Phase 1
N=59
Shockwave Therapy and Platelet Rich Plasma for the Treatment of Erectile Dysfunction
Erectile Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT05048667 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Number of Participants With Treatment Emergent Serious Adverse Events (TE-SAEs) During the Study Period. — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Shock Wave therapy (SWT) (Device); Platelet Rich Plasma (PRP) (Drug); Sham SWT (Other); Placebo Saline (Other)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- Male
- Sponsor
- University of Miami
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Serious Adverse Events (TE-SAEs) During the Study Period. |
0; 0 | — |
| SECONDARY Change in IIEF-EF Scores |
2; 2.5 | — |
| SECONDARY Percentage of Participants Achieving MCID in IIEF-EF at Any Post-treatment Timepoint in Each Group. |
12; 9 | — |
| SECONDARY Percentage of Participants Who Either Decrease or Discontinue Use of PDE5i After Three Months Post-therapy Compared to Control Group |
1; 0; 10; 14 | — |
Summary
The purpose of this research study is to evaluate whether the combination of Shock Wave Therapy (SWT) with Platelet Rich Plasma (PRP) is synergistic and can reverse the pathology of microvascular Erectile Dysfunction (ED) and enhance erectile function by improving vasodilation, and endothelial function
Eligibility Criteria
Inclusion Criteria
- Be Male
- Be 30 to 80 years of age (inclusive).
- Be able to provide written informed consent.
- 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.
- IIEF-EF score 12-25 at screening
- Agree to attempt sexual intercourse at least 4 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.
Exclusion Criteria
- Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting.
- Previous history of priapism or penile fracture
- Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL (±5%) (indicative of untreated hypogonadism), or greater than 1197 ng/dL (±5%).
- Current or previous hormone usage, other than prescribed testosterone, clomiphene or thyroid medication. (Subjects with prior or current use of hormonal treatment for prostate cancer are also excluded.
- Psychogenic ED as determined by study investigator.
- Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual activity) or neurological abnormalities in the treatment area.
- 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.
- History of consistent treatment failure with Phosphodiesterase Type 5 (PDE5) inhibitors for therapy of ED.
- Any history of significant psychiatric disease, such as bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity. Patients who are currently using Selective Serotonin Reuptake Inhibitors (SSRI) or psychotropic medications.
- Hemoglobin a1c >9%.
Data sourced from ClinicalTrials.gov (NCT05048667). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.