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

> **NIH NIH R01** · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · 2022 · $307,000

## Abstract

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.

## Key facts

- **NIH application ID:** 10490478
- **Project number:** 5R01DK130991-02
- **Recipient organization:** UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
- **Principal Investigator:** Ranjith Ramasamy
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $307,000
- **Award type:** 5
- **Project period:** 2021-09-21 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10490478

## Citation

> US National Institutes of Health, RePORTER application 10490478, Disease Modifying Treatment Using Combined Shockwave Therapy and Platelet Rich Plasma In Microvascular Erectile Dysfunction (5R01DK130991-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10490478. Licensed CC0.

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