Shockwave and platelet gel: a new hope for ED?
NCT ID NCT05048667
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested whether combining shockwave therapy with platelet-rich plasma (PRP) injections can improve erectile function in men with microvascular erectile dysfunction. Fifty-nine men received either the combination treatment or a sham procedure. The main goal was to check safety, with secondary measures looking at changes in erectile function scores.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Shockwave therapy and platelet-rich plasma (PRP) injections
- What this could lead to
- If it works, this could point toward a non-drug treatment that improves erectile function by repairing blood vessels.
- What could go wrong
- This is a small, early-phase safety trial, so effectiveness is not proven. The combination may not work better than placebo, and results may not apply to all men with ED.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
59 people
The number who actually took part.
- Started
-
Jun 2022
- Finished
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Mar 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 to 80 years
- Sex
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Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Be Male 2. Be 30 to 80 years of age (inclusive). 3. Be able to provide written informed consent. 4. Have a diagnosis of ED due to organic origin for at least 6 months prior to consent. 5. Sexually active in a stable, heterosexual relationship of more than three months duration. 6. IIEF-EF score 12-25 at screening 7. 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. 8. Agree to comply with all study related tests/procedures. Exclusion Criteria: 1. Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting. 2. Previous history of priapism or penile fracture 3. 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%). 4. 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. 5. Psychogenic ED as determined by study investigator. 6. Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual activity) or neurological abnormalities in the treatment area. 7. Patients using Intracavernosal Injection (ICI) for management of ED 8. Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's disease. 9. 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. 10. History of consistent treatment failure with Phosphodiesterase Type 5 (PDE5) inhibitors for therapy of ED. 11. 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. 12. Hemoglobin a1c \>9%.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
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Other studies related to the condition(s) this trial covers.
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