisfaction with treatment will be assessed using a 5-point Likert scale.
Participants will rate their overall satisfaction as: 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied.
Higher scores indicate greater treatment satisfaction.
Satisfaction scores will be compared between the two treatment groups.
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4, 12, and 24 weeks after intervention
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2027年3月1日
研究完成 (估计的)
2027年3月1日
研究注册日期
首次提交
2026年8月20日
首先提交符合 QC 标准的
2026年8月20日
首次发布 (实际的)
2026年8月24日
研究记录更新
最后更新发布 (实际的)
2026年8月24日
上次提交的符合 QC 标准的更新
2026年8月20日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他研究编号
- MS.46.4.2026
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