A Randomized Control, Double-Blind, Placebo Controlled, Multicenter Clinical Trial on Safety and Efficacy of Autologous Platelet-Rich Plasma Injection Treatment for Erectile Dysfunction.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Number of Participants Achieving MCID in IIEF-EF.
研究概览
简要总结
The purpose of this study is to evaluate changes in vascular parameters and International Index of Erectile Function (IIEF) scores with the administration of Platelet Rich Plasma (PRP) to participants with Erectile Dysfunction (ED)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Be 30 to 75 years of age (inclusive).
- •Be able to provide written informed consent.
- •Have a diagnosis of ED due to organic origin for at least 6 months prior to consent.
- •Sexually active in a stable, heterosexual relationship of more than three months duration.
- •IIEF-EF score 11-25 at screening (even if taking a single PDE5).
- •Agree to attempt sexual intercourse at least 4 times per month for the duration of the study without being under the influence of alcohol or recreational drugs.
- •Agree to comply with all study related tests/procedures.
排除标准
- •Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting.
- •Previous history of priapism or penile fracture
- •Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL (±5%) (indicative of untreated hypogonadism), or greater than 1197 ng/dL (±5%).
- •Current or previous hormone usage, other than prescribed testosterone, clomiphene or thyroid medication. (Subjects with prior or current use of hormonal treatment for prostate cancer are also excluded.
- •Psychogenic ED as determined by study investigator.
- •Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual activity) or neurological abnormalities in the treatment area.
- •Patients using Intra Cavernous Injection (ICI)for management of ED
- •Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's disease.
- •Have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.
- •History of consistent treatment failure with PDE5 inhibitors for therapy of ED.
- •Any history of significant psychiatric disease, such as bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity. Patients who are currently using Selective Serotonin Reuptake Inhibitor or psychotropic medications.
- •Hemoglobin a1c >9%.
研究组 & 干预措施
Placebo group
Participants in this group will receive 2 sessions of placebo injection, each administered 1 month apart ± 7 days.
干预措施: Saline solution (Other)
PRP group
Participants in this group will receive 2 sessions of autologous PRP penile injection, each administered 1 month apart ± 7 days
干预措施: Autologous Platelet Rich Plasma (Drug)
结局指标
主要结局
Number of Participants Achieving MCID in IIEF-EF.
时间窗: 1 month, 3 month, 6 month
Minimal clinically important difference (MCID) is measured by the number of participants who have achieved an increase in International Index of Erectile Function - Erectile Function Subdomain Score (IIEF-EF) based on their Erectile Dysfunction (ED) severity at baseline (an increase of 2 points from baseline for participants with mild ED and an increase of 5 points for participants with moderate ED). MCID in IIEF-EF scores are used to determine treatment efficacy of PRP compared to placebo. IIEF-EF is a 5-item subdomain self- evaluation questionnaire of erectile function with a total score ranging from 0-25 with the higher score indicating better erectile function. This outcome is reported as the number of participants who achieve MCID in each treatment group.
次要结局
- Change in Doppler Ultrasound Parameters - Peak Systolic Velocity (PSV)(Baseline to Month 6)
- Change in IIEF-EF Scores(Baseline up to Month 1, Month 3, and Month 6)
- Number of Adverse Events(24 weeks)
- Number of Participants With an End Diastolic Velocity (EDV) Value Greater Than 0, as Assessed by Penile Doppler Ultrasound at Baseline and Month 6.(Baseline and Month 6)
研究者
Ranjith Ramasamy, MD
Director of Male Fertility and Andrology, University of Miami
University of Miami