Shock Wave therapy (SWT) for Erectile Dysfunction

Phase-Based Progress Estimates
University of Miami Miller School of Medicine, Miami, FLErectile DysfunctionShock Wave therapy (SWT) - Device
30 - 80
What conditions do you have?

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

1 of 3

Study Objectives

6 Primary · 1 Secondary · Reporting Duration: Baseline, Month 3, Month 6

Baseline, Month 3
Number of participants reporting a decrease or discontinue in use of PDE5 inhibitors
Month 6
Change in IIEF-EF Scores
Circulating Angiogenic Factor levels
Percentage of participants achieving MCID in IIEF-EF
Baseline, Month 6
Penile Blood Flow
Up to 6 months
EPC-CFU levels
Penile Flow Mediated Dilation

Trial Safety

Safety Progress

1 of 3

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

SWT plus PRP GroupExperimental Group · 2 Interventions: Shock Wave therapy (SWT), Platelet Rich Plasma (PRP) · Intervention Types: Device, Drug
Sham SWT plus Placebo Saline GroupPlaceboComparator Group · 2 Interventions: Placebo Saline, Sham SWT · Intervention Types: Other, Other
First Studied
Drug Approval Stage
How many patients have taken this drug
Platelet Rich Plasma (PRP)
Completed Phase 4

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, month 3, month 6

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,182 Previous Clinical Trials
4,088,837 Total Patients Enrolled
1 Trials studying Erectile Dysfunction
568 Patients Enrolled for Erectile Dysfunction
University of MiamiLead Sponsor
805 Previous Clinical Trials
387,034 Total Patients Enrolled
4 Trials studying Erectile Dysfunction
299 Patients Enrolled for Erectile Dysfunction
Ranjith Ramasamy, MDPrincipal InvestigatorUniversity of Miami
11 Previous Clinical Trials
1,143 Total Patients Enrolled
3 Trials studying Erectile Dysfunction
284 Patients Enrolled for Erectile Dysfunction

Eligibility Criteria

Age 30 - 80 · Male Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with erectile dysfunction caused by a physical issue for at least 6 months before agreeing to participate.
You are in a committed heterosexual relationship and sexually active for more than three months.
You must be male.
You are willing to have sex at least 4 times per month during the study and agree to not use alcohol or recreational drugs before doing so.

Who else is applying?

What state do they live in?
North Carolina20.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Miami Miller School of Medicine100.0%
What portion of applicants met pre-screening criteria?
Met criteria60.0%
Did not meet criteria40.0%
Why did patients apply to this trial?
  • "I've tried several ED medications with no success"
How many prior treatments have patients received?

Frequently Asked Questions

Are any additional participants needed for this research endeavor?

"Affirmative. Data hosted on 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

Unverified Answer

What is the total participant quota for this medical experiment?

"Affirmative. According to, 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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.