跳至主要内容
临床试验/NCT07761806
NCT07761806已完成2 期

Comparison Between The Effect of Intracavernosal Injection of Platelet-Rich Plasma as a Single Agent vs Daily Oral 5 Phosphodiesterase Inhibitor Intake as a Single Agent Vs Combination In Improving of Erectile Dysfunction

Ain Shams University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年1月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
75
试验地点
1
主要终点
Treatment of Erectile Dysfunction

研究概览

简要总结

Erectile dysfunction (ED) is defined as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.Erectile dysfunction (ED) is one of the commonest disorders in adult males and affects 12-19% of men of reproductive age.Erectile dysfunction can be due to vasculogenic, neurogenic, hormonal, veno-occlusive, psychogenic and/or pharmacogenic factors.

PRP is autologous plasma that has a platelet concentration above the concentrations typically found in whole blood and is derived from the patient's own blood (autologous) through a process of centrifugation. PDE5Is inhibit the enzyme phosphodiesterase-5 (PDE-5) leading to dilatation of the penile arteries leads to a more prolonged erection.

详细描述

Erectile dysfunction (ED) is defined as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.The prevalence of erectile dysfunction (ED) increases with age, from 5% in men aged 20-39 years to 70% in men aged >70 years.

PDE5Is inhibit the enzyme phosphodiesterase-5 (PDE-5) present in the smooth muscle cells of the vessels. By inhibiting this enzyme, these drugs prevent the degradation of cGMP by PDE-5. GMP can cause activation of protein kinase G, leading to relaxation of the vascular smooth muscle. Prevention of degradation of cGMP by PDE-5 leads to the accumulation of cGMP in the vascular smooth muscle, thereby leading to dilatation of the blood vessels through phosphorylation of different downstream effector molecules. Dilatation of the penile arteries leads to a more prolonged erection. In addition, PDE5Is improve endothelial function and reduce apoptosis of vascular smooth muscle cells in the corpus cavernosum.

PRP is autologous plasma that has a platelet concentration above the concentrations typically found in whole blood and is derived from the patient's own blood (autologous) through a process of centrifugation.PRP has 7 fundamental proteins: platelet derived growth factors (PDGF), transforming growth factor-β (TGF-β), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), and adhesive proteins - fibrin, fibronectin and vitronectin.

PDGF is a glycoprotein, which emerges from degranulation of platelets at the site of injection. It activates cell membrane receptors on target cell which in turn develop high energy phosphate bonds, which activates the signal proteins to initiate specific activity of target cells. These specific activities include mitogenesis, angiogenesis.

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 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •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.
  • •Agree to attempt sexual intercourse at least 3 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.
  • •provide written informed consent.

排除标准

  • •Previous penile surgery of any kind (except circumcision ).
  • •Previous history of penile fracture or priapism.
  • •Psychogenic ED as determined by study investigator.
  • •Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual activity).
  • •Patients using Intracavernosal 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.
  • •Any history of significant psychiatric disease.

研究组 & 干预措施

5 phosphodiasterase inhibitor

Active Comparator

About 25 patients suffering from Erectile Function and took a daily dose of oral 5 mg tadalafil tablets

干预措施: Tadalafil 5mg (Drug)

INTRACAVERNOSAL PRP

Active Comparator

About 25 patients suffering from Erectile Function and underwent Intracaveronsal injection of 7-9 ml of PRP for 3 times 4weeks apart

干预措施: Tadalafil 5mg (Drug)

Prp and 5 phosphodiasterase inhibitor combined

Active Comparator

About 25 patients suffering from Erectile Function and underwent combined of both agents which includes daily dose of oral 5mg tadalafil tablets and Intracaveronsal injection of 7-9 ml of PRP for 3 injections 4 weeks apart

干预措施: Tadalafil 5mg (Drug)

结局指标

主要结局

Treatment of Erectile Dysfunction

时间窗: 6 Months

Treatment of the patients whom suffering from Erectile Dysfunction by using Intracavernosal Injection of Platelet-Rich Plasma as a single agent and daily oral 5 Phosphodiesterase Inhibitor intake as a single agent and combination of both agents evaluated by International Index of Erectile Function - Erectile Function Subdomain Score (IIEF-EF).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amr AbdelFattah

Resident at Urology Department

Ain Shams University

研究点 (1)

Loading locations...

相似试验