A Randomized, Double-blind Controlled Trial to Evaluate the Efficacy of Intracavernosal Infusion of Platelet Rich Plasma Against Platelet Poor Plasma in the Treatment of Vasculogenic Erectile Dysfunction.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Difference of increments between PRP and PPP treatment assessed by IIEF scale
研究概览
简要总结
Randomized, double-blind clinical trial to evaluate efficacy, feasibility and safety with two groups in a 1:1 ratio; where the control group corresponds to patients who will receive Platelet Poor plasma and an experimental group where patients will receive Platelet Rich Plasma, both collected by apheresis.
详细描述
Patients treated in the urology department of the Hospital Universitario Puerta de Hierro Majadahonda, are eligible and will be offered the participation in this clinical trial.
The target populations are patients who presented erectile dysfunction for at least 6 months with an IIEF-EF between 5 and 16 points. They will be pre-screened for eligibility.
The patient must complete the informed consent form (ICF) process and sign and date the informed consent form prior to participation in this study, including completion of any non-standard-of- care procedures required for this clinical Investigation.
If the patient meets the inclusion criteria and additionally meet with the apheresis procedures, the patient wil be included in the study.
The study include two phases. In the first phase, the patient will be randomized to PPP or PPP. In the second phase, according with the score IIEF-EF (responder or non responder), the patient will receive PRP.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Signed an ethics committee-reviewed and approved informed consent form.
- •Subjects must meet all inclusion criteria to be eligible for study enrollment.
- •Men between 40 and 75 years old, with a relationship of more than 6 months of duration.
- •Erectile dysfunction for at least 6 months with an IIEF-EF (while using the higher tolerated dose of PDE5-Is) between 5 and 16 points, inclusive.
- •Erectile dysfunction of vascular origin. In case of clinical doubt or incongruence, a Nocturnal Penile Tumescence and Rigidity Test (NPTR) will be performed. In this case, criteria inclusion is having no event in the night with a penile rigidity (tip) of ≥70% during ≥5min.
- •Subjects agree to attempt vaginal intercourse at least 4 times every month after the end of the treatment and agree to document the outcome using the Sexual Encounter Profile (SEP) and the Erection Hardness Score (EHS).
- •Commitment not to use other treatment for ED during the study (herbal, topical, intraurethral, intracavernosal, etc.).
- •Commitment to completing the rest of the questionnaires and other measurement instruments during the study phase.
- •Willingness and ability to comply with study procedures, other measurements instruments and visit schedules and able to follow oral and written instructions.
排除标准
- •Documented psychogenic erectile dysfunction (with NPTR test: at least one event in the night with a penile rigidity (tip) of ≥70% during ≥5min).
- •Erectile dysfunction of neurogenic origin (radical prostatectomy, pelvic surgery, spinal cord injury, multiple sclerosis, diabetes mellitus is not included unless documented diabetic neuropathy).
- •Some other current sexual dysfunction (premature ejaculation, etc.).
- •Prior implant of penile prosthesis or other penile surgeries different to circumcision, frenuloplasty or condyloma removal.
- •Previous history of penile fracture, Peyronie's disease or priapism.
- •History of radical prostatic or bladder surgery (radical cystectomy or prostatectomy).
- •Previous radiation to pelvis.
- •History of symptomatic hypogonadism (testosterone level <346ng/dl) not treated. If treated hypogonadism, testosterone levels non-stable for at least 3 months.
- •Major hematologic, renal, or hepatic abnormalities.
- •Severe decompensated cardiac and vascular insufficiency, or critical coronary heart disease.
- •Poorly controlled hypertension or diabetes mellitus (HbA1c >12%).
- •Recent (within previous six months of the inclusion) stroke or myocardial infarction.
- •Active peptic ulcer disease.
- •Neoplasm of any origin in active treatment or active progression.
- •History of psychiatric pathology (depressive syndrome, schizophrenia, bipolar disorder).
- •History of alcohol abuse (More than 7 alcohol drink units a week or more than 3 per occasion) or drug abuse (any drug consumption different to alcohol or tobacco, used more than three times per month).
- •Treatment with oral anticoagulants (dicoumarin or by-products) or antiandrogens.
- •Active treatment as nitric oxide (NO) donor drugs.
- •Prior positive serology to HBsAg, HCV (by genomic test), HIV-1/2, syphilis.
- •Thrombopenia less than 100 x 109 / L.
- •Anemia (Hemoglobin <13 g/dl).
- •Poor venous access or any other circumstance that preclude an apheresis procedure.
- •Lack of sexual practices in recent months (less than 4 attempts in the last three months).
- •Lack of commitment on the part of the patient to attend the tests requested.
研究组 & 干预措施
Treatment Arm
Intracavernosal infusion of Platelet Rich Plasma
干预措施: PRP (Drug)
Control Arm
Intracavernosal infusion of Platelet Poor Plasma
干预措施: PPP (Drug)
结局指标
主要结局
Difference of increments between PRP and PPP treatment assessed by IIEF scale
时间窗: 28 weeks
Difference of increments between both treatment groups assesed by International Index Erectile Function (IIEF) scale (referred to the investigator's study as mean PRP V9(PT)IIEF-EF - V3IIEF-EF vs mean PPP V9(PT)IIEF-EF - V3IIEF-EF) after 4 weeks of the end of the treatment.
次要结局
- Concentration of cytokines and growth factors in the PRP and PPP(28 weeks)
- Incidence of adverse events related with the use of PRP/PPP(28 weeks)
- Synergic efficcacy of PRP and PDE5 inhibitors(28 weeks)
研究者
Juan Ignacio Martinez Salamanca
Principal Investigator
Puerta de Hierro University Hospital