Study Summary
This trial will study whether Shock Wave Therapy combined with Platelet Rich Plasma can improve erectile function by improving vasodilation and endothelial function in men with microvascular Erectile Dysfunction.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
6 Primary · 1 Secondary · Reporting Duration: Baseline, Month 3, Month 6
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
SWT plus PRP Group
1 of 2
Sham SWT plus Placebo Saline Group
1 of 2
Experimental Treatment
Non-Treatment Group
60 Total Participants · 2 Treatment Groups
Primary Treatment: Shock Wave therapy (SWT) · Has Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 30 - 80 · Male Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Florida | 40.0% |
| North Carolina | 20.0% |
| California | 20.0% |
| Other | 20.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| University of Miami Miller School of Medicine | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 60.0% |
| Did not meet criteria | 40.0% |
Why did patients apply to this trial?
- "I've tried several ED medications with no success"
How many prior treatments have patients received?
| 3+ | 100.0% |
- Andia, Isabel, and Nicola Maffulli. 2013. “Platelet-rich Plasma for Managing Pain and Inflammation in Osteoarthritis”. Nature Reviews Rheumatology. Springer Science and Business Media LLC. doi:10.1038/nrrheum.2013.141.
- Haupt, Gerald, Angela Haupt, Axel Ekkernkamp, Bridget Gerety, and Milos Chvapil. 1992. “Influence of Shock Waves on Fracture Healing”. Urology. Elsevier BV. doi:10.1016/0090-4295(92)90009-l.
- Sampson, Steven, Michael Gerhardt, and Bert Mandelbaum. 2008. “Platelet Rich Plasma Injection Grafts for Musculoskeletal Injuries: A Review”. Current Reviews in Musculoskeletal Medicine. Springer Science and Business Media LLC. doi:10.1007/s12178-008-9032-5.
- Xie, Xuetao, Changqing Zhang, and Rocky S Tuan. 2014. “Biology of Platelet-rich Plasma and Its Clinical Application in Cartilage Repair”. Arthritis Research & Therapy. Springer Science and Business Media LLC. doi:10.1186/ar4493.
- Randelli, Pietro, Filippo Randelli, Vincenza Ragone, Alessandra Menon, Riccardo D’Ambrosi, Davide Cucchi, Paolo Cabitza, and Giuseppe Banfi. 2014. “Regenerative Medicine in Rotator Cuff Injuries”. Biomed Research International. Hindawi Limited. doi:10.1155/2014/129515.
- Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.
- Kikuchi, Yoku, Kenta Ito, Yoshitaka Ito, Takashi Shiroto, Ryuji Tsuburaya, Kentaro Aizawa, Kiyotaka Hao, et al.. 2010. “Double-blind and Placebo-controlled Study of the Effectiveness and Safety of Extracorporeal Cardiac Shock Wave Therapy for Severe Angina Pectoris”. Circulation Journal. Japanese Circulation Society. doi:10.1253/circj.cj-09-1028.
- Vlachopoulos, Charalambos, Konstantinos Rokkas, Nikolaos Ioakeimidis, Constadina Aggeli, Andreas Michaelides, Georgios Roussakis, Charalambos Fassoulakis, Athanasios Askitis, and Christodoulos Stefanadis. 2005. “Prevalence of Asymptomatic Coronary Artery Disease in Men with Vasculogenic Erectile Dysfunction: A Prospective Angiographic Study”. European Urology. Elsevier BV. doi:10.1016/j.eururo.2005.08.002.
- Kikuchi Y, Ito K, Ito Y, Shiroto T, Tsuburaya R, Aizawa K, Hao K, Fukumoto Y, Takahashi J, Takeda M, Nakayama M, Yasuda S, Kuriyama S, Tsuji I, Shimokawa H. Double-blind and placebo-controlled study of the effectiveness and safety of extracorporeal cardiac shock wave therapy for severe angina pectoris. Circ J. 2010 Mar;74(3):589-91. doi: 10.1253/circj.cj-09-1028. Epub 2010 Feb 4.
- Andia I, Maffulli N. Platelet-rich plasma for managing pain and inflammation in osteoarthritis. Nat Rev Rheumatol. 2013 Dec;9(12):721-30. doi: 10.1038/nrrheum.2013.141. Epub 2013 Oct 1.
- Vlachopoulos C, Rokkas K, Ioakeimidis N, Aggeli C, Michaelides A, Roussakis G, Fassoulakis C, Askitis A, Stefanadis C. Prevalence of asymptomatic coronary artery disease in men with vasculogenic erectile dysfunction: a prospective angiographic study. Eur Urol. 2005 Dec;48(6):996-1002; discussion 1002-3. doi: 10.1016/j.eururo.2005.08.002. Epub 2005 Aug 24.
- Haupt G, Haupt A, Ekkernkamp A, Gerety B, Chvapil M. Influence of shock waves on fracture healing. Urology. 1992 Jun;39(6):529-32. doi: 10.1016/0090-4295(92)90009-l.
- Melman A, Gingell JC. The epidemiology and pathophysiology of erectile dysfunction. J Urol. 1999 Jan;161(1):5-11.
- Xie X, Zhang C, Tuan RS. Biology of platelet-rich plasma and its clinical application in cartilage repair. Arthritis Res Ther. 2014 Feb 25;16(1):204. doi: 10.1186/ar4493.
- Randelli P, Randelli F, Ragone V, Menon A, D'Ambrosi R, Cucchi D, Cabitza P, Banfi G. Regenerative medicine in rotator cuff injuries. Biomed Res Int. 2014;2014:129515. doi: 10.1155/2014/129515. Epub 2014 Aug 13.
- Ranjith Ramasamy, MD 2022. "Shockwave Therapy and Platelet Rich Plasma for the Treatment of Erectile Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05048667.
Frequently Asked Questions
Are any additional participants needed for this research endeavor?
"Affirmative. Data hosted on clinicaltrials.gov attests that this medical experiment, which was initialised on June 27th 2022, is actively recruiting subjects. Approximately 60 participants are needed from 1 research centre." - Anonymous Online Contributor
What is the total participant quota for this medical experiment?
"Affirmative. According to clinicaltrials.gov, this trial is currently enrolling participants and was first made available on June 27th 2022 with the most up-to-date changes occurring on September 12th of the same year. The said research aims to recruit 60 volunteers from a single site." - Anonymous Online Contributor
Has the FDA sanctioned Shock Wave therapy (SWT) for public use?
"With limited evidence to support it, the safety rating of Shock Wave therapy (SWT) was appraised by our team at Power with a score of 1." - Anonymous Online Contributor
What characteristics make someone a suitable candidate for this research initiative?
"This clinical trial seeks 60 participants aged 30 to 80 with erectile dysfunction. To be considered for inclusion, applicants must agree to: Attempt sexual intercourse at least 4 times per month without being impaired by alcohol/recreational drugs., Abide by all study related tests/procedures., Present an International Index of Erectile Function-Erectile Function score between 12 and 25 at screening, Have a diagnosis of ED due to organic origin for 6 months prior to voluntary consent.." - Anonymous Online Contributor
Are individuals aged 35 and over eligible to become participants in this research?
"The guidelines for this trial dictate that the age range of eligible participants is between 30 and 80." - Anonymous Online Contributor