Shockwave Therapy and Platelet Rich Plasma for the Treatment of Erectile Dysfunction

Last updated: March 18, 2025
Sponsor: University of Miami
Overall Status: Completed

Phase

1

Condition

Male Hormonal Deficiencies/abnormalities

Erectile Dysfunction

Impotence

Treatment

Shock Wave therapy (SWT)

Sham SWT

Placebo Saline

Clinical Study ID

NCT05048667
20210887
R01DK130991
  • Ages 30-80
  • Male

Study 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

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 monthsduration.

  6. IIEF-EF score 12-25 at screening

  7. Agree to attempt sexual intercourse at least 4 times per month for the duration ofthe study without being under the influence of alcohol or recreational drugs.

  8. Agree to comply with all study related tests/procedures.

Exclusion

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 orthyroid medication. (Subjects with prior or current use of hormonal treatment forprostate cancer are also excluded.

  5. Psychogenic ED as determined by study investigator.

  6. Anatomical (Peyronie's Disease or penile curvature that negatively influences sexualactivity) 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 ofcause, such as severe diabetes, multiple sclerosis or Parkinson's disease.

  9. Have a serious comorbid illness/condition/behavior that, in the opinion of theinvestigator, may compromise the safety or compliance of the subject or precludesuccessful 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 orpsychosis, greater than one lifetime episode of major depression, current depressionof moderate or greater severity. Patients who are currently using SelectiveSerotonin Reuptake Inhibitors (SSRI) or psychotropic medications.

  12. Hemoglobin a1c >9%.

Study Design

Total Participants: 60
Treatment Group(s): 4
Primary Treatment: Shock Wave therapy (SWT)
Phase: 1
Study Start date:
June 27, 2022
Estimated Completion Date:
March 14, 2025

Connect with a study center

  • University of Miami Miller School of Medicine

    Miami, Florida 33136
    United States

    Site Not Available

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