Combining Shockwave Therapy and Platelet Rich Plasma to Treat Erectile Dysfunction in Diabetic Men (COCKTAIL-DM)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Markers of Vasodilation
研究概览
简要总结
The purpose of this research study is to evaluate whether the combination of Shockwave Therapy (SWT) with Platelet Rich Plasma (PRP) is synergistic and can reverse the pathology of microvascular Erectile Dysfunction (ED) and enhance erectile function in diabetics patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Between 30 to 80 years of age (inclusive).
- •Be able to provide written informed consent.
- •Have a diagnosis of Mild to Moderate ED (12-21) or Mild ED (22-25) based on International Index of Erectile Dysfunction - Erectile Function (IIEF-EF) questionnaire score.
- •Have diagnosis of Diabetes Mellitus (Type 1 or Type 2), as documented by history of Hemoglobin A1C > 7% OR on medical therapy for Diabetes.
- •Be in a stable relationship and have a minimum of 2 sexual attempts per month for at least one month prior to enrollment.
- •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, penile fracture, Peyronie's Disease, or penile curvature that negatively influences sexual activity.
- •Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL (±5%).
- •Psychogenic ED as determined by study investigator.
- •Patients using Intracavernous Injections (ICI) for management of ED.
- •Patients with generalized polyneuropathy, neurological conditions, or psychiatric disease (such as bipolar disorder or depression).
- •Have a serious comorbid illness or condition 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 Phosphodiesterase 5 (PDE5) inhibitors for therapy of ED.
- •Poorly controlled diabetes as indicated by Hemoglobin a1c > 7.5%.
- •Use of antiplatelet medications
研究组 & 干预措施
Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group
Participants will receive a combination of 5 weekly extracorporeal shockwave therapy sessions (SWT) and two sessions of autologous platelet-rich plasma (PRP) penile injection.
干预措施: Shockwave Therapy (SWT) (Device)
Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group
Participants will receive a combination of 5 weekly extracorporeal shockwave therapy sessions (SWT) and two sessions of autologous platelet-rich plasma (PRP) penile injection.
干预措施: Autologous Platelet-Rich Plasma (PRP) (Drug)
结局指标
主要结局
Markers of Vasodilation
时间窗: Baseline, Month 3, Month 6
Markers of vasodilation including Endothelial Nitric Oxide Synthase (eNOS) and Neuronal Nitric Oxide Synthase (nNOS) will be measured from serum blood samples in units of ug/mL.
Endothelial Function Markers
时间窗: Baseline, Month 3, Month 6
Markers of endothelial function will include Vascular Endothelial Growth Factor (VEGF), Stromal cell-derived factor 1 (SDF-1α), and Stem Cell Factor (SCF). All measured from serum blood samples in units of pg/mL.
Markers of Neo-angiogenesis
时间窗: Baseline to Month 3, Baseline to Month 6
Markers of neo-angiogenesis reported as the percentage of Cluster of Differentiation 31 positive cells (CD31+), as measured from serum blood samples and expressed as a percentage.
Endothelial Progenitor Cell Colony Forming Units (EPC-CFUs)
时间窗: Baseline, Month 3, Month 6
Endothelial Progenitor Cell (EPC) Colony Forming Units (CFUs) as measured from peripheral blood samples in units of average cells per well.
次要结局
- Penile Blood Flow(Baseline)
- EDITS Questionnaire Scores(Month 3 and Month 6)
- Incidence of Serious Adverse Events (SAEs)(Baseline, up to 6 months)
研究者
Thomas Masterson
Assistant Professor
University of Miami