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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change From Baseline in International Index of Erectile Function-5 (IIEF-5) Score
研究概览
简要总结
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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-
- •In a stable heterosexual relationship for at least 6 months.
- •Sexually active, with at least one sexual attempt per week.
排除标准
- •Severe erectile dysfunction, defined as IIEF-5 score <
- •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.
结局指标
主要结局
Change From Baseline in International Index of Erectile Function-5 (IIEF-5) Score
时间窗: Baseline and 4, 12, and 24 weeks after intervention
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.
Change From Baseline in Erection Hardness Score (EHS)
时间窗: Baseline and 4, 12, and 24 weeks after intervention
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.
次要结局
- Change From Baseline in Penile Peak Systolic Velocity(Baseline and 4, 12, and 24 weeks after intervention)
- Change From Baseline in Penile End-Diastolic Velocity(Baseline and 4, 12, and 24 weeks after intervention)
- Patient Satisfaction With Treatment(4, 12, and 24 weeks after intervention)
研究者
Tamer Abd El-Wahab Diab
Associate Professor of Urology
Benha University