Disease Modifying Treatment Using Combined Shockwave Therapy and Platelet Rich Plasma In Microvascular Erectile Dysfunction

使用组合冲击波疗法和富血小板血浆治疗微血管勃起功能障碍的疾病修饰治疗

• 批准号: 10705100
• 负责人: Emad Ibrahim
• 金额: $ 30.7万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-21 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10705100
• 关键词: Adoption; Adverse effects; Affect; Aftercare; Age; Alpha Granule; Alternative Therapies; Angiogenic Factor; Biological; Blood Platelets; Blood Vessels; Clinical; Clinical Research; Clinical Trials; Colony-forming units; Combined Modality Therapy; Conduct Clinical Trials; Data; Devices; Diabetes Mellitus; Disease; Dose; Double-Blind Method; Drops; Endothelium; Erectile dysfunction; Exclusion Criteria; Foundations; Functional disorder; Future; Goals; Growth Factor; Human; Hypertension; Injections; Institutional Review Boards; International; Intervention; Measures; Mediating; Metabolic syndrome; Microvascular Dysfunction; Mission; National Institute of Diabetes and Digestive and Kidney Diseases; Outcome; Painless; Pathology; Patient Selection; Patients; Peripheral Vascular Diseases; Placebos; Plasma; Predictive Value; Prevention; Publishing; Randomized; Research Design; Resistance; Safety; Sample Size; Serum; Shock; Structure; System; Techniques; Testing; Therapeutic; United States; Vascular Endothelial Growth Factors; Vascular System; Vasodilation; Western World; aging population; arm; cytokine; effective therapy; endothelial dysfunction; endothelial stem cell; hemodynamics; improved; indexing; inhibitor; men; novel; novel therapeutic intervention; novel therapeutics; open label; penis; peripheral blood; phosphodiesterase V; primary outcome; randomized placebo controlled trial; randomized trial; recruit; reparative capacity; response; safety and feasibility; safety study; secondary outcome; success; symptomatic improvement; tissue regeneration; treatment strategy

Project Summary Microvascular erectile dysfunction associated with hypertension and diabetes is becoming increasingly common in an aging population of the Western world. Despite several effective treatments available for ED, no disease modifying intervention capable of improving the underlying pathophysiology of ED and restoring erectile function is available. Shock wave therapy (SWT) is a novel, painless, non-invasive experimental strategy which elicits biological responses in the vascular system, including stimulation of endogenous reparative capacity and formation of new blood vessels. Platelet-rich plasma (PRP) is an alternative therapy to promote tissue regeneration mediated by the release of several growth factors and cytokines stored in the alpha granules of platelets. Although SWT and PRP has been investigated for ED in clinical trials as monotherapy, the combination has not been investigated. We have shown the safety of using SWT over a short duration for men with ED in a randomized superiority trial. We also have shown safety of PRP in an ongoing clinical trial. We believe that the action of SWT and PRP is additive. The working hypothesis underlying this proposal is that SWT and PRP will be additive for ED and improve subjective erective function scores, objective penile hemodynamics and promote penile endothelial function. We will conduct a single center open label trial with 30 men with mild to moderate ED who will receive two intracavernous injections of PRP (6 weeks apart) with weekly SWT in between. We will evaluate improvement in ED using International Index of Erectile Function score at 3 and 6 months (Aim1). We will determine the mechanism by which penile SWT + PRP improves microvascular ED (Aim 2) by evaluating penile vascular flow and endothelial function. SWT + PRP is a promising, cutting edge technique, which will likely contribute significantly towards management of ED. The proposed study is a pilot and feasibility clinical trial conducted in humans that will acquire preliminary data, collect feasibility data related to recruitment and retention, and lay the foundation for a larger clinical trial related to the prevention and/or treatment of ED, a disease within the mission of NIDDK.

项目摘要 与高血压和糖尿病相关的微血管勃起功能障碍越来越普遍 在西方世界的老龄化中。尽管有几种有效的治疗方法，但没有疾病 修改能够改善ED的潜在病理生理并恢复勃起功能的干预措施 可用。冲击波疗法（SWT）是一种新颖的，无痛的，无创的实验策略，引起了 血管系统中的生物反应，包括刺激内源性修复能力和 新血管的形成。富含血小板的血浆（PRP）是促进组织的替代疗法 再生是通过释放在α颗粒中存储的几种生长因子和细胞因子的释放所介导的 血小板。尽管已在临床试验中研究了SWT和PRP作为单一疗法的ED，但该组合 尚未进行调查。我们已经证明了在短时间内使用SWT的安全性 随机优势试验。我们还在正在进行的临床试验中显示了PRP的安全性。我们相信 SWT和PRP的动作是加性的。该提议的基础假设是SWT和PRP 为ED加性并提高主观的磨性功能评分，客观的阴茎血液动力学并促进 阴茎内皮功能。我们将对30名轻度至中度的男性进行单个中心开放式标签试验 Ed将接受两次prp的两次内部注射（相隔6周），每周一次。我们将 使用3个月和6个月的勃起功能评分的国际指数评估ED的改进（AIM1）。我们 将确定阴茎SWT + PRP通过评估来改善微血管ED（AIM 2）的机制 阴茎血管流和内皮功能。 SWT + PRP是一种有前途的尖端技术，它将 可能对ED的管理产生了重大贡献。拟议的研究是试点和可行性临床 在人类中进行的试验，该试验将获取初步数据，收集与招聘有关的可行性数据 保留，并为与ED的预防和/或治疗有关的更大的临床试验奠定了基础 NIDDK任务中的疾病。

项目成果

U-shaped association between prevalence of secondary hypogonadism and body mass index: a retrospective analysis of men with testosterone deficiency.

• DOI: 10.1038/s41443-022-00533-z
• 发表时间: 2023-06
• 期刊: International journal of impotence research
• 影响因子: 2.6

Is Time Spent on Prior Authorizations Associated With Approval?

事先授权所花费的时间与批准有关吗？

• DOI: 10.1016/j.nurpra.2022.10.008
• 发表时间: 2023
• 期刊: The journal for nurse practitioners : JNP
• 作者: Madhusoodanan,Vinayak;Ramos,Libert;Zucker,IsaacJ;Sathe,Aditya;Ramasamy,Ranjith
• 通讯作者: Ramasamy,Ranjith

Prevalence of Low Testosterone in Men With Cystic Fibrosis and Congenital Bilateral Absence of the Vas Deferens: A Cross-sectional Study Using a Large, Multi-institutional Database.

患有囊性纤维化和先天性双侧输精管缺失的男性睾酮水平低下的患病率：一项使用大型多机构数据库的横断面研究。

• DOI: 10.1016/j.urology.2023.08.039
• 发表时间: 2023
• 期刊: Urology
• 影响因子: 2.1
• 作者: Campbell,Katherine;Deebel,Nicholas;Kohn,Taylor;Passarelli,Rachel;Velez,Danielle;Ramasamy,Ranjith
• 通讯作者: Ramasamy,Ranjith

Editorial: Impact of coronavirus disease 2019 on urological healthcare.

社论：2019 年冠状病毒病对泌尿外科医疗保健的影响。

• DOI: 10.1097/mou.0000000000000960
• 发表时间: 2022
• 期刊: Current opinion in urology
• 影响因子: 2.5
• 作者: Kresch,Eliyahu;Ramasamy,Ranjith;Parekh,DipenJ
• 通讯作者: Parekh,DipenJ

Long-term evaluation of sperm parameters after coronavirus disease 2019 messenger ribonucleic acid vaccination.

• DOI: 10.1016/j.xfre.2022.07.007
• 发表时间: 2022-09
• 期刊: F&S reports
• 作者: Diaz, Parris;Dullea, Alexandra;Patel, Mehul;Blachman-Braun, Ruben;Reddy, Rohit;Khodamoradi, Kajal;Ibrahim, Emad;Bidhan, Joginder;Ramasamy, Ranjith
• 通讯作者: Ramasamy, Ranjith