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Shockwave and platelet gel: a new hope for ED?

NCT ID NCT05048667

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

30 to 80 years

Sex

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

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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