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COMPLETED

NCT05048667

PHASE1

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

Sponsor: University of Miami

View on ClinicalTrials.gov

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

Official title: Novel Treatment for Microvascular Erectile Dysfunction Combining Shockwave Therapy and Platelet Rich Plasma

Key Details

Gender

MALE

Age Range

30 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-06-27

Completion Date

2025-03-14

Last Updated

2026-05-22

Healthy Volunteers

Conditions

Erectile Dysfunction

Interventions

DEVICE

Shock Wave therapy (SWT)

Each SWT will administer 720 shocks in the treatment arm. Total of 3600 shocks are given over 5 weeks treatment period.

DRUG

Platelet Rich Plasma (PRP)

5 mL PRP will be administered via intracavernous injection

OTHER

Sham SWT

Sham Shockwave Therapy will be administered in the sham arm.

OTHER

Placebo Saline

5 mL Placebo saline will be administered via intracavernous injection in the sham arm.

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%.

Locations (1)

University of Miami Miller School of Medicine

Miami, Florida, United States